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Medivation, Astellas PREVAIL Trial Meets Endpoints

Enzalutamide demonstrates favorable benefit-risk ratio

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Medivation, Inc. and Astellas Pharma achieved positive results based on interim analysis of the global Phase III PREVAIL trial of enzalutamide in more than 1,700 men with metastatic prostate cancer that has progressed despite androgen deprivation therapy and who have not yet received chemotherapy. The trial’s co-primary endpoints are overall survival and radiographic progression-free survival. An Independent Data Monitoring Committee concluded enzalutamide demonstrated a favorable benefit-risk ratio and recommended patients treated with placebo be offered enzalutamide.  
 
The percentage of patients alive in the enzalutamide arm was 72% as compared with 65% in the placebo arm. Treatment with enzalutamide resulted in median overall survival of 32.4 months versus 30.2 months for patients receiving placebo. The median radiographic progression-free survival was not yet reached (95% confidence interval, 13.8 months-upper limit not yet reached) in the enzalutamide arm and was 3.9 months in the placebo arm.

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