Bayer AG (BAYRY) recently announced that a phase III trial of Nexavar (sorafenib), co-developed and marketed with Onyx Pharmaceuticals Inc. (ONXX), failed to meet the primary endpoint.
The MISSION (Monotherapy administration of Sorafenib in patients with non-small cell lung cancer) trial was designed to evaluate Nexavar plus best supportive care versus placebo plus best supportive care in treatment-experienced patients with advanced relapsed or refractory non-squamous non-small cell lung cancer (:NSCLC).
While Nexavar failed to meet the primary endpoint of overall survival, it showed an improvement in progression-free survival (PFS), a secondary endpoint. The drug was also safe and well-tolerated.
Currently, Nexavar is approved for the treatment of unresectable liver cancer and advanced kidney cancer. Onyx and Bayer have been working on expanding Nexavar’s label for additional indications including thyroid cancer and breast cancer. Nexavar is currently in phase III development for both indications. Label expansion would help boost Nexavar sales, which came in at $1.0 billion (as recorded by Bayer) in 2011.
Our Take
The failure of the phase III NSCLC trial is disappointing. The NSCLC indication represented significant potential - about 85-90% of diagnosed lung cancer cases are NSCLC. According to Bayer, approximately 226,000 and 417,000 new cases of lung cancer occur in the U.S. and Europe every year.
We currently have a Neutral recommendation on Bayer in the long run. The company carries a Zacks #3 Rank (Hold rating) in the short run.
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