Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals began enrolling patients in the STORM (Sorafenib as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma) trial. The randomized, double-blind, placebo-controlled Phase III study is evaluating Nexavar (sorafenib) tablets as adjuvant treatment for patients with hepatocellular carcinoma (HCC), or primary liver cancer.
   
“Nexavar is the only systemic therapy with proven efficacy and tolerability in HCC across multiple patient populations,” said Dimitris Voliotis, M.D., vice president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals. “Liver cancer is the third largest global cancer killer worldwide and there is a significant need for new therapies that can be used at all stages in the course of the disease to delay disease progression and prolong life.”
   
In addition, the FDA has completed a SPA for the STORM trial. An SPA is a written agreement on the design and size of a trial intended to form the basis for a new drug application.
   
The trial is expected to enroll approximately 1,100 patients and will include patients who have received surgical resection or local ablation. The study will look at whether oral Nexavar delays the time to recurrence and increases overall survival. The primary endpoint of the study is recurrence free survival. Secondary endpoints include overall survival, time to recurrence, patient-reported outcomes, plasma biomarkers, safety and tolerability.