PRINCETON, N.J.--(BUSINESS WIRE)--
Bristol-Myers
Squibb Company (NYSE: BMY) today reported the result of the phase
III BRISK-FL clinical trial of the investigational agent brivanib versus
sorafenib as first-line treatment in patients with advanced
hepatocellular carcinoma (HCC; liver cancer). The study did not meet its
primary overall survival objective based upon a non-inferiority
statistical design.
BRISK-FL is a randomized, double-blind, multi-center phase III study of
the investigational agent brivanib versus sorafenib in patients with
advanced HCC who have not received prior systemic treatment.
Bristol-Myers Squibb and the lead investigators plan to present the
findings of the study at an upcoming scientific meeting.
"The treatment options for patients with advanced hepatocellular
carcinoma are limited, and 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. "Bristol-Myers Squibb remains committed
to developing medicines for the treatment of diseases with serious unmet
medical need, including diseases of the liver such as hepatitis C,
hepatitis B, and liver cancer."
Bristol-Myers Squibb is considering options for the ongoing brivanib
development program. Ongoing clinical trials of brivanib, which include
hepatocellular carcinoma as well as other tumor types, will continue at
the present time. Additionally, Bristol-Myers Squibb shared the BRISK-FL
results with the clinical trial investigators and will work with the
investigators regarding the ongoing management of patients receiving
study drug.
About Bristol-Myers Squibb's Commitment to Liver Disease and Brivanib
Bristol-Myers Squibb is studying 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 that inhibits
vascular endothelial growth factor receptor (VEGFR) and fibroblast
growth factor receptors (FGFR).
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 the brivanib
development program will be continued or, if the development program is
continued, that it will support a regulatory filing or that brivanib
will receive regulatory approval in any jurisdiction. 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, 2011, 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.
