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Phase 3 Trial of Nexavar in First-Line Advanced Non-Small Cell Lung Cancer Does Not Meet Primary Endpoint of Overall Survival
Date:6/14/2010

ermine what, if any, impact these data might have on other ongoing clinical trials evaluating the safety and efficacy of Nexavar.

"Bayer and Onyx are disappointed with these results, in particular, for patients who are suffering from this deadly disease," said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare.  "We are confident in our clinical trial program exploring Nexavar's potential in a variety of tumor types, including lung cancer.  Based on encouraging data from a recently presented prospective biomarker trial and Phase 2 signal-generating lung cancer studies, we believe it's critical to continue our evaluation of Nexavar in combination with targeted agents and as a monotherapy in later lines of treatment in lung cancer patients."

Nexavar is being evaluated by the companies and individual investigators in a variety of treatment settings for patients with non-small cell lung cancer, including a Phase 3 monotherapy study in the third- and fourth-line setting and Phase 2 studies in combination with other therapies in the second-line setting.

NExUS Trial Design

This Phase 3, randomized, double-blind, placebo-controlled study evaluated Nexavar (sorafenib) tablets in combination with the chemotherapeutic agents, gemcitabine and cisplatin, in treatment-naive non-small cell lung cancer patients.  The primary endpoint was overall survival, and secondary endpoints included progression-free survival, tumor response and safety.  Patients were randomized to receive 400 mg of oral Nexavar or matching placebo twice daily, in addition to gemcitabine and cisplatin for up to six cycles.  Subsequently, patients continued in a maintenance phase where Nexavar or placebo was administered as a single agent.  The study enrolled approximately 90
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SOURCE Bayer HealthCare Pharmaceuticals, Inc.; Onyx Pharmaceuticals, Inc.
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