On September 27, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Lumara Bio, a dedicated oncology therapeutics division of ITM, reported encouraging new data of non-carrier-added (n.c.a.) 177Lu-edotreotide in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The findings were presented in two posters at the American Society for Radiation Oncology (ASTRO) 2026 Annual Meeting, held from September 26 – 30, 2026 in Boston, Massachusetts.

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The first poster, presented by study author Dr. Julia G. Fricke, Physician-Scientist and Researcher in Nuclear Medicine & Theranostics at the University Hospital Basel, Switzerland, highlighted first-time, real-world re-treatment outcomes from an independent, retrospective analysis of adults in the SwissNET registry, a database of patients diagnosed with NETs in Switzerland. The analysis included 49 adults with metastatic, well-differentiated, somatostatin receptor (SSTR)-positive NETs who were re-treated with 177Lu-edotreotide (n=37, Group A) or treated with a non-radiopharmaceutical systemic anti-cancer therapy (n=12, Group B) following disease progression ≥12 months after completing their initial 177Lu-edotreotide treatment.

Key findings included:

Patients in Group A demonstrated a longer median real-world progression-free survival (rwPFS) of 12.5 months compared to 4.8 months for patients in Group B (p<0.001)
Patients in Group A achieved a median overall survival (OS) of 90.1 months, compared to 39.8 months in Group B (p<0.001)
A second poster, presented by Dr. Amir Iravani, director of the Theranostics Program and vice chair of clinical research at University of California, Los Angeles, featured the dosimetry results from Substudy A of ITM’s Phase 3 COMPETE trial, consistent with data previously presented at medical conferences. The sub-study analysis evaluated absorbed radiation doses in healthy organs across 17 patients, and in 17 tumor lesions across 9 patients. These data build on previously reported dosimetry outcomes from COMPETE presented at EANM 2025 and SNMMI 2026.

Key findings included:

Tumor absorbed dose (AD) of 177Lu-edotreotide is significantly higher than AD to normal organs
Kidney absorbed dose coefficients (ADCs) remained constant with low intra-patient variability (median 14%), suggesting the potential utility of Cycle 1 data in future evaluations of individualized treatment and dosimetry strategies
ADC to tumors decreased over time, as previously reported for RPT, with tumor-to-kidney ADC ratios remaining favorable (>1) across all treatment cycles, suggesting that radiation delivery to lesions remains higher than to healthy organs
"The real-world insights as well as the dosimetry data provide signals that radiopharmaceutical therapy represents an approach worth investigating in settings in which it has not yet been studied," said Dr. Celine Wilke, chief medical officer of ITM. "Supported by these insights, we remain committed to ITM-11’s potential applications and profile in GEP-NETs."

177Lu-edotreotide (ITM-11) is an investigational product 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.

(Press release, ITM Isotopen Technologien Munchen, SEP 27, 2026, View Source [SID1234671106])