ITM Announces Phase 3 COMPETE Patient-Reported Quality Of Life Data With N.C.A. 177Lu-Edotreotide (ITM-11) Vs. Everolimus At ASCO 2026

• 177Exploratory analysis showed favorable patient-reported quality of life outcomes and delayed time to deterioration in patients receiving 177Lu-edotreotide
• Data build upon previously reported COMPETE efficacy results, adding patient-centered evidence for 177Lu-edotreotide in GEP-NETs

Chicago, Illinois, May 30, 2026 –– ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced encouraging Health-Related Quality of Life (HRQoL) data from its Phase 3 COMPETE trial in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The data showed favorable and durable quality of life outcomes for patients receiving non-carrier-added (n.c.a.) 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide) compared to everolimus, a systemic standard of care treatment.
The data were presented by Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d'Hebron University Hospital, Barcelona, Spain in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, held from May 29 - June 2, 2026 in Chicago, Illinois.
“For patients with GEP-NETs, treatment decisions are not only about preventing disease progression, but also about preserving daily functioning and quality of life,” said Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d'Hebron University Hospital, Barcelona, Spain.“The COMPETE data suggest more favorable patient-reported outcomes with 177Lu-edotreotide compared with everolimus, including a longer median time to deterioration in quality of life. Together with the previously reported efficacy results, these findings add important patient-centered evidence to inform treatment discussions.”
The quality of life analyses included 309 patients (177Lu-edotreotide, n=207; everolimus, n=102). More than 85% of patients completed the two validated EORTC QLQ questionnaires¹ throughout the study: the 30-item QLQ-C30 and the 21-item QLQ-GI21. Both surveys use standardized 0-100 scales to assess overall health, physical and social functioning, and GEP-NET symptom burden. Patients completed questionnaires at baseline, monthly in year one, and every three months thereafter.
Key QoL Findings:

• On average, patients on the 177Lu-edotreotide arm maintained their quality of life (score change: +0.9) while patients in the everolimus arm experienced a meaningful decline in quality of life (score change: -9.9)
• Patients on 177Lu-edotreotide experienced a longer period of time before their quality of life began to decline: a median of 10.3 months vs. 2.3 months for everolimus
• A meaningful overall improvement in quality of life was reported by 43.5% of patients on 177Lu-edotreotide vs. 30.4% of those on everolimus
  • Among those who improved, median duration of improvement was 22.0 months vs. 10.2 months, respectively

“These additional COMPETE results provide important insights into quality of life during treatment with 177Lu-edotreotide, and further add to the clinical data generated to date,” said Dr. Celine Wilke, chief medical officer of ITM.“Balancing treatment benefit, risk and personal preference to improve overall patient health remains a top priority for ITM, alongside delivering meaningful clinical outcomes through targeted radiopharmaceuticals.”
177Lu-edotreotide is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use.
About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.
About ITM Isotope Technologies Munich SE
ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply of medical radioisotopes. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company's high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life.
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¹ The European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ)-C30 questionnaire and the EORTC QLQ-gastrointestinal neuroendocrine tumors questionnaire

Attachment

• ITM Announces Phase 3 COMPETE Patient-Reported Quality of Life Data with n.c.a. 177Lu-edotreotide (ITM-11) vs. Everolimus at ASCO 2026

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