{"entity":{"id":"itm-11","kind":"drug","name":"177Lu-edotreotide","aka":[],"tldr":"A second lutetium radioligand for neuroendocrine tumours that beat the standard pill everolimus in a head-to-head trial and is awaiting an FDA decision.","summary":"COMPETE (Lancet 2025; 309 patients, grade 1-2 GEP-NETs): PFS 23.9 vs 14.1 months versus everolimus (HR 0.67); response rate higher; interim OS 63.4 vs 58.7 months, a difference that did not reach statistical significance (HR 0.78). Uses non-carrier-added 177Lu from ITM's own supply. NDA accepted with PDUFA 28 August 2026. COMPOSE (grade 2-3, versus CAPTEM/everolimus/FOLFOX) ongoing.","status":"phase-3","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03049189 (COMPETE)","url":"https://clinicaltrials.gov/study/NCT03049189"}],"tags":[],"related":[],"cancers":["neuroendocrine","grade-3-net"],"sections":[],"technologies":["prrt","radioligand-therapy"],"targets":["sstr2"],"drugs":[],"companies":["itm"],"institutions":[],"pathways":[],"terms":[],"trials":["compete","nct04919226"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"ITM-11, n.c.a. 177Lu-DOTATOC","modality":"Radioligand therapy (beta)","mechanism":"DOTATOC peptide (SSTR2 agonist) chelating 177Lu; four cycles of 7.5 GBq every 3 months.","approvals":[],"mechanismSteps":[],"dosing":{"route":"Intravenous","schedule":"7.5 GBq every 3 months × 4 with amino-acid renal protection"},"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2025-03","type":"designation","region":"US","note":"COMPETE topline at ENETS 2025","source":"https://www.itm-radiopharma.com/news/press-releases/press-releases-detail/itm-presents-positive-topline-phase-3-compete-trial-data-with-nca-177lu-edotreotide-itm-11-a-targeted-radiopharmaceutical-therapy-in-patients-with-grade-1-or-2-gastroenteropancreatic-neuroendocrine-tumors-at-the-enets-2025-conference-688/"},{"date":"2026-08-28","type":"pdufa","region":"US","note":"PDUFA goal date for GEP-NET indication","source":"https://www.cancernetwork.com/view/fda-accepts-new-drug-application-for-177lu-edotreotide-in-gep-nets"}]},"route":"/drugs/itm-11/","neighbours":{"cancer":[{"id":"grade-3-net","kind":"cancer","name":"Grade 3 well-differentiated neuroendocrine tumour","route":"/cancers/grade-3-net/"},{"id":"neuroendocrine","kind":"cancer","name":"Neuroendocrine tumours","route":"/cancers/neuroendocrine/"},{"id":"pancreatic-net","kind":"cancer","name":"Pancreatic neuroendocrine tumours","route":"/cancers/pancreatic-net/"},{"id":"small-intestinal-net","kind":"cancer","name":"Small intestinal neuroendocrine tumours","route":"/cancers/small-intestinal-net/"}],"technology":[{"id":"prrt","kind":"technology","name":"Peptide receptor radionuclide therapy (PRRT)","route":"/technologies/prrt/"},{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"}],"target":[{"id":"sstr2","kind":"target","name":"Somatostatin receptor 2","route":"/targets/sstr2/"}],"company":[{"id":"itm","kind":"company","name":"ITM Isotope Technologies Munich","route":"/companies/itm/"}],"trial":[{"id":"compete","kind":"trial","name":"COMPETE","route":"/trials/compete/"},{"id":"nct05918302","kind":"trial","name":"Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.","route":"/trials/nct05918302/"},{"id":"nct04919226","kind":"trial","name":"Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE","route":"/trials/nct04919226/"}],"pairing":[{"id":"sstr-pet-to-prrt","kind":"pairing","name":"SSTR PET → PRRT","route":"/pairings/sstr-pet-to-prrt/"}],"idea":[{"id":"idea-net-dosimetry-prrt","kind":"idea","name":"Dosimetry-personalised PRRT instead of four fixed cycles","route":"/ideas/idea-net-dosimetry-prrt/"}]}}