Successful Nexavar Phase 3 Trial Ends Early
Due to the superior survival rate inpatients taking sorafenib (Nexavar) inthe treatment of liver cancer, an independentdata-monitoring committee(DMC) recommended that a clinicaltrial be stopped early and all study participantsreceive the drug.
The phase 3 trial was an international,double-blind, randomized, placebo-controlledtrial of 602 patients withadvanced liver cancer who had no priorsystemic therapy. The primary end pointof the study was to compare survival andtime to symptom progression in patientsreceiving sorafenib, compared withpatients receiving placebo.
The 2 patient groups had no demonstrateddifference in serious adverseevents. Based on that information andthe achievement of the primary endpoint, the DMC made the recommendationto discontinue the trial.
The companies developing sorafenib,Onyx Pharmaceuticals and BayerHealth Care Pharmaceuticals, will filefor approval with the FDA and Europeanhealth authorities, as well as presentingthe trial results at the annualmeeting of the American Society ofClinical Oncology, in June 2007.
Ms. Farley is a freelance medicalwriter based in Wakefield, RI.