ITM Announces Primary Results from the Phase 3 COMPETE Trial Published in The Lancet Comparing 177Lu-edotreotide (ITM-11) vs. Everolimus in Advanced GEP-NETs

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Garching / Munich, July 7, 2026 – ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, today announced the publication of its primary result analysis of the Phase 3 COMPETE trial in The Lancet. The clinical data demonstrated that non-carrier-added (n.c.a.) 177 Lu-edotreotide (also known as 177 Lu-edotreotide or ITM-11) significantly improved progression-free survival (PFS) compared to everolimus in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The publication, titled “[ 177 Lu] Lu-edotreotide versus everolimus for gastroenteropancreatic neuroendocrine tumours (COMPETE): a phase 3, multicentre, randomised, open-label, superiority trial,” appeared online on July 2, 2026, and can be accessed via the following link: doi.org/10.1016/S0140-6736(26)00604-5 . “COMPETE provides the first high-level evidence directly comparing peptide receptor radionuclide therapy (PRRT) with everolimus, a commonly used systemic standard-of-care therapy, in the treatment of advanced GEP-NETs,” said Jaume Capdevila, MD, PhD, last author, study investigator and senior medical oncologist at Vall d'Hebron University Hospital, Barcelona . “The efficacy and safety results observed with 177 Lu-edotreotide support its consideration as a potential treatment option for appropriate patients, including those whose disease has progressed following somatostatin analog (SSA) therapy.” “Publication of these data in a peer-reviewed journal underscores the scientific importance of the COMPETE study and provides an important forum for dissemination of the results,” added Thomas Walter, MD, PhD, first author, study investigator and professor of gastroenterology, Hospices Civil of Lyon, France . “These findings offer additional insights into PRRT and support 177 Lu-edotreotide as a potential therapeutic option in advanced GEP-NETs, where a high unmet need remains.” COMPETE Trial Results The randomized, open-label Phase 3 COMPETE trial evaluated n.c.a. 177 Lu-edotreotide versus everolimus in 309 patients with advanced, progressive, Grade 1 or Grade 2 SSTR-positive GEP-NETs across 49 global sites. Patients were randomized 2:1 to receive 177 Lu-edotreotide every three months for up to four cycles or everolimus daily for up to 30 months. Patients were not required but permitted to receive SSAs at the investigator’s discretion for symptom control only. Overall, 21% of patients received concomitant SSA treatment during the study, with similar proportions receiving SSAs in each treatment arm. Top line results of the trial were initially presented at ENETS 2025 and ESMO 2025 . Key findings from the COMPETE trial include: