ITM’s Radiopharmaceutical ITM-11 Shows Promising Results in Phase III COMPOSE Trial for Advanced Neuroendocrine Tumors

Trial Overview:
The COMPOSE trial is a Phase III study evaluating the efficacy and safety of ITM-11 (177Lu-edotreotide) compared to best standard of care for patients with well-differentiated high-grade 2 and grade 3 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs)23.

Treatment Comparison:
The trial compares ITM-11 with investigator’s choice of best standard care, which could include chemotherapy (CAPTEM or FOLFOX) or everolimus23.

Primary Endpoint:
The primary endpoint of the study is progression-free survival (PFS), assessed every 12 weeks from randomization onwards23.

Secondary Endpoints:
Secondary outcome measures include overall survival (OS) up to two years after disease progression23.

Patient Enrollment: The study aims to enroll 202 patients, with a 1:
1 randomization to ITM-11 or best standard of care23.

Targeted Radionuclide Therapy:
ITM-11 is a targeted radionuclide therapy consisting of no-carrier-added lutetium-177 (n.c.a. 177Lu) combined with the somatostatin analogue edotreotide, which targets neuroendocrine tumor-specific receptors23.

Regulatory Status:
The FDA has granted a fast track designation to ITM-11 for use in patients with GEP-NETs2.

Clinical Significance:
The study aims to demonstrate the potential of ITM-11 to improve treatment outcomes and quality of life for patients with advanced neuroendocrine tumors23.

Sources:

2. https://www.onclive.com/view/fda-grants-fast-track-designation-to-itm-11-for-gastroenteropancreatic-neuroendocrine-tumors

3. https://www.biospace.com/itm-presents-design-of-second-phase-iii-trial-compose-with-radiopharmaceutical-itm-11-for-the-treatment-of-neuroendocrine-tumors-at-annual-enets-conference-2022