ALPHAMEDIX-02
An alpha-emitting radioligand met all its primary endpoints, with responses in more than half of patients new to radioligand therapy.
ORR 54.3% in PRRT-naive patients; ~70-75% progression-free at ~3 years; PRRT-exposed cohort ~83% progression-free at 18 months (Sanofi, October 2025). Breakthrough Therapy designation (2024). Registrational path being finalised.
Setting
Unresectable or metastatic SSTR-positive GEP-NETs, PRRT-naive and PRRT-exposed cohorts: 212Pb-DOTAMTATE single arm
Phase
Phase 2
Sponsor
RadioMedix / Orano Med / Sanofi
Registry
Headline result
ORR 54.3% (PRRT-naive); all primary endpoints met.
Reported
2025
In plain words
What these results mean for people, not percentages
Objective response rate (PRRT-naive)primaryresponse endpoint
- 54.3 out of 100 people had their tumour shrink with 212Pb-DOTAMTATE.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Unresectable or metastatic SSTR-positive GEP-NETs, PRRT-naive and PRRT-exposed cohorts: 212Pb-DOTAMTATE single arm. 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.