BAYER, ONYX REPORT POSITIVE DATA ON NEXAVAR FOR LIVER CANCER

Bayer Pharmaceuticals and Onyx Pharmaceuticals announced that an independent data monitoring committee (DMC) has reviewed the safety and efficacy data from the companies' pivotal Phase III trial in patients with advanced hepatocellular carcinoma, 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 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 give 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 the FDA and European health authorities regarding the next steps in filing for approval for the liver cancer indication.

The SHARP Trial, an international, double-blind, randomized, placebo-controlled trial, was designed to evaluate Nexavar in patients with primary liver cancer who had no prior systemic therapy. A total of 602 patients were enrolled. The primary objectives of the study are to compare overall survival and time to symptom progression in patients on Nexavar with those of patients given placebo.

Nexavar is currently approved in nearly 50 countries, including the U.S., for the treatment of patients with advanced kidney cancer.