Sanofi Challenges Novartis' Radiopharma Dominance with Positive Phase II Data for AlphaMedix in GEP-NETs

Oct 09, 2025 06:25 CST Updated 06:25

Orano Med

Radiopharmaceuticals Developer

Sanofi

Pharmaceutical R&D Developer

Abstract:On October 8, Sanofi and its partner Orano Med announced that AlphaMedix, their jointly developed radioligand therapy, achieved all primary efficacy endpoints, including objective response rate (ORR), in the Phase II trial for refractory gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Secondary endpoints such as progression-free survival and overall survival also showed benefits, with controllable safety. This data directly challenges Novartis' leading position in the radiopharmaceuticals field. The full results will be presented at the European Society for Medical Oncology (ESMO) Congress this month, followed by regulatory discussions.

1. Phase II Data "Breakthrough": AlphaMedix Achieves All Endpoints

This trial, named ALPHAMEDIX-02, targets patients with refractory GEP-NETs who have previously received treatment. These tumors originate from neuroendocrine cells in the pancreas and gastrointestinal tract, with some secreting hormones that cause discomfort. Surgery is the primary treatment option in the early stages, but options for advanced-stage patients have remained limited.

Although Sanofi did not disclose the specific value of ORR in the announcement, it explicitly emphasized that the efficacy was "clinically meaningful." At the same time, the safety of the drug was shown to be manageable, with no risks beyond expectations. Volker Wagner, Chief Medical Officer of Orano Med, mentioned in a statement that these results confirm the potential of targeted alpha-particle delivery to cancer cells, and “could bring a new treatment option for patients with GEP-NETs.”

2. Targeting Novartis: Competition in the Radiopharmaceuticals Sector Heats Up

For a long time, Novartis has been the "leader" in the radiopharmaceuticals field. Its GEP-NETs treatment drug Lutathera, approved in 2018, achieved sales of $724 million in 2024, representing a year-on-year increase of 20%. Another radiopharmaceutical for prostate cancer, Pluvicto, has become a blockbuster product with annual sales of $1.4 billion, solidifying Novartis's "crown" in this field.

Sanofi's entry into the field has been strategically planned. In October 2024, it invested $326 million in Orano Med, betting on the lead-212 isotope technology, with AlphaMedix being the core project of their collaboration. Now that trial data has materialized, it signifies that Novartis' leading position is facing a tangible challenge for the first time. It’s not just Sanofi; through the acquisition of Point Biopharma by Eli Lilly and RayzeBio by Bristol-Myers Squibb, other major players have also crowded into this arena, significantly heating up industry competition.

III. Next Step: ESMO Unveils Full Picture, Initiates Regulatory Communication

Sanofi revealed that the complete data of ALPHAMEDIX-02 will be disclosed at the ESMO conference in late October, which is also the core focus of the industry —— specific details such as response rates and survival data will directly impact the subsequent development pace of the drug.

At the same time, this data will serve as the foundation for communication with global regulatory authorities, advancing AlphaMedix towards its market launch. For patients, since the approval of Lutathera, radioligand therapy has become a key option for second-line treatment of GEP-NETs. The positive data from AlphaMedix may bring new hope to this patient population and also usher the field of radiopharmaceuticals into a new phase of competition.

Reference Source: https://www.biospace.com/drug-development/sanofi-comes-for-novartis-radiopharma-crown-with-clinically-meaningful-pancreatic-tumor-data

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