Multinational phase 3 trial of niraparib and abiraterone acetate for metastatic castration-resistant prostate cancer

Metastatic castration-resistant prostate cancer (mCRPC) remains a lethal disease with current-standard-of-care therapies. The multinational phase 3 MAGNITUTDE trial prospectively enrolled previously untreated mCRPC patients in two cohorts on the basis of HRR biomarker status, and compared the efficacy and safety of niraparib plus abiraterone acetate plus prednisone (AAP) versus placebo plus AAP. Among the HRR+ patients, the radiographic progression-free survival was significantly longer with niraparib plus AAP compared with placebo plus AAP, with no new safety signals. Among the HRR- patients, the rPFS was similar in the two groups. The authors conclude that these results underscore the need for HRR gene testing in metastatic prostate cancer and support the use of niraparib plus AAP as first-line therapy.