rPFS HR 0.41; OS confounded by 84% crossover. Approved 2025 in pre-chemotherapy setting.
Setting
PSMA+ mCRPC after one ARPI, taxane-naive: 177Lu-PSMA-617 vs ARPI switch
Phase
Phase 3
Sponsor
Novartis
Registry
Headline result
rPFS HR 0.41.
Reported
2023
Enrolled
468
Replication
Confirms VISION in the pre-chemotherapy line; SPLASH (177Lu-PSMA-I&T) showed a smaller rPFS effect and no OS benefit, so agent and setting details matter.
In plain words
What these results mean for people, not percentages
Radiographic progression-free survivalprimarysurrogate endpoint
- Median 12 vs 5.6 months with 177Lu-PSMA-617 compared with ARPI switch; about 6.4 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 59 percent lower chance of the event at any given time (hazard ratio 0.41, likely range 0.29 to 0.56).
- 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 (crossover-adjusted)survival endpoint
- The treated group had about 41 percent lower chance of the event at any given time (hazard ratio 0.59).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- Unadjusted OS HR 0.98 with 84% crossover from control
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- Unadjusted OS HR 0.98 with 84% crossover from control.
Be careful
- These results apply to the people the trial enrolled: PSMA+ mCRPC after one ARPI, taxane-naive: 177Lu-PSMA-617 vs ARPI switch. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PSMA); the result should not be assumed for people whose cancer does not have it.
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.
468 participants enrolled.
Radiographic progression-free survivalprimary
HR 0.41 (0.29–0.56) · p <0.0001
177Lu-PSMA-617
12 mo
ARPI switch
5.6 mo
Overall survival (crossover-adjusted)
HR 0.59
Unadjusted OS HR 0.98 with 84% crossover from control
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survivalprimary | 177Lu-PSMA-617 | 234 | 12 months | 0.41 (0.29–0.56) | <0.0001 | link |
| ARPI switch | 234 | 5.6 months | ||||
| Overall survival (crossover-adjusted) | 177Lu-PSMA-617 | — | Unadjusted OS HR 0.98 with 84% crossover from control | 0.59 | — | link |
| ARPI switch | — | — |
Replication
Confirms VISION in the pre-chemotherapy line; SPLASH (177Lu-PSMA-I&T) showed a smaller rPFS effect and no OS benefit, so agent and setting details matter.