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ITM Isotope Technologies Munich SE (ITM) and its oncology therapeutics division, Lumara Bio have shared clinical information about their experimental radiopharmaceutical, ¹⁷⁷Lu-edotreotide (ITM-11) for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The information was shared at the 2026 American Society for Radiation Oncology (ASTRO) Annual Meeting in Boston. The focus was on what happens when patients get treatment and how radiation is spread in the body during this targeted therapy.
The information includes results from a study done using data from the SwissNET registry and a part of the Phase 3 COMPETE trial. These results add information about how targeted radiopharmaceutical therapy might be used for patients with neuroendocrine tumors. However ITM-11 is still being. Has not been approved by any health authority.
SwissNET Registry Study Looks at Treatment for Patients
The first study shared information about what happened to 49 adults with advanced well-differentiated somatostatin receptor-positive neuroendocrine tumors. These patients had gotten worse at 12 months after their first round of ¹⁷⁷Lu-edotreotide.
Of the 49 people in the study 37 got treatment with ¹⁷⁷Lu-edotreotide. The other 12 got a kind of treatment that is not a radiopharmaceutical.
The study showed that people who got treatment had a median of 12.5 months before their disease got worse. People who got treatments had a median of 4.8 months. The average time people lived was 90.1 months for those who got treatment. It was 39.8 months for others. The differences found were important according to the numbers.
The results suggest that more treatment might be worth looking into for some patients whose disease gets worse after treatment.. Because the study was done after the fact and there were not many people in the comparison group the results do not prove that more treatment caused the differences, in how long people lived.
COMPETE Trial Provides Radiation-Dose Insights
The presentation focused on dosimetry results from Substudy A of the Phase 3 COMPETE trial, which is assessing ¹⁷⁷Lu-edotreotide in patients with GEP‑NETs.
The analysis measured the absorbed radiation doses that reached organs in 17 patients and also measured the doses that reached 17 tumor lesions in nine patients. The results revealed that the tumor absorbed radiation doses were higher than the doses received by organs.
The kidney absorbed‑dose coefficients stayed fairly consistent showing a median variability of 14 percent. The analysis also discovered that the tumor‑to‑kidney absorbed‑dose coefficient ratios stayed above one throughout all treatment cycles which means that the radiation dose measured in tumors was higher than the dose measured in kidneys.
These findings could help guide research into personalized dosimetry and treatment planning. The researchers also noted that the tumor absorbed‑dose coefficients declined over time a trend that has been seen before in studies of therapy.
What ITM-11 Could Mean for Neuroendocrine Tumor Treatment
GEP‑NETs are a group of tumors that grow in cells of the gastrointestinal tract and pancreas. Treatment options often become more limited as the disease progresses after therapies.
¹⁷⁷Lu‑edotreotide is a targeted radiopharmaceutical that is designed to deliver radiation to tumors that express somatostatin receptors. This approach falls under a treatment category called receptor radionuclide therapy or PRRT which uses a targeting molecule to carry a radioactive component directly to specific tumor cells.
The new data contribute to the evidence that is being built around ITM‑11 and they include findings from the COMPETE trial. The Phase 3 study compared the therapy with everolimus in patients who have progressive, Grade 1 or Grade 2 GEP‑NETs. ITM is also testing the candidate in the Phase 3 COMPOSE study for patients who have aggressive, well‑differentiated GEP‑NETs.
For the oncology community the findings highlight ongoing research, into targeted radiation delivery, retreatment strategies and dose monitoring. Further prospective research will be required to decide how these findings can be applied in practice.
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Regulatory Status and Next Steps
ITM-11 is a treatment and has not been approved for any specific use, by a regulatory organization. The ASTRO 2026 presentations include clinical and dosimetry information but the results do not create a new treatment standard.
As the research moves forward more information will be required to understand which patients might gain from being treated how the radiation doses can be customized for each person and how the treatment stacks up against other available options.
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