Astellas, Medivation Start Enzalutamide Phase 4 Trial - Quick Fact

(RTTNews) - Astellas Pharma US, Inc., a U.S. subsidiary of Astellas Pharma Inc. (ALPMY, ALPMY), and Medivation, Inc. (MDVN) announced the initiation of a Phase 4 clinical trial, known as PLATO. The study will evaluate the efficacy and safety of continued treatment with enzalutamide plus abiraterone acetate and prednisone as compared to treatment with abiraterone acetate and prednisone alone in patients with chemotherapy-naïve metastatic prostate cancer whose disease has progressed following enzalutamide therapy.

Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway.

The Phase 4 global randomized, double-blind, placebo-controlled trial is designed to enroll approximately 500 chemotherapy-naïve patients with metastatic castration-resistant prostate cancer. All enrolled patients will initially receive treatment with enzalutamide. Eligible patients with disease progression on enzalutamide will be randomized to treatment with enzalutamide plus abiraterone acetate and prednisone or to abiraterone acetate and prednisone. The primary endpoint of the trial is progression-free survival.