Sanofi Challenges Novartis’ Dominance with Clinically Meaningful Pancreatic Tumor Data from AlphaMedix Phase II Trial

Sanofi and partner Orano Med announced that their radioligand therapy, AlphaMedix, achieved all primary efficacy endpoints in the mid-stage ALPHAMEDIX-02 Phase II study targeting advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs)13791113.

The primary endpoint was a clinically meaningful overall response rate (ORR) in previously treated patients with difficult-to-treat GEP-NETs1313.

Benefits were also reported for key secondary endpoints, including progression-free survival and overall survival31.

AlphaMedix targets somatostatin receptors (SSTR) using highly potent alpha-emitters to deliver radiation directly to cancer cells, aiming for strong anti-tumor effects while sparing healthy tissue13.

The therapy demonstrated a 'manageable safety profile,' though detailed adverse event data were not provided in the initial announcement13.

Sanofi's announcement positions the company as a new contender in radiopharmaceuticals, directly challenging Novartis, the current dominant player in radioligand therapy for GEP-NETs1356.

Full results from the ALPHAMEDIX-02 study are anticipated to be presented at an upcoming European Society for Medical Oncology (ESMO) Congress3.

Sources:

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

3. https://www.noahai.co/discover/article/11295

5. https://patternofusa.com/2025/10/08/sanofi-challenges-novartis-leadership-in-radiopharma-with-clinically-significant-data-on-pancreatic-tumors/

6. https://synapse.patsnap.com/article/sanofi-enters-radiopharmaceuticals-with-110m-targeting-novartiss-market

7. https://www.sanofi.com/en/media-room/press-releases

9. https://www.biospace.com/press-releases/press-release-alphamedixtm-212pb-dotamtate-achieved-all-primary-efficacy-endpoints-in-phase-2-study-demonstrating-clinically-meaningful-benefits-in-patients-with-gastroenteropancreatic-neuroendocrine-tumors

11. https://convitgroup.com/2025/10/08/sanofi-comes-for-novartis-radiopharma-crown-with-clinically-meaningful-pancreatic-tumor-data/

13. https://trial.medpath.com/news/1f9087f09d803ea8/sanofi-s-alphamedix-radioligand-therapy-meets-all-primary-endpoints-in-phase-2-gep-net-trial