Drugs / Lu-177 DOTATATE
Lu-177 DOTATATE
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04086485 | Oct 2022 → Jul 2027 expected | digestive system neuroendocrine neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06121271 | Dec 2023 → Nov 2027 expected | medullary thyroid gland carcinoma, pheochromocytoma-paraganglioma | University College, London | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03206060 | Oct 2017 → Jan 2030 expected | paraganglioma, pheochromocytoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT03629847 Background | Dec 2012 → Dec 2018 | neuroendocrine neoplasm | King Faisal Specialist Hospital & Research Center | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-09-25 | Novartis Pharmaceuticals | Results Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) novartis.com ↗ |
| 2021-06-03 | Novartis Pharmaceuticals | Results Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera novartis.com ↗
In the final analysis of overall survival, a secondary objective of the trial, treatment with Lutathera resulted in a clinically relevant prolongation in median overall survival of 11.7 months [48.0 months (95%CI: 37.4-55.2) compared to the control arm (36.3 months (95%CI: 25.9-51.7)] 1. |
| 2018-10-19 | Novartis Pharmaceuticals | Results Novartis announces presentation of new Lutathera® NETTER-1 data at ESMO demonstrating significant improvement in PFS regardless of baseline liver tumor burden novartis.com ↗
Lutathera treatment was associated with an ~80% reduction in the estimated risk of tumor progression or death vs comparator, regardless of baseline liver tumor burden[1] |
| 2018-06-07 | Novartis Pharmaceuticals | Results Novartis announces JCO publication of Lutathera® NETTER-1 data showing significantly longer time to deterioration of key quality of life measures in patients with progressive midgut NETs novartis.com ↗
The data demonstrate that treatment with Lutathera provides significantly longer time to deterioration of quality of life for patients with progressive midgut Neuroendocrine tumors (NETs) compared to octreotide LAR alone[1]. |
All press releases naming this drug 4 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lu-177 DOTATATE | “The goal of this study is to assess the safety and efficacy of the combination of everolimus and the intravenous radiolabeled Lu-177 DOTATATE Therapy as a 1st line therapy in...” NCT03629847 ↗ |
| Known as | 177Lu-DOTATATE | “Lutetium 177 (177Lu) - DOTATATE is a form of peptide receptor radionuclide therapy (PRRT) utilized in the treatment of neuroendocrine tumors.” PMID 33551992 ↗ Jan 20211“The radiopeptide 177Lu-DOTATATE will be administered as a slow intravenous infusion via a cannula into a vein in the arm.” NCT06121271 ↗ |
| Known as | [177Lu]Lu-DOTA-TATE | “The study population included patients (≥18 years) enrolled in a phase 2 trial for treatment of somatostatin receptor (SSTR)-2+ inoperable/metastatic...” PMID 37886645 ↗ Oct 2023 |
| Known as | Lutathera | “Lu-177-DOTATATE (Lutathera) is a SSTR-agonist agent which emits ionizing radiation that causes DNA damage to its target cells through both direct and indirect mechanisms.” NCT04086485 ↗2“Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma” NCT03206060 ↗ “Lu-177 DOTATATE (Lutathera®)” NCT06121271 ↗ |
| Known as | Lutetium 177 (177Lu) - DOTATATE | “Lutetium 177 (177Lu) - DOTATATE is a form of peptide receptor radionuclide therapy (PRRT) utilized in the treatment of neuroendocrine tumors.” PMID 33551992 ↗ Jan 2021 |
| Modality | Peptide | “Lutetium 177 (177Lu) - DOTATATE is a form of peptide receptor radionuclide therapy (PRRT) utilized in the treatment of neuroendocrine tumors.” PMID 33551992 ↗ Jan 2021 |
| Route | Intravenous | “Lu-177-DOTATATE is administered IV every 8 (+/- 2) weeks, for a total of 4 administrations.” NCT03206060 ↗ |
| Target | SSTR2 | “Lu-177-DOTATATE is a somatostatin analog that predominantly recognizes SSTR2.” NCT03206060 ↗ |