tag:blogger.com,1999:blog-91128186162975701582024-03-10T14:23:42.350+05:30CognitrexCancerDigestcognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.comBlogger494125tag:blogger.com,1999:blog-9112818616297570158.post-73706232503483267552021-10-26T13:14:00.001+05:302021-10-26T13:14:07.524+05:30Roche launches genomic profiling kit to ease cancer researchZURICH, (Reuters) - Roche <a href="https://www.reuters.com/companies/ROG.S">(ROG.S)</a> is launching a new genomic profiling kit that lets cancer researchers explore tumours without having to send tissue samples to centralised laboratories, the Swiss drugmaker said on Monday.<br /><br />The AVENIO Tumour Tissue Comprehensive Genomic Profiling (CGP) Kit was developed with Roche unit Foundation Medicine, a molecular information specialist whose products help doctors match patients to appropriate therapies and clinical trials.<br /><br /><br />"The Kit complements the current CGP portfolio offered by Roche and Foundation Medicine and allows laboratories to expand their oncology research in-house," Roche said in a statement, giving no financial information about the product.<br /><br />"Ultimately, a future version of the kit may lead to additional resources for clinicians to use in the diagnosis and treatment of cancer."<br /><br />Source:https://www.reuters.com/business/healthcare-pharmaceuticals/roche-launches-genomic-profiling-kit-ease-cancer-research-2021-10-25/<div style="box-sizing: border-box; color: #333333; font-family: arial; font-size: 12px; margin: 0px; padding: 0px;"></div>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-54229881913158074092021-10-26T13:11:00.004+05:302021-10-26T13:11:25.597+05:30AstraZeneca announces positive results from TOPAZ-1 phase III trial of Imfinzi in combo with standard-of-care chemotherapy to treat advanced biliary tract cancerAstraZeneca announces positive high-level results from the TOPAZ-1 phase III trial showed Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit versus chemotherapy alone as a 1st-line treatment for patients with advanced biliary tract cancer (BTC).<br /><br />At a predefined interim analysis, the Independent Data Monitoring Committee concluded that the trial met the primary endpoint by demonstrating an improvement in OS in patients treated with Imfinzi plus chemotherapy versus chemotherapy alone. The combination also demonstrated an improvement in progression-free survival (PFS) and overall response rate, key secondary endpoints.<br /><br />Imfinzi plus chemotherapy was well tolerated, had a similar safety profile versus the comparator arm and did not increase the discontinuation rate due to adverse events compared to chemotherapy alone. <br /><br />BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder. Incidence of BTC often depends on the prevalence of common risk factors for each type within a geographical region.<br /><br />Approximately 50,000 people in the US, Europe and Japan and about 210,000 people worldwide are diagnosed with BTC each year. These patients have a poor prognosis, with approximately only 5% to 15% of all patients with BTC surviving five years.4 In December 2020, Imfinzi was granted Orphan Drug Designation in the US for the treatment of BTC.<br /><br />Do-Youn Oh, MD, PhD, Professor, Division of Medical Oncology, Department of Internal Medicine at Seoul National University Hospital and Seoul National University College of Medicine, and principal investigator in the TOPAZ-1 phase III trial, said: “Patients with advanced biliary tract cancer are in dire need of new treatments as progress in the 1st-line setting has remained largely stagnant for more than 10 years. TOPAZ-1 is the first phase III trial to show that adding an immunotherapy to standard chemotherapy delivers a meaningful overall survival benefit for patients in this setting. Today’s exciting results are a major step forward in treating this disease and represent new hope for our patients.”<br /><br />Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, said: “We are delighted TOPAZ-1 has been unblinded early due to clear evidence of efficacy for Imfinzi plus chemotherapy, which has also demonstrated a strong safety profile. We have now delivered two positive gastrointestinal cancer trials in a row for Imfinzi, following the HIMALAYA trial in liver cancer. We believe the significant survival benefit demonstrated marks a new era of immunotherapy treatment in this devastating disease, and it advances our commitment to improving long-term survival for patients across these cancers where treatment options are limited.”<br /><br />Biliary tract cancer (BTC) is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine). Cholangiocarcinoma is more common in China and Thailand and is on the rise in Western countries. Gallbladder cancer is more common in certain regions of South America, India and Japan.<br /><br />Apart from ampullary cancer, early-stage BTC often presents without symptoms and most new cases of BTC are therefore diagnosed at an advanced stage, when treatment options are limited and the prognosis is poor.<br /><br />TOPAZ-1 is a randomised, double-blind, placebo controlled, multicentre, global phase III trial of Imfinzi in combination with chemotherapy (gemcitabine plus cisplatin) versus placebo in combination with chemotherapy as a 1st-line treatment in 685 patients with unresectable advanced or metastatic BTC including intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer (ampullary carcinoma was excluded).<br /><br />The trial is being conducted in more than 145 centres across 17 countries including in the US, Europe, South America and several countries in Asia including South Korea, Thailand, Japan, Taiwan and China. The primary endpoint is OS and key secondary endpoints include progression-free survival, objective response rate and safety.<br /><br />Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.<br /><br />Imfinzi is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy and is the global standard of care in this setting based on the PACIFIC phase III trial.<br /><br />Imfinzi is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN phase III trial.<br /><br />Imfinzi is also approved for previously treated patients with advanced bladder cancer in several countries. Since the first approval in May 2017, more than 100,000 patients have been treated with Imfinzi.<br /><br />As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, liver cancer, BTC, oesophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer, and other solid tumours.<br /><br />AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines and a variety of tumour types and stages of disease. In 2020, GI cancers collectively represented approximately 5.1 million new cancer cases leading to approximately 3.6 million deaths.<br /><br /> <br />Source:http://pharmabiz.com/NewsDetails.aspx?aid=143491&sid=2<br /><table border="0" cellpadding="0" cellspacing="0" style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; width: 100%px;"><tbody><tr><td valign="top"><br /></td></tr><tr><td><br /></td></tr></tbody></table>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-77901914600230996892021-10-19T13:02:00.004+05:302021-10-19T13:02:47.881+05:30US FDA approves Merck’s Keytruda in combo with chemotherapy, with or without bevacizumab to treat patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1<br /><br /> Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] =1)as determined by an FDA-approved test. The approval is based on the phase 3 KEYNOTE-826 trial evaluating Keytruda plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without bevacizumab, compared to the same chemotherapy regimens, with or without bevacizumab.<br />In this patient population, Keytruda plus chemotherapy, with or without bevacizumab, demonstrated superior overall survival (OS; HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (PFS; HR=0.62 [95% CI, 0.50-0.77]; p<0.0001) compared to chemotherapy, with or without bevacizumab, in patients whose tumors express PD-L1 (CPS =1). Additionally, more patients responded to Keytruda plus chemotherapy, with or without bevacizumab, than to chemotherapy, with or without bevacizumab, with an objective response rate (ORR) of 68% (95% CI, 62-74) versus 50% (95% CI, 44-56), respectively. Among patients who responded, the median duration of response (DOR) was 18.0 months (range, 1.3+ to 24.2+) for Keytruda plus chemotherapy, with or without bevacizumab, and 10.4 months (range, 1.5+ to 22.0+) for chemotherapy, with or without bevacizumab.<br /><br />Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with Keytruda, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of Keytruda. Based on the severity of the adverse reaction, Keytruda should be withheld or permanently discontinued and corticosteroids administered if appropriate. Keytruda can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, Keytruda can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.<br /><br />“Cervical cancer more commonly affects younger women and certain women of color in the US, and unfortunately, women diagnosed with persistent, recurrent or metastatic cervical cancer often have a low survival rate,” said Dr. Bradley Monk, oncologist with Arizona Oncology, medical director of US Oncology Research Gynecology Program and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and Creighton University School of Medicine. “There have been no first-line approvals for women with persistent, recurrent or metastatic cervical cancer in the past seven years. I am excited for today’s approval of a new combination with Keytruda, which offers a new treatment option for appropriate patients.”<br /><br />“Today’s news is a meaningful step forward, as it offers a new therapeutic option for these patients and reinforces the role of Keytruda in treating certain types of cervical cancers, with a second indication for the disease,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “The data showing a 36% reduction in the risk of death are compelling, and this approval brings an important new first-line treatment option to women with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS =1).”<br /><br />Additionally, the FDA converted the accelerated approval of Keytruda as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS =1), as determined by an FDA-approved test, to a regular approval based on confirmatory data from KEYNOTE-826. This approval was originally granted in June 2018 based on results from the KEYNOTE-158 trial.<br /><br />Merck is committed to delivering meaningful advances in women’s cancers. The company is rapidly expanding its extensive clinical development program for Keytruda and several other investigational and approved medicines across gynecologic cancers, including researching Keytruda for the treatment of other types of cervical cancer.<br /><br />The approval was based on data from KEYNOTE-826 (ClinicalTrials.gov, NCT03635567), a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial that enrolled 617 patients with persistent, recurrent or first-line metastatic cervical cancer who had not been treated with chemotherapy except when used concurrently as a radio-sensitizing agent. Patients were enrolled regardless of tumor PD-L1 expression status. Patients with autoimmune disease that required systemic therapy within two years of treatment or a medical condition that required immunosuppression were ineligible. Randomization was stratified by metastatic status at initial diagnosis, investigator decision to use bevacizumab and PD-L1 status (CPS <1 vs. CPS 1 to <10 vs. CPS =10). Patients were randomized (1:1) to one of the two treatment groups.<br /><br />Patients in the Keytruda arm received Keytruda 200 mg intravenously every three weeks (Q3W) plus investigator’s choice of paclitaxel plus cisplatin or paclitaxel plus carboplatin Q3W, with or without bevacizumab Q3W. Patients in the placebo arm received placebo plus investigator’s choice of paclitaxel plus cisplatin or paclitaxel plus carboplatin Q3W, with or without bevacizumab Q3W. All study treatments were administered on Day 1 of each 3-week treatment cycle. Cisplatin could be administered on Day 2 of each three-week treatment cycle. Treatment with Keytruda continued until RECIST v1.1-defined progression of disease, unacceptable toxicity or a maximum of 24 months. Administration of Keytruda was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. Assessment of tumor status was performed every nine weeks for the first year, followed by every twelve weeks thereafter. The main efficacy outcome measures were OS and PFS as assessed by investigator review according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ. Additional efficacy outcome measures were ORR and DOR, according to RECIST v1.1, as assessed by investigator review.<br /><br />Of the 617 enrolled patients, 548 patients (89%) had tumors expressing PD-L1 with a CPS =1. Among these 548 enrolled patients with tumors expressing PD-L1, 273 patients were randomized to Keytruda in combination with chemotherapy, with or without bevacizumab, and 275 patients were randomized to placebo in combination with chemotherapy, with or without bevacizumab. Sixty-three percent of the 548 patients received bevacizumab as part of study treatment. At study entry, 21% of patients had metastatic disease only, and 79% had persistent or recurrent disease, with or without distant metastases, of whom 39% had received prior chemoradiation only, and 17% had received prior chemoradiation plus surgery.<br /><br /><br />Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.<br /><br />Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying Keytruda across a wide variety of cancers and treatment settings. The Keytruda clinical program seeks to understand the role of Keytruda across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with Keytruda, including exploring several different biomarkers.