Bristol-Myers brivanib fails in Ph III liver cancer trial

US drug major Bristol-Myers Squibb (NYSE: BMY) yesterday reported results of the Phase III BRISK-FL clinical trial of the investigational agent brivanib compared with Bayer and Onyx Pharmaceuticals' Nexavar (sorafenib) as first-line treatment in patients with advanced hepatocellular carcinoma (HCC; liver cancer), showing that the study did not meet its primary overall survival objective based upon a non-inferiority statistical design.

Last year, B-MS revealed disappointing results of a Phase III trial – dubbed BRISK-PS - with brivanib, saying that it failed to meet its primary endpoint of improving overall survival versus placebo (The Pharma Letter December 28, 2011). Until then, the company had expected to file for US and European approval and to launch brivanib in 2012. Analysts at Lerrink Swann had forecast peak annual sales for brivanib of $450 million. Mark Schoenebaum, an analyst at ISI Group, is less optimistic, with a sales target for the drug of just $150 million by 2020. The global market for liver cancer drugs has been forecast to reach $2 billion by 2015.

Limited treatment options for liver cancer