Isotope Technologies Munich (ITM) is highlighting positive results from a phase III trial in patients with inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
GEP-NETs originate in the neuroendocrine system and can occur anywhere in the gastrointestinal tract and pancreas. There is still a high unmet medical need for treatment options, as many patients are asymptomatic and are diagnosed with metastatic disease at a late stage, noted ITM.
The company said it anticipates submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2025. To that end, ITM said data from the COMPETE trial showed that ITM-11 (non-carrier-added [n.c.a.] lutetium-177 [Lu-177] edotreotide) met the primary endpoint of prolonging progression-free survival when compared with everolimus, a targeted molecular therapy.
ITM-11 is a synthetic, targeted radiotherapeutic agent comprised of n.c.a. Lu-177, a therapeutic beta-emitting radioisotope, and edotreotide, a somatostatin receptor (SSTR) agonist. The controlled, open-label, multicenter, prospective, randomized study evaluated the efficacy and safety of peptide receptor radionuclide therapy with Lu-177 edotreotide.
Enrolling 309 patients, the study randomized participants 2:1 to receive 7.5 GBq of ITM-11 with a nephroprotective amino acid solution every three months for a maximum of four cycles, or everolimus 10 mg daily for up to 30 months, or until disease progression, ITM explained. Dosimetry data and secondary endpoints, along with subgroup analyses, are currently being evaluated. More data is forthcoming.
ITM-11, a radiolabeled peptide conjugate, was granted orphan drug designation in the European Union and the U.S., and fast-track designation in the U.S. for the treatment of GEP-NETs, based on positive results from a retrospective phase II study with Lu-177 edotreotide, the company noted.
