- An exploratory analysis revealed positive patient-reported quality of life results and a delayed onset of deterioration for individuals treated with ¹⁷⁷Lu-edotreotide.
- These findings complement the previously disclosed COMPETE efficacy data, offering patient-centric evidence for ¹⁷⁷Lu-edotreotide in GEP-NETs.
(SeaPRwire) – Chicago, Illinois, May 30, 2026 — ITM Isotope Technologies Munich SE (ITM), a prominent radiopharmaceutical biotechnology firm, today announced encouraging Health-Related Quality of Life (HRQoL) outcomes from its Phase 3 COMPETE clinical trial involving patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The data indicated favorable and sustained quality of life for patients receiving non-carrier-added (n.c.a.) ¹⁷⁷Lu-edotreotide (also known as ITM-11 or ¹⁷⁷Lu-edotreotide) when compared to everolimus, a conventional systemic treatment.
The information was presented by Dr. Jaume Capdevila, a study investigator and senior medical oncologist at Vall d’Hebron University Hospital in Barcelona, Spain, during a poster session at the American Society of Clinical Oncology (ASCO) Annual Meeting, which took place from May 29 – June 2, 2026, in Chicago, Illinois.
“For individuals living with GEP-NETs, therapeutic choices extend beyond merely preventing disease progression; they also involve maintaining daily function and overall quality of life,” stated Dr. Jaume Capdevila, study investigator and senior medical oncologist at Vall d’Hebron University Hospital, Barcelona, Spain. “The COMPETE trial results suggest more positive patient-reported outcomes with ¹⁷⁷Lu-edotreotide compared to everolimus, including a longer median period before quality of life declined. These findings, alongside the previously reported efficacy data, contribute significant patient-focused evidence to guide treatment discussions.”
The quality of life assessments involved 309 patients (207 in the ¹⁷⁷Lu-edotreotide group; 102 in the everolimus group). Over 85% of participants completed the two validated EORTC QLQ questionnaires1 throughout the study: the 30-item QLQ-C30 and the 21-item QLQ-GI.NET21. Both questionnaires utilize standardized 0-100 scales to evaluate general health, physical and social capabilities, and the burden of GEP-NET symptoms. Patients filled out these questionnaires at the study’s start, monthly during the first year, and then every three months thereafter.
Key Quality of Life Findings:
- On average, patients in the ¹⁷⁷Lu-edotreotide cohort maintained their quality of life (score change: +0.9), whereas those in the everolimus cohort experienced a notable decrease in quality of life (score change: -9.9).
- Patients receiving ¹⁷⁷Lu-edotreotide experienced a longer duration before their quality of life started to worsen: a median of 10.3 months versus 2.3 months for everolimus.
- A significant overall improvement in quality of life was reported by 43.5% of patients on ¹⁷⁷Lu-edotreotide, compared to 30.4% of those on everolimus.
- Among patients who showed improvement, the median duration of this improvement was 22.0 months versus 10.2 months, respectively.
“These additional COMPETE outcomes offer crucial insights into the quality of life experienced during treatment with ¹⁷⁷Lu-edotreotide, further enriching the clinical data gathered to date,” commented Dr. Celine Wilke, chief medical officer of ITM. “For ITM, prioritizing the balance of treatment benefits, risks, and individual preferences to enhance overall patient health remains paramount, alongside achieving meaningful clinical results through targeted radiopharmaceuticals.”
¹⁷⁷Lu-edotreotide is an experimental product currently under review by the U.S. Food and Drug Administration (FDA) and has not received approval from any regulatory body for the safety and/or effectiveness of any intended application.
About the COMPETE Trial
The COMPETE trial (NCT03049189) assessed ¹⁷⁷Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent, against everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial successfully met its primary objective, with ¹⁷⁷Lu-edotreotide demonstrating a 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 for 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 committed to delivering a new generation of radiopharmaceutical therapies and diagnostics for challenging-to-treat tumors. We aim to address the needs of cancer patients, healthcare professionals, and our partners through excellence in the development, production, and global distribution of medical radioisotopes. With enhanced patient benefit as the core principle guiding all our endeavors, ITM is advancing a broad precision oncology pipeline, including several Phase 3 studies, by combining the company’s high-quality radioisotopes with various targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central position in the industry, and established global network, ITM strives to offer patients more effective targeted treatments to improve clinical outcomes and quality of life. www.itm-radiopharma.com
ITM Contact
Corporate Communications
Kathleen Noonan/Julia Westermeir
Phone: +49 89 329 8986 1500
Email: communications@itm-radiopharma.com
Investor Relations
Ben Orzelek
Phone: +49 89 329 8986 1009
Email: investors@itm-radiopharma.com
1 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
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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