Bayer’s Nexavar Phase 3 trial on NSCLC does not meet primary endpoint

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a Phase 3 trial evaluating Nexavar® (sorafenib) tablets in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer (NSCLC) whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival.  An improvement in the secondary endpoint of progression-free survival (PFS) was observed.

The study compared Nexavar plus best supportive care to placebo plus best supportive care. The safety and tolerability data were generally as expected.  The data will be presented at an upcoming scientific meeting.

"While we are disappointed that the primary endpoint was not met, we believe the study results will advance the scientific knowledge in lung cancer," said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare.

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