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- Exploratory analysis showed favorable patient-reported quality of life outcomes and delayed time to deterioration in patients receiving \u00b9\u2077\u2077Lu-edotreotide<\/li>\n
- Data build upon previously reported COMPETE efficacy results, adding patient-centered evidence for \u00b9\u2077\u2077Lu-edotreotide in GEP-NETs<\/li>\n<\/ul>\n
Chicago, Illinois, May 30<\/strong>, 2026 \u2014 <\/strong>ITM Isotope Technologies Munich SE (ITM)<\/a>, 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.) \u00b9\u2077\u2077Lu-edotreotide (also known as ITM-11 or \u00b9\u2077\u2077Lu-edotreotide) compared to everolimus, a systemic standard of care treatment. <\/p>\n
The data were presented by\u00a0Jaume 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.<\/p>\n
\u201cFor patients with GEP-NETs, treatment decisions are not only about preventing disease progression, but also about preserving daily functioning and quality of life,\u201d<\/em> said Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d’Hebron University Hospital, Barcelona, Spain<\/strong>. \u201c<\/em>The COMPETE data suggest more favorable patient-reported outcomes with \u00b9\u2077\u2077Lu-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.\u201d<\/em><\/p>\n
The quality of life analyses included 309 patients (\u00b9\u2077\u2077Lu-edotreotide, n=207; everolimus, n=102). More than 85% of patients completed the two validated EORTC QLQ questionnaires1<\/sup> throughout the study: the 30-item QLQ-C30 and the 21-item QLQ-GI.NET21. 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.<\/p>\n
Key QoL Findings:\u00a0<\/strong><\/p>\n
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- On average, patients on the \u00b9\u2077\u2077Lu-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)<\/li>\n
- Patients on \u00b9\u2077\u2077Lu-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<\/li>\n
- A meaningful overall improvement in quality of life was reported by 43.5% of patients on \u00b9\u2077\u2077Lu-edotreotide vs. 30.4% of those on everolimus\n
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- Among those who improved, median duration of improvement was 22.0 months vs. 10.2 months, respectively<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
\u201cThese additional COMPETE results provide important insights into quality of life during treatment with \u00b9\u2077\u2077Lu-edotreotide, and further add to the clinical data generated to date,\u201d<\/em> said Dr. Celine Wilke, chief medical officer of ITM<\/strong>. \u201cBalancing 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.\u201d<\/em>\u00a0<\/em><\/p>\n
\u00b9\u2077\u2077Lu-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.<\/p>\n
About the COMPETE Trial
<\/strong>The COMPETE trial (NCT03049189) evaluated \u00b9\u2077\u2077Lu-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 \u00b9\u2077\u2077Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. \u00b9\u2077\u2077Lu-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.<\/p>\nAbout ITM Isotope Technologies Munich SE<\/strong>
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\u2019s 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. www.itm-radiopharma.com<\/a><\/p>\nITM Contact
<\/strong>Corporate Communications
<\/strong>Kathleen Noonan\/Julia Westermeir
Phone: +49 89 329 8986 1500
Email: communications@itm-radiopharma.com<\/a><\/p>\nInvestor Relations
<\/strong>Ben Orzelek
Phone: +49 89 329 8986 1009
Email:\u00a0investors@itm-radiopharma.com<\/a><\/p>\n1<\/sup> The European Organisation for Research and Treatment of Cancer Quality of Life (EORTC QLQ)-C30 questionnaire and the EORTC QLQ-gastrointestinal neuroendocrine tumors (GI.NET21) questionnaire<\/em><\/strong><\/p>\n
- Among those who improved, median duration of improvement was 22.0 months vs. 10.2 months, respectively<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
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