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)
- 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.