Garching / Munich, September 6, 2022 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that a scientific poster on the design of its second phase III clinical trial, COMPOSE, in advanced neuroendocrine tumors (GEP-NETs) will be presented at the upcoming ESMO Congress from September 9-13, 2022, in Paris. The start of patient treatment in the pivotal COMPOSE trial was announced in January this year.
The poster will be presented by Dr. Jaume Capdevila, Vall d'Hebron University Hospital, Barcelona, and Principal Investigator for the trial, on Sunday, September 11, 2022, from 12 to 1 pm CEST in the poster area. COMPOSE (NCT04919226) is designed to evaluate the efficacy and safety of ITM’s lead candidate, ITM-11 (n.c.a. 177Lu-edotreotide), as first- or second-line treatment compared to best standard of care for patients with well-differentiated aggressive grade 2 and grade 3 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. ITM-11 is a Targeted Radionuclide Therapeutic consisting of the beta-emitting radioisotope, non-carrier-added lutetium-177 (n.c.a. 177Lu) combined with the tumor-specific targeting molecule edotreotide, a somatostatin analogue.
Poster Information:
Poster-ID: 902TiP
Title: COMPOSE: Pivotal phase III trial to compare 177Lu-edotreotide with best standard of care for well-differentiated aggressive grade 2 and 3 gastroenteropancreatic neuroendocrine tumours
Poster Session: EONS15
Date & Time: Sunday, September 11, from 12 to 1 pm CET
The poster will also be made available after presentation on the company’s website in the “scientific publications” section.
COMPETE, ITM’s second ongoing phase III clinical trial in neuroendocrine tumors (grade 1 and 2 GEP-NETS), completed patient recruitment in April this year.
About ITM-11 (n.c.a. 177Lu-edotreotide)
ITM-11, ITM’s therapeutic radiopharmaceutical candidate being investigated in the phase III clinical studies COMPETE and COMPOSE, consists of two components: the medical radioisotope non-carrier-added lutetium-177 (n.c.a. 177Lu) and the targeting molecule edotreotide, a synthetic form of the peptide hormone somatostatin that targets neuroendocrine tumor-specific receptors. Edotreotide binds to these receptors and places the medical radioisotope n.c.a. lutetium-177 directly onto the diseased neuroendocrine cells so that it accumulates at the tumor site. N.c.a. lutetium-177 is internalized into the tumor cells and decays, releasing medical radiation (ionizing beta-radiation) with a maximum radius of 1.7 mm and destroying tumor tissue.