US giant Johnson & Johnson (J&J, NYSE: JNJ) announced initial results from the Phase III AMPLITUDE study of Akeega (niraparib + abiraterone acetate) plus prednisone (AAP) at the 2025 ASCO Annual Meeting. The study evaluated the treatment in patients with homologous recombination repair (HRR) gene-mutated metastatic hormone-sensitive prostate cancer (mHSPC), including BRCA mutations. This marks the first Phase III trial to demonstrate clinical benefits of a PARP inhibitor combination in mHSPC.
Clinical Results
Akeega, a novel oral dual-action tablet combining niraparib (a highly selective PARP inhibitor) and abiraterone acetate (a CYP17 inhibitor), showed significant improvements in radiographic progression-free survival (rPFS) and time to symptomatic progression (TSP). The combination reduced the risk of disease progression or death by 48% and indicated an early trend toward overall survival (OS) benefit.
Safety Profile
While the combination therapy group had a higher incidence of Grade 3/4 adverse events (75% vs. 59% in the placebo group), the discontinuation rate due to adverse events remained relatively low (14.7% vs. 10.3%).-Fineline Info & Tech