<div><br />Source:http://pharmabiz.com/NewsDetails.aspx?aid=143276&sid=2</div>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-37654440942320922022021-10-18T11:45:00.003+05:302021-10-18T11:45:31.903+05:30Eli Lilly’s Verzenio in combo with endocrine therapy gets US FDA approval for certain people with HR+ HER2- high risk early breast cancerThe US Food and Drug Administration (FDA) has approved Eli Lilly and Company's Verzenio (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of =20% as determined by an FDA-approved test. Ki-67 is a marker of cellular proliferation. Verzenio is the first and only CDK4/6 inhibitor approved for this patient population. <br />"Over time, the collective results of the Verzenio clinical development programme have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options," said Jacob Van Naarden, senior vice president, CEO of Loxo Oncology at Lilly and president, Lilly Oncology. "We are pleased with this initial approval in the adjuvant setting and as these data continue to mature, we look forward to further opportunities to work with health authorities to expand the use of Verzenio in this setting."<br /><br />The Verzenio phase 3 monarchE trial is a randomized (1:1), open-label, two cohort, multicenter study in adult women and men with HR+ HER2-, node-positive, resected EBC with clinical and pathological features consistent with a high risk of disease recurrence. In the trial, patients were randomized to receive two years of Verzenio 150 mg twice daily plus physician's choice of standard endocrine therapy, or standard endocrine therapy alone. Patients in both treatment arms were instructed to continue to receive adjuvant endocrine therapy for up to 5-10 years as recommended by their clinician. The primary endpoint of the study is invasive disease-free survival (IDFS) and was met at a pre-specified interim analysis in the intent-to-treat (ITT) population, with a statistically significant improvement in IDFS for patients treated with Verzenio plus ET compared to those treated with ET alone. Consistent with expert guidelines, IDFS was defined as the length of time before breast cancer comes back, any new cancer develops, or death.<br /><br />Having achieved the study's primary endpoint in the entire enrolled population, a pre-specified analysis of IDFS was also conducted in patients with high-risk clinical and pathological factors and a Ki-67 score =20%. This subgroup analysis (N=2,003) included patients with =4 positive axillary lymph nodes (ALN), or 1-3 positive ALN with either Grade 3 disease and/or tumor size =5 cm, and whose tumors had a Ki-67 score of =20%. There was also a statistically significant improvement in IDFS for this pre-specified subgroup of patients receiving Verzenio plus ET compared to those who received ET alone (HR=0.643, 95% CI: 0.475, 0.872, p=0.0042).<br /><br />This approval is based on efficacy results from an analysis of this subgroup with additional follow-up, conducted post-hoc. In this analysis, Verzenio given in combination with ET continued to demonstrate a clinically meaningful benefit, with a 37 per cent decrease in the risk of breast cancer recurrence or death compared to standard adjuvant ET alone for patients with high risk clinical and pathological features and a Ki-67 score =20% (HR: 0.626 [95% CI: 0.49-0.80]), and an absolute benefit in IDFS event rate of 7.1 per cent at three years. The number of IDFS events at the time of this analysis was 104 with Verzenio plus ET compared to 158 with ET alone. Overall survival data were not mature and additional follow up is ongoing.<br /><br />Adverse reactions from monarchE were consistent with the known safety profile for Verzenio. Safety and tolerability were evaluated in 5,591 patients. The most common adverse reactions reported (>10%) in the Verzenio plus ET (tamoxifen or an aromatase inhibitor) arm, and >2% higher than the ET arm alone, were diarrhea, infections, fatigue, nausea, headache, vomiting, stomatitis, decreased appetite, dizziness, rash, and alopecia. The most common laboratory abnormalities (all grades =10%) were creatinine increased, white blood cell count decreased, neutrophil count decreased, anemia, lymphocyte count decreased, platelet count decreased, ALT increased, AST increased, and hypokalemia.<br /><br />This FDA approval builds on the established body of evidence for Verzenio, which is already approved for the treatment of certain types of HR+ HER2- advanced or metastatic breast cancer. Concurrent with this approval, the FDA has expanded the use of Verzenio in all indications, when given in combination with endocrine therapy, to include men. Verzenio is available in tablet strengths of 200 mg, 150 mg, 100 mg, and 50 mg.<br /><br />"The design and results of the monarchE study are practice-changing and represent the first advancement in adjuvant treatment of HR+ HER2- breast cancer in a very long time," said Sara M. Tolaney, MD, MPH, Harvard Medical School, Dana-Farber Cancer Institute, and investigator on the monarchE study. "This FDA approval for Verzenio in combination with endocrine therapy in the early breast cancer setting has the potential to become a new standard of care for this population. We are encouraged by the marked reduction in the risk of recurrence even beyond the two-year treatment period in these patients, and I'm grateful to be able to offer this as a treatment option to my patients."<br /><br />"Women and men living with high risk HR+ HER2- early breast cancer want to do all they can to reduce the risk of the disease coming back, with the hope of living free of cancer. The approval of Verzenio provides a new treatment option to help them do just that," said Jean Sachs, chief executive officer, Living Beyond Breast Cancer. "This approval brings new optimism to the breast cancer community."<br /><br />The labelling for Verzenio contains warnings and precautions for diarrhea, neutropenia, interstitial lung disease (ILD/pneumonitis), hepatotoxicity, venous thromboembolism, and embryo-fetal toxicity. Instruct patients at the first sign of loose stools to initiate antidiarrheal therapy, increase oral fluids, and notify their healthcare provider. Perform complete blood counts and liver function tests prior to the start of Verzenio treatment, every two weeks for the first two months, monthly for the next two months and as clinically indicated. Based on results, Verzenio may require dose modification. Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. Advise patients of potential risk to a fetus and to use effective contraception.<br /><br />monarchE is a global, randomized, open-label, two cohort, multicenter phase 3 study in adult women and men with HR+ HER2-, node-positive resected EBC with clinical and pathological features consistent with a high risk of disease recurrence. A total of 5,637 patients were randomized (1:1) to receive two years of Verzenio 150 mg twice daily plus physician's choice of standard endocrine therapy, or standard endocrine therapy alone. Patients in both treatment arms were instructed to continue to receive adjuvant endocrine therapy for up to 5-10 years as recommended by their clinician. Cohort 1 enrolled patients with =4 positive axillary lymph nodes (ALN), or 1-3 positive ALN and either Grade 3 disease or tumor size =5 cm. Cohort 2 enrolled patients with 1-3 positive ALN and centrally determined Ki-67 score of =20%. The primary endpoint was IDFS in the ITT population (Cohorts 1 & 2). Secondary endpoints were IDFS in patients with high Ki-67 score (in the ITT population and in the Cohort 1 population), DRFS, overall survival, and safety.<br /><br />It is estimated that 90 percent of all breast cancers are detected at an early stage. Although the prognosis for HR+ HER2- EBC is generally positive, 20 per cent of patients will experience recurrence potentially to incurable metastatic disease. Risk of recurrence is greatest within the initial two to three years post-diagnosis, particularly in patients with node-positive, high risk EBC. Factors associated with high risk of recurrence include: positive nodal status, large tumor size (=5 cm), high tumor grade (Grade 3), and high rate of cellular proliferation [Ki-67 score (=20%)].<br /><br />Node-positive means that cancer cells from the tumor in the breast have been found in the lymph nodes in the armpit area. Although the breast cancer is removed through surgery, the presence of cancer cells in the lymph nodes signifies that there is a higher chance of the cancer returning and spreading.<br /><br />Verzenio abemaciclib is a targeted treatment known as a CDK4/6 inhibitor. Verzenio is a non-chemotherapy oral tablet.<br /><br />Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies). Cyclin-dependent kinases (CDK)4/6 are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.<br /><br />In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio dosed daily without interruption resulted in reduction of tumor size. Inhibiting CDK4/6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of Verzenio and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.<br /><br />Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.<br /><br /><br />Source:http://pharmabiz.com/NewsDetails.aspx?aid=143236&sid=2cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-5068847275360864682021-10-04T13:03:00.002+05:302021-10-04T13:03:18.113+05:30Merck’s phase 3 KEYNOTE-394 trial of Keytruda meets primary endpoint of OS in patients with advanced HCC previously treated with sorafenibMerck, known as MSD outside the United States and Canada, announced that the phase 3 KEYNOTE-394 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in Asian patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib met its primary endpoint of overall survival (OS).<br /><br />The study found that treatment with Keytruda plus best supportive care resulted in a statistically significant improvement in OS compared with placebo plus best supportive care. KEYNOTE-394 also met its key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR), with statistically significant improvements for Keytruda compared with placebo. No new safety signals were observed. These results will be presented at an upcoming medical meeting.<br /><br />“Frequently diagnosed at an advanced stage, hepatocellular carcinoma has one of the highest mortality rates of solid cancers. Despite recent progress, there remains an unmet need for anti-PD-1 monotherapy after sorafenib, where Keytruda is an established treatment option for patients,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “It is very encouraging that Keytruda significantly improved overall survival in this study, and we look forward to engaging with regulatory authorities as quickly as possible.”<br /><br />Keytruda was granted accelerated approval in November 2018 for the treatment of patients with HCC who have been previously treated with sorafenib, based on ORR and durability of response data from KEYNOTE-224. A subsequent study, KEYNOTE-240, did not meet its dual primary endpoints of OS and PFS. This accelerated approval for Keytruda was discussed during the FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting on April 29, 2021 that voted 8-0 in favor of maintaining accelerated approval of Keytruda for this indication. KEYNOTE-394 was discussed at the ODAC meeting as a potential confirmatory trial that could verify the clinical benefit of Keytruda for these patients.<br /><br />Merck is dedicated to advancing research in HCC and has a global development program of seven clinical trials that have enrolled or are expected to enroll approximately 3,000 patients. In HCC, Keytruda is being studied across multiple settings and lines of therapy as monotherapy and in combination with other treatments, including therapies through our collaborations.<br /><br />KEYNOTE-394 is a randomized, double-blind, phase 3 trial (ClinicalTrials.gov, NCT03062358) evaluating Keytruda plus best supportive care versus placebo plus best supportive care in Asian patients with advanced HCC previously treated with sorafenib or oxaliplatin chemotherapy. The primary endpoint is OS and secondary endpoints include PFS, ORR, duration of response and disease control rate. The study enrolled 453 patients who were randomized to receive either Keytruda (intravenously every three weeks for up to 35 cycles of treatment [up to approximately two years]) plus best supportive care (including pain management and management of other potential complications including ascites per local standards of care) or placebo plus best supportive care.<br /><br />Hepatocellular carcinoma is the most common form of primary liver cancer, which is the sixth most frequently diagnosed cancer worldwide. It is estimated there were more than 905,000 new cases of liver cancer and more than 830,100 deaths from the disease globally in 2020, making it one of the leading causes of cancer deaths around the world. In the US, it is estimated there will be more than 42,200 new cases of liver cancer and nearly 30,300 deaths from this disease in 2021. Risk factors for liver cancer include gender, ethnicity, chronic viral hepatitis (Hep-B or Hep-C) infection, cirrhosis, alcohol use and metabolic syndrome. Hepatocellular carcinoma, which is often diagnosed at an advanced stage, has a five-year survival rate of less than 15%.<br /><br />Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.<br /><br />Merck has the industry’s largest immuno-oncology clinical research programme. There are currently more than 1,600 trials studying Keytruda across a wide variety of cancers and treatment settings. The Keytruda clinical program seeks to understand the role of Keytruda across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with Keytruda, including exploring several different biomarkers.