Bayer and Onyx halt Nexavar trial

27 April 2009

Germany's Bayer HealthCare and US partner Onyx Pharmaceutical have put an early halt to a Phase III trial evaluating Nexavar (sorafenib) in  unresectable stage III or stage IV melanoma.

The multicenter, randomized, double-blind, placebo-controlled trial's  independent Data Monitoring Committee concluded that the study would not  meet the primary endpoint of improved overall survival versus placebo.  The treatment effect was comparable in each arm.

"We're disappointed with the results of the study and that the therapy  did not bring benefit to patients with melanoma, a historically  difficult tumor to treat," said Dimitris Voliotis, vice president of  global clinical oncology at Bayer. "Onyx and Bayer remain committed to  our broad clinical program to investigate the potential of Nexavar in a  wide range of cancers, and we intend to build upon the success of  Nexavar in our approved indications in hepatocellular carcinoma and  advanced renal cell carcinoma," he added.

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