Final analysis of a large, open-label global early access protocol (EAP) with abiraterone acetate (AA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) progressing after chemotherapy.

5061 Background: A global EAP was conducted to provide broader access to pts with mCRPC post-chemotherapy and to generate additional clinical efficacy and safety data for AA after registrational study COU-AA-301 had completed enrollment. In COU-AA-301, a phase 3 randomized trial of 1195 pts, AA + prednisone (P) significantly prolonged median overall survival by 4.6 months with a 26% reduction (HR = 0.74 [95% CI, 0.64-0.86]; p < 0.0001) in the risk of death vs placebo + P. Methods: 2314 pts with mCRPC who progressed after a taxane and possibly 1 additional chemotherapy entered an open-label EAP. Pts received AA (1000 mg po/d) + P (5 mg BID) in 28-day cycles. Ongoing pts were to be transitioned to marketed product upon regulatory and marketing approval in individual countries. Efficacy measures, collected to guide treatment decisions, were prostate-specific antigen progression (PSAP) and clinical progression (CP). Safety assessments included treatment-emergent adverse events (AEs). The final results are pre...