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ITM Announces Positive Topline Results of Phase 3 COMPETE Trial with ITM-11, a Targeted Radiopharmaceutical Therapy, in Patients with Grade 1 or Grade 2 Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

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  • Phase 3 clinical trial with ITM-11 met its primary endpoint, demonstrating clinically relevant and statistically significant benefit in Progression-Free Survival (PFS) compared to everolimus.
  • ITM plans to submit the COMPETE data for presentation at a future medical conference, with potential US regulatory submission anticipated in 2025.
  • ITM continues to advance a broad clinical pipeline, with multiple assets being investigated across seven different tumor types, including glioblastoma and clear cell renal cell carcinoma.


About the Phase 3 COMPETE Trial

COMPETE is a prospective, randomized, controlled, open-label Phase 3 trial evaluating the efficacy and safety of ITM-11 compared to everolimus, a standard of care treatment. ITM-11 is comprised of non-carrier-added (n.c.a.) lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a somatostatin receptor (SSTR) agonist.

The trial enrolled 309 patients with Grade 1 or Grade 2 inoperable, progressive, somatostatin receptor-positive neuroendocrine tumors of gastroenteric or pancreatic origin (Ki-67 ≤20%). Patients were randomized 2:1 to receive 7.5 GBq of ITM-11 with a nephroprotective amino acid solution every three months for a maximum of four cycles, or everolimus 10 mg daily for up to 30 months, or until disease progression. The COMPETE trial was conducted at multiple sites throughout the world.


About ITM-11 (n.c.a. 177Lu-edotreotide)

ITM-11 is a radiolabeled peptide conjugate agent that uses beta radiation to attack specific tumor cells (SSTR-positive) while avoiding harm to healthy tissues. It is given through an IV and combines a radioactive substance, lutetium-177, with edotreotide, which targets tumor cells. ITM-11 has been recognized as an orphan drug in the EU and US and received fast track designation in the US for treating GEP-NETs, based on positive results from a retrospective Phase 2 study1.

About GEP-NETs

GEP-NETs are the most common sub-type of NETs, comprising between 55 to 70% of all NETs, or an estimated 93,500 to 119,000 patients in the United States. The incidence of NETs has steadily increased over recent decades, resulting, in part, from improved diagnosis. Gastroenteropancreatic neuroendocrine tumors (GEP-NETS) originate in the neuroendocrine system and are made up of nerve cells and hormone-producing cells. They can occur anywhere in the GI tract and pancreas, including the stomach, small intestine, colon, rectum, and appendix. There is still a high unmet medical need for treatment options, as many patients are asymptomatic and diagnosed at a late stage with metastatic disease.

What’s Next?

The company plans to submit the results for presentation at a future medical meeting and anticipates discussing a potential New Drug Application (NDA) submission with the FDA in 2025.  These findings will also be shared through ongoing collaborations, aiming to advance better treatment outcomes for GEP-NET patients.

About ITM Isotope Technologies Munich SE

ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com.

Media Contact Information

ITM Corporate Communications
Kathleen Noonan/Julia Westermeir
Phone: +49 89 329 8986 1500
Email: communications(at)itm-radiopharma.com

Investor Relations
Ben Orzelek
Phone: +49 89 329 8986 1009
Email: investors(at)itm-radiopharma.com

References:

  1. Baum RP, Kluge AW, Kulkarni H, et al. [(177)Lu-DOTA](0)-D-Phe(1)-Tyr(3)-Octreotide ((177)Lu-DOTATOC) For Peptide Receptor Radiotherapy in Patients with Advanced Neuroendocrine Tumours: A Phase-II Study. Theranostics. 2016;6(4):501-510.