Bayer, Onyx Report Primary Endpoint of Phase 3 Study Results of NEXAVAR as Adjuvant Treatment for Patients with Liver Cancer Who Have Undergone Surgery or Local Ablation was Not Met
Bayer HealthCare Pharmaceuticals (OTC: BAYRY) and Onyx Pharmaceuticals, Inc., an Amgen subsidiary (Nasdaq: AMGN), today announced that a Phase 3 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.
"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," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "The outcome announced today does not affect the currently approved indications. NEXAVAR is approved for the treatment of patients with unresectable liver cancer."
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