Nexavar fails Phase III STORM trial as adjuvant treatment for Liver Cancer - Bayer + Onyzx/Amgen

Bayer HealthCare Pharmaceuticals and Onyx/Amgen announced that a Phase III trial evaluating the investigational use of Nexavar (sorafenib) tablets as an adjuvant treatment for patients with Hepatocellular Carcinoma (HCC), or Liver Cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival. The safety findings were consistent with the known profile of sorafenib. Data from this study will be submitted for presentation at an upcoming scientific congress.

The Phase III, randomized, double-blind, placebo-controlled STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial is an international multicenter study that evaluated clinical benefit of sorafenib versus placebo as an adjuvant treatment in patients with HCC following potential curative treatment (surgical resection or local ablation). The primary endpoint of the study was recurrence-free survival (i.e., the length of time that a patient survives without recurrence of HCC). Secondary endpoints included time to recurrence of HCC (intrahepatic and extrahepatic) and overall survival.