ITM Announces First Patient Treated in Second Phase III Trial, COMPOSE, with ITM-11 (n.c.a. lutetium-177-edotreotide) for Treatment of Neuroendocrine Tumors
ITM
Isotope Technologies Munich SE (ITM), the radiopharmaceutical biotech company,
announced that the first patient has been treated in its second pivotal phase
III clinical trial, COMPOSE (NCT04919226), evaluating the company’s lead
radiopharmaceutical candidate, ITM-11 (n.c.a. 177Lu-edotreotide), for the
treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 is
a Targeted Radionuclide Therapeutic consisting of the high-quality radioisotope
no-carrier-added lutetium-177 (n.c.a. 177Lu) fused with a somatostatin analogue
to specifically target somatostatin receptor-positive (SSTR+) GEP-NETs. While
COMPOSE is evaluating ITM-11 for the treatment of well-differentiated high
grade 2 and grade 3 GEP-NETs, the radiopharmaceutical is also being
investigated in ITM’s ongoing pivotal phase III trial, COMPETE (NCT03049189),
in patients with grade 1 and 2 GEP-NETs. GEP-NETs are rare types of tumors that
can occur in the pancreas or in other parts of the gastrointestinal tract. Due
to their frequent asymptomatic and progressive nature, GEP-NETs often present
late with advanced disease requiring innovative therapeutic measures. The trial
design of COMPOSE was recently presented at the 2022 ASCO Gastrointestinal
Cancers Symposium (ASCO-GI) and the 2021 North American Neuroendocrine Tumor
Society (NANETS) annual symposium.
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Source: ITM