New Indication: Niraparib and Abiraterone for Prostate Cancer
Study
Phase III, randomized, double-blind, placebo-controlled, multicenter (MAGNITUDE)
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Treatment naïve, Homologous Recombination Repair positive (HRR+) mCRPC
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Niraparib + Abiraterone acetat + prednizon (Niraparib + AAP group, n=212) vs. PBO + Abirateron acetat + prednizon (PBO + AAP group, n=211)
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Efficacy
BRCA1/2 mutant subgroup
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mrPFS: 16.6 vs. 10.9 mos, p=0.001
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non-BRCA1/2 mutant HRR subgroup
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mrPFS: 16.5 vs. 13.5 mos, p=0.022
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Safety
Any grade: anemia (46.2% vs. 20.4%), hypertension (31.1% vs. 20.9%), constipation (30.7% vs. 13.7%), fatigue (26.4% vs.16.6%)
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Grade≥3 AEs: Anemia (28.3% vs. 7.6%), hypertension (14.6% vs. 12.3%).
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Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer
Reviewed by Elvin Chalabiyev, MD on Apr 14, 2023
