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Garching / Munich, October 27, 2022
ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for ITM-11 (n.c.a. 177Lu-edotreotide), an investigational radiopharmaceutical for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 is being evaluated as a Targeted Radionuclide Therapy in two phase III clinical trials, COMPETE and COMPOSE.
The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. The purpose is to bring new and promising medicines to patients sooner. The Fast Track designation enables ITM to have more frequent interactions with the FDA to discuss the ITM-11 development path. It also allows rolling review of the new drug application (NDA) for ITM-11, when submitted. The rolling submission will allow ITM to submit completed sections of an application for review by FDA, rather than wait until all sections are completed.
COMPETE – low grade 1 and 2 NET
COMPOSE – aggressive grade 2 and 3 NET
Update 22 Jan 2022.
ITM Isotope Technologies Munich SE (ITM), today 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.
The trial design of COMPOSE was presented at the 2022 ASCO Gastrointestinal Cancers Symposium (ASCO-GI).
Brief Summary of the COMPOSE trial
Graphic courtesy of ITM – clinical trial sites as of 14 Oct 2021
This is an Open-label, Multicentre Study. Its purpose is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin. The standard of care comparison is based on either CAPTEM or everolimus or FOLFOX in patients with advanced grade 2 or grade 3 GEP-NETs.
So, this trial is focused on more aggressive tumours, which is great news.
OK that is the COMPOSE trial, what about COMPETE?
While COMPOSE is evaluating ITM-11 for the treatment of well-differentiated high (ki67) 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 low (ki67) grade 2 GEP-NETs.
I’ve written about this product before. It’s a synthetic, low-energy beta-emitting isotope of Lutetium 177 (a radioactive component already used within an approved product called Lutathera). Attaching the radiopharmaceutical Solucin® it’s administered as an intravenous infusion, specifically targeting and destroying the tumor cells with ionizing radiation, i.e. it works in exactly the same way as conventional PRRT. Read more by clicking this link plus news of an existing trial in Phase 3 – Phase 3 Clinical Trial of 177Lu-Edotreotide (Solucin®) – COMPETE for GEPNETs
General Clinical Trials Disclaimer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net
The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
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Whenever I post about a trial or study, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it’s also possible that clinical trials can be halted, or that national approval agencies will not approve the final product. Plus, not everyone will be eligible, so always check the exclusion and inclusion criteria in the relevant clinical trials document. Please bear that in mind when reading studies/clinical trials posted on RonnyAllan.NET
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