Bristol-Myers Squibb Co. (BMY) 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 or HCC; liver cancer. The company said 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.
"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.
The company said it 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.
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