Medivation (MDVN), Astellas Report Publication of Statistically Significant Data from AFFIRM Phase 3
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Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. announced the publication in the New England Journal of Medicine of the results from the Phase 3 AFFIRM trial, an international, randomized, double-blind, placebo-controlled clinical study of enzalutamide (formerly MDV3100) in men with metastatic castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy. The paper, "Increased Survival with Enzalutamide in Prostate Cancer After Chemotherapy," appears in the August 15 online issue of the Journal.
In the AFFIRM trial, the data showed that enzalutamide exhibited a statistically significant benefit in overall survival compared to placebo. Men treated with enzalutamide had a median overall survival of 18.4 months (95% confidence interval, 17.3 to not yet reached) compared to 13.6 months (95% confidence interval 11.3 -15.8) for men treated with placebo (hazard ratio 0.63; p < 0.0001), representing a 37 percent reduction in the risk of death.
In the Phase 3 AFFIRM trial three most common side effects observed more frequently in enzalutamide as compared with placebo-treated patients included fatigue, diarrhea and hot flush. Seizure was reported in less than 1% of enzalutamide-treated patients. Serious adverse events were lower in the enzalutamide group than in the placebo group.
In the AFFIRM trial, the data showed that enzalutamide exhibited a statistically significant benefit in overall survival compared to placebo. Men treated with enzalutamide had a median overall survival of 18.4 months (95% confidence interval, 17.3 to not yet reached) compared to 13.6 months (95% confidence interval 11.3 -15.8) for men treated with placebo (hazard ratio 0.63; p < 0.0001), representing a 37 percent reduction in the risk of death.
In the Phase 3 AFFIRM trial three most common side effects observed more frequently in enzalutamide as compared with placebo-treated patients included fatigue, diarrhea and hot flush. Seizure was reported in less than 1% of enzalutamide-treated patients. Serious adverse events were lower in the enzalutamide group than in the placebo group.
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