Bayer's NEVAXAR Fails To Meet Phase III Trial Primary Endpoint

Bayer HealthCare Pharmaceuticals Inc. and Amgen subsidiary Onyx Pharmaceuticals Inc. reported that Nevaxar (sorafenib) failed to meet its primary endpoint in a Phase III trial evaluating investigative use.

Sorefenib was assessed in the Phase III STORM trial as an adjuvant treatment for patients with hepatocellular carcinoma (HCC) who had no detectable signs of disease following surgical resection or local ablation. The drug did not meet its primary endpoint of improving recurrence-free survival in patients.

Pamela A. Cyrus, Vice President and Head of U.S. Medical Affairs at Bayer HealthCare Pharmaceuticals, said “While the primary endpoint of this adjuvant trial was not met, Bayer and Onyx remain dedicated to ongoing research in all stages of liver cancer. The outcome announced today does not affect the currently approved indications. NEXAVAR is approved for the treatment of patients with unresectable liver cancer.”

Liver cancer is the sixth most common form of cancer and the second leading cause of death from cancer around the world. Hepatocellular carcinoma is responsible for nearly 80 percent of primary malignant liver tumors in adults and is the most common form of liver cancer. In 2012, an estimated 746,000 people died from liver cancer worldwide. Over 780,000 new cases of liver are diagnosed every year around the globe.

Nevaxar is co-developed by Onyx and Bayer and approved in the U.S. for several treatment indications. These include treatment of unresectable hepatocellular carcinoma, advanced renal cell carcinoma, and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

The STORM trial is a randomized, double-blind, placebo-controlled, Phase III trial that evaluated clinical benefit of sorafenib compared to placebo as an adjuvant treatment in patients with HCC after potential curative treatment. The trial’s primary endpoint was recurrence-free survival and its secondary endpoint included time to recurrence of HCC together with overall survival. The drug maintained the consistency of its safety findings with its known profile during the trial.

The company said it will present data from the study at an upcoming scientific congress.