The goal of this study is to propose the first direct comparison of Ga-68-DOTATATE PET/CT or PET/MR and Ga-68-DOTATOC PET/CT in patients with meningioma.

Start Date01 Mar 2025

Sponsor / Collaborator

Weill Medical College of Cornell University

[+1]

NCT06611891

/ RecruitingPhase 3IIT

Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer

DOTABREAST: Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer
This is a prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.

Start Date06 Jan 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Grenoble

NCT06256705

/ RecruitingNot ApplicableIIT

Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated with Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort

Operandi project aims to address unmet clinical needs in the current management of GEP-NETs treated with PRRT by exploring new opportunities provided by imaging-based (AI algorithms) and data augmentation, simultaneous 68Ga-DOTATOC PET-MRI imaging, and novel approaches to increase patient selection and PRRT efficacy (genomic profiling, radiopotentiators, and new radionuclides). The study aim to identify predictive and early markers indicative of PRRT effectiveness based on a large prospective cohort of GEP-NET patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 68Ga-DOTATOC PET-MRI.
Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic PET-MRI at baseline, at mid course of PRRT and 1 year after PRRT initiation, in patients with advanced GEP-NETs treated with PRRT.

Start Date25 Mar 2024

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

100 Clinical Results associated with 68Ga-Edotreotide

100 Translational Medicine associated with 68Ga-Edotreotide

100 Patents (Medical) associated with 68Ga-Edotreotide

352

Literatures (Medical) associated with 68Ga-Edotreotide

20 Jan 2025·Theranostics

First-in-human study of an optimized, potential kit-type, SSTR antagonist ⁶⁸Ga-DATA^5m-LM4 in patients with metastatic neuroendocrine tumors

Article

Author: Rösch, Frank ; Greifenstein, Lukas ; Baum, Richard P ; Mueller, Corinna ; Zan, Elcin ; Landvogt, Christian ; Zhang, Jingjing ; Klega, Andre ; Jakobsson, Vivianne

Radiolabeled somatostatin receptor (SSTR) agonists ⁶⁸Ga-DOTA-TATE and ⁶⁸Ga-DOTA-TOC are widely applied for imaging of patients with neuroendocrine tumors (NETs). Preclinical and preliminary clinical evidence has indicated that SSTR antagonists perform better for NET imaging. In this study, we assessed the feasibility of using a new hybrid chelator DATA^5m ((6-pentanoic acid)-6-(amino)methyl-1,4-diazepinetriacetate))-conjugated kit-type SSTR antagonist ⁶⁸Ga-DATA^5m-LM4 for PET and evaluated the safety, biodistribution, and preliminary diagnostic efficacy of ⁶⁸Ga-DATA^5m-LM4 in patients with metastatic NETs. Methods: The DATA^5m-conjugated form of LM4, was labeled with ⁶⁸Ga. A total of 27 patients (19 men/8 women; mean age 61 years) with histopathologically confirmed well-differentiated NETs underwent ⁶⁸Ga-DATA^5m-LM4 PET/CT for the staging and restaging or patient selection for PRRT. All the patients underwent PET/CT scans 60 min after intravenous bolus injection of 1.85 MBq (0.05 mCi) per kilogram of body weight (151 ± 54 MBq mean ± SD) of ⁶⁸Ga-DATA^5m-LM4. Results: DATA5m-LM4 was successfully labeled with ⁶⁸Ga, achieving high yield and purity. After decay correction, radiochemical yields (RCYs) of 80-95% and radiochemical purities (RCP) greater than 98% were obtained. ⁶⁸Ga -DATA^5m-LM4 was well tolerated in all patients, without clinically relevant adverse effects. A significantly lower uptake in normal liver parenchyma was observed with ⁶⁸Ga-DATA^5m-LM4 compared to ⁶⁸Ga-DOTA-TATE PET/CT (3.90 ± 0.88 vs. 9.12 ± 3.64, P < 0.000001). Additionally, uptake in the thyroid gland, pancreas, and spleen was also lower (P < 0.05). 14 patients underwent ⁶⁸Ga-DOTA-TOC PET/CT. ⁶⁸Ga-DATA^5m-LM4 uptakes in the liver and spleen were significantly lower than those of ⁶⁸Ga-DOTA-TOC uptake (3.70 ± 0.79 vs. 5.33 ± 2.43, P = 0.0397; 11.88 ± 6.88 vs. 26.55 ± 16.07, P = 0.0022). Tumor lesions showed high uptake intensity on ⁶⁸Ga-DATA^5m-LM4 PET/CT, with the highest SUVmax up to 167.93 (mean ± SD, 44.47 ± 36.22). With SUVmean of healthy liver, kidneys, and blood pool as background to normalize the SUVmax of the single most intense lesion, tumor-to-background ratios were 20.32 ± 19.97 (range, 3.40 - 98.78) and 4.30 ± 3.03 (range, 0.65 - 14.70), 38.63 ± 35.97 (range, 4.1 - 173.12), respectively. Conclusion: This study demonstrated that the novel SSTR antagonist ⁶⁸Ga-DATA^5m-LM4 can be efficiently labeled with high radiochemical yield and purity, supported by a highly convenient production process. The tracer exhibited excellent imaging performance, with a highly favorable biodistribution characterized by high tumor contrast and minimal uptake in normal organs, particularly the liver, enabling superior lesion detection. The practical advantages of this straightforward labeling process, achieved without any apparent loss in diagnostic efficacy, offer a significant benefit over other competing antagonists. The ease of production, including the potential for a "kit-type" labeling method, makes ⁶⁸Ga-DATA^5m-LM4 an overall extraordinarily promising radiopharmaceutical for the staging and restaging of NET patients.

