Topline results from the COMPETE trial showed that ITM-11 met the study’s primary end point of PFS in inoperable, progressive grade 1 or grade 2 GEP-NETs.
Topline results from the phase 3 COMPETE trial showed that the targeted radiotherapeutic agent, ITM-11 (n.c.a. 177Lu-edotreotide), met the primary end point of prolonging progression-free survival (PFS) compared with the targeted molecular therapy, everolimus, in patients with inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs), according to a press release from ITM Isotope Technologies Munich SE (ITM).
The proprietary, synthetic agent was well-tolerated with favorable safety results, the release also stated. Furthermore, the company went on to share that they plan to submit the COMPETE data for presentation at a future medical conference, and, in 2025, discussing a potential New Drug Application (NDA) submission with the Food and Drug Administration (FDA) is anticipated.
Objective response rate: the percentage of patients who have a partial or complete response to a treatment within a specific time period.
Overall survival: the amount of time a patient lives after being diagnosed with a disease or starting treatment.
Quality of life: a person's overall sense of well-being and enjoyment of life.
“With COMPETE, this marks the first time that a targeted radiopharmaceutical therapy has demonstrated improved PFS compared with a targeted molecular therapy, everolimus, in patients with grade 1 and grade 2 GEP-NETs 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,” Dr. Jaume Capdevila, study investigator and senior medical oncologist at Vall d'Hebron University Hospital, in Barcelona, Spain, explained in the press release. “As a clinician, I am highly encouraged by these data and look forward to seeing further results.”
The incidence of NETs, a rare form of cancer, has steadily increased in recent decades, evidenced with an estimated 8 new cases per 100,000 people diagnosed each year in the U.S. and 9 cases per 100,000 in Europe. GEP-NETS, specifically, originate in the neuroendocrine system, and are made up of nerve cells and hormone-producing cells which can occur anywhere in the GI tract and pancreas. Because many patients are asymptomatic and diagnosed at a late stage with metastatic disease, there remains an unmet medical need for treatment options.
To combat this need, investigators are evaluating ITM-11, a radiolabeled peptide conjugate which delivers beta radiation specifically to tumor cells, sparing healthy organs and tissue. The agent is delivered intravenously, or through an IV, and was granted orphan drug designation in the European Union and the U.S. Additionally, fast track designation was granted in the U.S. for the treatment of GEP-NETs, based on positive results from a retrospective phase 2 study.
The prospective, randomized, controlled, open-label COMPETE trial is investigating the efficacy and safety of ITM-11 compared to everolimus, the current standard-of-care treatment for patients within this population; the clinical trial is being conducted at multiple sites throughout the world. Eligible patients included those with grade 1 or 2 inoperable, progressive, somatostatin receptor-positive NETs of gastroenteric or pancreatic origin. In total, 309 patients were enrolled and were randomly assigned in a two to one fashion 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 at 10 mg daily for up to 30 months, or until disease progression.
Secondary end points of the study include objective response rate, overall survival and quality of life assessments, according to the press release, which added that dosimetry was used to assess the absorbed ITM-11 dose in tumors. This was then compared with healthy tissue to enhance monitoring of the patient's safety and efficacy, and these data as well as end point data and subgroup analyses are currently being evaluated.
“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,” Dr. Andrew Cavey, chief executive officer of ITM, concluded in the press release. “Our organization now has demonstrated both early and late-stage clinical development capabilities that complement our leadership in global isotope manufacturing.”
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