Trial Data Show Safety and Efficacy of ITM-11 in Patients With GEP-NETs

Dosimetry data from a phase 3 clinical trial reveals favorable safety and efficacy with nca ¹⁷⁷Lu-edotreotide (ITM-11) in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs).^1,2

The results were announced at the European Association of Nuclear Medicine 2025 Annual Congress in October, and additional data will be announced at future conferences.

What Were the Results of the COMPETE Trial?

The phase 3 COMPETE trial (NCT03049189) examined patients with grade 1 or grade 2 somatostatin receptor–positive (SSTR+) GEP-NETs treated with ITM-11. The study of 309 patients showed targeted tumor uptake with low healthy organ exposure. The results support the therapeutic potential of ITM’s proprietary targeted radiotherapeutic agent.^1,2

The primary end point of the study was achieved, with patients demonstrating a significantly longer median progression-free survival (PFS) with ITM-11 than with everolimus.¹

Absorbed doses (ADs) for target tumors and all organs except red bone marrow were measured via whole body planar (2D) and abdominal single-photon emission CT 3D imaging at cycle 1. In a subset of 20 patients, red bone marrow dosimetry was performed with additional blood samples at prespecified time points to determine the time-activity curves. The AD in tumors was significantly higher than in normal organs, and the normal organ ADs were well below safety thresholds. Grade 1 or higher adverse events (AEs) occurred less often with ITM-11 than with everolimus (14.7% vs 21.2%, respectively).^1,2

What Was the Patient Criteria?

Patient eligibility criteria included a historically confirmed diagnosis of well-differentiated neuroendocrine tumor of nonfunctional gastroenteric origin or both functional or nonfunctional pancreatic origin, measurable disease per RECIST 1.1, SSTR+ disease, and progressive disease based on RECIST 1.1 criteria as evidenced by 2 morphological imaging examinations made with the same imaging method, either CT or MRI.¹

Patient exclusion criteria included, but was not limited to, a known hypersensitivity to edotreotide or everolimus, a hypersensitivity to any excipient of edotreotide or everolimus or another rapamycin derivative, prior exposure to any peptide receptor radionuclide therapy (PRRT), prior therapy with mTor inhibitors, and prior external field radiation GEP-NET lesions within 90 days before randomization or radioembolization therapy.¹

The secondary end points of the COMPETE trial were objective response rate and overall survival (OS).¹

“With these data combining extensive dosimetry information from more than 200 patients included in a prospective trial, ITM is laying the groundwork for improved therapeutic decision-making by providing important insights into tumor uptake and treatment variability,” Emmanuel Deshayes, MD, PhD, professor in biophysics and nuclear medicine at the Montpellier Cancer Institute in France, said in a news release.² “It may offer clinically meaningful implications for optimizing individualized patient management.”

What Are the Next Steps in Research?

Interim dosimetry data from COMPETE shaped the design of ITM’s phase 3 COMPOSE (NCT04919226) trial, with ITM-11 in well-differentiated, aggressive grade 2 or grade 3 SSTR+ GEP-NET tumors, as well as the upcoming phase 1 pediatric KinLET (NCT06441331) study in SSTR+ tumors.^3,4

ITM’s COMPOSE trial was supported by data found in the COMPETE trial. The purpose of COMPOSE is to evaluate the efficacy, safety, and patient-reported outcomes of PRRT, with ITM-11 as the first or second line of treatment compared with best standard of care in patients with well-differentiated aggressive grade 2 and grade 3 SSTR+ NETs of gastroenteric or pancreatic origin. There are 259 patients enrolled in the trial. The primary and secondary end points of the trial are PFS and OS.³

Data from COMPETE also helped shaped the KinLET trial, which will examine the appropriate pediatric dosage, safety, and pharmacokinetics of ITM-11 targeted radiopharmaceutical therapy as a monotherapy or following standard of care in patients aged 2 to 18 years with SSTR+ tumors.⁴

REFERENCES:

1. Efficacy and safety of 177Lu-edotreotide PRRT in GEP-NET patients (COMPETE). ClinicalTrials.gov. Updated May 30, 2025. Accessed October 13, 2025. https://www.clinicaltrials.gov/study/NCT03049189

2. ITM presents dosimetry data from phase 3 COMPETE trial supporting favorable efficacy and safety profile with n.c.a. 177Lu-edotreotide (ITM-11) in patients with gastroenteropancreatic neuroendocrine tumors at EANM 2025 Annual Congress. News release. ITM. October 8, 2025. Accessed October 13, 2025. https://tinyurl.com/3nuscs4m

3. Lutetium 177Lu-Edotreotide versus best standard of care in well-differentiated aggressive grade-2 and grade-3 gastroenteropancreatic neuroendocrine tumors (GEP-NETs) – COMPOSE (COMPOSE). ClinicalTrials.gov. Updated September 10, 2025. Accessed October 13, 2025. https://www.clinicaltrials.gov/study/NCT04919226

4. Phase I trial to determine the dose and evaluate the PK and safety of lutetium Lu 177 edotreotide therapy in pediatric participants with SSTR-positive tumors (KinLET). ClinicalTrials.gov. Updated September 19, 2025. Accessed October 13, 2025. https://www.clinicaltrials.gov/study/NCT06441331