Translate
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.
In the News. On the heels of the approval of PRRT in USA and UK and elsewhere, here’s news of a new PRRT compound undergoing a phase 3 clinical trial. ITM Isotope Technologies Munich SE, a specialized radiopharmaceutical company, today (7th Dec 2017) announced the enrolment of the first patient recruited in Europe for the COMPETE phase III clinical trial at the University Hospital Marburg, Germany. The CEO of ITM said “This marks the starting point of COMPETE in Europe, whereby we expect a rapid increase in the number of recruits.”
What is the COMPETE TRIAL?
COMPETE is led as an international pivotal multi-center phase III clinical trial evaluating the efficacy and safety of (no-carrier-added) n.c.a.177Lu-Edotreotide (Solucin®) and the trial is comparing it to Everolimus (Afinitor). The trial runs until Dec 2020. The enrolment requires patients with inoperable, progressive, somatostatin-receptor positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The primary endpoint is progression-free survival (PFS). The study will be conducted predominantly in Europe, North America, South Africa and Australia. The first patient to be enrolled and treated was in Australia. The clinical trial document (see references below) indicates it’s for non-functional GI tumours but for non-functional and functional pNETs. The list of locations can also be found in the clinical trial document. The usual inclusion/exclusion rules apply but the most notable would appear to be an exclusion for those with prior exposure to any PRRT or mTor inhibitor such as Everolimus (Afinitor).
What is 177Lu-Edotreotide (Solucin®)?
The compound under investigation, Solucin®, is known as a Targeted Radionuclide Therapy (TRT) agent, which consists of the targeting molecule Edotreotide, an octreotide-derived somatostatin analogue and ITM´s EndolucinBeta® (no-carrier-added Lutetium-177). EndolucinBeta® is a synthetic, low-energy beta-emitting isotope of Lutetium which is a recently EMA approved pharmaceutical precursor. The radiopharmaceutical Solucin® is administered as an intravenous infusion, specifically targeting and destroying the tumor cells with ionizing radiation. Solucin® received an Orphan Designation (EMA/OD/196/13) for the treatment of GEP-NET, based on early clinical experience, which has demonstrated a substantial clinical benefit with increased PFS and quality of life.
From ITM’s website … “Edotreotide contains DOTA which functions as a chelator for radioisotopes and TOC, a synthetic Somatostatin receptor ligand” (chelator and ligand are just fancy names for ‘bonding’ or ‘binding’). “The compound Edotreotide binds with high affinity Somatostatin receptors and retains both its receptor binding properties and its physiological function when labeled with 177Lu. Somatostatin receptors are predominantly overexpressed by neuroendocrine tumors. 177Lu-Edotreotide, upon binding to Somastotatin receptors in vivo is internalized and retained by tumor cells.”
“Compared to 90Y-Edotreotide, 177Lu-Edotreotide Targeted Radionuclide Therapy in NET was found to be less haematotoxic and associated with a longer median overall survival. That was highly significant for patients with low tumor uptake as well as for patients with extra hepatic and solitary metastases. In a retrospective Phase II trial 177Lu-Edotreotide showed a low uptake/dose delivered to normal organs and very high tumor-to-kidney ratio.”
Theranostic pairing from ITM – TOCscan®
68Ga-Edotreotide is the Ga68 PET radionuclide from ITM for true theranostic pairing with the SOLUCIN PRRT. See here.
Bonus read – my interview with ITM for their staff newsletter – click here
References:
1. ITM Website – click here
2. Clinical Trials Document – click here
3. Phase 2 results – click here
There’s also a Phase 3 trial known as COMPOSE designed for Grade 2 and 3 NETs – read more here.
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.
Subscribe to my newsletter
Top 10 Posts & Pages in the last 48 hours (auto updates) (Click the titles to read them)
Thanks for reading.
I’m also active on Facebook. Like my page for even more news. Help me build up my new site here – click here and ‘Like’
Sign up for my newsletters – Click Here
My Diagnosis and Treatment History
Check out my online presentations
Check out my WEGO Health Awards
Like my new awareness page – click here or on the photo. (Like rather than follow please!)
Check out my Glossary of Terms – click here
Please Share this post for Neuroendocrine Cancer awareness and to help another patient
RonnyAllan.NET – Summary of January 2023 – Ronny Allan – Living with Neuroendocrine Cancer
Summary Great start to 2023 and I thank those who continue to support my social media and this blog. I’m keen to hear any suggestions
Phase I study of procaspase-activating compound-1 (PAC-1) in the treatment of advanced malignancies (incl NET)
Trial Summary This interesting trial is a multi-cancer effort including NET. The phase I clinical trial of Procaspase Activating Compound-1 (PAC-1), a drug that spurs
Dustin Diamond
I’m behind the curve on this one after being ahead on celebrities such as Steve Jobs, Aretha Franklin, Wilko Johnson and Olivia Williams. But in
Neuroendocrine tumors are uncommon but definitely not rare
USA finally commits UK and Australian figures recently confirmed that Neuroendocrine Cancer is the 10th and 7th most common cancer type. It was great to
Cancer Ablation
What is Cancer Ablation? This is a minimally invasive surgical method to treat solid cancers. Special probes are used to “burn” or “freeze” cancers. Computed
Lactose intolerance – the NET Effect
Background When I cast my mind back to my very first surgery, I remember asking my Oncologist what I could do to put on weight.
EUS Guided Ablation for small pancreatic NETs (Less than 2cm)
To burn or not to burn? I once wrote a post about Pancreatic NET “to cut or not to cut”. You can read that here.
RonnyAllan.NET – a review of 2022
Review In 2022, my pet project (my blog) hit 2 million views in early November – that was a major boost. It takes 3-4 years to get
RonnyAllan.NET – Summary of December 2022
Summary December is always the quietest month of the year, no surprise why! However, the top 10 below is somewhat surprising, I guess some posts
Off tomorrow for my second PRT treatment at BU Medical Boston, Ma. Rather painless wit no nausea because of a specific amino acids they use to protect the kidneys.
Excellent article again Ronny. How does one access the ‘waiting list’ to be considered for trials on Compete?
Contact the trial coordinator for advice, they will have a view on suitability (normally driven by the inclusion/exclusion criteria I guess). Locations in UK, at Royal Free or Liverpool. I guess one way is to go via your specialist. He/she might have a view on suitability and that would be something useful to know in any case.
Thanks, The Christie doesn’t seem to be participating, which is surprising considering its reputation. Will investigate further!
https://polldaddy.com/js/rating/rating.js