ITM Isotope Technologies Munich SE (ITM) has announced positive topline results from its Phase 3 COMPETE trial, revealing that ITM-11 (177Lu-edotreotide) significantly improved progression-free survival (PFS) compared to everolimus in patients with inoperable, progressive Grade 1 or 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This outcome marks a potential shift in the treatment paradigm for this rare cancer. The company plans to submit the data for presentation at a future medical conference and anticipates discussing a potential New Drug Application (NDA) submission with the FDA in 2025.
The COMPETE trial is a prospective, randomized, controlled, open-label Phase 3 study designed to evaluate the efficacy and safety of ITM-11 compared to everolimus, a standard-of-care treatment. The trial enrolled 309 patients with Grade 1 or 2 inoperable, progressive, somatostatin receptor-positive neuroendocrine tumors of gastroenteric or pancreatic origin. Participants were randomized 2:1 to receive either ITM-11 (7.5 GBq every three months for up to four cycles) with a nephroprotective amino acid solution or everolimus (10 mg daily for up to 30 months or until disease progression).
Clinically Meaningful Improvement in PFS
The primary endpoint of the COMPETE trial was PFS. According to the press release, ITM-11 demonstrated a clinically relevant and statistically significant improvement in PFS compared to everolimus. ITM-11 was also well-tolerated, with a favorable safety profile observed. Secondary endpoints, including objective response rate, overall survival, and quality of life assessments, are currently being evaluated.
Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d'Hebron University Hospital in Barcelona, stated, "With COMPETE, this marks the first time that a targeted radiopharmaceutical therapy has demonstrated improved progression-free survival compared to a targeted molecular therapy, everolimus, in patients with Grade 1 and Grade 2 gastroenteropancreatic neuroendocrine tumours in a Phase 3 clinical trial. The patients included represent a real-life scenario, and the COMPETE study evaluates the important question of which therapy might be used first to provide greater benefit to patients."
ITM-11: A Targeted Radiopharmaceutical Approach
ITM-11 is a radiolabeled peptide conjugate designed to deliver beta radiation specifically to somatostatin receptor (SSTR)-positive tumor cells, sparing healthy organs and tissue. It comprises non-carrier-added lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a synthetic SSTR agonist. The agent is administered intravenously.
Addressing an Unmet Need in GEP-NET Treatment
Neuroendocrine tumors (NETs) are a rare form of cancer, with an estimated incidence of 8 new cases per 100,000 individuals diagnosed each year in the U.S. and 9 cases per 100,000 in Europe. Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) originate in the neuroendocrine system and can occur anywhere in the GI tract and pancreas. Many patients are asymptomatic and diagnosed at a late stage with metastatic disease, highlighting the need for more effective treatment options.
Expanding Clinical Development Program
In addition to the COMPETE trial, ITM-11 is being evaluated in a Phase 3 trial (COMPOSE) in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors. Additional clinical programs with ITM-11 include a Phase 1 pediatric trial in SSTR-positive tumors (KinLET) and a Phase 3 investigator-sponsored trial in lung and thymus neuroendocrine tumors (LEVEL).
