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]