ITM, Lumara unveil new 177Lu-edotreotide data

ITM Isotope Technologies Munich SE and Lumara Bio presented new data on non-carrier-added 177Lu-edotreotide (ITM-11) at the American Society for Radiation Oncology (ASTRO) 2026 Annual Meeting, held from September 26 to 30, 2026 in Boston, Massachusetts. The results were summarized in two scientific posters, one focusing on real-world re-treatment outcomes and the other on detailed dosimetry findings from a Phase 3 study.

The data release on September 27, 2026 highlighted both clinical effectiveness signals in a registry setting and radiation dose distribution in patients enrolled in a controlled trial. Together, the posters addressed treatment results in neuroendocrine tumors and organ-level exposure during therapy.

An independent, retrospective analysis from the SwissNET registry evaluated 49 adults with metastatic, well-differentiated, somatostatin receptor–positive neuroendocrine tumors. All patients had experienced disease progression at least 12 months after completing an initial course of 177Lu-edotreotide before entering the analysis.

Patients were divided into two groups: 37 individuals re-treated with 177Lu-edotreotide (Group A) and 12 individuals who received a non-radiopharmaceutical systemic anti-cancer therapy (Group B). This design allowed comparison of outcomes between re-treatment with the radiopharmaceutical and alternative systemic regimens in a real-world setting.

The analysis reported a median real-world progression-free survival of 12.5 months for the re-treated group versus 4.8 months for the non-radiopharmaceutical group, with a p-value of less than 0.001. Median overall survival was 90.1 months in Group A compared with 39.8 months in Group B, also with a p-value of less than 0.001.

These results, presented by Dr. Julia G. Fricke, provide observational evidence on outcomes following re-treatment with 177Lu-edotreotide after a defined interval from initial therapy in patients with somatostatin receptor–positive disease.

A second poster presented dosimetry data from Substudy A of the Phase 3 COMPETE trial of 177Lu-edotreotide. This substudy evaluated absorbed radiation doses in healthy organs across 17 patients and in 17 tumor lesions across 9 patients.

The dosimetry analysis found that tumor absorbed dose from 177Lu-edotreotide was significantly higher than absorbed dose to normal organs. Tumor-to-kidney absorbed dose ratios remained favorable, staying above 1 across treatment cycles in the evaluated patients.

Kidney absorbed dose coefficients demonstrated low intra-patient variability, with a reported median variability of 14%. These findings, presented by Dr. Amir Iravani, characterize the distribution of radiation between tumor tissue and key organs during treatment with 177Lu-edotreotide.

By combining real-world outcome data from the SwissNET registry with quantitative dosimetry from the COMPETE substudy, the new results add to the evidence base for 177Lu-edotreotide use in somatostatin receptor–positive neuroendocrine tumors, particularly in the context of re-treatment after prior therapy.