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Press Release Bristol-Myers Squibb
July 19, 2012 04:30 PM Eastern Daylight Time
BRISK-FL Study with Investigational Compound Brivanib in Hepatocellular Carcinoma Does Not Meet Overall Survival Primary Endpoint
PRINCETON, N.J.--(BUSINESS WIRE)--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.”
BRISK-FL Study with Investigational Compound Brivanib in Hepatocellular Carcinoma Does Not Meet Overall Survival Primary Endpoint
PRINCETON, N.J.--(BUSINESS WIRE)--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.”
Yes very disappointing news. I think the scariest part is the number of people who do not know they are HCV infected and can lead to HCC. We can send men to the moon but we can't get the word out about the importance of HCV testing.
Jules
Jules
Sorafenib (Brand name: Nexavar) is used when HCC (Hepatocellular Carcinoma) is terminal stage 3 or 4 and local treatments such as TACE, RFA can no longer be used.
Sorafenib adds about 3 months of extra life to patients. No other drug has had any any effect on longevity.
Hopefully no one here will ever have to get to this point.
Hector
Sorafenib adds about 3 months of extra life to patients. No other drug has had any any effect on longevity.
Hopefully no one here will ever have to get to this point.
Hector
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