01 Jan 2025·European Journal of Nuclear Medicine and Molecular Imaging

Survival impact of [225Ac]Ac-DOTATOC alpha-therapy in a preclinical model of pancreatic neuroendocrine tumor liver micrometastases

Article

Author: Gaschet, Joëlle ; Gouard, Sébastien ; Chocteau, Florian ; Marionneau-Lambot, Séverine ; Esnault, Mathilde ; Faivre-Chauvet, Alain ; Chérel, Michel ; Morgenstern, Alfred ; Chouin, Nicolas ; Frampas, Éric ; Lugat, Alexandre ; Kraeber-Bodéré, Françoise ; Ansquer, Catherine ; Bourgeois, Mickaël ; Bruchertseifer, Frank

Although peptide radionuclide therapy (PRRT) using a somatostatin analog (SSA) radiolabeled with a beta- emitter: [¹⁷⁷Lu]Lu-DOTATATE has shown a good clinical efficacy in neuroendocrine tumors (NETs), most of the patients only achieved tumoral stabilization and rare but severe long-term hematological toxicities have been reported. One of the promising options to improve PRRT is targeted alpha therapy. It is therefore essential to propose animal models that can mimic systemic spread disease, especially microscopic disease such as early stage of NET liver metastases to explore targeted alpha therapy. Herein, we report the evaluation of efficacy and toxicity of [²²⁵Ac]Ac-DOTATOC in an original preclinical murine model simulating the development of well-characterized liver metastases of pancreatic NETs with SSTR overexpression.METHODSA mouse model of liver metastases of pancreatic NETs was developed by intraportal injection of AR42J cells and explored using [⁶⁸ Ga]Ga-DOTATOC and [¹⁸F]F-FDG PET/MRI. Biodistribution study and radiation dosimetry of [²²⁵Ac]Ac-DOTATOC were determined in subcutaneous tumor-bearing NMRI-nude mice. Efficacy and toxicity were determined by intravenous injection of increasing activities of [²²⁵Ac]Ac-DOTATOC 10 days after intraportal graft.RESULTSLiver tumors showed a high uptake of [⁶⁸ Ga]Ga-DOTATOC and no uptake of [¹⁸F]F-FDG confirming the well-differentiated phenotype. All groups treated with [²²⁵Ac]Ac-DOTATOC showed a significant increase in overall survival compared with DOTATOC-treated mice, especially those treated with the highest activities: 53 days with 240 kBq (p = 0.0001), and 58 days with 2 × 120 kBq (p < 0.0001) vs 28 days with non-radiolabeled DOTATOC. On blood tests, a transient and moderate decreased in white blood cells count after treatment and no severe hepatic or renal toxicity were observed after treatment which was consistent with pathological and radiation dosimetry findings.CONCLUSION[²²⁵Ac]Ac-DOTATOC exhibit a favorable efficacy and toxicity profile in a mouse model of liver micrometastatic pancreatic NET.

