212Pb-DOTAMTATE Advances to Phase 3 Trial in GEP-NETs, Continues Phase 2 Follow-Up

Following the 2025 North American Neuroendocrine Tumor Society (NANETS) Multidisciplinary NET Medical Symposium, in an interview with Targeted Oncology®, Mary Maluccio, MD, MPH, FACS, Louisiana State University School of Medicine, explains next steps in clinical development for the investigational targeted alpha particle therapy ²¹²Pb-DOTAMTATE (AlphaMedix), which is being evaluated in patients with SSTR-expressing, unresectable or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in the phase 2 ALPHAMEDIX-02 trial (NCT05153772).

Watch the first part of Maluccio’s interview.

Maluccio revealed that the agent will move into a randomized phase 3 trial to be evaluated against standard-of-care beta particle therapy. This trial will involve only patients who have not been previously treated with peptide receptor radionuclide therapy (PRRT). This phase 3 trial is either currently open or will soon open at Maluccio’s site, and will subsequently open at several sites over the next few months.

Furthermore, both cohorts of patients from phase 2—PRRT-naive patients and pretreated patients—continue to be followed in parallel to phase 3 despite completion of patient accrual. This prolonged follow-up is necessary because the data presented thus far have not reached the median event rate. The goal of extended follow-up is to obtain robust, longer-term, real-world outcome data to accurately discuss the risks and benefits of this alpha therapy with patients. Key focal points of data collection will include the safety concerns discussed in part 1 of the interview, including renal dysfunction, dysphagia, and a possible late onset of myelodysplastic syndromes (MDS). A surprising finding during phase 2, according to Maluccio, is that MDS events were not observed in either patient cohort.

Over the next year, real 36- or 48-month data concerning safety and efficacy could be presented at future scientific conferences.

Read the full interview here.