BRISK-FL Study with Investigational Compound Brivanib in Hepatocellular Carcinoma Does Not Meet Overall Survival Primary Endpoint
(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 , 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.
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-tumorigenicthatinhibits vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptors (FGFR).
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.
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