MAGNITUDE
PARP inhibitor plus abiraterone helped men with BRCA mutations and did nothing for those without, settling a debate.
HRR-negative cohort stopped for futility; BRCA cohort rPFS HR 0.53 and OS benefit in updated analysis. Akeega (fixed-dose combination) approved 2023 for BRCA-mutant mCRPC.
Setting
First-line mCRPC: abiraterone + niraparib vs abiraterone + placebo, HRR-mutant and HRR-negative cohorts
Phase
Phase 3
Sponsor
Janssen
Registry
Headline result
BRCA cohort rPFS HR 0.53; HRR-negative futility.
Reported
2022
Enrolled
423
Replication
Consistent with PROpel and TALAPRO-2 in BRCA-mutant disease; the HRR-negative cohort showed no benefit and was stopped for futility.
In plain words
What these results mean for people, not percentages
Radiographic progression-free survival, BRCA1/2 subgroupprimarysurrogate endpoint
- Median 16.6 vs 10.9 months with Niraparib + abiraterone compared with Placebo + abiraterone; about 5.7 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 47 percent lower chance of the event at any given time (hazard ratio 0.53, likely range 0.36 to 0.79).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: First-line mCRPC: abiraterone + niraparib vs abiraterone + placebo, HRR-mutant and HRR-negative cohorts. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
423 participants enrolled.
Radiographic progression-free survival, BRCA1/2 subgroupprimary
HR 0.53 (0.36–0.79) · p = 0.001
Niraparib + abiraterone
16.6 mo
Placebo + abiraterone
10.9 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survival, BRCA1/2 subgroupprimary | Niraparib + abiraterone | 113 | 16.6 months | 0.53 (0.36–0.79) | 0.001 | link |
| Placebo + abiraterone | 112 | 10.9 months |
Replication
Consistent with PROpel and TALAPRO-2 in BRCA-mutant disease; the HRR-negative cohort showed no benefit and was stopped for futility.