ITM’s ITM-11 radiopharmaceutical is showing promise for treating neuroendocrine tumors, according to research presented at the European Association of Nuclear Medicine (EANM) annual meeting in Barcelona, Spain.
The company presented new dosimetry data from its phase III COMPETE trial in patients with grade 1 and grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs) treated with ITM-11 (Lutetium-177 edotreotide).
Key findings included the following, ITM said:
Absorbed dose in tumors was significantly higher compared to normal organs, supporting therapeutic efficacy and safety.
Normal organ absorbed doses were well below safety thresholds.
Grade ≥ 1 renal adverse events occurred less often with ITM-11 versus everolimus (14.7% vs. 21.2%).
The dosimetry assessments are in alignment with the efficacy and safety outcomes of the trial.
ITM is on track for submitting a new drug application for ITM-11 to the U.S. Food and Drug Administration this year, the company noted.
