Bayer and Onyx Initiate Phase 3 Trial of Nexavar in Non-Small Cell L... ( WAYNE N.J. and EMERYVILLE Calif. June...)

Bayer and Onyx Initiate Phase 3 Trial of Nexavar in Non-Small Cell Lung Cancer

Date:6/1/2009

WAYNE, N.J. and EMERYVILLE, Calif., June 1 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the companies have begun enrolling patients in an international Phase 3 trial to evaluate Nexavar(R) (sorafenib) tablets in patients with non-squamous non-small cell lung cancer (NSCLC) who have failed two or three previous treatments.

"Nexavar has proven efficacy in liver cancer and kidney cancer and we are committed to researching Nexavar in a variety of other solid tumors," said Dimitris Voliotis, MD, vice president, Nexavar Clinical Development, Bayer HealthCare Pharmaceuticals. "Based on the results of a signal generating Phase 2 study, Bayer and Onyx initiated this Phase 3 trial to evaluate Nexavar in non-small cell lung cancer."

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 will enroll approximately 850 patients with advanced relapsed or refractory non-squamous NSCLC who have failed two or three previous treatments. Patients will be randomized to receive either Nexavar as single agent or placebo. In both treatment arms, best supportive care will be provided. The primary endpoint of this trial is overall survival, and secondary endpoints include progression-free survival and overall response rate. The safety and tolerability of the two treatment groups will also be compared.

The study will be conducted at more than 120 sites in North America, South America, Europe, Africa and the Asia-Pacific region, including Japan. For information about this study, please visit www.clinicaltrials.gov.

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