Nexavar phase 3 drug trial ended

Published: Feb. 20, 2008 at 1:18 PM
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WAYNE, N.J., Feb. 21 (UPI) -- The phase 3 trial of Nexavar in those with non-small cell lung cancer halted because it didn't increase patient survival, U.S.-based unit of Bayer AG said.

The drug, co-developed by Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals Inc., said the trial has been stopped after the independent Data Monitoring Committee concluded the drug didn't meet its primary endpoint of improved overall survival.

The Phase 3 trial evaluated Nexavar, also known as sorafenib, when administered in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with non-small cell lung cancer, Bayer HealthCare Pharmaceuticals said in a statement.

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.

The randomized, double-blind, placebo controlled Phase 3 trial involved more than 900 patients in more than 140 clinics in North America, South America, Europe and Asia.

© 2008 United Press International, Inc. All Rights Reserved.
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