Niraparib and Abiraterone Acetate plus Prednisone in Metastatic Castration-resistant Prostate Cancer: Final Overall Survival Analysis for the Phase 3 MAGNITUDE Trial

BACKGROUND AND OBJECTIVE: ), particularly in BRCA1/2. METHODS: Patients were prospectively screened for HRR alterations and randomized 1:1 to niraparib + AAP (n = 212) or placebo + AAP (n = 211). We report results from the prespecified, event-driven, final analysis of secondary efficacy endpoints. KEY FINDINGS AND LIMITATIONS: population (HR 0.688, 95% CI 0.499-0.950; p = 0.022) and the BRCA1/2 subgroup (HR 0.598, 95% CI 0.387-0.924; nominal p = 0.019) in comparison to placebo + AAP. The niraparib + AAP safety profile remains unchanged at longer follow-up; adverse events were primarily hematologic and manageable. CONCLUSIONS AND CLINICAL IMPLICATIONS: mCRPC, including those with the approved indication of BRCA-altered mCRPC, generally continue to benefit from first-line treatment with niraparib + AAP in comparison to placebo + AAP.