<br /><br /> <br />Source:http://pharmabiz.com/NewsDetails.aspx?aid=142839&sid=2<br /><table border="0" cellpadding="0" cellspacing="0" style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; width: 100%px;"><tbody><tr><td valign="top"><br /></td></tr><tr><td><br /></td></tr></tbody></table>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-66705602559543711762021-09-28T14:34:00.001+05:302021-09-28T14:34:04.066+05:30BDR Pharma launches generic cancer drug in India<br /><br /> Drug firm BDR Pharmaceuticals on Tuesday said it has launched generic Cabozantinib, used for the treatment of various types of <a href="https://indianexpress.com/about/cancer/">cancer</a>, and will bring the product in India in the next few days.<br /><br /><br />Cabozantinib is used for the treatment of metastatic medullary thyroid cancer, advanced renal cell carcinoma and hepatocellular carcinoma, BDR Pharma said in a statement.<br /><br />“Ensuring that all our patients have access to quality-produced, world-class treatment at a reasonable rate was the main reason for launching the drug in India,” BDR Pharmaceuticals, Business Development – Director, Raheel Shah said.<br /><br /><br />The company, however, did not give any details about the cost of the drug.<br /><br />Cabozantinib is prescribed for treating patients with progressive, metastatic medullary thyroid cancer and as a second-line treatment for renal cell carcinoma apart from treating hepatocellular carcinoma, BDR Pharma said.<br /><br /><br />The drug is available in the strengths of 20 mg, 40 mg and 60 mg, it added.<div><br /></div><div>Source:https://indianexpress.com/article/india/bdr-pharma-launches-generic-cancer-drug-in-india-7508783/<br /><br /><br /><br /><br /></div>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-84137165561794621472021-09-28T14:32:00.003+05:302021-09-28T14:32:29.567+05:30MSN Labs launches generic drug for renal cancer treatmentMSN Labs has launched Cabolong, a branded generic of Cabozantinib, for the treatment of renal cell carcinoma.<br /><br />Cabolong is available in 20mg/40mg/60mg strengths at a pricing of below ₹10,000 for monthly treatment regimen with the highest strength. In contrast, the same therapy cost runs into lakhs (of rupees) with imported brands currently available in the market, the company said in a release on Thursday.<br /><br />MSN Labs said it has set up a dedicated oncology division, whose focus is on presenting a comprehensive range of affordable high quality, bio-equivalent generic oncology medicines to benefit patients in India. “Given the rising cancer incidence in our country and overwhelming treatment costs, launch of our dedicated oncology division demonstrates our unwavering commitment to patients’ health and economic well-being,” it said.<br /><br />Cabolong is manufactured at MSN Labs facility approved by global regulatory authorities such as US FDA and EU GMP, the company said.<br /><br />Source:https://www.thehindu.com/news/cities/Hyderabad/msn-labs-launches-generic-drug-for-renal-cancer-treatment/article36635140.ececognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-31275112675877181682021-09-28T12:40:00.003+05:302021-09-28T12:40:43.874+05:30US FDA accepts for priority review Bristol Myers’s BLA for LAG-3-blocking antibody relatlimab & nivolumab FDC to treat unresectable or metastatic melanoma<p> </p><table border="0" cellpadding="0" cellspacing="0" style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify; width: 100%px;"><tbody><tr><td valign="top"><p align="justify">Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.<br /><br />“Although we’ve seen significant advances in the treatment of melanoma since the introduction of immune checkpoint inhibitors, there continue to be patients who could benefit from a novel dual immunotherapy approach,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb. “Based on the results of the RELATIVITY-047 trial, we believe that the relatlimab and nivolumab fixed-dose combination has the potential to improve outcomes for patients with metastatic or unresectable melanoma. We look forward to potentially introducing the first LAG-3-blocking antibody, and Bristol Myers Squibb’s third distinct checkpoint inhibitor, to help patients in need.”<br /><br />The BLA submission was based on the efficacy and safety results of the phase 2/3 RELATIVITY-047 trial, which demonstrated a statistically significant and clinically meaningful progression-free survival benefit of a combination therapy over standard of care anti-PD-1 monotherapy in metastatic melanoma. Relatlimab is the first LAG-3-blocking antibody to demonstrate a clinical benefit for patients with phase 3 data. Primary results from the RELATIVITY-047 trial were presented in an oral session during the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2021 and were selected for the official ASCO press program.<br /><br />The fixed-dose combination of relatlimab and nivolumab is an investigational therapy and is not approved for use in any country.<br /><br />RELATIVITY-047 (CA224-047) is a global, randomized; double-blind phase 2/3 study evaluating the fixed-dose combination of relatlimab and nivolumab in patients with previously untreated metastatic or unresectable melanoma versus Opdivo alone. The primary endpoint of the trial is progression-free survival (PFS) by Blinded Independent Central Review (BICR) and the secondary endpoints are overall survival (OS) and objective response rate (ORR). A total of 714 patients were randomized 1:1 to receive a fixed-dose combination of relatlimab 160 mg and nivolumab 480 mg or Opdivo 480 mg by intravenous infusion every four weeks (Q4W) until disease recurrence, unacceptable toxicity or withdrawal of consent. Follow-up for the secondary endpoints of OS and ORR is ongoing.<br /><br />Lymphocyte-activation gene 3 (LAG-3) is a cell-surface molecule expressed on effector T cells and regulatory T cells (Tregs) and functions to control T-cell response, activation and growth. Preclinical studies indicate that inhibition of LAG-3 may restore effector function of exhausted T cells and potentially promote an anti-tumor response. Early research demonstrates that targeting LAG-3 in combination with other potentially complementary immune checkpoints may be a key strategy to more effectively potentiate anti-tumor immune activity.<br /><br />Bristol Myers Squibb is evaluating relatlimab, its LAG-3-blocking antibody, in clinical trials in combination with other agents in a variety of tumor types.<br /><br />Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.<br /><br />Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including phase 3, in a variety of tumor types.<br /></p></td></tr><tr><td> <br />Source:http://pharmabiz.com/NewsDetails.aspx?aid=142704&sid=2<br /><br /></td></tr></tbody></table>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-22395174600911390342021-09-28T12:39:00.001+05:302021-09-28T12:39:35.599+05:30Boehringer Ingelhein acquires biopharma company, Abexxa Biologics<p> <span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">Boehringer Ingelheim announced the acquisition of Abexxa Biologics, a biopharmaceutical company taking a new approach in the fields of immuno-oncology and oncology research to develop the next generation of precision medicines designed to revolutionize cancer treatments. The acquisition will allow Boehringer Ingelheim to access Abexxa’s expertise in targeting cancer-specific proteins that are located inside the cell, rather than those expressed on the cell membrane. This enlarges the pool of potential cancer antigen targets. In particular, Abexxa’s technology could lead to the development of cancer immunotherapies that are effective in a broader range of patients and cancer types.</span></p><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">“The acquisition of Abexxa bolsters our commitment to tumor-antigen discovery and new ways of targeting intracellular antigens. Their cutting-edge know-how and technologies for antigen discovery and novel antibody generation strongly complement the current approaches we have been applying successfully to enable immune-targeting of cancer cells,” said Clive R. Wood, Ph.D., corporate senior vice president and global head of discovery research, Boehringer Ingelheim. “By expanding our portfolio of antibodies binding novel intracellular tumor antigens, we are striving to develop unique and broadly applicable new immunotherapeutic approaches for cancer patients,” added Wood. </span><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">Abexxa’s innovative platform unlocks the ability to target intracellular antigens of cancer cells by recognizing their presentation on the cell surface by MHC class 1 molecules. While the Abexxa platform addresses the more common HLA-A2 peptide presentation, the company has developed specific expertise in the nonclassical MHC class 1 molecule HLA-E, which has the potential to impact a broader set of cancer patients’ antigens. More specifically, Abexxa has developed a first-in-class T-cell receptor (TCR)-like antibody that can be used to disrupt the NKG2A: HLA-E immune checkpoint axis in oncology. Abexxa molecules are also being formulated to recruit immune cells targeting HLA-E peptide complexes on tumors.</span><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">In 2016, Boehringer Ingelheim’s Venture Fund, the arm of the company that invests in ground-breaking therapeutic and digital health approaches, awarded Abexxa initial investment funding. Later that year, Abexxa won Boehringer Ingelheim’s Innovation Prize, which facilitates business growth and rewards new companies for their dedication to innovation. The prize allowed Abexxa to expand operations into a shared lab space in Cambridge, Massachusetts, to continue its research. Boehringer Ingelheim’s investment in Abexxa demonstrates how the company is seeking to foster innovation across leading biotech communities, including the Dallas-Fort Worth, Texas, area.</span><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">“The investment by Boehringer Ingelheim’s Venture Fund in 2016 was a defining moment for Abexxa,” said Debra Wawro Weidanz, co-founder and CEO of Abexxa. “The acquisition by Boehringer Ingelheim allows our team to access the company’s expertise and capabilities in immuno-oncology and antibody development and to have the opportunity to translate Abexxa technology into a clinical asset,” said Jon Weidanz, Ph.D., co-founder and CSO of Abexxa.</span><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">This transaction is the latest in a series of strategic acquisitions and collaborations that reinforce Boehringer Ingelheim’s overall oncology strategy, bringing together cancer immunology and cancer cell directed therapies to fight cancer. This strategy has further strengthened Boehringer Ingelheim’s position in oncology through the development of leading assets and robust capabilities in cancer vaccines, oncolytic viruses, T-cell engagers; antibody drug conjugates (ADCs) and myeloid and stromal cell modulators. By combining its world-class in-house research and development with that of highly innovative biotechnology companies like Abexxa, Boehringer Ingelheim is developing innovative cancer immunology therapies and accelerating the delivery of the next generation of cancer treatments.</span><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">The total transaction includes an upfront payment, milestones and other consideration payments. Abexxa will continue to operate in the Arlington, Texas, area as a Boehringer Ingelheim family company, collaborating extensively with the colleagues at Boehringer Ingelheim’s US research site in Ridgefield, Connecticut.</span><div><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;"><br /></span></div><div><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">Source:</span><span style="color: #222222; font-family: arial, tahoma, verdana;"><span style="font-size: 12px;">http://pharmabiz.com/NewsDetails.aspx?aid=142730&sid=2</span></span></div><div><span style="color: #222222; font-family: arial, tahoma, verdana;"><span style="font-size: 12px;"><br /></span></span></div>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-20049992196335555992021-09-22T12:29:00.002+05:302021-09-22T12:29:23.656+05:30Merck announces positive results from phase 3 KEYNOTE-355 trial of Keytruda in combo with chemotherapy to treat mTNBC whose tumors expressed PD-L1<p> </p><table border="0" cellpadding="0" cellspacing="0" style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify; width: 100%px;"><tbody><tr><td valign="top"><p align="justify">Merck announced the final overall survival (OS) results from the pivotal phase 3 KEYNOTE-355 trial investigating Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel, nab-paclitaxel or gemcitabine/carboplatin) for the first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC). Keytruda is the first anti-PD-1 therapy in combination with chemotherapy to demonstrate a statistically significant and clinically meaningful improvement in OS for these patients.<br /><br />In this study, Keytruda plus chemotherapy reduced the risk of death by 27% (HR=0.73 [95% CI, 0.55-0.95]; p=0.0093) in patients with mTNBC whose tumors expressed PD-L1 (Combined Positive Score [CPS] =10), as compared to chemotherapy alone. There was an increase of 6.9 months in median OS with Keytruda plus chemotherapy compared to chemotherapy alone (23.0 months [95% CI, 19.0-26.3] vs. 16.1 months [95% CI, 12.6-18.8], respectively). Although the trial was not powered to compare efficacy between treatment groups by different chemotherapy regimens, the increase in OS was observed for Keytruda plus chemotherapy across the three chemotherapy choices.<br /><br />“Metastatic TNBC has the worst survival prognosis among breast cancer subtypes, and there is an urgent need for treatment options that improve survival,” said Dr. Hope Rugo, director, Breast Oncology and Clinical Trials Education, University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center. “I am very encouraged to see these new overall survival data for the KEYTRUDA combination, demonstrating a 27% relative reduction in the risk of death compared to chemotherapy alone in patients with mTNBC whose tumors expressed PD-L1 (CPS =10).”