FDAnews
www.fdanews.com/articles/82207-update-provided-on-nexavar-trial

UPDATE PROVIDED ON NEXAVAR TRIAL

November 4, 2005

Bayer Pharmaceuticals and Onyx Pharmaceuticals have provided an update on the Nexavar (sorafenib tosylate) tablets Phase III trial in patients with advanced renal cell carcinoma (RCC). Based on an interim analysis, there was an estimated 39 percent improvement in survival for patients receiving Nexavar versus those receiving placebo.

This interim analysis was conducted while the study was ongoing and soon after the Bayer and Onyx decision to allow patients receiving placebo to "cross over" to treatment with Nexavar. The analysis was based on the 220 survival events (patient deaths) that had occurred by May 31, 2005. The final survival analysis, which is planned when 540 events have occurred, is not expected for some time. Therefore, while the findings of the interim analysis did not reach statistical significance, these early results suggest a favorable survival trend for patients who received Nexavar.