Core Insights - New data from the ALPHAMEDIX-02 phase 2 study supports the first-in-class potential of AlphaMedix (212Pb-DOTAMTATE) for treating advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) [1][5][10] - The study demonstrated significant efficacy in both radioligand therapy (RLT)-naïve and RLT-exposed patients, indicating its potential to address unmet medical needs in this challenging cancer type [2][5][10] Study Overview - ALPHAMEDIX-02 is a phase 2, open-label, multicenter study assessing the efficacy and safety of AlphaMedix in patients with unresectable or metastatic SSTR+ GEP-NETs, including cohorts for RLT-naïve and RLT-exposed patients [3][12] - The primary efficacy endpoint was the overall response rate (ORR), with secondary endpoints including progression-free survival (PFS) and overall survival (OS) [3][12] Efficacy Results - In the RLT-naïve cohort (n=35), the ORR was 60.0% per investigator assessment and 57.1% per independent assessment, with a disease control rate (DCR) of 94.3% [4][6] - In the RLT-exposed cohort (n=26), the ORR was 34.6% per investigator assessment and 19.2% per independent assessment, with a DCR of 96.2% [6] - The 36-month PFS rate for RLT-naïve patients was 72.3%, while the 18-month PFS rate for RLT-exposed patients was 82.6% [6] Safety Profile - AlphaMedix exhibited a similar safety profile across both cohorts, with 85.7% of RLT-naïve patients and 84.6% of RLT-exposed patients completing all four doses [6][10] - Treatment-emergent adverse events (TEAEs) were reported in all patients, with grade ≥3 TEAEs occurring in 42.3% of RLT-exposed and 54.3% of RLT-naïve patients, primarily involving lymphocyte count decrease [6][10] Future Development - The positive results from the ALPHAMEDIX-02 study will inform further discussions with health authorities and support the planning of an international phase 3 study [10][11] - Sanofi has entered an exclusive licensing agreement with Orano Med and RadioMedix to globally commercialize AlphaMedix, indicating strong commercial interest and potential market impact [11]

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]

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]