Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the final analysis of the Phase 3 NExUS (NSCLC research Experience Utilizing Sorafenib) trial evaluating Nexavar® (sorafenib) tablets in patients with advanced non-squamous non-small cell lung cancer (NSCLC) showed that the study did not meet its primary endpoint of improving overall survival in the first-line setting.  NExUS evaluated Nexavar versus placebo in combination with two chemotherapeutic agents, gemcitabine and cisplatin.  A positive secondary endpoint of progression-free survival (PFS) was observed in the trial.  The safety and tolerability of the treatment triplet was as expected and did not show any new or unexpected toxicities.  Data from this study are expected to be presented at an upcoming scientific meeting.

Nexavar is currently marketed worldwide for the treatment of hepatocellular carcinoma (HCC), or liver cancer, and advanced renal cell carcinoma (RCC), or kidney cancer.

Enrollment in NExUS commenced in February 2007. In 2008, based on the results seen in a previous Nexavar first-line NSCLC Phase 3 trial, the NExUS study protocol was amended to stop enrolling and treating squamous cell carcinoma patients.  Of the squamous cell patients who were enrolled in the NExUS trial before the amendment, a higher mortality was observed.  This finding was consistent with what was seen in the previous trial.  

Bayer and Onyx will further review the findings of this analysis to determine what, if any, impact these data might have on other ongoing clinical trials evaluating the safety and efficacy of Nexavar.

"Bayer and Onyx are disappointed with these results, in particular, for patients who are suffering from this deadly disease," said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare.  "We are confident in our clinical trial program exploring Nexavar's potential in a variety of tumor types, including lung cancer.  Based on encouraging data from a recently presented prospective biomarker trial and Phase 2 signal-generating lung cancer studies, we believe it's critical to continue our evaluation of Nexavar in combination with targeted agents and as a monotherapy in later lines of treatment in lung cancer patients."

Nexavar is being evaluated by the companies and individual investigators in a variety of treatment settings for patients with non-small cell lung cancer, including a Phase 3 monotherapy study in the third- and fourth-line setting and Phase 2 studies in combination with other therapies in the second-line setting.