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Bayer/Onyx Nexavar trial update

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bayer/Onyx' interim analysis of a pivotal renal cell carcinoma trial of Nexavar (sorafenib), conducted after placebo-treated patients crossed over to Nexavar, finds that the oral multi-kinase inhibitor "did not reach statistical significance (p<0.0005)," the firms say Nov. 3. Nevertheless, "these early results suggest a favorable survival trend." Based on the cross-over analysis, "there was an estimated 39% improvement in survival for patients receiving Nexavar versus those receiving placebo (p=0.018; hazard ratio=0.72)." The analysis was based on 220 survival events (patient deaths), while the final analysis is planned "when 540 events have occurred." The Nexavar NDA, submitted July 11, is based on 24-week data from the trial, in which a highly statistically significant progression-free survival benefit was seen (1Pharmaceutical Approvals Monthly August 2005, p. 14)...
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