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BRISK-PS Study with Investigational Compound Brivanib in Hepatocellular Carcinoma Completed
 
 
  Bristol-Myers Squibb's (BMS) brivanib was unable to improve overall survival in a phase III trial in a form of liver cancer known as hepatocellular carcinoma (HCC).

BMS had been hoping that the BRISK-PS study would help position brivanib as a viable treatment option for HCC patients whose cancer had progressed despite treatment with Bayer/Onyx Pharmaceuticals' Nexavar (sorafenib).

The study compared overall survival rates for brivanib or placebo on top of best supportive care in 395 HCC patients who had failed or were intolerant to Nexavar treatment, but found no significant difference between the two groups.

BRISK-PS is one of four phase III trials of brivanib in different HCC populations, however, and the company said it expects to complete another study comparing brivanib to Nexavar in the first-line treatment setting in 2012.

"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, senior vice president, global development and medical affairs at BMS.

"We remain committed to the development of brivanib as a potential treatment option for patients with liver cancer," he added.

BMS has identified brivanib as one of five late-stage compounds it is hoping will help it plug the revenue gap when blockbuster anticoagulant Plavix (clopidogrel) goes off-patent in the important US market in 2012.

In addition to HCC, BMS has ongoing clinical trials of brivanib in colorectal, cervical, kidney and gastrointestinal cancers.

Previously, the company has said it plans to file for marketing approval of brivanib in both the US and Europe next year.

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Subject: Brivanib

December 22, 2011

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

PRINCETON, N.J.--Bristol Myers-Squibb 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-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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