BioCentury
ARTICLE | Clinical News

Medivation jumps on PREVAIL data

January 30, 2014 2:18 AM UTC

Medivation Inc. (NASDAQ:MDVN) jumped $8.51 (11%) to $84.29 on Wednesday after the company and partner Astellas Pharma Inc. (Tokyo:4503) reported final data from the Phase III PREVAIL trial evaluating Xtandi enzalutamide in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC). Once-daily oral Xtandi plus standard of care (SOC) significantly increased time to initiation of chemotherapy (28 vs. 10.8 months, p<0.0001) and median time to prostate-specific antigen ( KLK3; PSA) progression (11.2 vs. 2.8 months, HR=0.17, p<0.0001) vs. placebo plus SOC. Data were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco. The double-blind, international trial enrolled 1,715 CRPC patients who failed androgen deprivation therapy.

In October, PREVAIL was stopped early on the recommendation of an independent DMC after an interim analysis showed that Xtandi plus SOC met the co-primary endpoints of improving median overall survival (OS) (32.4 vs. 30.2 months, p<0.0001) and median radiographic progression-free survival (PFS) (not yet reached vs. 3.9 months, p<0.0001) vs. placebo plus SOC (see BioCentury Extra, Oct. 22, 2013). ...