PARIS (dpa-AFX) - Sanofi SA (SNY, SNYNF, SAN.PA) announced promising results from its ALPHAMEDIX-02 Phase 2 clinical trial evaluating AlphaMedix (212Pb-DOTAMTATE), a novel somatostatin receptor-targeted alpha therapy using the lead-212 isotope. The therapy met all primary efficacy endpoints, demonstrating significant overall response rates (ORR) and sustained clinical benefits in patients with unresectable or metastatic SSTR-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), regardless of prior peptide receptor radionuclide therapy (PRRT) exposure.
Secondary endpoints also showed encouraging outcomes, including improvements in progression-free survival (PFS) and overall survival (OS) across both PRRT-naïve and PRRT-exposed groups. The safety profile of AlphaMedix was consistent and manageable in both cohorts.
The U.S. Food and Drug Administration (FDA) granted AlphaMedix Breakthrough Therapy Designation in February 2024 for the treatment of PRRT-naïve patients with progressive, unresectable or metastatic SSTR-expressing GEP-NETs.
SNY closed Tuesday's regular trading at $49.19 down $0.51 or 1.04%.
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