Medivation and Astellas Provide Update on PREVAIL Enrollment
Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (TSE: 4503) today announced the completion of targeted enrollment of 1,680 patients in the PREVAIL study, a global Phase 3 clinical trial evaluating enzalutamide in men with advanced prostate cancer who have not yet received chemotherapy. The Companies have elected to keep selected sites open in Asia to gain additional information in these unique populations. Medivation is conducting this study under its agreement with Astellas.
"Completing the targeted patient enrollment in PREVAIL is an important step forward in our strategy to evaluate enzalutamide in earlier prostate cancer disease states," said Lynn Seely, M.D., chief medical officer of Medivation. "This study is powered to demonstrate a potential benefit in overall survival in the chemotherapy-naïve patient population."
The randomized, double-blind, placebo-controlled, multi-national Phase 3 PREVAIL trial has enrolled 1,680 patients at sites in the United States, Canada, Europe, Australia, Asia and Israel. The trial enrolled patients with metastatic prostate cancer who progressed despite treatment with androgen deprivation therapy. The co-primary endpoints of the trial are overall survival and progression-free 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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