Fuzuloparib (PARP inhibitor) + abiraterone extends rPFS in 1L mCRPC, with biggest lift in DRD+

FUZUPRO (NCT04691804) is an international, randomized, double-blind Phase 3 trial testing fuzuloparib (oral PARP inhibitor) 150mg BID plus abiraterone acetate/prednisone (AA-P) vs placebo + AA-P as first-line therapy for mCRPC (n=496). At the prespecified interim analysis (data cut March 23, 2025; median follow-up 33.3 months), BICR-assessed median rPFS improved to 24.8 vs 19.9 months (HR 0.71, 95% CI 0.55–0.91; 1-sided p=0.0034); in DRD+ disease (n=116) rPFS was 27.7 vs 13.9 months (HR 0.51), while DRD-negative/unknown (n=380) showed a smaller separation (22.8 vs 21.2 months; HR 0.81). OS was immature/neutral at this look (median 41.9 vs 36.8 months; HR 0.96), and the main added toxicities were hematologic—grade ≥3 anemia 20.1% plus grade ≥3 leukopenia 5.6% and thrombocytopenia/neutropenia 5.2% each (TRAEs 81.9% vs 76.0%); the efficacy magnitude looks directionally similar to the established PARP+abiraterone class signal (e.g., PROpel olaparib+abiraterone HR ~0.66 in an all-comer population), while the clearest “why treat” subgroup again appears to be HRR/DRD-enriched disease rather than biomarker-negative patients.