ITM, a German radiopharmaceutical company, has announced positive topline results from its Phase III COMPETE trial, evaluating ITM-11 in patients with inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The trial demonstrated that ITM-11 achieved a clinically significant and statistically robust improvement in progression-free survival (PFS) compared to everolimus, a targeted molecular therapy. This success positions ITM-11 as a potential first-line treatment option and marks a significant milestone for the radiopharmaceutical field.
ITM-11: A Novel Approach to GEP-NET Treatment
GEP-NETs are rare cancers arising from neuroendocrine cells in the gastrointestinal tract and pancreas. ITM-11 is a targeted radionuclide therapeutic composed of edotreotide, a somatostatin receptor (SSTR) analog, and no-carrier-added (n.c.a.) Lutetium-177, a beta-emitting radioisotope. Edotreotide binds with high affinity to SSTRs overexpressed on neuroendocrine tumor cells, facilitating the internalization of ITM-11. Once inside, the Lutetium-177 decays, emitting cytotoxic beta particles that destroy tumor cells while minimizing damage to surrounding healthy tissues.
According to Andrew Cavey, CEO of ITM, ITM-11 distinguishes itself from other SSTR-targeting radiopharmaceuticals through its use of n.c.a. lutetium, which is more user-friendly, and the design of its clinical trials.
COMPETE Trial: A Landmark Achievement
The Phase III COMPETE trial is the first to demonstrate that a targeted radiopharmaceutical therapy can outperform a molecular targeted therapy in a head-to-head Phase III study for GEP-NETs. The trial's results highlight ITM-11's ability to deliver targeted radiation to tumor cells while sparing healthy tissues, reinforcing its precision and safety. ITM-11 was well-tolerated, with a favorable safety profile observed, which is critical for GEP-NET patients requiring long-term treatment. Additional outcomes, such as overall survival, objective response rate, and quality of life metrics, are still being evaluated.
Radiopharmaceutical Market: A Growing Field
The radiopharmaceutical market is experiencing significant growth, projected to reach $26.51 billion by 2031, up from $9.07 billion in 2023. This growth is driven by the success of therapies like Novartis’ Pluvicto and Lutathera, which have demonstrated the efficacy of targeted radioligand therapies in treating specific cancers. The success of ITM-11 could further boost investment in radiopharma in 2025.
Challenges and Future Directions
Despite the promise of radiopharmaceuticals, challenges remain, including the limited availability of critical isotopes like actinium-225, manufacturing complexities, and logistical hurdles. Efforts are underway to scale up isotope production and streamline supply chains. Cavey noted that regulations are adapting to the evolving field.
ITM's pipeline includes trials for other indications, such as glioblastoma and clear cell renal cell carcinoma, signaling the potential of radiopharmaceuticals to address a wider range of cancers. With a potential U.S. Food and Drug Administration (FDA) submission in 2025, ITM-11 may become one of the first radiopharmaceuticals to achieve regulatory approval based on head-to-head superiority against a molecular therapy, setting a precedent for future approvals.
