ITM's Radiopharmaceutical Outperforms Standard of Care in Phase 3 Neuroendocrine Tumor Trial

German firm ITM Isotope Technologies has announced promising results from a phase 3 trial of its lead radiopharmaceutical, ITM-11, in patients with inoperable neuroendocrine tumors. The study, which enrolled 309 patients with grade 1 or 2 progressive somatostatin receptor (SSTR)-positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NETs), demonstrated that ITM-11 outperformed the current standard-of-care treatment, everolimus, in prolonging progression-free survival.

Clinical Trial Success and Regulatory Plans

ITM-11, delivered intravenously, showed favorable safety results and was well-tolerated by patients in the trial. The company plans to discuss a new drug application with the FDA in 2025 and intends to submit the phase 3 results for presentation at a future medical conference.

Andrew Cavey, M.D., CEO of ITM, emphasized the significance of these results, stating, "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."

Secondary endpoints, including objective response rate, overall survival, and quality of life, are still under evaluation. The company is also conducting additional trials of ITM-11, including another phase 3 study in patients with well-differentiated, aggressive grade 2 or 3 SSTR-positive GEP-NETs, a phase 3 trial in lung and thymus neuroendocrine tumors, and a phase 1 pediatric trial in SSTR-positive tumors.

ITM's Expanding Pipeline and Industry Position

With 20 years of experience as a radioisotope manufacturer and supplier, ITM is now positioning itself as a drug developer. The company's pipeline includes 12 other drug candidates ranging from preclinical to phase 3 stages of development.

ITM has established itself as a key player in the radiopharmaceutical industry, serving as the long-term supplier of lutetium-177 to Novartis for the creation of Pluvicto, a metastatic pancreatic cancer drug. Pluvicto has achieved significant commercial success, with sales reaching $1.04 billion in the first three quarters of 2024, making it the most successful radioligand therapy to date.

As ITM transitions from a manufacturing focus to drug development, the positive results from the ITM-11 trial mark a significant milestone for the company and potentially for patients with neuroendocrine tumors who may benefit from this new treatment option.