Bristol-Myers Phase III HCC trial fails to meet primary endpoint

19th July 2012 (Last Updated July 19th, 2012 18:30)

Bristol-Myers Squibb Company has announced the Phase III BRISK-FL trial results of investigational agent brivanib versus sorafenib as a first-line treatment in patients with advanced hepatocellular carcinoma (HCC).

hepatocellular carcinoma

Bristol-Myers Squibb Company has announced the Phase III BRISK-FL trial results of investigational agent brivanib versus sorafenib as a first-line treatment in patients with advanced hepatocellular carcinoma (HCC).

The randomised, double-blind study conducted in patients with advanced HCC who have not received prior systemic treatment, failed to meet its primary overall survival objective based on a non-inferiority statistical design.

Bristol-Myers Squibb global development and medical affairs senior vice president Brian Daniels said that the treatment options for patients with advanced hepatocellular carcinoma were limited, and the company was 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."

"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 programme and will continue with ongoing clinical trials of brivanib, which include hepatocellular carcinoma and other tumor types.

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

Brivanib is an investigational, oral, anti-tumourigenic, which inhibits vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptors (FGFR).


Image: Gross specimen of the liver showing hepatocellular carcinoma. Photo: courtesy of Netha Hussain.