Published on July 20, 2012 at 4:47 AM
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.
Source: Bristol-Myers Squibb