CognitrexCancerDigest

Roche announced that the phase III VIALE-A study met its dual primary endpoints of overall survival and composite complete remission rate (CR + CRi). Venclexta/Venclyxto (venetoclax) in combination with azacitidine, a hypomethylating agent, showed a statistically significant improvement in overall survival in people with previously untreated acute myeloid leukaemia (AML) who were ineligible for intensive induction chemotherapy, compared to azacitidine alone. Safety for Venclexta/Venclyxto plus azacitidine appeared consistent with the known safety profile of these medicines. “Acute myeloid leukaemia remains a challenging blood cancer, with particularly low median survival rates in patients who cannot tolerate intensive chemotherapy given their age or underlying health,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and Head of Global Product Development. “These data validate the benefit that this Venclexta/Venclyxto-based combination can bring to patients and we look f...

India based Zydus Cadila, an innovation-driven global pharmaceutical company, and US based XOMA Corporation have announced they have entered into a licensing agreement to advance an IL-2-based immuno-oncology (IO) drug candidate that combines Zydus’ IL-2 with XOMA’s novel anti-IL-2 monoclonal antibody. As part of the agreement, Zydus will advance the new IO candidate through formal clinical trials. Zydus has been granted exclusive rights to develop and commercialize the therapy in India, Brazil, Mexico and other emerging markets, and XOMA has the potential to receive single-to double-digit royalties on commercial sales in those territories. XOMA retains rights in all other territories (i.e., XOMA territory). Through this collaboration, Zydus will develop the new IO drug candidate through human proof-of-concept and each company has the potential to receive pre-defined shares of future proceeds that may arise from licensing and commercialization activities. Speaking about the developmen...

AstraZeneca and MSD Inc, announced high-level results from the phase III GY004 trial, led by NRG Oncology and sponsored by the US National Cancer Institute (NCI), that examined primarily the efficacy and safety of the potential new medicine cediranib added to Lynparza (olaparib) versus platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer. Ovarian cancer is the eighth most common cause of death from cancer in women worldwide. The trial did not meet the primary endpoint in the intent-to-treat (ITT) population of a statistically significant improvement in progression-free survival (PFS) with cediranib added to Lynparza versus platinum-based chemotherapy. Cediranib is an oral vascular endothelial growth factor receptor (VEGFR) inhibitor, which blocks the growth of blood vessels supporting tumour growth. Jose´ Baselga, executive vice president, Oncology R&D said, “Despite these disappointing results, we remain committed to expanding on the benefits al...

In a optimistic for Biocon, US drug regulator USFDA has accepted a biologics licence software by biopharmaceutical main and associate Mylan for a proposed biosimilar to deal with superior colon or rectal most cancers. The software seeks approval of biosimilar bevacizumab for therapy of sufferers with metastatic colorectal most cancers along with different illnesses. “Once authorised, our proposed biosimilar bevacizumab will present an reasonably priced various to the branded biologic for the authorised indications. Biocon Biologics’ robust R&D and manufacturing capabilities have enabled us to supply two key biosimilars to most cancers sufferers within the US and bevacizumab will additional develop our oncology portfolio,” stated Christiane Hamacher, chief govt officer, Biocon Biologics. The biosimilar, the approval of which is anticipated by year-end, can be the third biosimilar from the partnered portfolio of Biocon and Mylan for most cancers sufferers within the US. It is at th...

NuCana, a clinical-stage biopharmaceutical company announced that the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for orphan drug designation of Acelarin for the treatment of patients with biliary tract cancer. Acelarin, in combination with cisplatin, is currently being evaluated in a global phase III study (NuTide:121) for the first-line treatment of patients with biliary tract cancer. “The receipt of a positive opinion for our orphan drug application in the European Union marks another important milestone in Acelarin’s development,” said Hugh S. Griffith, NuCana’s chief executive officer. “Acelarin in combination with cisplatin has achieved an approximate doubling in response rates when compared to the historical results achieved with the standard of care, gemcitabine plus cisplatin. NuTide:121 has the potential to establish Acelarin plus cisplatin as the first approved medicines for the treatment of patients with bi...

