Translate
Subscribe to Blog via Email
Ronny Allan
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.
References:
1. ITM Website – click here
2. COMPOSE Clinical Trials Document – click here
3. COMPOSE Phase 2 results – click here
Bonus read – my interview with ITM for their staff newsletter
click here or on the picture
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.
Disclaimer
I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.
Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional.
Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.
Finally
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
Top 10 Posts & Pages in the last 48 hours (auto updates) (Click the titles to read them)
Neuroendocrine Cancer: Question, Clarify, Confirm
One of the many observations I make in my private Neuroendocrine Cancer Facebook group is the misunderstandings caused by the use of non-standard terminology combined
Clinical Trial – Lutathera NETTER-2 Important Update
UPDATE – Sep 25th, 2023 – Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors
Lanreotide: Ipsen injection devices vs generic injection devices
Whenever I get a chance to talk to a pharma involved in somatostatin analogue injection devices, I tell them one very important thing …… “To
Cancer doesn’t take holidays (but I do)
Glen Etive Scotland in 2018 After diagnosis in July 2010, with the exception of a planned holiday to Turkey prior to my ‘big surgery’, holidays
Update from Ronny Allan: No evidence of progressive disease at any site
Update August 2023. Latest CT surveillance scan reports “No evidence of progressive disease at any site”. Very pleased! With incurable but treatable cancers such as
Exercise is Medicine
Exercise is medicine. Clearly I need to be careful with that statement given my aversion for cancer myths. However, those who know me will totally
Jimmy Buffett 1946-2023 – Neuroendocrine Carcinoma (Merkel Cell Carcinoma)
US singer-songwriter Jimmy Buffett, best known for his 1970’s hit Margaritaville, has died aged 76. “Jimmy passed away peacefully on the night of September 1
Passive patient or active advocate?
I’ve been researching Neuroendocrine Cancer for some time now. Why do I do this? Whilst I have a great medical team, I’d also like to
Childhood Cancer Awareness Month – Neuroendocrine Cancer (featuring Elizabeth)
September is Childhood Cancer Awareness Month! The newspapers and social media will no doubt be featuring many childhood cancer articles. You may not see one
A cup of tea
I would also mention those who contributed to my “Tea Fund” which resides on PayPal. You don’t need a PayPal account as you can select a card but don’t forget to select the number of units first (i.e. 1 = £4, 2 = £8, 3 = £12, and so on), plus further on, tick a button to NOT create a PayPal account if you don’t need one. Clearly, if you have a PayPal account, the process is much simpler
Through your generosity, I am able to keep my sites running and provide various services for you. I have some ideas for 2023 but they are not detailed enough to make announcements yet.
This screenshot is from every single post on my website and depending on which machine you are using, it will either be top right of the post or at the bottom (my posts are often long, so scroll down!)
