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Bayer and Onyx Halt Phase III Lung Cancer Trial

Posted on: Tuesday, 19 February 2008, 12:00 CST

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have reported that a Phase III trial evaluating Nexavar tablets in patients with non-small cell lung cancer or NSCLC was stopped early following a planned interim analysis, when the independent Data Monitoring Committee or DMC concluded that the study would not meet its primary endpoint of improved overall survival.

The Phase III ESCAPE (Evaluation of Sorafenib, Carboplatin And Paclitaxel Efficacy in NSCLC) trial evaluated Nexavar when administered in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with NSCLC. Safety events were generally consistent with those previously reported. However, higher mortality was observed in the subset of patients with squamous cell carcinoma of the lung treated with sorafenib and carboplatin and paclitaxel versus those treated with carboplatin and paclitaxel alone.

Bayer and Onyx are providing information regarding this DMC recommendation to health authorities and those clinical investigators involved in studies of Nexavar. In addition, the companies will further review the findings of this analysis and DMC recommendation to determine its impact on other ongoing Nexavar lung cancer trials.

Susan Kelley, vice president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals, said: "Nexavar has proven significant clinical benefit for patients with liver cancer and advanced kidney cancer and we will continue to investigate its potential across a wide variety of tumors."

Source: Datamonitor

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