NANETS2025 18th Annual Multidisciplinary NET Medical Symposium NANETS 2025 Clinical – Nuclear Medicine/Interventional Radiology/Imaging (22 abstracts)
Long-term Follow-up of PRRT-Naïve Patients with GEP-NETs Treated with Targeted Alpha Therapy 212Pb-DOTAMTATE in the Phase 2 ALPHAMEDIX 02 Trial
Jonathan R. Strosberg 1 , Shagufta Naqvi 2 , Allen L. Cohn 3 , Ebrahim S. Delpassand 4 , Volker J. Wagner 5 , Izabela Tworowska 4 , Julien Torgue 5 , Rachel Woloski 5 , Katherine Ruffner 5 , Ashok Krishna 6 , Fatima Menas 7 , Zhe Chen 6 & Mary A. Maluccio 8
1Moffitt Cancer Center and Research Institute, Tampa, FL; 2Excel Diagnostics Nuclear Oncology Center, Houston, TX; 3Rocky Mountain Cancer Centers, Denver, CO; 4RadioMedix Inc., Houston, TX; 5Orano Med LLC, Plano, TX; 6Sanofi, Cambridge, MA; 7Sanofi, Madrid, Spain; 8Louisiana State University, New Orleans, LA
Background: Alpha-emitting radioisotopes efficiently induce double-stranded DNA breaks in tumors while aiming to spare healthy tissue, given their high linear energy transfer over short ranges. 212Pb-DOTAMTATE (SAR447873) is a novel somatostatin receptor (SSTR)-targeted alpha therapy under clinical evaluation for patients with unresectable or metastatic SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) (ALPHAMEDIX 02 [NCT05153772]). Here we present a two-year landmark analysis of the efficacy and safety of 212Pb-DOTAMTATE in patients with no prior exposure to peptide receptor radionuclide therapy (PRRT).
Methods: ALPHAMEDIX 02 is a Phase 2, open-label, multicenter study evaluating the efficacy, safety, and tolerability of 212Pb-DOTAMTATE in PRRT-naïve (cohort 1, n = 35) and PRRT-exposed (cohort 2, N = 26) patients with histologically confirmed unresectable or metastatic GEP-NETs, positive somatostatin analogue imaging and at least 1 site of measurable disease. 212Pb-DOTAMTATE was administered at 67.6 μCi/kg every 8 weeks for up to 4 cycles. Primary endpoints include ORR per RECIST1.1, and incidence and severity of adverse events (AEs). Secondary endpoints include progression free survival (PFS) and overall survival (OS).
Results: As of 14 April, among 35 PRRT-naïve patients, the most common primary tumor sites were pancreas and small intestine (both n = 15, 42.9%). The majority (n = 31, 88.6%) had Grade 1/2 tumors. Twenty patients achieved a confirmed partial response (ORR 57.1%; 95% CI: 39.4–73.7); 13 (37.1%), stable disease; and 1 (2.9%), progressive disease (1 patient not evaluable). Fourteen of 20 patients with a confirmed response had a duration of response (DOR) ≥12 months; 2 patients had a DOR ≥24 months. Two-year PFS and OS rates were 71.3% and 88.2%, respectively. All patients experienced ≥1 treatment-emergent adverse event (TEAE). The most common Grade 3 or 4 TEAE was decreased lymphocyte count (25.7%).
Conclusions: With 2 years median follow-up, 212Pb-DOTAMTATE (SAR447873) treatment continues to be associated with frequent, durable responses and survival in patients with advanced SSTR+ GEP-NETs. No new safety signals emerged with longer follow-up.
Abstract ID #33414
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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