Showing posts from October, 2021

Roche launches genomic profiling kit to ease cancer research

ZURICH, (Reuters) - Roche (ROG.S) 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. 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. "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. "Ultimately, a future version of the kit may lead to additional resources for clinicians to use in the diagnosis and treatment of cancer." Source:

AstraZeneca announces positive results from TOPAZ-1 phase III trial of Imfinzi in combo with standard-of-care chemotherapy to treat advanced biliary tract cancer

AstraZeneca 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). 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. 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. BTC is a group of rare and aggressive cancers that occu

US 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

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. 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 exp

Eli Lilly’s Verzenio in combo with endocrine therapy gets US FDA approval for certain people with HR+ HER2- high risk early breast cancer

The 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. "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,

Merck’s phase 3 KEYNOTE-394 trial of Keytruda meets primary endpoint of OS in patients with advanced HCC previously treated with sorafenib

Merck, 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). 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. “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