PROpel
Showed PARP inhibitor plus abiraterone delays progression in first-line mCRPC, with the largest benefit in BRCA-mutant men.
796 men; rPFS 24.8 vs 16.6 months (HR 0.66); OS not significant overall (HR 0.81); FDA restricted approval (2023) to BRCA-mutant disease, EMA approved all-comers.
Setting
First-line mCRPC, all-comers: abiraterone + olaparib vs abiraterone + placebo
Phase
Phase 3
Sponsor
AstraZeneca / Merck
Registry
Headline result
rPFS HR 0.66 (ITT); OS HR 0.81 (NS).
Reported
2022
Enrolled
796
Replication
Consistent with MAGNITUDE and TALAPRO-2 in HRR-mutant disease; the all-comers benefit is debated and labels differ by region.
In plain words
What these results mean for people, not percentages
Radiographic progression-free survival (investigator), all comersprimarysurrogate endpoint
- Median 24.8 vs 16.6 months with Olaparib + abiraterone compared with Placebo + abiraterone; about 8.2 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 34 percent lower chance of the event at any given time (hazard ratio 0.66, likely range 0.54 to 0.81).
- 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.
Overall survival, all comerssurvival endpoint
- Median 42.1 vs 34.7 months with Olaparib + abiraterone compared with Placebo + abiraterone; about 7.4 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 19 percent lower chance of the event at any given time (hazard ratio 0.81, likely range 0.67 to 1).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- Not significant; larger effect in BRCA-mutant.
Be careful
- These results apply to the people the trial enrolled: First-line mCRPC, all-comers: abiraterone + olaparib vs abiraterone + placebo. 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.
796 participants enrolled.
Radiographic progression-free survival (investigator), all comersprimary
HR 0.66 (0.54–0.81) · p <0.001
Olaparib + abiraterone
24.8 mo
Placebo + abiraterone
16.6 mo
Overall survival, all comers
HR 0.81 (0.67–1)
Olaparib + abiraterone
42.1 mo
Placebo + abiraterone
34.7 mo
Not significant; larger effect in BRCA-mutant
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survival (investigator), all comersprimary | Olaparib + abiraterone | 399 | 24.8 months | 0.66 (0.54–0.81) | <0.001 | link |
| Placebo + abiraterone | 397 | 16.6 months | ||||
| Overall survival, all comers | Olaparib + abiraterone | — | 42.1 months | 0.81 (0.67–1) | — | link |
| Placebo + abiraterone | — | 34.7 months |
Replication
Consistent with MAGNITUDE and TALAPRO-2 in HRR-mutant disease; the all-comers benefit is debated and labels differ by region.