Here’s a breakdown of the provided references, focusing on the key information about the study of 177Lu-edotreotide (ITM-11) in GEP-NETs:
1. COMPETE Trial (ESMO 2025)
* What it is: A Phase 3 clinical trial.
* presented at: European Society for Medical Oncology (ESMO) congress, october 17-20, 2025, Berlin, Germany.
* Abstract Number: 1706O
* Focus: NETs (Neuroendocrine Tumors) – specifically, evaluating 177Lu-edotreotide.
* Key takeaway: This presentation likely details the results of the Phase 3 trial.
2. ITM Press Release (EANM 2025)
* Source: ITM (the company developing the drug).
* Date: October 8, 2025.
* Presented at: European Association of Nuclear Medicine (EANM) Annual Congress.
* Focus: Dosimetry data from the Phase 3 COMPETE trial.
* Key takeaway: This release highlights favorable efficacy and safety data based on dosimetry (measuring radiation dose) from the COMPETE trial. This suggests the drug is delivering the intended radiation dose effectively and safely.
* Link: https://tinyurl.com/3nuscs4m
3. COMPOSE Trial (ClinicalTrials.gov)
* Trial Name: COMPOSE (Lutetium 177Lu-Edotreotide versus best standard of care…)
* ClinicalTrials.gov Identifier: NCT04919226
* Updated: September 10, 2025.
* Focus: Well-differentiated,aggressive Grade 2 and Grade 3 Gastroenteropancreatic Neuroendocrine tumors (GEP-NETs).
* Key takeaway: This is the official trial record on ClinicalTrials.gov, providing detailed information about the study design, eligibility criteria, and objectives.
* Link: https://www.clinicaltrials.gov/study/NCT04919226
In summary: These references document the development and reporting of a Phase 3 trial (COMPETE) evaluating 177Lu-edotreotide (ITM-11) for GEP-NETs. The data presented at ESMO and EANM in October 2025 suggest a promising efficacy and safety profile. The COMPOSE trial record on ClinicalTrials.gov provides comprehensive details about the study itself.
