ITM and Lumara Bio present COMPETE dose-response data at EANM 2026
ITM Isotope Technologies Munich and its oncology division Lumara Bio used the European Association of Nuclear Medicine (EANM) 2026 Congress in Vienna to present a dose-response analysis from the Phase 3 COMPETE trial of 177Lu-edotreotide (ITM-11) alongside early-stage pipeline data spanning clear cell renal cell carcinoma and glioblastoma.
The headline finding, delivered in an oral presentation by Dr Anthime Flaus of the Hospices Civils de Lyon, showed a clear gradient between cumulative tumour absorbed dose and objective response in 106 evaluable GEP-NET patients who received four treatment cycles of ITM-11. The objective response rate rose from 12% in the lowest absorbed-dose quartile to 64% in the highest, with three complete responses recorded above a cumulative threshold of 86.1 Gy. Multivariate logistic regression identified cumulative tumour absorbed dose and tumour type as the primary predictors of response. Lesion-level analysis returned a statistically significant association in the same direction.
"The dosimetry data from the COMPETE trial offer insights into how tumour absorbed dose correlates with objective response," said Dr Flaus. "Understanding this dose-response relationship provides important evidence that could potentially support the development of more individualised radiopharmaceutical treatment approaches."
Early-pipeline highlights
Three additional datasets were drawn from independent, investigator-led studies rather than ITM-sponsored trials, and the company was careful to frame them accordingly.
Ga-DPI-4452, a gallium-68-labelled PET imaging agent targeting carbonic anhydrase IX and designated as ITM-94, was evaluated in a bicentric retrospective registry of 98 patients with suspected or confirmed ccRCC. The agent identified abnormal findings in 91.8% of patients with subsequently confirmed disease and outperformed conventional CT across 153 predefined anatomical regions, including primary tumour sites, regional and distant lymph nodes, bone metastases, and visceral metastases. ITM-94 received FDA Fast Track Designation in October 2025.
Data from the Phase 0b BETA PLUS study of Tb-DOTA-LM3 (ITM-63), a terbium-161-labelled SSTR2 antagonist, were presented for six patients with metastatic GEP-NETs. Reducing peptide mass from 300 to 400 micrograms down to below 100 micrograms nearly doubled tumour absorbed dose (23.3 versus 12.5 Gy/GBq; p less than 0.001), with improved tumour-to-kidney and tumour-to-bone-marrow dose ratios. No dose-limiting toxicities were reported.
An e-poster covered translational work supporting n.c.a. 177Lu-TTM (ITM-31), an intracavitary radioimmunotherapy targeting carbonic anhydrase XII in glioblastoma. Immunohistochemical analysis found high CAXII expression in the tumour infiltration zone, reinforcing the target rationale for ITM-31 following surgical resection.
Market and competitive context
The radiopharmaceutical therapeutics sector has attracted substantial commercial attention over the past three years. Novartis's 177Lu-DOTATATE (Lutathera) is already approved for SSTR-positive GEP-NETs, and the COMPETE programme positions ITM-11 as a competing or complementary lutetium-177 SSTR-targeted agent. The dose-response data presented at EANM carry practical implications: if dosimetry-guided individualisation proves feasible at scale, it could differentiate ITM-11 on outcomes rather than competing solely on manufacturing or pricing. A number of companies, including RayzeBio (now part of Bristol-Myers Squibb) and Lantheus, are advancing their own radiopharmaceutical pipelines across multiple tumour types, intensifying the race for regulatory approval and commercial partnerships.
All four candidates mentioned in the release remain investigational and have not received regulatory approval. The next milestone to watch for ITM-11 will be whether the COMPETE dosimetry data inform the ongoing COMPOSE Phase 3 study design for higher-grade GEP-NETs.