Johnson & Johnson has announced the results of the Phase 3 AMPLITUDE study, which evaluates the combination of niraparib and abiraterone acetate plus prednisone in patients with metastatic castration-sensitive prostate cancer (mCSPC) with homologous recombination repair $(HRR.AU)$ genetic alterations, including BRCA. The study demonstrated a significant improvement in radiographic progression-free survival and time to symptomatic progression, with an early indication of enhanced overall survival. This marks the first Phase 3 data showing clinical improvement with a PARP-based combination in mCSPC. The results indicate a nearly 50 percent reduction in disease progression in BRCA-altered mCSPC compared to the standard of care. These findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting and have been included in the ASCO Press Program.
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