The Phase 3 COMPETE trial (NCT03049189) demonstrates that the radioligand therapy ¹⁷⁷Lu-edotreotide (ITM-11) offers substantial benefits for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Patients receiving ITM-11 had a median progression-free survival (PFS) of 23.9 months, compared with 14.1 months for those treated with everolimus. The therapy showed consistent benefit across both gastrointestinal and pancreatic tumors and achieved a higher objective response rate, with 19.3% of patients experiencing tumor shrinkage versus 3.9% with everolimus. Overall survival data are still being collected.
ITM-11 was well tolerated, with fewer discontinuations due to side effects (1.8% vs. 15.2% for everolimus). Long-term risks were low, with no cases of leukemia and only one case of myelodysplastic syndrome after over 40 months of follow-up, likely aided by spacing doses every three months. Bone marrow effects were the main expected toxicity.
These results suggest ITM-11 may change standard care for GEP-NETs, raising questions about optimal integration, management of post-progression patients, and potential combination strategies to further reduce long-term toxicity.