Citing positive data from a planned interim analysis, Bayer and Onyx Pharmaceuticals halted a late-stage trial of Nexavar for liver cancer early and will allow all trial participants to receive the drug. A data monitoring committee concluded the trial met its primary endpoint, resulting in superior overall survival in patients receiving Nexavar versus those patients receiving placebo. The companies say they will discuss the next step for treatment approval with the FDA and European health authorities. This is welcome news for Bayer and Onyx, which recently announced Nexavar flunked a late-stage trial for kidney cancer. The drug is still being tested for lung cancer and was approved last year as a therapy for advanced renal-cell carcinoma.
"The observed superiority in overall survival for Nexavar-treated patients over patients receiving placebo demonstrates the efficacy of Nexavar in advanced primary liver cancer," said Dr. Jordi Bruix, co-principal investigator and Head of the Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona, Spain.
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