01 Jul 2024·Annals of Surgical Oncology

Radio-Guided Surgery with a New-Generation β-Probe for Radiolabeled Somatostatin Analog, in Patients with Small Intestinal Neuroendocrine Tumors

Article

Author: Morganti, Silvio ; Mirabelli, Riccardo ; Pisa, Eleonora ; Ferrari, Mahila E ; Fazio, Nicola ; Mattana, Francesco ; Bertani, Emilio ; Collamati, Francesco ; Bagnardi, Vincenzo ; Fumagalli Romario, Uberto ; Ceci, Francesco ; Frassoni, Samuele

BACKGROUNDRadio-guided surgery (RGS) holds promise for improving surgical outcomes in neuroendocrine tumors (NETs). Previous studies showed low specificity (SP) using γ-probes to detect radiation emitted by radio-labeled somatostatin analogs.OBJECTIVEWe aimed to assess the sensitivity (SE) and SP of the intraoperative RGS approach using a β-probe with a per-lesion analysis, while assessing safety and feasibility as secondary objectives.METHODSThis prospective, single-arm, single-center, phase II trial (NCT05448157) enrolled 20 patients diagnosed with small intestine NETs (SI-NETs) with positive lesions detected at ⁶⁸Ga-DOTA-TOC positron emission tomography/computed tomography (PET/CT). Patients received an intravenous injection of 1.1 MBq/Kg of 68Ga-DOTA-TOC 10 min prior to surgery. In vivo measurements were conducted using a β-probe. Receiver operating characteristic (ROC) analysis was performed, with the tumor-to-background ratio (TBR) as the independent variable and pathology result (cancer vs. non-cancer) as the dependent variable. The area under the curve (AUC), optimal TBR, and absorbed dose for the surgery staff were reported.RESULTSThe intraoperative RGS approach was feasible in all cases without adverse effects. Of 134 specimens, the AUC was 0.928, with a TBR cut-off of 1.35 yielding 89.3% SE and 86.4% SP. The median absorbed dose for the surgery staff was 30 µSv (range 12-41 µSv).CONCLUSIONThis study reports optimal accuracy in detecting lesions of SI-NETs using the intraoperative RGS approach with a novel β-probe. The method was found to be safe, feasible, and easily reproducible in daily clinical practice, with minimal radiation exposure for the staff. RGS might potentially improve radical resection rates in SI-NETs.CLINICAL TRIALS REGISTRATION⁶⁸Ga-DOTATOC Radio-Guided Surgery with β-Probe in GEP-NET (RGS GEP-NET) [NCT0544815; https://classic.CLINICALTRIALSgov/ct2/show/NCT05448157 ].

News (Medical) associated with 68Ga-Edotreotide

07 Mar 2025

·pipelinereview.com

ITM Presents Positive Topline Phase 3 COMPETE Trial Data with n.c.a. 177Lu-edotreotide (ITM-11), a Targeted Radiopharmaceutical Therapy, in Patients with Grade 1 or 2 Gastroenteropancreatic Neuroendocrine Tumors at the ENETS 2025 Conference

