Niraparib With Abiraterone Acetate Plus Prednisone as First-Line Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Repair Gene Alterations: Final Analysis of the Asian Subgroup From the MAGNITUDE Study

Ye, D; Saad, M; Lee, JY; Jung, W; Pang, ST; Li, L; Gurney, H; Attard, G; Chi, KN; Mundle, S; Zhuo, J; Singh, A; Lin, Y; Sandhu, S

Author(s): Ye, D; Saad, M; Lee, JY; Jung, W; Pang, ST; Li, L; Gurney, H; Attard, G; Chi, KN; Mundle, S; Zhuo, J; Singh, A; Lin, Y; Sandhu, S;
Details: Publication Year 2026-04,Volume 33,Issue #4,Page e70455
Journal Title: International Journal of Urology
Publication Type: Research article
Abstract: OBJECTIVES: Patients with homologous recombination repair gene altered (HRR+) metastatic castration-resistant prostate cancer (mCRPC) have a poor prognosis but achieved clinical benefits when treated with first-line niraparib and abiraterone acetate plus prednisone (niraparib + AAP) in the MAGNITUDE trial. We report final exploratory results from MAGNITUDE for the subgroup of patients with Breast Cancer gene-positive (BRCA+) mCRPC enrolled in Asia (NCT03748641). METHODS: Participants with HRR + mCRPC were randomized 1:1 to treatment with niraparib + AAP or placebo + AAP. The primary endpoint of radiographic progression-free survival (rPFS) by blinded independent central review (BICR) and secondary survival endpoints were calculated for the BRCA+ Asian subgroup. Safety was assessed in the Asian HRR+ population. RESULTS: The Asian subgroup included 35 participants with BRCA + mCRPC (all BRCA2+). After 34.99 months of follow-up, median rPFS by BICR was 38.6 months in the niraparib + AAP group versus 8.3 months in the placebo+AAP group (hazard ratio [HR] 0.33, 95% confidence interval [CI] 0.13-0.83, nominal p-value = 0.0141). Clinically relevant benefits were also observed in time to PSA progression (HR 0.32, 95% CI 0.13-0.83), and time to cytotoxic chemotherapy (HR 0.098, 95% CI 0.01-0.68). Median overall survival was not reached in the niraparib+AAP group and was 24.0 months in the placebo+AAP group (HR 0.67, 95% CI 0.27-1.71). The safety profile of niraparib+AAP was consistent with the main study population. CONCLUSIONS: In this final exploratory analysis of the Asian subgroup, participants with BRCA + mCRPC continued to benefit from first-line treatment with niraparib + AAP in comparison to placebo + AAP, with efficacy and toxicity profiles consistent with the global study population. TRIAL REGISTRATION: United States National Library of Medicine (https://clinicaltrials.gov); NCT03748641.
Publisher: Wiley
Keywords: Humans; Male; *Prostatic Neoplasms, Castration-Resistant/drug; therapy/genetics/mortality/pathology; *Prednisone/administration & dosage/adverse effects/therapeutic use; Aged; *Abiraterone Acetate/administration & dosage/adverse effects/therapeutic use; *Antineoplastic Combined Chemotherapy Protocols/therapeutic use/adverse; effects/administration & dosage; Middle Aged; *Piperidines/administration & dosage/adverse effects/therapeutic use; *Indazoles/administration & dosage/adverse effects/therapeutic use; Progression-Free Survival; Recombinational DNA Repair/genetics; Double-Blind Method; BRCA2 Protein/genetics; Asia; niraparib; prostate cancer; safety; survival
Department(s): Medical Oncology
Publisher's Version: https://doi.org/10.1111/iju.70455
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2026-05-21 04:00:20

Last Modified: 2026-05-21 04:00:28