<br /><br />There was no statistically significant difference in OS between the treatment groups in the CPS =1 population; due to statistical testing hierarchy, formal testing was not performed in the intention-to-treat (ITT) population. The incidence of treatment-related adverse events (TRAEs) was similar among patients in the two treatment groups, with Grade 3-5 TRAEs occurring in 68.1% of patients in the Keytruda plus chemotherapy arm and 66.9% of patients in the chemotherapy arm. Treatment-related adverse events led to discontinuation in 18.3% of patients in the Keytruda plus chemotherapy arm and 11.0% of patients in the chemotherapy arm.<br /><br />“With these new data, KEYNOTE-355 has now met both primary endpoints, improving progression-free and overall survival for the approximately 40% of patients from this trial with metastatic TNBC whose tumors expressed PD-L1 (CPS =10),” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “These OS data add to a strong body of evidence evaluating the use of Keytruda plus chemotherapy for appropriate patients with TNBC. We remain committed to continuing to advance scientific understanding in TNBC.”<br /><br />These OS data follow prior analyses from KEYNOTE-355 that showed Keytruda plus chemotherapy resulted in a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with chemotherapy alone for the first-line treatment of patients with mTNBC whose tumors expressed PD-L1 (CPS =10) and supported approval of this regimen in the US and Japan.<br /><br />KEYNOTE-355 is a randomized, two-part, placebo-controlled phase 3 trial evaluating Keytruda in combination with one of the three different chemotherapies compared with placebo plus one of the three chemotherapy regimens for the first-line treatment of mTNBC that has not been previously treated with chemotherapy in the advanced setting. The study endpoints include OS and PFS in patients whose tumors expressed PD-L1 (CPS =1 and CPS =10) and in all participants (ITT population). The other endpoints include objective response rate, duration of response, disease control rate, patient-reported outcomes and safety.<br /><br /><br />Immune-mediated adverse reactions (AEs) of any grade occurred in 26.5% of patients receiving Keytruda plus chemotherapy and 6.4% of patients receiving chemotherapy alone. For patients receiving Keytruda plus chemotherapy, the most common immune-mediated AE (occurring in =10% of patients) was hypothyroidism (15.8%). There were two treatment-related deaths due to acute kidney injury and pneumonia in patients receiving Keytruda plus chemotherapy; neither was considered immune-mediated.<br /><br />Triple-negative breast cancer is a type of breast cancer that tests negative for estrogen hormone receptors, progesterone hormone receptors and overexpression of human epidermal growth factor receptor 2 (HER2). It is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. Approximately 10-15% of patients with breast cancer are diagnosed with TNBC, which tends to be more common in people who are younger than 40 years of age, who are African American or who have a BRCA1 mutation.<br /><br />Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.<br /></p></td></tr><tr><td> <br />Source:http://pharmabiz.com/NewsDetails.aspx?aid=142673&sid=2<br /><br /></td></tr></tbody></table>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-36767881826490192522021-09-14T14:28:00.004+05:302021-09-14T14:28:44.332+05:30GSK to present new data in oncology pipeline and portfolio at ESMO Congress 2021GlaxoSmithKline (GSK) plc will present new data across the company’s oncology pipeline and portfolio at the upcoming European Society for Medical Oncology (ESMO) Congress 2021 (16-21 September), including new data on Jemperli (dostarlimab) and Zejula (niraparib), as well as early-stage research in immuno-oncology and oncology cell therapy. With 13 presentations at the meeting (12 GSK-sponsored and one GSK-supported), GSK will demonstrate its momentum in advancing dostarlimab and niraparib, and provide new insights into investigational therapies through early-stage research.<br /><br />The data being presented at ESMO reflect GSK’s commitment to strengthening its oncology pipeline across its focus areas of immuno-oncology, synthetic lethality and oncology cell therapy. GSK has a diverse portfolio and pipeline, including three marketed oncology medicines and 16 assets in clinical development that leverage the science of the immune system, human genetics and advanced technologies to address a variety of tumour types.<br /><br />Presentations from the phase I GARNET study will address anti-tumour activity by tumour mutational burden in patients with recurrent or advanced endometrial cancer (Abstract #76P) in addition to treatment-related adverse events occurring during the study (Abstract #991P). GSK will also present a real-world analysis of the demographics and survival outcomes in patients from England with advanced or recurrent endometrial cancer following platinum-based doublet therapies (Abstract #812P).<br /><br />Dostarlimab is the first anti-PD-1 monotherapy approved for endometrial cancer in the European Union (EU) and received a conditional approval in April for the treatment of women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen. The treatment also received accelerated approval in the United States (US) for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, who have progressed on or following prior treatment with a platinum-containing regimen.<br /><br />Last month, the FDA granted accelerated approval of an additional indication for dostarlimab for the treatment of adult patients with dMMR recurrent or advanced solid tumours, as determined by an FDA-approved test, who have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The new indication for dostarlimab is the fourth approval for GSK oncology in less than 1.5 years, demonstrating GSK’s unyielding commitment to address the unmet needs of cancer patients.<br /><br />Results from the phase III PRIMA trial will examine quality-adjusted time without symptom or toxicity of niraparib in patients with advanced ovarian cancer (Abstract #738P). Additionally, GSK will present real-world analyses from three studies in patients with advanced ovarian cancer across the UK, France and US.<br /><br />Niraparib is a once-daily oral monotherapy maintenance treatment approved for women with first-line platinum-responsive advanced ovarian cancer regardless of biomarker status in the US and the EU. The research that will be presented at ESMO bolsters the understanding of the use of this poly (ADP-ribose) polymerase (PARP) inhibitor for maintenance treatment in ovarian cancer.<br /><br />GSK will also present a trial in progress poster on the recently initiated phase III ZEAL-1L study in advanced or metastatic non-small cell lung cancer, expanding the company’s clinical development programme into other solid tumours to potentially bring niraparib to more patients.<br /><br />Dostarlimab is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2. In addition to GARNET, dostarlimab is being investigated in other registrational enabling studies, as monotherapy and as part of combination regimens, including in women with recurrent or primary advanced endometrial cancer, women with stage III or IV non-mucinous epithelial ovarian cancer, and in patients with other advanced solid tumours or metastatic cancers.<br /><br />Dostarlimab was discovered by AnaptysBio and licensed to TESARO, Inc., under a Collaboration and Exclusive License Agreement signed in March 2014. The collaboration has resulted in three monospecific antibody therapies that have progressed into the clinic. These are: dostarlimab, a PD-1 antagonist; cobolimab, (GSK4069889), a TIM-3 antagonist; and GSK4074386, a LAG-3 antagonist. GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of each of these Products under the Agreement.<br /><br />Jemperli is indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.<br /><br />Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies.<br /><br />Zejula is indicated as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.<br /><br /> <br />Source:http://pharmabiz.com/NewsDetails.aspx?aid=142439&sid=2<br /><table border="0" cellpadding="0" cellspacing="0" style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; width: 100%px;"><tbody><tr><td valign="top"><br /></td></tr><tr><td><br /></td></tr></tbody></table>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-50082282754998281772021-08-20T12:35:00.004+05:302021-08-20T12:35:52.720+05:30Precision Oncology Company 4baseCare launches one-of-its-kind Indian Population Specific Cancer Gene Panel4baseCare, a precision oncology company in India, launched their product - TARGT Indiegene, India's largest and first population-specific tumour gene panel derived from Whole Exome and Whole Transcriptome data of over 1,500 cancer patients across 28 different cancer types. Most of the patients were presented with stage III/IV disease, and presented with disease progression and had exhausted all the options in the standard of care.<br /><br />Most of the cancer panels currently available in the market are based on data from the Caucasian population, and the same panel is used for testing across all the geographies. For example, the TARGT Indiegene' cancer panel is based on insights generated from tumour tissues of Indian cancer patients resulting in better success rates using precision medicine in the management of cancer. The insights from research have helped build the largest resource of mutational signatures identified in cancer patients in India. Research has provided insights into 1,044 unique genes across 28 different cancer types with mutational landscape and associated mutations.<br /><br />Commenting on the occasion, Hitesh Goswami, CEO, 4baseCare, said, "Our vision is to leverage technology to develop affordable solutions to personalise patient care in oncology. With TARGT Indiegene, we want to deliver the promise of precision to help personalise the treatment for Indian cancer patients."<br /><br />4baseCare had already partnered with WIPRO in July to build a framework of efficient, streamlined, and well-regulated workflows to develop advanced gene panels and to ensure the highest data quality, data security and regulatory compliance. Similarly, 4baseCare and ACTREC-Tata Memorial Centre join hands in the development of an AI-based clinical interpretation platform. Supporting the research and commercialisation initiative are Illumina Accelerator, Mount Judi Ventures, growX Ventures, Season Two Ventures, First In Ventures and a few strategic angel investors.<br /><br />Dr. Kumar Prabhash, Professor and Medical Oncologist at TMH, Mumbai and one of the collaborator for the project said that with such massive research on Indian patient cohort and the availability of TARGT Indiegene kind of a cancer gene panel validated on Indian patient tumour samples, the oncologists will have better decision making capability lead by science towards precision oncology solutions that will improve the affordability and timely availability of accurate gene-testing reports for cancer patients.<br /><br />Dr. Amit Dutt, Principal Investigator (Scientist G) and India's leading cancer researcher from ACTREC-TMC said that such research sets a precedence for a very strong Industry-Academia collaboration leading to translational research outcomes like TARGT Indiegene which will have a direct benefit for the patients.<br /><br />4baseCare, an Illumina Accelerator Company, is engaged in the development of cutting-edge precision oncology solutions, using advanced genomics and next-gen digital health technology, to personalise patient care in oncology. They have developed a unique set of comprehensive genomic panels which allows oncologists to choose the optimal targeted therapy for their patients.<br /><br />Source:https://www.business-standard.com/content/press-releases-ani/precision-oncology-company-4basecare-launches-one-of-its-kind-indian-population-specific-cancer-gene-panel-121081801130_1.htmlcognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-818409722098710412021-08-12T13:12:00.002+05:302021-08-12T13:12:15.915+05:30Memorial Sloan Kettering Cancer Center Launches MSKCC India to Expand Access to World-Renowned Oncologists, Cancer Care, Research, and EducationFirst-of-its-kind initiative provides patients in <a href="https://www.devdiscourse.com/news?tag=India">India</a> with access to remote opinions and consultations, using technology from India-based telemedicine provider <a href="https://www.devdiscourse.com/news?tag=iCliniq">iCliniq</a> Physical location in <a href="https://www.devdiscourse.com/news?tag=Chennai">Chennai</a>, <a href="https://www.devdiscourse.com/news?tag=India">India</a> will serve as a telemedicine hub to coordinate with <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center specialists <a href="https://www.devdiscourse.com/news?tag=NEW+YORK">NEW YORK</a> and <a href="https://www.devdiscourse.com/news?tag=CHENNAI">CHENNAI</a>, <a href="https://www.devdiscourse.com/news?tag=India">India</a>, Aug. 2, 2021 /PRNewswire/ -- <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center, the world's oldest and largest private cancer center, has launched MSKCC <a href="https://www.devdiscourse.com/news?tag=India">India</a> to provide cancer patients in <a href="https://www.devdiscourse.com/news?tag=India">India</a> with access to the institution's world-renowned oncologists, research, clinical trials, and education. The effort stems from the institution's core mission of advancing transformative cancer care through education and research worldwide.