Sanofi's Radioligand Therapy Shows Promise in Phase 2 Neuroendocrine Tumor Trial

Sanofi's recent foray into the radioligand therapy space appears to be yielding positive results, as their novel treatment for neuroendocrine tumors hits key endpoints in a phase 2 clinical trial. The pharmaceutical giant's €100 million ($110 million) investment in AlphaMedix, a targeted alpha therapy, is showing signs of clinical efficacy and a manageable safety profile in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Phase 2 Trial Results Validate Sanofi's Investment

The phase 2 study, involving 61 patients with unresectable or metastatic GEP-NETs, demonstrated that AlphaMedix met its primary endpoints of overall response rate and safety. The trial included patients who had previously received Novartis' Lutathera, a beta particle emitter, as well as those who had not, providing insights into the therapy's potential across different patient populations.

While specific data points are being reserved for presentation at the upcoming European Society for Medical Oncology Congress in Germany, Sanofi has indicated that "benefits were observed" in the secondary endpoints of progression-free survival and overall survival across both cohorts.

Dr. Christopher Corsico, Global Head of Development at Sanofi, expressed optimism about the results, stating, "The promising AlphaMedix-02 results represent a significant step forward, reinforcing the potential of targeted alpha therapy to deliver precise treatment for GEP-NETs." He further emphasized the company's commitment to developing innovative therapies for difficult-to-treat cancers.

Strategic Expansion into Radioligand Therapies

Sanofi's acquisition of AlphaMedix in September 2024 marked its entry into the competitive radioligand therapy market. The deal, which included up to €220 million in potential sales milestone payments, established a partnership with RadioMedix and Orano Med. Under this agreement, Orano Med is responsible for manufacturing the therapy, while Sanofi oversees global commercialization efforts.

The success of this initial venture has prompted further investment in the field. Just weeks after the AlphaMedix deal, Sanofi announced a €300 million collaboration with Orano Med to establish a more extensive radioligand therapy project, signaling the company's long-term commitment to this innovative treatment modality.

Dr. Volker Wagner, Chief Medical Officer at Orano Med, highlighted the significance of the study results for their 212Pb-based platform, stating, "These data reinforce our belief that delivering highly potent alpha-emitters directly to cancer cells could potentially offer a meaningful new treatment option for people living with GEP-NETs."

As Sanofi prepares to engage in discussions with health authorities based on these findings, the pharmaceutical industry watches closely to see how this development might reshape the landscape of neuroendocrine tumor treatment and the broader field of targeted radiopharmaceuticals.