Phase 3 Study Update for Zytiga Plus Prednisone in Metastatic Castration-Resistant Prostate Cancer

Janssen Research & Development announced further results from pre-specified interim analyses of the Phase 3 study of Zytiga (abiraterone acetate) plus prednisone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC). Results showed a statistically significant improvement in radiographic progression-free survival (rPFS) and a trend for increased median overall survival (OS), the co-primary endpoint, in patients receiving Zytiga plus prednisone.

The COU-AA-302 study was an international, randomized, double-blind, placebo controlled study that included 1,088 asymptomatic or mildly symptomatic patients with mCRPC who had not received chemotherapy. Data showed statistically significant improvement in rPFS in the Zytiga arm of the study compared to the control arm (n=150 vs. 251, respectively; HR=0.43; 95% confidence interval [0.35, 0.52]; P<0.0001). Additionally, treatment with Zytiga plus prednisone resulted in an estimated 33% improvement in survival (HR=0.75; 95% confidence interval: [0.61, 0.93], P=0.0097).

Zytiga in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel.

For more information call (800) 457-6399 or visit www.zytiga.com