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Disappointment for BMS over brivanib phase III failure

Drug unable to improved overall survival in form of liver cancer

Bristol-Myers Squibb's (BMS) brivanib was unable to improve overall survival in a phase III trial in a form of liver cancer known as hepatocellular carcinoma (HCC).

BMS had been hoping that the BRISK-PS study would help position brivanib as a viable treatment option for HCC patients whose cancer had progressed despite treatment with Bayer/Onyx Pharmaceuticals' Nexavar (sorafenib).

The study compared overall survival rates for brivanib or placebo on top of best supportive care in 395 HCC patients who had failed or were intolerant to Nexavar treatment, but found no significant difference between the two groups.

BRISK-PS is one of four phase III trials of brivanib in different HCC populations, however, and the company said it expects to complete another study comparing brivanib to Nexavar in the first-line treatment setting in 2012.

"The treatment options for patients with HCC following failure of sorafenib are limited, and thus we are disappointed that the primary endpoint was not met," said Brian Daniels, senior vice president, global development and medical affairs at BMS.

"We remain committed to the development of brivanib as a potential treatment option for patients with liver cancer," he added.

BMS has identified brivanib as one of five late-stage compounds it is hoping will help it plug the revenue gap when blockbuster anticoagulant Plavix (clopidogrel) goes off-patent in the important US market in 2012.

In addition to HCC, BMS has ongoing clinical trials of brivanib in colorectal, cervical, kidney and gastrointestinal cancers.

Previously, the company has said it plans to file for marketing approval of brivanib in both the US and Europe next year.

23rd December 2011

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