ESMO 2025: Fresh data boosts ITM’s ITM-11 filing
Isotope Technologies Munich (ITM) has announced a higher objective response rate (ORR) and prolonged median progression-free survival (mPFS) across subgroups in patients treated with non-carrier-added (nca) 177Lu-edotreotide—also known as ITM-11 or 177Lu-edotreotide—compared to everolimus from its Phase III COMPETE trial in Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
ITM, a privately-held German radiopharmaceutical company, is on track to submit a new drug application (NDA) for ITM-11 to the US Food and Drug Administration in 2025 based on the positive results gathered to date.
The company is hopeful that, as one of the only radiopharma drugs at this stage of development, ITM-11 has great potential to further advance radiopharmaceutical therapy into the oncology mainstream and expand treatment options for patients with high unmet need.
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