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Phase 3 MISSION trial of Nexavar (sorafenib) in Patients with Non-Small Cell Lung Cancer Did Not Meet Primary Endpoint of Improving Overall Survival
Date:5/22/2012

WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., May 22, 2012 /PRNewswire/ -- 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.

Phase 3 Trial Design

The MISSION (Monotherapy admInistration of Sorafenib in patientS wIth nOn-small cell luNg cancer) trial is an international multicenter study that randomized 703 patients with advanced relapsed or refractory non-squamous NSCLC whose disease progressed after two or three previous treatments. Patients were randomized to receive either Nexavar as single agent or placebo. In both study arms, best supportive care was provided. The primary endpoint of the trial was overall survival, and secondary endpoints included progression-free survival, disease control rate, overall response rate, time to progression and quality of life.

The study was conducted at more than 150 sites in North America, South America, Europe, Africa and the Asia-Pacific region, inclu
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SOURCE Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc.
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