ALPHAMEDIX-02
An alpha-emitting radioligand met all its primary endpoints, with responses in more than half of patients new to radioligand therapy.
Overview
ALPHAMEDIX-02, trial NCT05153772 sponsored by RadioMedix, Orano Med and Sanofi and reported in 2025, showed that the alpha-emitting radioligand 212Pb-DOTAMTATE met all its primary endpoints, with responses in more than half of patients with somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumours who were new to radioligand therapy. In the single-arm phase 2 the objective response rate in PRRT-naive patients was 54.3 percent, most were still progression-free around three years, and the PRRT-exposed cohort was largely progression-free at eighteen months, as Sanofi reported in October 2025; the drug holds Breakthrough Therapy designation and the registrational path is being finalised. Nuclide links it to targeted alpha therapy, PRRT, 212Pb-DOTAMTATE and the pairing of beta then alpha PRRT. Whether a randomised trial confirms superiority over lutetium is the open question.
- 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.
Similar pages
not linked directly; found by shared links- CompanyRadioMedix
Shares 212Pb-DOTAMTATE, Alpha-emitter roadmap: radium-223 → 225Ac-PSMA-617 → a phase 3 pipeline, Lead-212, Peptide receptor radionuclide therapy (PRRT).
- TrialACTION-1
Shares Beta PRRT → alpha PRRT, SSTR theranostics roadmap: octreotide scintigraphy → 68Ga-DOTATATE → 177Lu-DOTATATE → alpha, Alpha-emitter roadmap: radium-223 → 225Ac-PSMA-617 → a phase 3 pipeline, Targeted alpha therapy.
- IdeaSSTR antagonist radioligands to increase tumour dose
Shares SSTR theranostics roadmap: octreotide scintigraphy → 68Ga-DOTATATE → 177Lu-DOTATATE → alpha, Peptide receptor radionuclide therapy (PRRT), Neuroendocrine tumours.
- AgentLead-212 VMT-alpha-NET
Shares 212Pb-DOTAMTATE, Lead-212, Targeted alpha therapy, Neuroendocrine tumours.
- CompanyOrano Med
Shares 212Pb-DOTAMTATE, Alpha-emitter roadmap: radium-223 → 225Ac-PSMA-617 → a phase 3 pipeline, Lead-212, Peptide receptor radionuclide therapy (PRRT).
- TechnologyAlpha-emitter daughter redistribution ('free daughter' problem)
Shares 212Pb-DOTAMTATE, Lead-212, Targeted alpha therapy.
- CompanyRayzeBio (BMS)
Shares Alpha-emitter roadmap: radium-223 → 225Ac-PSMA-617 → a phase 3 pipeline, Peptide receptor radionuclide therapy (PRRT), Targeted alpha therapy, Neuroendocrine tumours.
- TrialStudy of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors
Shares Lead-212, Neuroendocrine tumours.