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 (Pb-DOTAMTATE) achieved all primary efficacy endpoints in the ALPHAMEDIX-02 phase 2 study, demonstrating clinically meaningful benefits in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) [1][2][6] - The study showed significant 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: PRRT-naïve (n=35) and PRRT-exposed (n=26) patients, with AlphaMedix administered at 67.6 μCi/kg every eight weeks for up to four cycles [4] - Primary endpoints included ORR per RECIST1.1 and safety, while secondary endpoints included 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 needs for patients with GEP-NETs [2][3] - Alpha-emitters are being studied for their targeted tumor activity and reduced exposure to surrounding healthy tissue, which could represent a significant advancement over current therapies [2] - The study's findings will inform future discussions with health authorities regarding the potential approval and commercialization of AlphaMedix [3][6]