BioCentury
ARTICLE | Clinical News

Xtandi meets in chemotherapy-naïve CRPC patients

October 23, 2013 12:48 AM UTC

Medivation Inc. (NASDAQ:MDVN) and partner Astellas Pharma Inc. (Tokyo:4503) stopped early the Phase III PREVAIL trial on the recommendation of an independent DMC after an interim analysis showed enzalutamide met the co-primary endpoints in chemotherapy-naïve metastatic castration-resistant prostate cancer (CRPC) patients. Once-daily oral enzalutamide plus standard of care (SOC) improved both median overall survival (OS) (32.4 vs. 30.2 months, HR=0.7, p<0.0001) and median radiographic progression-free survival (PFS) (not yet reached vs. 3.9 months, HR=0.19, p<0.0001) vs. placebo plus SOC. Patients in the placebo arm will now be offered enzalutamide. The double-blind, international trial enrolled 1,715 chemotherapy-naïve patients with metastatic CRPC who failed androgen deprivation therapy.

Early next year, Medivation and partner Astellas plan to submit regulatory applications in the U.S. and EU to expand the indication of enzalutamide to include chemotherapy-naïve patients with metastatic CRPC. The oral androgen receptor antagonist is approved as Xtandi in the U.S., EU, Canada and South Korea to treat metastatic CRPC in patients previously treated with docetaxel. Medivation and Astellas partnered to develop and commercialize enzalutamide in 2009. ...