Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announced that a Phase 3 trial evaluating Nexavar (sorafenib) tablets in patients with unresectable stage III or stage IV melanoma was stopped early following a planned interim analysis by the independent Data Monitoring Committee (DMC). The DMC concluded that the study would not meet the primary endpoint of improved overall survival among patients receiving Nexavar in combination with the chemotherapeutic agents carboplatin and paclitaxel versus patients receiving placebo plus the chemotherapeutic agents. The treatment effect was comparable in each arm.
Nexavar is a multikinase inhibitor indicated for the treatment of advanced renal cell carcinoma and unresectable hepatocellular carcinoma.
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