BRISK-PS Study with Investigational Compound Brivanib in Hepatocellular Carcinoma Completed
PRINCETON, N.J.--(BUSINESS WIRE)--Dec 22, 2011 - Bristol-Myers Squibb Company (NYSE: BMY) today reported that the Phase III BRISK-PS (Brivanib Study in HCC Patients at Risk Post Sorafenib) clinical trial in patients with hepatocellular carcinoma (HCC; liver cancer) who failed or are intolerant to sorafenib did not meet the primary endpoint of improving overall survival versus placebo.
BRISK-PS is a multicenter, double-blind, randomized study of the investigational agent brivanib plus best supportive care (BSC) versus placebo plus BSC in HCC in patients who have progressed on sorafenib. Bristol-Myers Squibb and the lead investigators plan to present the findings of the study, including secondary efficacy and safety endpoints, at an upcoming scientific meeting. The BRISK-PS study is one of four Phase III clinical trials evaluating brivanib in different HCC patient populations. These ongoing Phase III studies continue as planned.
“The treatment options for patients with HCC following failure of sorafenib are limited, and thus we are disappointed that the primary endpoint was not met,” said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “We remain committed to the development of brivanib as a potential treatment option for patients with liver cancer, and the ongoing study investigating brivanib ˜first-line' is expected to complete in 2012.”
About Bristol-Myers Squibb's Commitment to Liver Disease and Brivanib
Bristol-Myers Squibb is advancing a portfolio of compounds that aim to address unmet medical needs across the liver disease continuum, including hepatitis C, hepatitis B and liver cancer. Brivanib is an investigational, oral, anti-tumorigenic being developed by Bristol-Myers Squibb for the treatment of hepatocellular carcinoma (HCC). Brivanib inhibits vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptors (FGFR). Brivanib has been investigated in 29 studies to date, including more than 4,000 patients around the world.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that clinical trials of brivanib will support a regulatory filing, that brivanib will receive regulatory approval or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2010, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Posted: December 2011