<br /><br />As part of this first-of-its-kind offering, MSKCC <a href="https://www.devdiscourse.com/news?tag=India">India</a> will provide remote opinions via video or written consultations. A <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center oncologist who specializes in a patient's form of cancer will review their medical records, test results, and other materials and provide a comprehensive written opinion, meet with the patient virtually using telemedicine technology, or speak with the patient's local oncologist about their diagnosis and care plan. In some cases, they may recommend that the patient travel to receive care at <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center in New York City. Specific services include: • Pathology diagnosis • Radiology scan reviews • Next-generation sequencing (MSK-IMPACTTM) of a patient's tumor and treatment recommendations • Travel assistance to <a href="https://www.devdiscourse.com/news?tag=New+York+City">New York City</a> ''Meeting the needs of cancer patients in <a href="https://www.devdiscourse.com/news?tag=India">India</a> and improving their long-term health and survival rates will require close collaboration with the cancer community in <a href="https://www.devdiscourse.com/news?tag=India">India</a>, and MSKCC <a href="https://www.devdiscourse.com/news?tag=India">India</a> marks an important first step toward advancing such collaborations,'' said Sir <a href="https://www.devdiscourse.com/news?tag=Murray+Brennan">Murray Brennan</a>, MD, Senior Vice President of <a href="https://www.devdiscourse.com/news?tag=International+Programs">International Programs</a> at <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center. ''MSKCC <a href="https://www.devdiscourse.com/news?tag=India">India</a> will help serve the needs of cancer patients and their physicians to improve their cancer care.'' As part of this effort to bring world-class care to people in <a href="https://www.devdiscourse.com/news?tag=India">India</a> diagnosed with cancer, <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center has partnered with <a href="https://www.devdiscourse.com/news?tag=iCliniq">iCliniq</a>, a leading global telemedicine provider based in India. This partnership is the first of its kind for both <a href="https://www.devdiscourse.com/news?tag=iCliniq">iCliniq</a> and <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center.<br /><br />MSKCC <a href="https://www.devdiscourse.com/news?tag=India">India</a> will open a physical location in <a href="https://www.devdiscourse.com/news?tag=Chennai">Chennai</a>, centrally located for patients and staff members. This location will serve as a hub for medical staff who will help patients coordinate written or virtual consultations, and they will be able to communicate in <a href="https://www.devdiscourse.com/news?tag=English">English</a>, <a href="https://www.devdiscourse.com/news?tag=Hindi">Hindi</a>, <a href="https://www.devdiscourse.com/news?tag=Urdu">Urdu</a>, <a href="https://www.devdiscourse.com/news?tag=Tamil">Tamil</a>, <a href="https://www.devdiscourse.com/news?tag=Telugu">Telugu</a> and Kannada. If necessary, employees will also be able to collect medical records from patients' homes, making the process more convenient for those utilizing this service. Patients across <a href="https://www.devdiscourse.com/news?tag=India">India</a> will be able to obtain a remote opinion from experts at <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center in the comfort of their home or any Internet-enabled location without traveling to MSKCC <a href="https://www.devdiscourse.com/news?tag=India">India</a> in Chennai.<br /><br />''At <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center, we are committed to leading in the prevention, diagnosis, treatment, and cure of cancer and associated diseases through programs of excellence in research, education and patient care. MSKCC <a href="https://www.devdiscourse.com/news?tag=India">India</a> will help us provide high-quality care to more individuals by bringing together our experts, <a href="https://www.devdiscourse.com/news?tag=Indian">Indian</a> doctors and scientists, patient advocacy groups, and other stakeholders,'' said <a href="https://www.devdiscourse.com/news?tag=Mrinal+Gounder">Mrinal Gounder</a>, MD, a medical oncologist and Physician Ambassador to <a href="https://www.devdiscourse.com/news?tag=India">India</a> and <a href="https://www.devdiscourse.com/news?tag=Asia">Asia</a> at <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center. ''This sort of comprehensive effort is critical to providing the level of care that patients need in <a href="https://www.devdiscourse.com/news?tag=India">India</a> and beyond, and to ultimately eradicate cancer in the 21st century globally.'' Patients in <a href="https://www.devdiscourse.com/news?tag=India">India</a> can visit <a href="https://www.devdiscourse.com/news?tag=in.mskcc.org%2findia">in.mskcc.org/india</a> to learn more about MSKCC <a href="https://www.devdiscourse.com/news?tag=India">India</a> and how to schedule a consultation with a <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center expert. About <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center (MSK): As the world's oldest and largest private cancer center, <a href="https://www.devdiscourse.com/news?tag=Memorial+Sloan">Memorial Sloan</a> Kettering Cancer Center has devoted more than 135 years to exceptional patient care, influential educational programs, and innovative research to discover more effective strategies to prevent, control and, ultimately, cure cancer. MSK is home to more than 20,000 physicians, scientists, nurses, and staff united by a relentless dedication to conquering cancer. Today, we are one of 51 <a href="https://www.devdiscourse.com/news?tag=National">National</a> Cancer Institute-designated <a href="https://www.devdiscourse.com/news?tag=Comprehensive+Cancer+Centers">Comprehensive Cancer Centers</a>, with state-of-the-art science and technology supporting groundbreaking clinical studies, personalized treatment, and compassionate care for our patients. We also train the next generation of clinical and scientific leaders in oncology through our continually evolving educational programs, here and around the world. Year after year, we are ranked among the top two cancer hospitals in the country, consistently recognized for our expertise in adult and pediatric oncology specialties. www.mskcc.org.<br /><br />About <a href="https://www.devdiscourse.com/news?tag=iCliniq">iCliniq</a> Based in <a href="https://www.devdiscourse.com/news?tag=India">India</a>, <a href="https://www.devdiscourse.com/news?tag=iCliniq">iCliniq</a> is a global second opinion and online medical consultation platform servicing patients across 196 countries with more than 3,500 highly qualified doctors from more than 80 specialties. <a href="https://www.devdiscourse.com/news?tag=Utilizing+iCliniq%27s">Utilizing iCliniq's</a> telemedicine capabilities and vast experience in the <a href="https://www.devdiscourse.com/news?tag=Indian">Indian</a> health care market, this new service allows cancer patients in <a href="https://www.devdiscourse.com/news?tag=India">India</a> to access MSKCC's high-level of care and expertise<br /><br />Source:https://www.devdiscourse.com/article/education/1676697-memorial-sloan-kettering-cancer-center-launches-mskcc-india-to-expand-access-to-world-renowned-oncologists-cancer-care-res<br /><br />cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-64197988206313619102021-07-29T14:59:00.001+05:302021-07-29T14:59:24.604+05:30US FDA approves Merck’s Keytruda in combo with chemotherapy to treat high-risk early-stage TNBCMerck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the phase 3 KEYNOTE-522 trial.<br /><br />TNBC is an aggressive type of breast cancer with an increased risk for disease recurrence. KEYNOTE-522 showed that Keytruda in combination with chemotherapy (carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide) before surgery and continued as a single agent after surgery significantly prolonged event-free survival (EFS) versus the same neoadjuvant chemotherapy regimens alone in patients with previously untreated stage II or stage III TNBC – there was a 37% reduction in the risk of disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause (HR=0.63 [95% CI, 0.48-0.82]; p=0.00031). With this approval, Keytruda is now approved in the U.S. for 30 indications.<br /><br />“Even when TNBC is diagnosed early, 30-40% of patients will suffer cancer recurrence after standard neoadjuvant chemotherapy and surgery,” said Dr. Joyce O’Shaughnessy, chair of Breast Cancer Research, Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, Texas. “Therefore, there is a high unmet need for new treatment options. Today’s approval is very welcome news and has the potential to change the treatment paradigm by now including an immunotherapy as part of the regimen for patients with high-risk early-stage TNBC.”<br /><br />Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with Keytruda, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of Keytruda. Based on the severity of the adverse reaction, Keytruda should be withheld or permanently discontinued and corticosteroids administered if appropriate. Keytruda can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, Keytruda can cause fetal harm when administered to a pregnant woman.<br /><br />“Triple-negative is a difficult-to-treat type of breast cancer that unfortunately is more common in the US in younger women and in Black women,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “We are proud to offer a new treatment option for patients faced with this challenging cancer. This neoadjuvant and adjuvant combination with Keytruda is the first immunotherapy regimen to be approved in high-risk early-stage TNBC, marking a meaningful milestone for the breast cancer community.”<br /><br />Additionally, the FDA converted the accelerated approval of Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (Combined Positive Score [CPS] =10) as determined by an FDA-approved test to a full (regular) approval based on confirmatory data from KEYNOTE-522. This approval was originally granted in November 2020 based on results from the phase 3 KEYNOTE-355 trial.<br /><br />Merck is rapidly advancing a broad portfolio in gynecologic and breast cancers with an extensive clinical development program for Keytruda and several other investigational and approved medicines across these areas.<br /><br />The approval was based on data from KEYNOTE-522 (ClinicalTrials.gov, NCT03036488), a randomized, multicenter, double-blind, placebo-controlled trial conducted in 1,174 patients with newly diagnosed previously untreated high-risk early-stage TNBC (tumor size >1 centimeter [cm] but =2 cm in diameter with nodal involvement or tumor size >2 cm in diameter regardless of nodal involvement). Patients were enrolled regardless of tumor programmed death ligand 1 (PD-L1) expression. Patients with active autoimmune disease that required systemic therapy within two years of treatment or a medical condition that required immunosuppression were ineligible. Randomization was stratified by nodal status (positive vs. negative), tumor size (T1/T2 vs. T3/T4) and choice of carboplatin (dosed every three weeks vs. weekly). Patients were randomized (2:1) to one of the following two treatment arms; all study mediations were administered intravenously:<br /><br />Arm 1: Four cycles of preoperative Keytruda 200 mg every three weeks on Day 1 of Cycles 1-4 of treatment regimen in combination with carboplatin Area Under Curve (AUC) 5 mg/mL/min every three weeks on Day 1 of Cycles 1-4 of treatment regimen or AUC 1.5 mg/mL/min every week on Days 1, 8, and 15 of Cycles 1-4 of treatment regimen plus paclitaxel 80 mg/m2 every week on Days 1, 8, and 15 of Cycles 1-4 of treatment regimen; Followed by four additional cycles of preoperative Keytruda 200 mg every three weeks on Day 1 of Cycles 5-8 of treatment regimen in combination with either doxorubicin 60 mg/m2or epirubicin 90 mg/m2 every three weeks on Day 1 of Cycles 5-8 of treatment regimen plus cyclophosphamide 600 mg/m2 every three weeks on Day 1 of Cycles 5-8 of treatment regimen; Following surgery, nine cycles of Keytruda 200 mg every three weeks were administered.<br /><br />Arm 2: Four cycles of preoperative placebo every three weeks on Day 1 of Cycles 1-4 of treatment regimen in combination with carboplatin AUC 5 mg/mL/min every three weeks on Day 1 of Cycles 1-4 of treatment regimen or AUC 1.5 mg/mL/min every week on Days 1, 8, and 15 of Cycles 1-4 of treatment regimen plus paclitaxel 80 mg/m2 every week on Days 1, 8, and 15 of Cycles 1-4 of treatment regimen; Followed by four cycles of preoperative placebo every three weeks on Day 1 of Cycles 5-8 of treatment regimen in combination with either doxorubicin 60 mg/m2or epirubicin 90 mg/m2 every three weeks on Day 1 of Cycles 5-8 of treatment regimen plus cyclophosphamide 600 mg/m2 every three weeks on Day 1 of Cycles 5-8 of treatment regimen; Following surgery, nine cycles of placebo every three weeks were administered.<br /><br />The main efficacy outcomes were pathological complete response (pCR) rate and EFS. Pathological complete response rate was defined as absence of invasive cancer in the breast and lymph nodes (ypT0/Tis ypN0) and was assessed by the blinded local pathologist at the time of definitive surgery. Event-free survival was defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes definitive surgery, local or distant recurrence, secondary primary malignancy, or death due to any cause. An additional efficacy outcome was overall survival (OS).<br /><br />The study population characteristics were: median age of 49 years (range, 22 to 80), 11% age 65 or older; 99.9% female; 64% White, 20% Asian, 4.5% Black, and 1.8% American Indian or Alaska Native; 87% Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, and 13% ECOG PS of 1; 56% were pre-menopausal, and 44% were post-menopausal; 7% were primary Tumor 1 (T1), 68% T2, 19% T3, and 7% T4; 49% were nodal involvement 0 (N0), 40% N1, 11% N2, and 0.2% N3; 75% of patients were overall stage II, and 25% were stage III.