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-tumorigenicbeing 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
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
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