(niraparib and abiraterone acetate)
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AKEEGA® (niraparib and abiraterone acetate)
Medical Information
AKEEGA - Second Progression-Free Survival (PFS2)
Last Updated: 12/23/2025
SUMMARY
In MAGNITUDE, the 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 Brease cancer genes (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
- The AMPLITUDE study is a phase 3 study evaluating the efficacy and safety of AKEEGA with prednisone plus androgen deprivation therapy (ADT) compared to matching oral placebo/abiraterone acetate plus prednisone (AAP) plus ADT in patients with deleterious germline or somatic HRR gene-altered metastatic castration-sensitive prostate cancer (mCSPC, N=696).6
- Patients treated with AKEEGA plus abiraterone experienced a longer PFS2 compared to abiraterone alone (median, nonestimable [NE] vs 44.0 months; hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.51-0.86; nominal P=0.002).
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. | ||||
Attard et al (2025)6 reported the efficacy and safety results of AKEEGA with prednisone plus ADT vs placebo/AAP plus ADT in patients with deleterious germline or somatic HRR gene-altered mCSPC (N=696).
- Patients treated with AKEEGA plus abiraterone experienced a longer PFS2 compared to abiraterone alone (median, NE vs 44.0 months; HR, 0.66; 95% CI, 0.51-0.86; nominal P=0.002).
- PFS2 results are listed in Table: PFS2 Results in the AMPLITUDE Study.
| BRCA subgroup | HRR Effector subgroup | ITT population | ||||
|---|---|---|---|---|---|---|
| AKEEGA + Prednisone Group (n=191) | PBO/AAP Group (n=196) | AKEEGA + Prednisone Group (n=230) | PBO/AAP Group (n=226) | AKEEGA + Prednisone Group (N=348) | PBO/AAP Group (N=348) | |
| Median PFS2, months | NE | 44.0 | NE | 44.0 | NE | 44.0 |
| HR (95% CI) | 0.59 (0.41-0.83) | 0.63 (0.45-0.87) | 0.66 (0.51-0.86) | |||
| P-Value | Nominal P=0.0026a | Nominal P=0.0049a | Nominal P=0.0017a | |||
| Abbreviations: AAP, abiraterone acetate with prednisone; CI, confidence interval; HR, hazard ratio; NE, not estimable; PBO, placebo; PFS2, second progression-free survival. aThese endpoints were not adjusted for multiple comparisons. Therefore, the P-values displayed are nominal, and statistical significance has not been established. b c | ||||||
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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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