en.Wedoany.com Reported - ITM Isotope Technologies Munich SE (ITM) presented the latest single-time-point dosimetry data from its Phase 3 COMPETE trial for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in a poster at the 2026 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI).
The COMPETE trial (NCT03049189) aims to evaluate ¹⁷⁷Lu-edotreotide (ITM-11) versus everolimus in patients with unresectable, progressive Grade 1 or 2 GEP-NETs. Previously announced results showed that the ¹⁷⁷Lu-edotreotide group achieved a median progression-free survival of 23.9 months, significantly superior to the 14.1 months in the everolimus group (p=0.022).
In this prospective dosimetry sub-study, researchers utilized dosimetric data from 177 patients receiving ¹⁷⁷Lu-edotreotide, encompassing planar and SPECT/CT imaging of 207 kidneys and 154 tumors. They applied a population-based nonlinear least squares model (PBMS NLMEM) to assess the feasibility of obtaining individualized kidney and tumor dose estimates from a single imaging time point, and compared this model with existing Madsen and Hänscheid methods.
The PBMS method demonstrated a mean absolute percentage error (MAPE) of 3% to 20% for kidney dosimetry, outperforming the comparator methods at all evaluated time points. The study indicated that individualized dosimetry can be achieved with just one scan approximately six hours post-treatment, offering an alternative for centers with limited imaging equipment.
Dr. Deni Hardiansyah, Associate Professor at the University of Indonesia and co-author of the study, noted that the clinical value of individualized dosimetry is well-recognized, but the complexity of repeated imaging procedures has limited its adoption. These findings support its more practical integration into routine clinical practice.
Dr. Celine Wilke, Chief Medical Officer of ITM, stated that a single scan enables same-day precise dosimetry, helping to reduce patient burden, streamline workflows, and minimize inter-center variability, making personalized dosimetry feasible in a broader range of clinical settings.
¹⁷⁷Lu-edotreotide is an investigational product currently under review by the U.S. Food and Drug Administration (FDA) and has not been approved for any intended use. ITM is also evaluating this drug in the COMPOSE study for patients with Grade 2 or 3 GEP-NETs.
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