Medivation, Inc. (MDVN) and Astellas Pharma Inc. Monday said the companies have established an updated interim analysis plan for the PREVAIL trial, a global Phase 3 clinical trial evaluating androgen receptor inhibitor Xtandi (enzalutamide) capsules in men with metastatic castration-resistant prostate cancer or mCRPC who have not yet received chemotherapy.
The planned interim analysis for the PREVAIL trial is expected to occur in 2013. Additionally, the protocol-specified number of radiographic progression-free survival or PFS events has been exceeded. The primary PFS analysis will occur at the time of the interim analysis for overall survival.
Medivation is conducting this study under its agreement with Astellas.
The randomized, double-blind, placebo-controlled, multi-national Phase 3 PREVAIL trial had met its enrollment goals in May 2012. The trial includes 1,717 patients who have progressed following treatment with a luteinizing hormone releasing hormone or LHRH analog drug only, as well as patients who have progressed following treatment with both an LHRH analog drug and an anti-androgen drug.
The study co-primary endpoints are radiographic progression-free survival and overall survival. Secondary endpoints include time to first skeletal-related event and time to initiation of chemotherapy.
The trial is designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily plus standard of care versus placebo plus standard of care.
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