AstraZeneca has announced that the phase III DANUBE clinical trial for Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV (metastatic) bladder cancer did not meet the primary endpoints of improving overall survival (OS) versus standard-of-care (SoC) chemotherapy for Imfinzi monotherapy in patients whose tumour cells and/or tumour-infiltrating immune cells express high levels (=25%) of PD-L1. “We remain committed to addressing unmet needs in bladder cancer and the potential for immunotherapy to improve outcomes for these patients. The results from this trial will inform our comprehensive phase III development programme in bladder cancer. We look forward to the results of the phase III NILE trial also in the 1st-line metastatic setting, and we continue to advance clinical trials for patients at earlier stages of the disease”, said José Baselga, executive VP of Oncology R&D, AstraZeneca. The safety and tolerability profiles for Imfinzi and the combination wi...

Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection. The product is supplied as a powder for solution in single-dose vials for intravenous, intracavitary, or intravesical use. The company expects shipping of the product to commence shortly. The combined Thiotepa brand and generic sales are trending over $36.5mil during the previous 12 months according to recent published sales data. Thiotepa for injection is indicated for treatment of adenocarcinoma of the breast or ovary. The recommended dose of Thiotepa for injection for treatment of adenocarcinoma of the breast or ovary is 0.3 to 0.4 mg/kg intravenously. Doses should be given at 1 to 4 week intervals. Initially the higher dose in the given range is commonly administered. The maintenance dose should be adjusted weekly based on pretreatment control blood counts and subsequent b...

Brigatinib was granted priority review by the FDA as a first-line treatment for anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer. It was the top story in hematology/oncology last week. Another top story included interim results of the phase 2 TALAPRO-1 study that showed the PARP inhibitor talazoparib (Talzenna, Pfizer Oncology) was active and safe in certain men with metastatic prostate cancer. FDA grants priority review to  brigatinib  for first-line treatment of  ALK -positive lung cancer The FDA granted priority review to brigatinib as first-line treatment for anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer, according to the agent’s manufacturer. Talazoparib  active, safe among subset of men with metastatic prostate cancer. Talazoparib monotherapy induced promising antitumor activity in men with metastatic castration-resistant prostate cancer who previously received docetaxel, according to the first inte...

Boehringer Ingelheim and Trutino Biosciences today announced they have entered into a research collaboration and worldwide licensing agreement based on Trutino’s innovative On-Demand-Cytokine (ODC) platform. Under the terms of strategic alliance, Boehringer Ingelheim gains access to Trutino’s ODC platform technology for the generation and development of up to three new ODC candidates. This new collaboration combines Boehringer Ingelheim’s long-term strategy to provide first-in-class, breakthrough therapies for cancer patients with Trutino’s unique knowledge and expertise in increasing the safety and efficacy of cytokine therapies. “Developing a strong and innovative cytokine therapeutic program as an additional component of our cancer immunology portfolio, demonstrates how we are ‘Taking Cancer On,’ and provides a high potential combination partner for our existing cancer vaccine, oncolytic virus, T cell engager and myeloid-targeting therapeutics portfolio,” said Jonathon Sedgwick, Ph...

GlaxoSmithKline plc announced that the European Medicines Agency (EMA) has validated the company’s Type II Variation (T2V) for Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. Validation of the T2V confirms that the submission is accepted and begins the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP). The submission is based on data from the PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated clinically meaningful outcomes of niraparib treatment in the first-line maintenance setting. Results from the PRIMA study were presented at the 2019 European Society for Medical Oncology Congress and simultaneously published in the New England Journal of Medicine. The PRIMA study enrolled women who responded to first-line treatment with platinum-based chemotherapy, including those with high risk of disease progression, a popu...