BRISK-FL Study with investigational compound brivanib in hepatocellular carcinoma does not meet overall survival primary endpoint

Posted: 19 July 2012 | | No comments yet

Results of the phase III BRISK-FL clinical trial…

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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).

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