VIENNA, Austria — October 20, 2026
ITM Isotope Technologies Munich SE (ITM) and Lumara Bio, ITM’s oncology therapeutics division, announced new clinical and translational findings supporting their targeted radiopharmaceutical pipeline at the European Association of Nuclear Medicine (EANM) 2026 Congress, held October 17–21 in Vienna. Presented through three oral presentations and one e-poster, the data covered gastroenteropancreatic neuroendocrine tumors (GEP-NETs), clear cell renal cell carcinoma (ccRCC), and glioblastoma. Findings included a dose-response analysis of investigational ¹⁷⁷Lu-edotreotide (ITM-11) from the Phase 3 COMPETE trial and independent investigator-led research on Ga-DPI-4452, Tb-DOTA-LM3 and n.c.a. ¹⁷⁷Lu-TTM. According to ITM Chief Medical Officer Dr. Celine Wilke, the presentations highlight the potential of radiopharmaceutical approaches using established and novel targets and radioisotopes in cancers with significant unmet medical needs.
COMPETE Analysis Links Higher Tumor Dose to Response
A late-stage dose-response analysis from the Phase 3 COMPETE trial evaluated the relationship between cumulative tumor-absorbed radiation dose and clinical response to ¹⁷⁷Lu-edotreotide in patients with Grade 1 or 2 GEP-NETs. Presented by Dr. Anthime Flaus of Hospices Civils de Lyon, France, the analysis included 106 evaluable patients who received four treatment cycles. The objective response rate increased from 12% in the lowest absorbed-dose quartile to 64% in the highest quartile. Three complete responses occurred among patients receiving cumulative tumor doses above 86.1 Gy, corresponding to the third and fourth quartiles. Multivariate logistic regression identified cumulative tumor-absorbed dose and tumor type as the main predictors of response, while lesion-level analysis also showed a statistically significant association between absorbed dose and response. The findings may inform further investigation of individualized radiopharmaceutical dosing strategies. ITM reported that the COMPETE trial (NCT03049189), which compared ¹⁷⁷Lu-edotreotide with everolimus in patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs, met its primary endpoint, demonstrating a clinically and statistically significant improvement in progression-free survival. The agent is also being evaluated in the Phase 3 COMPOSE study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor-positive GEP-NETs.
Ga-DPI-4452 Shows Promise in Renal Cancer Imaging
Independent research presented at EANM also highlighted Ga-DPI-4452 (ITM-94), an investigational gallium-68 PET imaging agent targeting carbonic anhydrase IX (CAIX). In interim results from a retrospective, two-center registry, Dr. Alina Küper of University Hospital Essen, Germany, reported findings from 98 patients with suspected or confirmed ccRCC. Ga-DPI-4452 showed abnormal findings in 91.8% of patients with subsequently confirmed ccRCC. Across 153 predefined anatomical regions, the imaging agent demonstrated high tumor uptake and better detection than conventional CT in the evaluated regions, including primary or recurrent renal tumors, regional and distant lymph nodes, bone metastases and visceral metastases. The agent is designed to support characterization of indeterminate renal masses and improve ccRCC diagnosis and staging. ITM-94 received U.S. Food and Drug Administration Fast Track designation in October 2025 but remains investigational.
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Early-Stage Candidates Advance Across Multiple Cancer Types
Additional presentations addressed two other investigational radiopharmaceutical candidates. In the Phase 0b BETA PLUS study, researchers from University Hospital Basel evaluated [¹⁶¹Tb]Tb-DOTA-LM3 (ITM-63), a somatostatin receptor 2 antagonist, in six patients with metastatic GEP-NETs. A peptide mass-dependent effect was observed: a lower peptide mass of less than 100 micrograms was associated with a higher tumor-absorbed dose than a mass of 300–400 micrograms, at 23.3 versus 12.5 Gy/GBq (p<0.001). Researchers also reported numerically improved tumor-to-kidney and tumor-to-bone-marrow absorbed-dose ratios at the lower peptide mass. Preliminary antitumor activity was observed, with no dose-limiting toxicities reported, supporting further clinical evaluation. Separately, translational research from the Technical University of Munich found high carbonic anhydrase XII (CAXII) expression in the infiltration zone of primary glioblastomas. These findings support continued investigation of n.c.a. ¹⁷⁷Lu-TTM (ITM-31), a CAXII-targeting radiotherapeutic designed for intracavitary treatment of residual tumor cells following surgery and standard-of-care therapy. ITM and Lumara Bio said the presentations contribute evidence for continued development of their precision oncology pipeline. ¹⁷⁷Lu-edotreotide, Ga-DPI-4452, Tb-DOTA-LM3 and n.c.a. ¹⁷⁷Lu-TTM are investigational products and are not approved by any regulatory authority for the safety or efficacy of any intended use.
Source::ITM,,,press release
