COMPETE
The first head-to-head trial of a radioligand against a targeted pill in neuroendocrine tumours; the radioligand won on progression-free survival.
PFS 23.9 vs 14.1 months (HR 0.67, p=0.022); ORR significantly higher; interim OS 63.4 vs 58.7 months (HR 0.78, not significant). Published in The Lancet (2025). Supports the FDA filing with a 28 August 2026 PDUFA date.
Setting
Progressive grade 1-2 SSTR-positive GEP-NETs: 177Lu-edotreotide vs everolimus
Phase
Phase 3
Sponsor
ITM Isotope Technologies Munich
Registry
Headline result
PFS 23.9 vs 14.1 months, HR 0.67.
Reported
2025
Enrolled
309
In plain words
What these results mean for people, not percentages
Progression-free survivalprimarysurrogate endpoint
- Median 23.9 vs 14.1 months with 177Lu-edotreotide compared with Everolimus; about 9.8 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 33 percent lower chance of the event at any given time (hazard ratio 0.67, likely range 0.48 to 0.95).
- 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 (interim)survival endpoint
- Median 63.4 vs 58.7 months with 177Lu-edotreotide compared with Everolimus; about 4.7 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 22 percent lower chance of the event at any given time (hazard ratio 0.78, likely range 0.5 to 1.1).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
- These results apply to the people the trial enrolled: Progressive grade 1-2 SSTR-positive GEP-NETs: 177Lu-edotreotide vs everolimus. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (SSTR); 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.
309 participants enrolled.
Progression-free survivalprimary
HR 0.67 (0.48–0.95) · p = 0.022
177Lu-edotreotide
23.9 mo
Everolimus
14.1 mo
Overall survival (interim)
HR 0.78 (0.5–1.1) · p = 0.206
177Lu-edotreotide
63.4 mo
Everolimus
58.7 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survivalprimary | 177Lu-edotreotide | 207 | 23.9 months | 0.67 (0.48–0.95) | 0.022 | — |
| Everolimus | 102 | 14.1 months | ||||
| Overall survival (interim) | 177Lu-edotreotide | — | 63.4 months | 0.78 (0.5–1.1) | 0.206 | — |
| Everolimus | — | 58.7 months |