Press Release: AlphaMedixTM (212Pb-DOTAMTATE) achieved all primary efficacy endpoints in phase 2 study, demonstrating clinically meaningful benefits in patients with gastroenteropancreatic neuroendocrine tumors

Core Insights - AlphaMedix™ (212Pb-DOTAMTATE) achieved all primary efficacy endpoints in the ALPHAMEDIX-02 phase 2 study, demonstrating significant clinical benefits for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) [1][2][6] - The study showed clinically meaningful overall response rates (ORR) and prolonged clinical benefits in both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-exposed patients [1][2][6] - AlphaMedix™ has a manageable safety profile, consistent across both patient cohorts [1][3] Study Details - The ALPHAMEDIX-02 study is a phase 2, open-label, multicenter trial evaluating the efficacy and safety of AlphaMedix™ in patients with unresectable or metastatic GEP-NETs [4] - The study included two cohorts: 35 PRRT-naïve patients and 26 PRRT-exposed patients, with the latter having progressive disease after receiving up to four doses of 177Lu-DOTATATE [4] - AlphaMedix™ was administered at a dosage of 67.6 μCi/kg every eight weeks for up to four cycles, with primary endpoints including ORR and safety, and secondary endpoints including progression-free survival (PFS) and overall survival (OS) [4] Industry Context - The results from the ALPHAMEDIX-02 study highlight the potential of lead-212-based radiopharmaceuticals in addressing unmet medical needs for patients with GEP-NETs [2][3] - AlphaMedix™ was granted Breakthrough Therapy Designation by the FDA in February 2024, recognizing its potential clinical benefits for PRRT-naïve patients with unresectable or metastatic GEP-NETs [2] - The study results will be presented at the 2025 European Society for Medical Oncology (ESMO) Congress and will inform discussions with health authorities regarding future regulatory approvals [3][6] Company Background - Orano Med is a clinical-stage biotechnology company focused on developing targeted therapies against cancer using lead-212, an alpha-emitting radioisotope [8] - Sanofi is an R&D-driven biopharma company committed to improving healthcare through innovative therapies, including those for difficult-to-treat cancers [9]