<br /><br />In the study, the median duration of exposure to Keytruda was 13.3 months (range, 1 day to 21.9 months). Fatal adverse reactions occurred in 0.9% of patients receiving Keytruda, including one each of adrenal crisis, autoimmune encephalitis, hepatitis, pneumonia, pneumonitis, pulmonary embolism, and sepsis in association with multiple organ dysfunction syndrome and myocardial infarction. Serious adverse reactions occurred in 44% of patients receiving Keytruda. Serious adverse reactions in =2% of patients who received Keytruda included febrile neutropenia (15%), pyrexia (3.7%), anemia (2.6%), and neutropenia (2.2%). Keytruda was discontinued due to adverse reactions in 20% of patients. The most common adverse reactions (=1%) resulting in permanent discontinuation of Keytruda were increased alanine aminotransferase (ALT) (2.7%), increased aspartate aminotransferase (AST) (1.5%), and rash (1%). Adverse reactions leading to the interruption of Keytruda occurred in 57% of patients. The most common adverse reactions leading to interruption of Keytruda (=2%) were neutropenia (26%), thrombocytopenia and increased ALT (6% each), increased AST (3.7%), anemia (3.5%), rash (3.2%), febrile neutropenia and leukopenia (2.8% each), upper respiratory tract infection (2.6%), pyrexia (2.2%), and fatigue (2.1%). The most common adverse reactions (all grades =20%) were fatigue (70%), nausea (67%), alopecia (61%), rash (52%), constipation (42%), diarrhea and peripheral neuropathy (41% each), stomatitis (34%), vomiting (31%), headache (30%), arthralgia (29%), pyrexia (28%), cough (26%), abdominal pain (24%), decreased appetite (23%), insomnia (21%), and myalgia (20%).<br /><br />Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.<br /><br />Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,500 trials studying Keytruda across a wide variety of cancers and treatment settings. The Keytruda clinical programme seeks to understand the role of Keytruda across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with Keytruda, including exploring several different biomarkers.<br /><br /><br />Source:http://www.pharmabiz.com/NewsDetails.aspx?aid=140330&sid=2<br /> <br /><br /><br /><table border="0" cellpadding="0" cellspacing="0" style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; width: 100%px;"><tbody><tr><td valign="top"><br /></td></tr><tr><td><br /></td></tr></tbody></table>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-61817237439082245882021-07-19T14:28:00.003+05:302021-07-19T14:28:31.397+05:30Merck announces positive event-free survival data from phase 3 KEYNOTE-522 study of Keytruda to treat triple-negative breast cancerMerck announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant phase 3 study KEYNOTE-522. The trial investigated neoadjuvant Keytruda, Merck’s anti-PD-1 therapy, plus chemotherapy followed by adjuvant Keytruda as monotherapy (the Keytruda regimen) compared with neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy-placebo regimen) in patients with high-risk early-stage triple-negative breast cancer (TNBC). This is the first time an anti-PD-1/L1 therapy has demonstrated a statistically significant EFS result as combined neoadjuvant and adjuvant therapy for these patients. These results are being presented today during a European Society for Medical Oncology (ESMO) Virtual Plenary.<br />After a median follow-up of 39 months, the Keytruda regimen reduced the risk of EFS events by 37% (HR=0.63 [95% CI, 0.48-0.82]; p=0.00031) versus the chemotherapy-placebo regimen – a statistically significant and clinically meaningful EFS result. EFS was defined as the time from randomization to the first occurrence of either disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause. As previously announced, KEYNOTE-522 met the dual primary endpoint of pathological complete response (pCR) at the first interim analysis. The trial is continuing to allow for additional follow-up of overall survival (OS), a key secondary endpoint. At this fourth interim analysis, although these data have not crossed the boundary for statistical significance, there was a 28% reduction in the risk of death with the Keytruda regimen versus the chemotherapy-placebo regimen (HR=0.72 [95% CI, 0.51-1.02]; p=0.03214).<br /><br />“Given the high rates of recurrence within the first five years of diagnosis, patients with high-risk early-stage TNBC need new treatment options,” said Dr. Peter Schmid, lead, Centre for Experimental Cancer Medicine, Barts Cancer Institute in London, England. “KEYNOTE-522 was designed to study whether the combined neoadjuvant and adjuvant regimen with Keytruda could help treat the cancer earlier. Now, with more than three years of follow-up, we see the potential of this approach. These event-free survival data are very encouraging for patients and show that this combination of Keytruda plus chemotherapy as neoadjuvant therapy, followed by single-agent Keytruda as adjuvant therapy, may offer women with high-risk early-stage TNBC a new treatment option for this aggressive disease.”<br /><br />“These highly anticipated event-free survival results in this TNBC population build upon earlier findings from the KEYNOTE-522 trial and further support the potential use of Keytruda in these patients,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “KEYNOTE-522 is the first large randomized phase 3 study to report a statistically significant and clinically meaningful EFS result among patients with stage II and stage III TNBC. We have submitted these data to the FDA and are working closely with the agency on its review of our application.”<br /><br />Keytruda is currently approved under accelerated approval in the US in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (Combined Positive Score [CPS] =10) as determined by an FDA-approved test.<br /><br />KEYNOTE-522 is a phase 3, randomized, double-blind trial. The dual primary endpoints are pCR, defined as pathological stage ypT0/Tis ypN0 at the time of definitive surgery, and EFS, defined as the time from randomization to the first occurrence of either disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause in all patients randomized. Secondary endpoints include pCR rate using alternative definitions, OS in all patients randomized, pCR rate according to all definitions, EFS and OS in patients whose tumors express PD-L1 (CPS =1), safety and health-related quality of life assessments. The study enrolled 1,174 patients who were randomized 2:1 to receive either:<br /><br />Triple-negative breast cancer is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis. While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of human epidermal growth factor receptor 2 (HER2).<br /><br />Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.<br /><br /><br />Source:http://www.pharmabiz.com/NewsDetails.aspx?aid=140104&sid=2cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-8269230395727453832021-07-19T14:26:00.000+05:302021-07-19T14:26:16.498+05:30Spice up For Most cancers Care In India: Tata Memorial Health center, IIT Bombay Conducts First CAR-T Mobile Treatment In Early Section Medical TrialChimeric antigen receptor T-cell (CAR-T) treatment has emerged as a leap forward in most cancers remedy. Medical research performed international have proven promising ends up in end-stage sufferers, particularly the ones affected by acute lymphoblastic leukemia. Whilst this generation has exceptional healing possible for most cancers sufferers, it’s not recently to be had in India. Every affected person’s CAR-T mobile treatment prices Rs 3-4 crore. The problem is due to this fact to expand this generation in an economical means and make it to be had to sufferers.<br /><br /><br />The complexity of producing is a significant motive force of treatment prices. To advertise and fortify the advance of CAR-T mobile generation in opposition to most cancers and different sicknesses, BIRAC and DBT have initiated projects and introduced specialised calls to ask proposals during the last 2 years.<br /><br />June 4, 2021 was once a ancient day for TMH, IIT Bombay group and most cancers care in India as the primary CAR-T mobile treatment (a kind of gene treatment) was once carried out at ACTREC’s bone marrow transplant unit, Tata Memorial Heart in Bombay. The CAR-T cells had been designed and manufactured on the Division of Bioscience and Bioengineering (BSBE) of IIT Bombay.<br /><br />This paintings is supported partly by means of the BIRAC-PACE scheme. The TMC-IIT Bombay group is additional supported to amplify this venture to behavior Section I/II trial in their CAR-T product by means of DBT/BIRAC, via Nationwide Biopharma Venture.<br /><br />It is a “first in India” gene treatment in an early part medical trial find out about and the devoted efforts and superb collaboration between IIT Bombay and Tata Memorial Health center, Mumbai. The central executive’s Nationwide Biopharma Venture-BIRAC has authorized 19.15 crore for the group to behavior a first-in-human phase-1/2 medical trial of the CAR-T cells. The medical trials shall be performed by means of Dr (Surg Cdr) Gaurav Narula, Professor of Pediatric Oncology and Well being Sciences, and his group from TMC, Mumbai, and the brand new CAR-T cells that can act as medication manufactured by means of Prof Rahul Purwar, Division of Bioscience and Bioengineering (BSBE) and his group at IIT Bombay. The design, building and intensive preclinical checking out was once carried out by means of IIT-B as a collaborative venture with Tata Memorial Heart, Mumbai by means of the 2 researchers.<br /><br />IIT-B director Subhasis Chaudhuri stated this was once an important success for each the institute and the rustic. “We at IIT-B are thrilled that our scientists have partnered with Tata Memorial Health center to provide probably the most complex treatment in most cancers remedy. If the rigors are a hit, it would save thousands and thousands of lives by means of making the remedy to be had in India at an inexpensive value. It’s an IIT-B investigation this is anticipated to the touch everybody’s lives,” Chaudhuri stated.<br /><br />Nationwide Biopharma Venture may be supporting the advance of lentiviral vector manufacturing facility for packaging plasmids used to switch the changed T mobile into the frame, cGMP facility for T mobile transduction and growth for CAR T mobile manufacturing to 2 different organizations. The advance of CAR-T mobile generation for sicknesses comparable to acute lymphoblastic leukemia, a couple of myeloma, glioblastoma, hepatocellular carcinoma and kind 2 diabetes is supported by means of DBT.<br /><br />Source:https://thenewstrace.com/spice-up-for-most-cancers-care-in-india-tata-memorial-health-center-iit-bombay-conducts-first-car-t-mobile-treatment-in-early-section-medical-trial/166914/cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-13423643133236571152021-07-08T12:23:00.003+05:302021-07-08T12:23:33.706+05:30Merck plans to withdraw US accelerated approval of Keytruda to treat recurrent locally advanced or metastatic gastric<p> <span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">Merck announced that the company plans to voluntarily withdraw the US accelerated approval indication for Keytruda for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 [combined positive score (CPS =1)] as determined by a US Food and Drug Administration (FDA)-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, human epidermal growth factor receptor 2 (HER2)/neu-targeted therapy.</span></p><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">The decision was made in consultation with the FDA following the April 29 Oncologic Drugs Advisory Committee evaluation of this third-line gastric cancer indication for Keytruda as a monotherapy because it failed to meet its post-marketing requirement of demonstrating an overall survival benefit in a phase 3 study. As agreed with the FDA, Merck will initiate the withdrawal in six months. Patients being treated with Keytruda for metastatic gastric cancer in the third- or further-line setting should discuss their care with their health care provider. This decision does not affect other indications for Keytruda.</span><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">“While there remains an unmet need for heavily pre-treated patients with advanced gastric cancer, we recognize that the treatment landscape has evolved and we respect the FDA’s efforts to continually evaluate accelerated approvals,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “Our research with Keytruda has contributed to recent advances in the treatment of gastric cancer, and we are continuing to advance studies to help more patients with this disease.”</span><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.</span><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><br style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;" /><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,500 trials studying Keytruda across a wide variety of cancers and treatment settings. The Keytruda clinical program seeks to understand the role of Keytruda across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with Keytruda, including exploring several different biomarkers.</span><div><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;"><br /></span></div><div><span style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify;">Source:</span><span style="color: #222222; font-family: arial, tahoma, verdana;"><span style="font-size: 12px;">http://www.pharmabiz.com/NewsDetails.aspx?aid=139732&sid=2</span></span></div>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-79675679129182769822021-06-04T15:22:00.002+05:302021-06-04T15:22:19.916+05:30Novartis announces positive data from phase II ELARA trial of Kymriah in patients with relapsed or refractory follicular lymphoma<p> </p><table border="0" cellpadding="0" cellspacing="0" style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify; width: 100%px;"><tbody><tr><td valign="top"><p align="justify">Novartis announced robust data from the primary analysis of the pivotal phase II ELARA trial of Kymriah (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL). Data will be presented as an oral presentation during the 2021 Annual American Society of Clinical Oncology (ASCO) Virtual Scientific Meeting (Abstract #7508; oral presentation: Monday, June 7, 10:30 AM CDT).