Successful Nexavar Phase 3 Trial Ends Early

Susan Farley
Published Online: Tuesday, May 1, 2007

Due to the superior survival rate in patients taking sorafenib (Nexavar) in the treatment of liver cancer, an independent data-monitoring committee (DMC) recommended that a clinical trial be stopped early and all study participants receive the drug.

The phase 3 trial was an international, double-blind, randomized, placebo-controlled trial of 602 patients with advanced liver cancer who had no prior systemic therapy. The primary end point of the study was to compare survival and time to symptom progression in patients receiving sorafenib, compared with patients receiving placebo.

The 2 patient groups had no demonstrated difference in serious adverse events. Based on that information and the achievement of the primary end point, the DMC made the recommendation to discontinue the trial.

The companies developing sorafenib, Onyx Pharmaceuticals and Bayer Health Care Pharmaceuticals, will file for approval with the FDA and European health authorities, as well as presenting the trial results at the annual meeting of the American Society of Clinical Oncology, in June 2007.

Ms. Farley is a freelance medical writer based in Wakefield, RI.

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