Johnson & Johnson’s Akeega tablet shows delay in cancer progression

Johnson & Johnson announced first results from the Phase 3 AMPLITUDE study evaluating the combination of niraparib and abiraterone acetate plus prednisone, or AAP, in patients with metastatic castration-sensitive prostate cancer, or 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 and time to symptomatic progression , with an early trend toward improved overall survival. This marks the first Phase 3 data to show clinical improvement with a PARP-based combination in mCSPC. The findings are being presented at the 2025 ASCO Meeting. The Phase 3 AMPLITUDE study of 696 patients with mCSPC and HRR alterations met its primary endpoint of rPFS. Patients with BRCA alterations showed the greatest benefit of treatment with the combination of niraparib plus AAP, as the median rPFS was not reached compared to 26 months in patients treated with the placebo plus AAP, reducing the risk of radiographic progression or death by 48%. In patients with any HRR alteration treated with the niraparib combination, median rPFS was also not reached in comparison to 29.5 months in patients treated with the placebo plus AAP, with a reduction in risk of progression or death by 37%. Treatment with the niraparib combination reduced the risk of symptomatic progression by 56% in patients with BRCA alterations and 50% in patients with HRR alterations. To date, the safety profile of niraparib plus abiraterone acetate and prednisone has been consistent with prior experiences.