<br /><br />“Patients with follicular lymphoma who do not respond to their current treatment or who relapse early after treatment often have to endure multiple treatments, which can result in diminished clinical outcomes with each successive therapy,” said Stephen J. Schuster, MD, the Robert and Margarita Louis-Dreyfus Professor in Chronic Lymphocytic Leukemia and Lymphoma Clinical Care and Research in Penn’s Perelman School of Medicine and director of the Lymphoma Program at the Abramson Cancer Center. Schuster will present the results at ASCO. “Our goal as researchers is to continue to explore the potential of CAR-T therapy, and the robust ELARA safety and efficacy findings suggest Kymriah may play an important role in the third-line treatment of relapsed or refractory follicular lymphoma.”<br /><br />In the primary ELARA analysis, 97 patients were infused and evaluated for safety, 94 patients were evaluable for efficacy with a median follow-up of 11 months. Importantly, no patients experienced grade 3/4 cytokine release syndrome (CRS), the most common side effect associated with CAR-T therapy. Grade 1 or 2 CRS, as defined by the Lee Scale, occurred in 49% of patients. Grade 1 or 2 neurological events (NEs) (per CTCAE v4.03) occurred in 9% of patients and one patient experienced grade 4 NEs and recovered. Sixty-five percent of patients experienced grade =3 adverse events within 8 weeks post-infusion, most commonly neutropenia (28%) and anemia (13%). Three patients died from progressive disease and no deaths were treatment related. Kymriah was administered in the outpatient setting for 18% of patients in the ELARA trial.<br /><br />Kymriah led to responses for the majority of patients treated, with 66% achieving a complete response (CR) (95% CI, 56-75). The overall response rate was 86% (95% CI, 78-92). Response rates were consistent across high-risk patient subgroups. The median duration of response (DOR) in all responders (95% CI, NE-NE), progression free survival (PFS) (95% CI, 12.1-NE), and overall survival (OS) (95% CI, NE-NE) were not reached. Estimated DOR in patients with CR and PFS rates at six months were 94% (95% CI, 82-98) and 76% (95% CI, 65-84), respectively. Efficacy findings include data from nearly twice as many patients as were reported at the interim analysis, including high-risk and heavily pretreated patients who continued to relapse or have refractory disease despite exposure to numerous prior lines of therapy. The median number of prior therapies was 4 (range, 2-13), 78% of patients were refractory to their last treatment (76% to =2 prior regimens) and 60% progressed within 2 years of initial anti-CD20-containing treatment.<br /><br />“The strength of these pivotal results from the ELARA trial underscore the promising potential of Kymriah in the treatment of patients with relapsed or refractory follicular lymphoma,” said Stefan Hendriks, Global Head Cell & Gene, Novartis Oncology. “With deep experience in CAR-T cell therapy and the largest global manufacturing footprint, Novartis is boldly committed to bringing the benefits of Kymriah to more patients with advanced blood cancers, and we look forward to advancing global regulatory submissions in this indication as quickly as possible.”<br /><br />ELARA is a phase II, single-arm, multicenter, open-label trial investigating the efficacy and safety of Kymriah in adult patients with r/r FL. This international trial has enrolled patients from over 30 sites in 12 countries worldwide. The primary endpoint is CRR based on best response by central review (Lugano 2014 criteria). Patients evaluable for efficacy had measurable disease at infusion and more than six months of follow-up from infusion or discontinued early. After infusion, disease assessments were performed every three months. Secondary endpoints include overall response rate, duration of response, progression-free survival, overall survival and safety.<br /><br />In Q2 2020, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Kymriah in r/r FL, based on preliminary results from the ELARA trial. RMAT designation is intended to expedite the development and review of Kymriah as a regenerative therapy for this underserved patient population. Kymriah also has Orphan Drug designation from the FDA for this disease.<br /><br />Kymriah is the first-ever FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. It is a one-time treatment designed to empower patients’ immune systems to fight their cancer. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to and including 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL).<br /></p></td></tr><tr><td> <br />Source:http://www.pharmabiz.com/NewsDetails.aspx?aid=138996&sid=2</td></tr></tbody></table>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-65706211247832934792021-06-04T15:20:00.003+05:302021-06-04T15:20:44.795+05:30Bristol Myers Squibb gets European approval for Opdivo plus Yervoy to treat unresectable malignant pleural mesothelioma<p> </p><table border="0" cellpadding="0" cellspacing="0" style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; text-align: justify; width: 100%px;"><tbody><tr><td valign="top"><p align="justify">Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM). The EC’s decision is based on results from the CheckMate -743 trial, the first and only positive phase 3 study of an immunotherapy in first-line MPM. The trial met its primary endpoint, showing superior overall survival (OS) with Opdivo plus Yervoy versus chemotherapy (pemetrexed and cisplatin or carboplatin) in all randomized patients.<br /><br />“After many years of limited progress in the treatment of malignant mesothelioma, we saw an important clinical benefit for patients with nivolumab plus ipilimumab in the CheckMate -743 trial,” said Paul Baas, M.D., Ph.D., Department of Thoracic Oncology, Netherlands Cancer Institute and the University of Leiden. “With the European Commission approval of this dual immunotherapy combination, patients and doctors will now have a new treatment option that has shown significant improvements in survival to manage this resistant disease.”<br /><br />The EC decision allows for the use of Opdivo plus Yervoy in first-line unresectable MPM in the 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. In addition to the EU, the combination has been approved in six countries, including the United States, and additional regulatory applications are under review by global health authorities.<br /><br />“Mesothelioma can be a devastating diagnosis for patients and their families, and the disease has a significant impact throughout Europe, which has the highest incidence rate of mesothelioma globally,” said Stefania Vallone, board member, Women against Lung Cancer in Europe. “Mesothelioma is often detected decades after exposure to asbestos, and for years these patients have faced this aggressive cancer with few treatment options. We are pleased to see a new therapy approved that may offer patients and their families hope for a longer life. Our wish is that it will soon be available in all European countries.”<br /><br />“The European Commission’s approval of Opdivo plus Yervoy is a crucial step in addressing the unmet needs of patients with malignant pleural mesothelioma. In the CheckMate -743 trial, this dual immunotherapy combination demonstrated a clinically meaningful improvement in survival over the standard of care, with 41% of patients who received Opdivo plus Yervoy still alive at two years, compared to only 27% with chemotherapy,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “We thank the patients and investigators involved in the CheckMate -743 trial, whose contributions were essential to bringing the first immunotherapy option to mesothelioma patients throughout the EU.”<br /><br />CheckMate -743 is an open-label, multi-center, randomized phase 3 trial evaluating Opdivo plus Yervoy compared to chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with previously untreated malignant pleural mesothelioma (n=605). Patients with interstitial lung disease, active autoimmune disease, medical conditions requiring systemic immunosuppression, or active brain metastasis were excluded from the trial. In the trial, 303 patients were randomized to receive Opdivo at 3 mg/kg every two weeks and Yervoy at 1 mg/kg every six weeks; 302 patients were randomized to receive cisplatin 75 mg/m2 or carboplatin AUC 5 plus pemetrexed 500 mg/m2 in 21-day cycles for six cycles.<br /><br />Treatment in both arms continued until disease progression or unacceptable toxicity or, in the Opdivo plus Yervoy arm, up to 24 months. The primary endpoint of the trial was overall survival (OS) in all randomized patients. Additional efficacy outcome measures included progression-free survival (PFS), objective response rate (ORR) and duration of response (DOR), as assessed by blinded independent central review (BICR) utilizing modified RECIST criteria. Exploratory endpoints included safety, pharmacokinetics, immunogenicity and patient reported outcomes.<br /><br />Malignant pleural mesothelioma is a rare but aggressive form of cancer that forms in the lining of the lungs. It is most frequently caused by exposure to asbestos. Diagnosis is often delayed, with the majority of patients presenting with advanced or metastatic disease.<br /><br />Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.<br /><br />Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response.<br /></p></td></tr><tr><td> <br />Source:http://www.pharmabiz.com/NewsDetails.aspx?aid=138997&sid=2</td></tr></tbody></table>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-91117340739890091532021-06-04T15:19:00.005+05:302021-06-04T15:19:42.333+05:30Zydus Cadila gets tentative USFDA nod to market lung cancer treatment drug<a href="https://health.economictimes.indiatimes.com/tag/drug">Drug</a> firm <a href="https://health.economictimes.indiatimes.com/tag/zydus+cadila">Zydus Cadila</a> on Thursday said it has received tentative approval from the US health regulator to market <a href="https://health.economictimes.indiatimes.com/tag/osimertinib+tablets">Osimertinib tablets</a>, used to treat <a href="https://health.economictimes.indiatimes.com/tag/lung+cancer">lung cancer</a>.<br /><br />The company has received tentative approval from the <a href="https://health.economictimes.indiatimes.com/tag/us+food+and+drug+administration">US Food and Drug Administration</a> (<a href="https://health.economictimes.indiatimes.com/tag/usfda">USFDA</a>) to market Osimertinib tablets in the strengths of 40 mg and 80 mg, Zydus Cadila, part of the <a href="https://health.economictimes.indiatimes.com/tag/cadila+healthcare">Cadila Healthcare</a> group, said in a regulatory filing.<br /><br />Osimertinib is used to treat lung cancer. Osimertinib works by slowing or stopping the growth of cancer cells.<br /><br /><br />The company said the newly approved <a href="https://health.economictimes.indiatimes.com/tag/medication">medication</a> will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.<br /><br />The group now has 318 approvals and has so far filed over 400 abbreviated new drug applications since the commencement of the filing process in the financial year 2003-04.<br /><br /><br />Source:https://health.economictimes.indiatimes.com/news/pharma/zydus-cadila-gets-tentative-usfda-nod-to-market-lung-cancer-treatment-drug/83201464cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-46199624007951191882021-05-31T12:19:00.004+05:302021-05-31T12:19:40.888+05:30BDR Pharma launches the first generic RUCAPARIB to treat advanced ovarian and prostate cancers in IndiaBDR Pharmaceutical launched <a href="https://health.economictimes.indiatimes.com/tag/bdparib">BDPARIB</a> (RUCAPARIB) to treat advanced ovarian and prostate cancers today. BDPARIB is the first affordable generic in the India available in the form of a tablet, with the cost of therapy less expensive than any existing drugs in the market.<br />RUCAPARIB is an oral, small-molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2, and 3 used as a monotherapy and in conjunction with other anti-cancer agents in several tumor forms, including ovarian and prostate cancers. It has played a significant role in treating <a href="https://health.economictimes.indiatimes.com/tag/ovarian+cancer">ovarian cancer</a> patients with BRCA mutation (germline or somatic) associated with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapy.<br /><br />"BDPARIB was developed to treat patients living with advanced ovarian and prostate cancer with an unmet need. This research's positive results through the ARIEL3 study & TRITON2 study are highly promising and indicate that the benefits extend beyond the BRCAm population. This represents a significant advancement in the treatment of cancer patients in the future. Approvals for generics like Rucaparib, a PARP inhibitor, enables us to progress in this emerging era of personalized medicine and eradicate life-threatening diseases", said Mr.<a href="https://health.economictimes.indiatimes.com/tag/dharmesh+shah">Dharmesh Shah</a>, CMD, BDR Pharma<br /><br />Source:https://health.economictimes.indiatimes.com/news/pharma/bdr-pharma-launches-the-first-generic-rucaparib-to-treat-advanced-ovarian-and-prostate-cancers-in-india/83001274<div><br /></div>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-61576689842004137022021-05-31T12:18:00.002+05:302021-05-31T12:18:29.112+05:30Lupin receives $50 million from Boehringer Ingelheim for achievement of key milestones<a href="https://health.economictimes.indiatimes.com/tag/drug+major">Drug major</a> <a href="https://health.economictimes.indiatimes.com/tag/lupin">Lupin</a> on Thursday said it has received payment of USD 50 million (around Rs 363.5 crore) from Germany-based <a href="https://health.economictimes.indiatimes.com/tag/boehringer+ingelheim">Boehringer Ingelheim</a> for achievement of key milestones by its novel cancer drug, a potential target therapy for patients with difficult-to-treat <a href="https://health.economictimes.indiatimes.com/tag/cancers">cancers</a>.