Sanofi’s $110 million bet on radioligand therapy appears to be paying off. The company announced that its targeted alpha therapy AlphaMedix achieved the primary endpoints of efficacy and safety in a phase 2 trial involving patients with unresectable or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
A Targeted Alpha Therapy for GEP-NETs #
AlphaMedix is designed to deliver a radioactive payload precisely to tumor cells that express somatostatin receptors, a biomarker found in most neuroendocrine tumors.
Sanofi acquired the therapy in 2024 through a €100 million ($110 million) upfront deal with RadioMedix and Orano Med, marking the company’s strategic entry into the fast-evolving radioligand space.
Phase 2 Data Show Clinically Meaningful Activity #
The multicenter phase 2 trial enrolled 61 patients with advanced GEP-NETs, evenly split between those who had received Novartis’ Lutathera—a beta-particle radiopharmaceutical—and treatment-naive participants.
Sanofi reported that AlphaMedix met its primary endpoints of overall response rate and safety, while “benefits were observed” across both patient cohorts for progression-free survival (PFS) and overall survival (OS), the study’s secondary measures.
While full data are being reserved for the European Society for Medical Oncology (ESMO) Congress later this month in Germany, Sanofi stated that the findings will serve as a basis for regulatory discussions.
“The promising AlphaMedix-02 results represent a significant step forward, reinforcing the potential of targeted alpha therapy to deliver precise treatment for GEP-NETs,” said Christopher Corsico, M.D., Sanofi’s Global Head of Development.
“These data demonstrate clinically meaningful activity and a manageable safety profile, underscoring our unrelenting commitment to developing innovative therapies for difficult-to-treat cancers.”
Partner Contributions and Technology Platform #
Sanofi co-developed AlphaMedix with Orano Med, which manufactures the therapy using its lead-212 (²¹²Pb) platform.
“The positive results from AlphaMedix-02 represent a pivotal moment for our ²¹²Pb-based platform and highlight the potential of targeted alpha-emitters in oncology,” said Volker Wagner, M.D., Ph.D., Chief Medical Officer at Orano Med.
The use of lead-212 enables short-range, high-energy alpha radiation, which can destroy tumor cells with extreme precision while minimizing damage to surrounding healthy tissue — a key advancement over traditional beta emitters like Lutathera.
Sanofi’s Growing Radioligand Ambitions #
The acquisition of AlphaMedix in 2024 marked Sanofi’s formal entry into radioligand therapy, previously dominated by Novartis with its Lutathera and Pluvicto franchises.
Under the agreement, Sanofi committed up to €220 million in milestone payments, with Orano Med managing production and Sanofi overseeing global commercialization. Weeks later, Sanofi deepened its investment by allocating €300 million to establish a dedicated radioligand development collaboration with Orano Med—signaling a long-term strategic commitment to precision oncology.
What Are Targeted Alpha Therapies? #
Targeted alpha therapies (TATs) are a new class of radiopharmaceuticals that link alpha-emitting isotopes to molecules capable of seeking out and binding to cancer cells.
Unlike beta emitters, which release lower-energy particles over longer distances, alpha particles deliver high-energy radiation across just a few cell diameters, causing lethal double-strand DNA breaks precisely within the tumor.
This targeted potency makes TATs highly attractive for treating micro-metastatic or radioresistant cancers while sparing nearby healthy tissue. However, challenges remain in manufacturing isotopes, managing radiation safety, and conducting large-scale clinical validation.
A Promising Future for Precision Oncology #
With radioligand therapies gaining global momentum, the success of AlphaMedix represents both scientific validation and strategic positioning for Sanofi.
If ongoing and future trials confirm these results, AlphaMedix could become one of the first alpha-based therapies approved for neuroendocrine tumors, offering a new treatment path for patients who have exhausted current standards of care.
In summary:
Sanofi’s AlphaMedix delivers a strong proof of concept for targeted alpha therapy, demonstrating clinically meaningful response rates and safety in GEP-NETs.
These findings not only strengthen Sanofi’s position in next-generation radiopharmaceuticals but also mark an important step forward in the global race to bring alpha-based oncology treatments to market.