Post-hoc COMPETE Analysis Shows 177Lu-edotreotide Extends PFS, Boosts ORR in P-NETs

ITM Isotope Technologies Munich SE is presenting post-hoc subgroup analyses from the Phase 3 COMPETE trial at the 23rd Annual Meeting of the European Neuroendocrine Tumor Society in Kraków, reporting that n.c.a. 177Lu-edotreotide (ITM-11) prolonged progression-free survival and produced higher objective response rates in the pancreatic neuroendocrine tumor subgroup versus everolimus. The company and conference materials identify the COMPETE study as NCT03049189 and say the P‑NET subgroup represented approximately 58% of trial participants.

Thomas Walter delivered the data in a mini-oral presentation and an accompanying poster in Clinical Science Session 2B, presentation ID D54, with the oral slot scheduled for 11:50–11:57 AM CET on March 5, 2026, in Theatre Hall S2 at the ICE Kraków Congress Centre. Markets Financialcontent reports Walter as “MD, PhD, professor of gastroenterology, Hospices Civil of Lyon, France” while ITM press materials list him as “Prof. Dr. Thomas Walter, Medical Oncologist, Lyon, France”; both affiliations appear in the distributed materials. Walter said, “Given that the data on peptide receptor radionuclide therapy in pancreatic NETs has been limited to date, we are encouraged by the activity of 177Lu‑edotreotide observed in this prespecified exploratory subgroup of patients with Grade 1 or 2 pancreatic NETs, who represented approximately 58% of trial participants.”

ITM’s February 25, 2026 corporate release from Garching / Munich frames the subgroup analyses as exploratory and post-hoc, while the Markets report characterizes the subgroup as prespecified exploratory; the source set therefore uses both terms. Celine Wilke, chief medical officer of ITM, is quoted in the Markets text: “These additional results from our Phase 3 COMPETE trial provide important insights into treatment options for patients with pancreatic NETs, and further enhance the robust clinical data of 177Lu‑edotreotide.”

Company press materials reiterate that COMPETE compared n.c.a. 177Lu‑edotreotide to everolimus in patients with inoperable, progressive Grade 1 or Grade 2 somatostatin receptor-positive gastroenteropancreatic NETs and state the trial “met its primary endpoint, with 177Lu‑edotreotide demonstrating clinically and statistically significant improvement in progression‑free survival (PFS) compared to everolimus.” The supplied notices do not include numerical subgroup efficacy results; no medians, hazard ratios, confidence intervals, p-values, ORR percentages, or subgroup safety data were provided in the distributed texts.

ITM is also running a conference booth #6 and hosting a satellite interactive symposium titled “Vote and Learn: Radiopharmaceutical Therapy in NETs” on March 5, 2026, from 07:45–08:45 AM CET in Theatre Hall S2. The company’s materials repeat the regulatory disclaimer: “177Lu‑edotreotide (ITM‑11) is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use.”

Clinicians and journalists at ENETS are now seeking the missing numerical details: the number of patients included in the P‑NET subgroup, the median PFS values, hazard ratios with confidence intervals, exact ORR percentages, and any subgroup safety or adverse event tables that would allow assessment of the magnitude and clinical implications of the reported activity.