Enzalutamide decreases the risk of death and radiographic disease progression in patients with metastatic castration-resistant prostate cancer (mCRPC) who have not received prior chemotherapy, according to the results of a planned interim analysis of the phase 3 PREVAIL trial.
In the trial, which included more than 1,700 mCRPC patients, subjects received either enzalutamide or placebo. Compared with placebo recipients, those treated with enzalutamide had a 30% reduction in the risk of death and an 81% reduction in the risk of radiographic progression or death, according to a press release issued by Medivation and Astellas, the companies marketing the drug. The percentage of patients alive at the time of the interim analysis was 72% in the enzalutamide arm compared with 65% in the placebo arm.
The Independent Data Monitoring Committee for the trial concluded that enzalutamide demonstrated a favorable benefit-risk ratio and recommended that the study be stopped and patients treated with placebo be offered enzalutamide.
Enzalutamide is a novel, oral, once-daily drug that blocks androgen from binding to androgen receptors.