Astellas Pharma and Medivation announced data from the Phase 2 STRIVE trial comparing Xtandi (enzalutamide) and bicalutamide in non-metastatic (M0) and metastatic (M1) prostate cancer patients whose disease progressed despite treatment with a luteinizing hormone-releasing hormone (LHRH) analogue therapy of following surgical castration.
The STRIVE trial randomized 257 patients with metastatic prostate cancer and 139 patients with non-metastatic prostate cancer whose disease progressed despite treatment with a LHRH analogue therapy or following surgical castration. The primary endpoint of the trial was progression-free survival (PFS), defined as time from randomization to radiographic (bone or soft tissue) progression, PSA progression (defined by Prostate Cancer Working Group 2 criteria), or death due to any cause, whichever occurs first.
The study achieved its primary endpoint demonstrating a statistically significant increase in PFS for enzalutamide compared with bicalutamide (HR=0.24; 95% CI, 0.18–0.32; P<0.0001). The median PFS was 19.4 months in the enzalutamide arm and 5.7 months in the bicalutamide arm.