After 20 years of building radioisotope expertise as a manufacturer and supplier, German firm ITM Isotope Technologies is ready to take center stage with drugs of its own. ITM’s lead radiopharmaceutical outperformed the current standard-of-care treatment at prolonging progression-free survival in a phase 3 trial in patients with inoperable neuroendocrine tumors.
ITM endeavors to discuss a new drug application for the candidate, called ITM-11, with the FDA in 2025, the company said in a Jan. 28 release. The company also plans to submit the phase 3 results for presentation at a future medical conference, ITM said.
The global phase 3 trial enrolled 309 patients with grade 1 or 2 progressive somatostatin receptor (SSTR)-positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NETs). It compared ITM-11 with targeted molecular therapy everolimus, sold by Novartis as Afinitor for advanced neuroendocrine tumors and other indications.
ITM-11 was well tolerated by patients and had favorable safety results, according to the release. ITM did not disclose whether there were adverse events in the trial.
The trial’s secondary endpoints of objective response rate, overall survival and quality of life are still being evaluated, ITM said.
“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,” ITM CEO Andrew Cavey, M.D., said in the release. “Our organization now has demonstrated both early and late-stage clinical development capabilities that complement our leadership in global isotope manufacturing.”
That manufacturing leadership includes being the long-term supplier of radioisotope lutetium-177 to Novartis for the creation of metastatic prostate cancer drug Pluvicto. Pluvicto is now the most successful radioligand therapy, with sales of $1.04 billion in the first three quarters of 2024.
Lutetium-177 is also used in ITM-11, which is delivered intravenously, ITM said.
ITM is also testing ITM-11 in multiple other trials, including another phase 3 trial with a different subset of patients with GEP-NETs, those with well-differentiated, aggressive grade 2 or 3 SSTR-positive tumors. A third phase 3 trial is running in patients with lung and thymus neuroendocrine tumors, according to the release, as well as a phase 1 pediatric trial in SSTR-positive tumors.
ITM is not putting all of its hopes into one radioactive basket. In addition to ITM-11, the firm has 12 other drug candidates in its pipeline that range in development from preclinical to phase 3.