Efficacy
& Safety

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.

Duo2

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.