ITM and Lumara Bio Announce Real-World Re-treatment Data and Dosimetry Results from COMPETE for ¹⁷⁷Luedotreotide (ITM-11) in GEP-NETs at ASTRO 2026

• Investigator-led SwissNET registry analysis showed longer real-world progression-free and overall survival for patients re-treated with ¹⁷⁷Lu-edotreotide compared to those receiving non-radiopharmaceutical systemic therapy
• Phase 3 COMPETE trial dosimetry analysis demonstrated favorable tumor-to-kidney absorbed dose ratio with low intra-patient variability

Boston, Massachusetts, September 27, 2026 — ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Lumara Bio, a dedicated oncology therapeutics division of ITM, today announced 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.

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.

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. www.itm-radiopharma.com

About Lumara Bio
Lumara Bio, a division of ITM, builds on more than two decades of radiopharmaceutical expertise and is advancing a focused pipeline of targeted therapies for cancers where treatment options remain limited. https://lumarabio.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

Attachment

• ITM Announces Re-treatment Data and Dosimetry Results from COMPETE at ASTRO 2026