Bristol-Myer's brivanib disappoints in Ph III study

US drug major Bristol-Myers Squibb (NYSE: BMY) has revealed disappointing results of a Phase III trial with the firm’s hepatocellular carcinoma (HCC; liver cancer) drug candidate brivanib, saying that it failed to meet its primary endpoint of improving overall survival versus placebo.

The company had previously said that it expects to file for US and European approval next year and to launch brivanib in 2012. Until this latest news, analysts at Lerrink Swann had forecast peak annual sales for the drug 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.

Dubbed BRISK-PS, this is a multicenter, double-blind, randomized study of the investigational agent brivanib plus best supportive care (BSC) versus placebo plus BSC in HCC in patients who have progressed on sorafenib (Bayer’s Nexavar). B-MS and the lead investigators plan to present the findings of the study, including secondary efficacy and safety endpoints, at an upcoming scientific meeting.