India Pharma Outlook Team | Thursday, 09 October 2025
AlphaMedix (212Pb-DOTAMTATE), an investigational somatostatin receptor (SSTR)-targeted alpha therapy using the lead-212 isotope, met all primary efficacy endpoints and demonstrated clinically meaningful overall response rates (ORR) and prolonged clinical benefits in both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-exposed patients with unresectable or metastatic SSTR-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Positive results were obtained from the ALPHAMEDIX-02 phase 2 clinical study (clinical study identifier: NCT05153772). Both cohorts also showed improvements in important secondary endpoints, including overall survival (OS) and progression-free survival (PFS).
The safety profile of AlphaMedix was comparable in both cohorts and was controllable.
Also Read: AstraZeneca India Gains Approval for Solid Tumor Therapy
"The positive results from the ALPHAMEDIX-02 study represent a pivotal movement for the Orano Med 212Pb-based platform and underscore the profound potential of lead-212-based radiopharmaceuticals in addressing critical unmet needs for patients with GEP-NETs. We are very encouraged by AlphaMedix's consistent and clinically meaningful activity across both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-exposed patients,” said Volker Wagner, MD, PhD, chief medical officer at Orano Med.
“These data reinforce our belief that delivering highly potent alpha-emitters directly to cancer cells could potentially offer a meaningful new treatment options for people living with GEP-NETs.”
In comparison to currently licensed medicines, alpha-emitters are being investigated to ascertain their relative potency and targeted tumor action. Because alpha particles have a limited range, it is thought that they may be able to lessen the exposure of nearby healthy tissue.
