During Wednesday’s trade, Shares of Exelixis, Inc. (NASDAQ:EXEL), gain 1.23% to $5.32.
Exelixis, Inc. (EXEL) declared the presentation of positive data from subgroup analyses of METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with renal cell carcinoma (RCC) who have practiced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI). Cabozantinib treatment resulted in benefits in progression-free survival (PFS), the trial’s primary endpoint, and objective response rate (ORR), a secondary endpoint, across various prespecified and post-hoc analysis subgroups. Importantly, observed benefits were independent of the location and number of organ metastases, tumor burden, the type, duration and number of prior VEGF receptor TKI therapies, and prior PD-1/PD-L1 therapy.
Bernard Escudier, M.D., chair of the Genitourinary Oncology Committee at the Institut Gustave Roussy (Villejuif, France) and an investigator on the METEOR trial, summarized the results during a press briefing in advance of the American Society of Clinical Oncology 2016 Genitourinary Cancers Symposium (ASCO GU), which is being held January 7-9, 2016 in San Francisco. Dr. Escudier will formally present the data (Abstract #499) at ASCO GU during an oral presentation session starting at 2:45 p.m. PT on Saturday, January 9, 2016.
“In the METEOR trial, cabozantinib was formerly associated with statistically noteworthy improvements in progression-free survival and objective response rate as contrast to everolimus, a standard of care in the second-line renal cell carcinoma treatment setting,” said Dr. Escudier. “This latest data set demonstrates that these benefits are favorable across a variety of prespecified and post-hoc subgroups, counting patients who have received prior therapy with immune checkpoint inhibitors. In addition, cabozantinib was active in patients with low and high tumor burden, counting patients with both bone and visceral metastases. Collectively, the data from METEOR suggest that cabozantinib could become an important addition to the renal cell carcinoma treatment landscape if approved.”
As formerly declared, the METEOR trial met its primary endpoint of demonstrating a statistically noteworthy improvement in PFS for cabozantinib as contrast to everolimus, as determined by an independent radiology committee. Per the trial protocol, the primary analysis was conducted among the first 375 patients randomized to ensure sufficient follow up and a PFS profile that would not be primarily weighted toward early events. The median PFS for this population was 7.4 months for the cabozantinib arm as contrast to 3.8 months for the everolimus arm, corresponding to a 42% reduction in the rate of disease progression or death for cabozantinib as contrast to everolimus (hazard ratio [HR]=0.58, 95% confidence interval [CI] 0.45-0.75, p<0.001). These data were later presented at the European Cancer Congress (ECC) in September 2015 and co presently published in The New England Journal of Medicine.
Exelixis, Inc., a biopharmaceutical company, develops and sells small molecule therapies for the treatment of cancer in the United States. The company offers COMETRIQ, an inhibitor of multiple receptor tyrosine kinases for the treatment of patients with progressive, metastatic medullary thyroid cancer.
Shares of Gilead Sciences, Inc. (NASDAQ:GILD), inclined 0.86% to $100.13, during its current trading session.
Gilead Sciences, Inc. (Nasdaq:GILD) declared that the company is stopping its Phase 2 clinical study of the investigational monoclonal antibody simtuzumab among patients with idiopathic pulmonary fibrosis (IPF). This decision follows an analysis of unblinded efficacy and safety data by the study’s Data Monitoring Committee (DMC), which recommended that the study be terminated early due to lack of efficacy. Gilead has also reviewed the data and determined the study has not shown evidence of a treatment benefit in the group of patients randomized to receive simtuzumab.
Separately, Phase 2 studies of simtuzumab are ongoing in patients with non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). The DMC for these studies also met and recommended the continuation of the studies, which have a 96-week endpoint.
Gilead Sciences, Inc., a biopharmaceutical company, discovers, develops, and commercializes medicines in areas of unmet medical need in North America, South America, Europe, and the Asia-Pacific.
Finally, Shares of Bristol-Myers Squibb Co (NYSE:BMY), lost – 0.75%, and is now trading at $67.83.
Bristol-Myers Squibb Company (BMY) will present at the J.P. Morgan Healthcare Conference on Tuesday, January 12, 2016, in San Francisco. Giovanni Caforio, chief executive officer, will make a formal presentation about the company at 9:30 a.m. PST (12:30 p.m. EST).
Investors and the general public are invited to listen to a live webcast of the presentation at http://investor.bms.com. Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the presentation will be available later that day.
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. It provides chemically-synthesized drugs or small molecules, and biologics in various therapeutic areas, counting virology comprising human immunodeficiency virus infection (HIV); oncology; neuroscience; immunoscience; and cardiovascular.