Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that an independent data monitoring committee (DMC) has reviewed the safety and efficacy data from the companies’ pivotal Phase 3 trial in patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer.
Based on this planned interim analysis, the DMC has concluded that the trial met its primary endpoint resulting in superior overall survival (OS) in those patients receiving Nexavar? (sorafenib) tablets versus those patients receiving placebo. The DMC also noted that there was no demonstrated difference in serious adverse event rates between the two treatment arms (Nexavar and placebo). Based on these conclusions, the DMC recommended that the trial be stopped early.
As a result of this recommendation, Bayer and Onyx will stop the trial and allow all patients enrolled in this trial access to Nexavar. Given that there are limited approved systemic therapies for this disease, the companies will continue discussions with health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and European health authorities regarding the next steps in filing for approval for the treatment of HCC. Following these discussions, the companies will proceed to file as rapidly as possible. The two companies also reported that they plan to submit the results from the trial to the American Society of Clinical Oncology (ASCO), for presentation at its annual meeting, June 1-5, 2007.
“The observed superiority in overall survival for Nexavar-treated patients over patients receiving placebo demonstrates the efficacy of Nexavar in advanced primary liver cancer,” said Dr. Jordi Bruix, co-principal investigator and Head of the Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona, Spain.
Dr. Josep M. Llovet, co-principal investigator and Associate Professor of Medicine/Director, HCC Research Program, Division of Liver Diseases, Mount Sinai School of Medicine, New York, and Professor of Research at Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic Barcelona added, “These results point to new potential treatment options for those patients suffering from this devastating disease.”