Johnson & Johnson's AKEEGA Combo Shows Nearly 50% Reduction In Disease Progression For BRCA-Altered Prostate Cancer In Phase 3 AMPLITUDE Study

Results from the Phase 3 AMPLITUDE study show the potential of AKEEGA® (niraparib and abiraterone acetate dual-action tablet) to delay cancer progression and worsening of symptoms

Data show a nearly 50 percent reduction in disease progression in BRCA-altered mCSPC vs. current standard of care

CHICAGO, June 3, 2025 /PRNewswire/ -- Johnson & Johnson announced today first results from the Phase 3, randomized, double-blind, placebo-controlled AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair (HRR) genetic alterations including BRCA. The results show a clinically meaningful and statistically significant improvement in both radiographic progression-free survival (rPFS) and time to symptomatic progression (TSP), with an early trend toward improved overall survival (OS)—highlighting the potential of the combination in this patient population to delay both cancer progression and the worsening of symptoms.1 This marks the first Phase 3 data to show clinical improvement with a PARP-based combination in mCSPC. The findings are being presented as a late-breaking oral presentation (Abstract #LBA5006) at the 2025 American Society of Clinical Oncology Annual Meeting. The data have also been selected for Best of ASCO and included in the ASCO Press Program.