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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