French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) reported on Wednesday that AlphaMedix (212Pb-DOTAMTATE), an investigational somatostatin receptor (SSTR)-targeted alpha therapy, met all primary efficacy endpoints in the ALPHAMEDIX-02 phase 2 study.
The therapy demonstrated clinically meaningful overall response rates and prolonged benefits in both PRRT-naïve and PRRT-exposed patients with unresectable or metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Key secondary endpoints, including progression-free survival and overall survival, also showed positive trends across both patient cohorts. The therapy exhibited a manageable safety profile consistent between cohorts.
Alpha-emitters like lead-212 are under study for their potential to target tumours while minimising exposure to healthy tissue. In February 2024, AlphaMedix received Breakthrough Therapy Designation from the US Food and Drug Administration for PRRT-naïve patients with progressive SSTR-positive GEP-NETs.
The study is ongoing, with full results scheduled for presentation at the 2025 European Society for Medical Oncology Congress. These findings will form the basis of discussions with health authorities.
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