KRAKOW, Poland I March 6, 2025 I ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today presented positive topline data from its Phase 3 COMPETE trial in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The trial results demonstrated that n.c.a. 177 Lu-edotreotide (also known as ITM-11 or 177 Lu-edotreotide), a proprietary, synthetic, targeted radiotherapeutic agent, met the primary endpoint and significantly prolonged progression-free survival in patients when compared to everolimus, a standard of care cancer treatment. The data were presented by study investigator Jaume Capdevila, MD, PhD, at the 22 nd Annual European Neuroendocrine Tumor Society (ENETS) 2025 Conference, held in Krakow, Poland from March 5-7, 2025. “ COMPETE is the first pivotal trial comparing a radiopharmaceutical drug candidate to a targeted molecular therapy without the routine use of accompanying somatostatin analogues in this GEP-NET patient population. These data show unequivocal support for 177 Lu-edotreotide’s potential benefit in extending PFS,” said Dr. Capdevila, senior medical oncologist at Vall d’Hebron University Hospital, Barcelona . “ Additionally, 177 Lu-edotreotide’s convenient dosing schedule and favorable safety results reinforce its potential as a compelling new treatment option .” COMPETE is a prospective, randomized, controlled, open-label Phase 3 trial that enrolled 309 patients with inoperable, progressive, Grade 1 or Grade 2 somatostatin receptor-positive neuroendocrine tumors of gastroenteric or pancreatic origin (Ki-67 ≤20%) in Europe, the United States, Australia and South Africa. The study objectives were to evaluate the efficacy and safety of 177 Lu-edotreotide compared to everolimus. 177 Lu-edotreotide is comprised of non-carrier-added (n.c.a.) lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a somatostatin receptor agonist. It is the first radiopharmaceutical to be tested in the GEP-NET patient population using non-carrier-added lutetium, which has a higher isotopic purity than carrier-added lutetium. Patients were randomized 2:1 to receive 7.5 GBq of 177 Lu-edotreotide with a nephroprotective amino acid solution every three months for up to four cycles, or everolimus 10 mg daily for up to 30 months, or until disease progression. There were 207 patients on the 177 Lu-edotreotide arm and 102 on the everolimus arm. Dosimetry was used to assess the absorbed dose in tumors compared to that in healthy tissue to enhance safety and efficacy monitoring of the study drug in patients. Topline Clinical Results Summary “ The COMPETE results represent a major step forward in the development of new treatment options for people living with progressive, inoperable GEP-NETs. By extending progression-free survival by almost ten months compared to standard of care in this trial, 177 Lu-edotreotide showed the potential to significantly improve the treatment paradigm for physicians and their patients ,” said Jonathan Strosberg, MD, past president, North American Neuroendocrine Tumor Society and chair, GI Research Program, Moffitt Cancer Center and Research Institute in Tampa, FL . The median overall survival as of January 21, 2025 was 63.4 months for the 177 Lu-edotreotide arm and 58.7 months for the everolimus arm. While not statistically significant, the interim analysis showed a favorable trend for 177 Lu-edotreotide. Patients were permitted to start an alternative therapy after disease progression, potentially confounding the overall survival data. Overall survival data will continue to be updated. 177 Lu-edotreotide was observed to be well-tolerated and there were no unforeseen treatment-emergent adverse events. Additional data, including objective response rate, subgroup analyses, quality of life assessments and dosimetry, are currently being evaluated and expected to be submitted for presentations at future medical meetings. ITM is planning to submit a New Drug Application (NDA) to the FDA in 2025. “ These successful results validate our decision to design a pivotal Phase 3 trial directly comparing a targeted radiopharmaceutical against a targeted molecular therapy in Grade 1/2 GEP-NETS, underscoring our commitment to improving the lives of people living with this challenging cancer ,” said Andrew Cavey, MD, PhD, chief executive officer, ITM . “ With this successful readout, 177 Lu-edotreotide becomes the first drug candidate in ITM’s broad portfolio of early- to late-stage radiopharmaceuticals to deliver positive Phase 3 results and progress towards NDA submission and commercial launch preparations. Together, with our global isotopes manufacturing business, robust supply chain, and experienced clinical and commercial team, we believe we are uniquely positioned as a standout leader in the fast-growing radiopharmaceutical industry.” ENETS Oral Presentation Details Title : “Efficacy and safety of [ 177 Lu]Lu-edotreotide vs. everolimus in patients with grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumours: COMPETE phase 3 trial” Date and Time : March 6, 2025; 10:05 am – 10:12 am CET Session and Room Number: Clinical science, Session 1: Theranostics in NENs – Integrating experience for a brighter future; Auditorium Hall (S1) Presenter: Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d’Hebron University Hospital, Barcelona Additional n.c.a. 177 Lu-edotreotide Clinical Trials 177 Lu-edotreotide is also being evaluated in a Phase 3 trial (COMPOSE) in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors. The COMPOSE trial is a prospective, randomized, controlled, open-label trial evaluating the efficacy, safety and patient-reported outcomes of 177 Lu-edotreotide as first- or second-line treatment compared to physician’s choice standard of care chemotherapy. Additional clinical programs with 177 Lu-edotreotide include a Phase 1 pediatric trial in SSTR-positive tumors (KinLET) and a Phase 3 investigator-sponsored trial in lung and thymus neuroendocrine tumors (LEVEL). About GEP-NETS Neuroendocrine tumors (NETs) are a rare form of cancer, with an estimated 8 new cases per 100,000 individuals diagnosed each year in the U.S. and 9 cases per 100,000 in Europe. The incidence of NETs has steadily increased over recent decades, resulting, in part, from improved diagnosis. Gastroenteropancreatic neuroendocrine tumors (GEP-NETS) originate in the neuroendocrine system and are made up of nerve cells and hormone-producing cells. They can occur anywhere in the GI tract and pancreas, including the stomach, small intestine, colon, rectum, and appendix. There is still a high unmet medical need for treatment options, as many patients are asymptomatic and diagnosed at a late stage with metastatic disease. About n.c.a. 177 Lu-edotreotide 177 Lu-edotreotide is a radiolabeled peptide conjugate that delivers beta radiation specifically to SSTR-positive tumor cells, sparing healthy organs and tissue. The drug candidate, delivered intravenously, is comprised of non-carrier-added lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a synthetic SSTR agonist. 177 Lu-edotreotide was granted orphan drug designation in the EU and the US, and fast track designation in the US for the treatment of GEP-NETs, based on positive results from a retrospective Phase 2 study with 177 Lu-edotreotide. About ITM Isotope Technologies Munich SE ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcomes and quality of life. www.itm-radiopharma.com References: SOURCE: ITM Isotope Technologies Munich

