Bayer and Onyx' Nexavar fails in Ph III lung cancer study

23 May 2012

There was disappointment for German drug major Bayer (BAYB: DE) and partner Onyx Pharmaceuticals (Nasdaq: ONXX), when the companies reported that a Phase III trial evaluating Nexavar (sorafenib) 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. Nexavar, which is approved for liver and kidney cancer, is important for Bayer; it is set for blockbuster status, generating first-quarter 2012 revenues of 186 million euros ($236.6 million).

"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 Dimitris Voliotis, vice president, global clinical development oncology, at the groups Bayer HealthCare unit.

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