ITM Announces Analyses from Phase 3 COMPETE Data Showing Higher Objective Response Rates with n.c.a. 177Lu-edotreotide (ITM-11) vs. Everolimus Across Subgroups of Patients with GEP-NETs at NANETS 2025 Annual Symposium

Austin, Texas,October 25, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, announced analyses data from its Phase 3 COMPETE trial in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Results showed consistently higher objective response rates (ORR) and longer progression-free survival (PFS) across subgroups in patients treated with n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide) compared to everolimus, reinforcing its previously reported efficacy profile. Data were shared by study investigator, Jaume Capdevila, MD, PhD, in both oral and poster presentations at the 2025 North American Neuroendocrine Tumor Society (NANETS) Annual Multidisciplinary NET Medical Symposium, held October 23-25, 2025, in Austin, Texas.

As previously announced at ENETS 2025, the COMPETE trial, which included a total of 309 patients randomized to either 177Lu-edotreotide (n=207) or everolimus (n=102), met its primary endpoint of progression-free survival, or PFS, (23.9 vs. 14.1 months; p=0.022; HR 0.67, 95% CI [0.48, 0.95]). At ESMO 2025, ITM announced that the COMPETE trial also met a key secondary endpoint of objective response rate (ORR) (21.9% vs 4.2%, p