(niraparib and abiraterone acetate)
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AKEEGA® (niraparib and abiraterone acetate)
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AKEEGA - Second Progression-Free Survival (PFS2)
Last Updated: 07/11/2025
SUMMARY
In MAGNITUDE, the ongoing, phase 3 study evaluating the efficacy and safety of AKEEGA plus prednisone as first-line (L1) therapy in metastatic castration-resistant prostate cancer (mCRPC) for patients with certain homologous recombination repair (HRR) mutations, including BRCA1/2, progression-free survival on first subsequent therapy (PFS2) is a prespecified exploratory endpoint.1 - 5 - PFS2 results have been reported from a post hoc analysis that adjusted for imbalances in baseline characteristics using inverse probability of treatment weighting (IPTW) analysis (Table: Unadjusted and Adjusted Time to PFS2).4
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- PFS2 results have been reported from a post hoc analysis that adjusted for imbalances in baseline characteristics using inverse probability of treatment weighting (IPTW) analysis (Table: Unadjusted and Adjusted Time to PFS2).4
Roubaud et al (2024)4,5 reported the efficacy of niraparib with abiraterone acetate and prednisone in patients with BRCA1/2-altered mCRPC (n=225) in a MAGNITUDE post hoc analysis, adjusting for imbalances in baseline characteristics using IPTW analysis. Time-to-event outcome analyses were evaluated and multivariate analysis was conducted based on prespecified prognostic variables of overall survival in mCRPC. PFS2 outcomes using data from the final analysis are described in Table: Unadjusted and Adjusted Time to PFS2.
| NIRA/AAP (n=113) | PBO/AAP (n=112) | Hazard Ratio (95% CI) | P-Value | |
|---|---|---|---|---|
| PFS2, months | ||||
| Unadjusted, median (95% CI) | 28.7 (25.2-34.1) | 23.8 (19.5-28.6) | 0.72 (0.51-1.02) | 0.0606 |
| IPTW, median (95% CI) | 29.5 (27.0-NE) | 22.9 (18.0-25.7) | 0.58 (0.41-0.82) | 0.002 |
| Multivariate analysis | - | - | 0.64 (0.45-0.90) | 0.0116 |
| Abbreviations: AAP, abiraterone acetate plus prednisone; CI, confidence interval; IPTW, inverse probability of treatment weighting; NE, nonestimable; NIRA, niraparib; PBO, placebo; PFS2, second progression-free survival. a Note: Unadjusted hazard ratios were calculated using a stratified model, with prior AAP and prior taxane-based chemotherapy as stratification factors. | ||||
References
| 1 | Chi KN, Rathkopf D, Smith MR, et al. Protocol for: Niraparib and abiraterone acetate for metastatic castration-resistant prostate cancer. J Clin Oncol. 2023;41(18):3339-3351. |
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