Sorafenib Fails to Meet Primary Endpoint of Overall Survival in Advanced Nonsquamous NSCLC

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(ChemotherapyAdvisor) – The Phase 3 MISSION trial, which evaluated sorafenib (Nexavar) in patients with advanced relapsed or refractory non-squamous non–small-cell lung cancer (NSCLC) who had disease progression following 2 or 3 previous treatment regimens, did not meet its primary endpoint of improving overall survival, the agent's manufacturers announced today.

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc., added that sorafenib improved progression-free survival, a secondary endpoint. Other secondary endpoints were disease control rate, overall response rate, time to progression, and quality of life.

"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, in a press release.

The MISSION (Monotherapy admInistration of Sorafenib in patientS wIth nOn-small cell luNg cancer) trial randomized 703 patients to sorafenib 400mg twice daily plus best supportive care or placebo plus best supportive care. The study was conducted at more than 150 sites in North America, South America, Europe, Africa, and the Asia-Pacific region, including Japan.

Sorafenib safety and tolerability data were generally as expected, the companies reported. Study data will be presented at an upcoming meeting.

Clinical Trial

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