Significant efficacy after a median 4 years (49 months) of follow-up
In the final analysis of overall survival (OS) from the pivotal Phase 3 study,* ZYTIGA® + prednisone achieved:
MEDIAN OVERALL SURVIVAL
for ZYTIGA® + prednisone vs 30.3 months with placebo + prednisone (active compound).‡
IMPROVEMENT IN MEDIAN OVERALL SURVIVAL
compared with placebo + prednisone.
Co-primary end point—OS: hazard ratio (HR)=0.81; 95% CI: 0.70, 0.93;P=0.0033.
Co-primary end point—rPFS: at the prespecified radiographic progression-free survival (rPFS) analysis, median not reached for ZYTIGA® + prednisone vs a median of 8.28 months for placebo + prednisone; HR=0.425; 95% CI: 0.347, 0.522; P<0.0001.
35% of patients in the ZYTIGA® + prednisone arm were still alive vs 29% in the placebo + prednisone arm after a median follow-up of 49 months†
*COU-AA-302 Study - Phase 3 Study conducted in patients with mCRPC who had not received prior chemotherapy. †At a prespecified final analysis for OS, 65% (354/546) of patients treated with ZYTIGA® plus prednisone compared with 71% (387/542) of patients treated with placebo plus prednisone had died. ‡Prednisone, as a single agent, is not approved for the treatment of prostate cancer.