<br />In a regulatory filing, Lupin announced "the achievement of key milestones for Lupin's MEK inhibitor compound (LNP3794) that is planned for development by Boehringer Ingelheim in combination as potential targeted therapy for patients with difficult-to-treat cancers." In 2019, Lupin and Boehringer Ingelheim had inked a licensing, development and commercialisation agreement for Lupin's novel oncology compound.<br /><br />"As part of the agreement, Lupin has received payment of USD 50 million from Boehringer Ingelheim for achievement of key milestones," Lupin said in the regulatory filing.<div><br /></div><div>Lupin said its new chemical entity research team is focused on building a pipeline of highly differentiated and innovative new chemical entities, primarily in the <a href="https://health.economictimes.indiatimes.com/tag/oncology+space">oncology space</a>.<br /><br /><br />Source:https://health.economictimes.indiatimes.com/news/finance/lupin-receives-50-million-from-boehringer-ingelheim-for-achievement-of-key-milestones/82998364<br /><br /><br /></div>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-13946747269418097652021-05-24T14:42:00.001+05:302021-05-24T14:42:06.295+05:30Zydus launches Ujvira, a breakthrough in Breast Cancer treatmentZydus Cadila, a global innovation driven healthcare company, launched Trastuzumab Emtansine, the first Antibody Drug Conjugate (ADC) biosimilar and a highly effective drug for treating both Early and Advanced HER2 positive Breast Cancer, under the brand name 'Ujvira'. HER2 positive Breast Cancer is considered an aggressive form and constitutes 20 to 25% of all Breast Cancers.<br />In a step that can significantly reduce treatment cost by almost 80%, the drug is being offered at Rs. 32495 for a 100 mg vial. The current MRP of existing Trastuzumab Emtansine drug is Rs. 1,59,225 for 100 mg vial. Ujvira will be available in two strengths, 100 mg and 160 mg.<br /><br />Speaking on this milestone, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Limited said, "The launch of Ujvira reinforces the innovation capabilities that India has to be able to create complex therapies like ADCs and Zydus' ongoing commitment to offer breakthroughs backed by science and innovation. This research breakthrough enables access to a critical drug for patients who are undergoing therapy for Breast Cancer. We hope that with this innovation, patients will be able to adhere to the treatment and stand to benefit from the advanced technology without worrying about the cost of the treatment."<br /><br />Trastuzumab Emtansine ADC biosimilar is developmental breakthrough due to its complexity in manufacturing and similarity assays. This drug is made by combining Trastuzumab and a cytotoxic compound Emtansine (DM1) with the help of a stable linker by a process called Antibody Drug Conjugation. Due to this technology the targeted delivery of the cytotoxic agent is enabled and the other toxicities on body are reduced. Ujvira is backed up with rigorous drug development programme. Patients already treated with Trastuzumab may still have the disease and would require this therapy as the next step. The high cost of therapy is a barrier to availing this therapy and Ujvira bridges this need.<br /><br />With more than 2.1 lakh new cases in 2020, Breast Cancer is the leading cancer in females in India and the risk increases with age. It is estimated that 1 in 29 women in India has a risk of developing Breast Cancer in her lifetime. Though rare, the incidence of HER2 Breast Cancer is also found in men. Other risk factors such as obesity, family history, genetics, alcohol, smoking, hormonal imbalance and improper diet have been identified as the contributing factors towards an increased incidence of Breast Cancer.<br /><br /><br /><br />Source:https://www.equitybulls.com/admin/news2006/news_det.asp?id=289188cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-41295932582646664402021-05-24T14:37:00.008+05:302021-05-24T14:39:58.753+05:30 US FDA approves Bristol Myers’ Opdivo as adjuvant treatment of completely resected esophageal or GEJ cancer in patients who have received n eoadjuvant CRTBristol Myers Squibb announced that the US Food and Drug Administration (FDA) has approved Opdivo (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).<br /><br />The approval is based on results from the phase 3 CheckMate -577 trial that evaluated Opdivo (n=532) compared to placebo (n=262) in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection.<br /><br />In the trial, among patients who received Opdivo, median disease-free survival (DFS) was twice as long as in those who received placebo (22.4 months [95% Confidence Interval [CI]: 16.6 to 34.0] compared to 11.0 months [95% CI: 8.3 to 14.3]). Opdivo reduced the risk of disease recurrence or death by 31% compared to placebo (Hazard Ratio [HR] 0.69; 95% CI: 0.56 to 0.85; P=0.0003).<br /><br /> In an exploratory analysis, among patients with adenocarcinoma (n=563, 70.9%), mDFS was 19.4 months (95% CI: 15.9 to 29.4) with Opdivo versus 11.1 months (95% CI: 8.3 to 16.8) with placebo (unstratified HR 0.75; 95% CI: 0.59 to 0.96), and among squamous cell carcinoma patients (n=230, 29%), mDFS was 29.7 months (95% CI: 14.4 to NE) with Opdivo versus 11.0 months (95% CI: 7.6 to 17.8) with placebo (unstratified HR 0.61; 95% CI: 0.42 to 0.88).<br />“Locally advanced esophageal and gastroesophageal junction cancers are aggressive tumor types that often require multiple approaches to address the disease, including chemotherapy, radiation and surgery,” said Ronan J. Kelly M.D., MBA., director, Baylor Scott & White Charles A. Sammons Cancer Center, and W.W. Caruth Jr. Endowed Chair of Immunology at Baylor University Medical Center. “Even after neoadjuvant CRT followed by surgery, there may be a high risk of recurrence for patients who do not achieve a pathologic complete response. In the CheckMate -577 trial, we saw a doubling in median disease-free survival compared to placebo, which suggests that Opdivo could become a new standard of care for these patients. This is exciting news, providing renewed hope.”<br /><br />“Esophageal and GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection face a high risk of disease recurrence; however, the predominant option for these patients has been surveillance,” said Adam Lenkowsky, senior vice president and general manager, US Cardiovascular, Immunology and Oncology, Bristol Myers Squibb. “This news marks an important step for patients as well as meaningful progress toward our commitment to pioneering immunotherapy treatment options in earlier stages of disease where there is the potential to reduce the risk of recurrence.”<br /><br />This application was reviewed under the US FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.10 The review was also conducted under the US FDA’s Project Orbis initiative, which enabled concurrent review by the health authorities in Australia, Canada and Switzerland.<br /><br />CheckMate -577 was a phase 3 randomized, placebo-controlled, double-blind, multi-center trial, evaluating Opdivo as an adjuvant treatment in patients with esophageal or GEJ cancer with residual pathologic disease following neoadjuvant CRT and complete resection. The trial excluded patients who did not receive CRT prior to surgery, had stage IV resectable disease, autoimmune disease, or any condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications.<br /><br />The primary endpoint of the trial was DFS (investigator assessed). Following neoadjuvant CRT and complete tumor surgical resection (also known as trimodality therapy), a total of 794 patients were randomized to receive either Opdivo 240 mg (n=532) or placebo (n=262) by intravenous infusion every two weeks for 16 weeks, followed by Opdivo 480 mg or placebo by intravenous infusion every four weeks beginning at week 17. Treatment was until disease recurrence, unacceptable toxicity, or for up to one year in total duration.<br /><br />The US FDA-approved dosing for Opdivo (injection for intravenous use) for adjuvant treatment of patients with resected esophageal or GEJ cancer is 240 mg intravenous infusion over 30 minutes every two weeks or 480 mg intravenous infusion over 30 minutes every four weeks until disease progression or unacceptable toxicity for a total treatment duration of one year.<br /><br />Esophageal and gastroesophageal junction cancers are classified as upper gastrointestinal cancers. Esophageal cancer is a type of gastrointestinal cancer that starts in the inner layer of the esophagus (the mucosa) and grows. In the United States, it is estimated there will be approximately 19,260 new cases of esophageal cancer diagnosed and 15,530 deaths resulted from the disease in 2021. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma.<br /><br />The gastroesophageal junction (GEJ) is the area of the body that connects the lower part of the esophagus to the stomach. The prevalence of GEJ cancer has continued to rise.<br /><br /> <br />Source:http://www.pharmabiz.com/NewsDetails.aspx?aid=138685&sid=2<br /><table border="0" cellpadding="0" cellspacing="0" style="background-color: white; color: #222222; font-family: arial, tahoma, verdana; font-size: 12px; width: 100%px;"><tbody><tr><td valign="top"></td></tr><tr></tr></tbody></table>cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0tag:blogger.com,1999:blog-9112818616297570158.post-74057076406670823882021-05-21T16:15:00.001+05:302021-05-21T16:15:06.124+05:30Takeda to present positive primary analysis from phase 2 OPTIC trial of Iclusig to treat chronic-phase chronic myeloid leukemia at ASCO meetingTakeda Pharmaceutical Company announced that primary analysis data from the phase 2 OPTIC (optimizing ponatinib treatment in CML) trial will be presented during an oral session at the virtual 57th American Society of Clinical Oncology (ASCO) Annual Meeting, and as an oral session at the virtual 26th European Hematology Association (EHA) Annual Meeting.<br />The OPTIC trial is a randomized, open-label study prospectively evaluating response-based dosing regimens of Iclusig (ponatinib) over a range of three starting doses (45-, 30-, or 15-mg) with the aim of optimizing its efficacy and safety in patients with chronic-phase chronic myeloid leukemia (CP-CML) who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy.<br /><br />The OPTIC trial, which evaluated treatment in patients with resistant disease, with and without mutations, met its primary endpoint. The study demonstrates that the optimal benefit-risk profile for Iclusig in patients with CP-CML is achieved with a daily starting dose of 45-mg and, upon achieving =1% BCR-ABL1IS, dose reduction to 15-mg. The results also suggest a clinically manageable safety and arterial occlusive event (AOE) profile for Iclusig.<br /><br />“The primary analysis of the OPTIC data reinforce that Iclusig is very valuable in the management of patients with resistant and intolerant chronic-phase CML. Iclusig should be considered following failure of two or more TKIs. This approach minimizes the need to use back-to-back second-generation TKIs, which is usually associated with low probability of response and poor outcomes,” said Jorge Cortes, MD, Georgia Cancer Center at Augusta University, and an OPTIC trial principal investigator. “These findings further demonstrate that the optimal Iclusig benefit-risk profile can be achieved with a response-based dosing regimen, providing efficacy while reducing risk for arterial occlusive events.”<br /><br />“There is a misconception that chronic-phase CML is a ‘good cancer’ due to the fact it can be well controlled, but for patients with resistant and intolerant disease, continued investigation and treatment options are critical. The primary analysis of OPTIC solidifies our understanding of how ICLUSIG can address gaps in care for these patients,” said Christopher Arendt, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. “The OPTIC data, along with the recently updated US FDA indication, demonstrate the benefit Iclusig can offer as a third-generation TKI.”<br /><br />OPTIC (optimizing ponatinib treatment in CML) is an ongoing randomized, dose-ranging trial designed to evaluate three starting doses of Iclusig (45-, 30-, and 15-mg) in patients with resistant chronic-phase chronic myeloid leukemia (CP-CML) or who had documented history of presence of T315I mutation after receiving any number of prior TKIs. Dose reduction at response occurred per study protocol. The trial is expected to inform the optimal use of Iclusig (ponatinib) in these patients. 282 patients were enrolled at clinical sites around the world, with 94 patients receiving the 45-mg starting dose. The primary endpoint of the trial is achieving =1% BCR-ABL1IS at 12 months.<br /><br />CML – a rare malignancy – is one of four main types of leukemia; it is a result of a genetic mutation that takes place in early, immature versions of myeloid cells, which form red blood cells, platelets and most types of white blood cells. Subsequently, an abnormal gene called BCR-ABL1 forms, turning the damaged cell into a CML cell. CML typically progresses slowly, but it can change into a fast-growing acute leukemia that is hard to treat.<br /><br />Iclusig is a kinase inhibitor targeting BCR-ABL1, an abnormal tyrosine kinase that is expressed in CML and Ph+ ALL. Iclusig is a targeted cancer medicine developed using a computational and structure-based drug-design platform, specifically designed to inhibit the activity of BCR-ABL1 and its mutations.<br /><br /><br />Source:http://www.pharmabiz.com/NewsDetails.aspx?aid=138644&sid=2cognitrexcancerdigesthttp://www.blogger.com/profile/08278019542594305746noreply@blogger.com0