Sanofi SA (NASDAQ:SNY) on Wednesday released topline data from a phase 2 study evaluating the efficacy and safety of AlphaMedix (212Pb-DOTAMTATE).
The patients had unresectable or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs), positive somatostatin analog imaging, and at least one site of measurable disease.
The study showed AlphaMedix (212Pb-DOTAMTATE) met all primary efficacy endpoints.
AlphaMedix is an investigational somatostatin receptor (SSTR)-Targeted Alpha Therapy using the lead-212 isotope.
It showed clinically meaningful overall response rates (ORR) and prolonged clinical benefits in both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-exposed patients.
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Benefits in key secondary endpoints, including progression-free survival (PFS) and overall survival (OS), were also observed across both cohorts. AlphaMedix had a manageable safety profile that was similar across both cohorts.
Alpha-emitters are being studied to determine their relative potency and targeted tumor activity compared to approved therapies. It is believed they could reduce the exposure of surrounding healthy tissue due to the short range of alpha particles.
The results from the ALPHAMEDIX-02 study represent “a pivotal movement,” for the Orano Med 212Pb-based platform, according to Volker Wagner, Chief Medical Officer at Orano Med.
In February 2024, AlphaMedix received US Food and Drug Administration (FDA) Breakthrough Therapy Designation for PRRT-naïve patients with unresectable or metastatic, progressive SSTR-expressing GEP-NETs.
The study is ongoing, and the full results will be presented at the 2025 European Society for Medical Oncology Congress.
Price Action: SNY stock is down 0.64% at $48.88 during the premarket session at the last check on Wednesday.
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