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Brivanib Does Not Improve Liver Cancer Survival for Treatment-Experienced Patients

Bristol-Meyers Squibb's investigational anti-cancer drug brivanib did not improve overall survival of patients with hepatocellular carcinoma (HCC) who were unable to take or did not respond to sorafenib (Nexavar) in the Phase 3 BRISK-PS trial, the company recently reported. The drug is still being tested in other patients populations.

Over years or decades chronic hepatitis B or C, heavy alcohol consumption, and other types of liver injury can lead to liver cirrhosis and HCC, a form of primary liver cancer. A majority of people with HCC are diagnosed at later stages and it is a difficult type of cancer to treat.

Below is an edited excerpt from a press release describing the study and its findings.

BRISK-PS Study with Investigational Compound Brivanib in Hepatocellular Carcinoma Completed

• Primary endpoint of study not met

Princeton, N.J. -- December 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, MD, 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.

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Source

Bristol-Myers Squibb Company. BRISK-PS Study with Investigational Compound Brivanib in Hepatocellular Carcinoma Completed. Press release. December 22, 2011.