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Research Report
Lutetium Lu177 Edotreotide (ITM-11): A Comprehensive Monograph on a Novel Radiopharmaceutical for Neuroendocrine Tumors
Executive Summary
Lutetium Lu177 Edotreotide, also known by the development code ITM-11, is an investigational, small-molecule radiopharmaceutical agent representing a significant advancement in the field of peptide receptor radionuclide therapy (PRRT). It is designed for the targeted treatment of somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs), a heterogeneous group of malignancies for which therapeutic options remain limited. The drug is a complex radioconjugate, composed of the somatostatin analogue edotreotide (DOTATOC), the chelator DOTA, and the therapeutic beta-emitting radioisotope Lutetium-177 (177Lu). Its mechanism of action relies on the high-affinity binding of edotreotide to SSTRs, particularly subtype 2, which are densely expressed on the surface of many NET cells. Following binding, the agent is internalized, delivering a highly localized and cytotoxic dose of radiation that induces DNA damage and subsequent tumor cell apoptosis.
The clinical development of Lutetium Lu177 Edotreotide is spearheaded by two pivotal Phase III trials. The recently completed COMPETE trial (NCT03049189) evaluated its efficacy and safety in patients with Grade 1 and 2 gastroenteropancreatic NETs (GEP-NETs) against the approved standard-of-care mTOR inhibitor, everolimus. The trial successfully met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS). Patients treated with Lutetium Lu177 Edotreotide experienced a median PFS of 23.9 months compared to 14.1 months for those receiving everolimus. Furthermore, the drug exhibited a favorable safety profile, with a lower incidence of treatment-related adverse events compared to the active comparator.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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2024/06/04 | Phase 1 | Not yet recruiting | |||
2023/09/21 | Phase 2 | Recruiting | |||
2023/06/26 | Phase 3 | Recruiting | Grupo Espanol de Tumores Neuroendocrinos | ||
2022/05/24 | Phase 3 | Recruiting | |||
2022/05/03 | Early Phase 1 | Recruiting | University Hospital, Basel, Switzerland | ||
2021/06/07 | Phase 2 | Withdrawn | |||
2020/02/19 | Phase 2 | Withdrawn | Excel Diagnostics and Nuclear Oncology Center | ||
2019/12/11 | Phase 2 | UNKNOWN | University of Warmia and Mazury | ||
2017/02/09 | Phase 3 | Active, not recruiting |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
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No UK EMC drug information found for this drug. |
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