Johnson & Johnson's AKEEGA® (niraparib and abiraterone acetate dual-action tablet) is the first PARP inhibitor combo to show improved efficacy in patients with HRR-mutated mHSPC vs. current standard of care

Core Insights - The Phase 3 AMPLITUDE study demonstrates the efficacy of the combination of niraparib and abiraterone acetate in delaying cancer progression and symptom worsening in patients with metastatic hormone-sensitive prostate cancer (mHSPC) with homologous recombination repair (HRR) genetic alterations, particularly BRCA [1][2][3] Study Results - The study involved 696 patients and met its primary endpoint of radiographic progression-free survival (rPFS), showing a nearly 50% reduction in disease progression for patients with BRCA alterations, with a hazard ratio (HR) of 0.52 [1][3] - Patients with any HRR alteration also benefited, with a 37% reduction in risk of progression (HR 0.63) [1] - The combination treatment reduced the risk of symptomatic progression by 56% in BRCA patients and 50% in all HRR-altered patients [1] Clinical Implications - Approximately 25% of mHSPC patients have HRR alterations, with BRCA mutations leading to faster disease progression and poorer outcomes [1][2] - The AMPLITUDE trial is the first to show clinical improvement with a PARP inhibitor-based combination in mHSPC, suggesting a new treatment option for these patients [1][2] Safety Profile - Grade 3/4 adverse events were more frequent in the niraparib combination group (75% vs. 59% in placebo), but treatment discontinuations due to adverse events remained low [1][3] Future Directions - The findings highlight the need for early initiation of personalized treatment strategies for patients with mHSPC and HRR alterations, particularly BRCA [1][2]