Xtandi (Medivation/Astellas) success as pre-chemotherapy treatment for Prostate Cancer
The Independent Data Monitoring Committee (IDMC) has confirmed positive results from a planned interim analysis of the Phase III PREVAIL trial of Xtandi (enzalutamide) from Medivation/Astellas, in more than 1,700 men with metastatic castration-resistant Prostate Cancer (mCRPC) that has progressed despite androgen deprivation therapy and who have not received chemotherapy. Enzalutamide provided a 30% reduction in risk of death compared with placebo and provided an 81% reduction in risk of radiographic progression or death compared with placebo. The percentage of patients alive in the enzalutamide arm was 72% as compared with 65% in the placebo arm. Treatment with enzalutamide also resulted in a calculated median overall survival of 32.4 months versus 30.2 months for patients receiving placebo. Given the observed benefits, and considering the observed safety profile, the IDMC concluded enzalutamide demonstrated a favourable benefit-risk ratio. The IDMC recommended the study be stopped and patients treated with placebo be offered enzalutamide.
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