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Bristol-Myers reports Phase III BRISK-FL trial results

Bristol-Myers Squibb Company reported that Phase III BRISK-FL trial of investigational agent brivanib versus sorafenib had failed to meet its primary overall survival objective based upon a non-inferiority statistical design.

The randomised, double-blind multi-center Phase III study was conducted in patients with advanced hepatocellular carcinoma (HCC), who have not received prior systemic treatment.

Bristol-Myers Squibb global development and medical affairs senior vice president Brian Daniels said the treatment options for patients with advanced hepatocellular carcinoma are limited, and the company is disappointed that the primary endpoint was not met.

"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," Daniels added.

Bristol-Myers Squibb is considering options for the ongoing brivanib development program and will presently continue ongoing clinical trials of brivanib, which include hepatocellular carcinoma as well as other tumor types.

Additionally, the company shared the BRISK-FL results with the clinical trial investigators and is considering working with the investigators for the ongoing management of patients receiving the study drug.