Sanofi announced that AlphaMedix, its targeted radioligand therapy developed in partnership with Orano Med, achieved all primary efficacy endpoints in a Phase 2 trial involving patients with unresectable or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The ALPHAMEDIX-02 study enrolled 61 patients, including both those previously treated with Novartis’ Lutathera and those who were radioligand-naïve. AlphaMedix demonstrated a clinically meaningful overall response rate (ORR) and showed benefits in secondary endpoints such as progression-free survival and overall survival.
The trial evaluated AlphaMedix (212Pb-DOTAMTATE), an alpha-emitting therapy that targets somatostatin receptors prevalent in neuroendocrine tumors, aiming to deliver highly potent payloads with minimal collateral damage to surrounding healthy tissue. Sanofi acquired AlphaMedix in a €100 million upfront deal with additional milestone commitments in 2024, signaling its commitment to enter the competitive radioligand therapy space long dominated by Novartis.
Safety data from the trial indicated a manageable profile, though higher-grade toxicities and serious adverse events were reported and will be further detailed at the European Society for Medical Oncology Congress. Sanofi intends to present full data at ESMO 2025 and begin discussions with regulatory authorities regarding potential registration.
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