Phase 3 Trial of Nexavar in First-Line Advanced Non-Small Cell Lung Cancer Does Not Meet Primary Endpoint of Overall Survival

Mon, 06/14/2010 - 12:37am

WAYNE, N.J. and EMERYVILLE, Calif., June 14 /PRNewswire-FirstCall/ -- 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 det




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