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

Garching / Munich, January 28, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced positive topline results from its Phase 3 COMPETE trial in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The data showed that ITM-11 (n.c.a. 177 Lu-edotreotide), a proprietary, synthetic, targeted radiotherapeutic agent, met the primary endpoint of prolonging progression-free survival (PFS) when compared to everolimus, a targeted molecular therapy. ITM-11 was well-tolerated with favorable safety results observed.

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 noncarrier-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.

“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 tumors 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,” said Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d'Hebron University Hospital, Barcelona. “As a clinician, I am highly encouraged by these data and look forward to seeing further results.”

“We want to thank the patients, families and caregivers, and investigators for their commitment to and trust in this trial. People with GEP-NETs, whose journey from diagnosis to proper treatment can take years, remain in significant need of more robust, data-driven treatment options to maximize outcomes. The successful COMPETE data support ITM-11’s potential and we believe mark an important milestone for patients and for ITM,” said Dr. Andrew Cavey, CEO of ITM. “Our organization now has demonstrated both early and late-stage clinical development capabilities that complement our leadership in global isotope manufacturing.”

Secondary endpoints in the COMPETE trial include objective response rate, overall survival, and quality of life assessments. Additionally, dosimetry was used to assess the absorbed ITM-11 dose in tumors compared to that in healthy tissue to enhance monitoring of the patient's safety and efficacy. These dosimetry data and secondary endpoints, along with subgroup analyses, are currently being evaluated.

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.

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. The COMPOSE trial is a prospective randomized, controlled, open-label trial evaluating the efficacy, safety and patient-reported outcomes of ITM-11 as first or second line treatment compared to physician’s choice standard of care chemotherapy. 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).