Clinical ResultPhase 3Orphan DrugFast TrackPhase 2

06 Mar 2025

·www.fiercebiotech.com

ITM shares details of radiopharma\'s phase 3 win, reveals overall survival miss

When it came to the secondary endpoint of interim overall survival, the ITM-11 cohort reached 63.4 months while the everolimus group was not far behind at 58.7 months.\n ITM Isotope Technologies has provided more detail on how its lead radiotherapy bested the standard of care in a recent phase 3 study while revealing that the candidate was unable to prove a statistically significant benefit in median overall survival.The therapy, dubbed ITM-11, consists of a therapeutic β-emitting radioisotope called lutetium-177 along with a somatostatin receptor (SSTR) agonist called edotreotide. ITM already announced in January that a phase 3 study of 309 patients with SSTR-positive neuroendocrine tumors of the stomach or pancreas had shown that ITM-11 met the primary endpoint of prolonging progression-free survival (PFS) when compared to everolimus.Now, ITM is providing details of that phase 3 win—while acknowledging that another survival endpoint wasn’t quite as successful.Median PFS was “significantly longer” for ITM-11, at 23.9 months, compared to 14.1 months seen by the everolimus cohort, the radiopharma explained. Everolimus, which has been sold by Novartis as Afinitor, is a targeted molecular therapy approved for advanced neuroendocrine tumors and other indications. But when it came to the secondary endpoint of interim overall survival (OS), the ITM-11 cohort reached 63.4 months while the everolimus group was not far behind at 58.7 months. This gap was “numerically higher” but not statistically significant, the company admitted in its data release. To help explain this finding, ITM pointed out that patients had been permitted to start an alternative therapy after disease progression, which “potentially confound[ed] the overall survival data.”When it came to safety, 82.5% of the ITM-11 cohort experienced treatment-emergent adverse events compared to 97% of those who received everolimus. One grade 2 serious event of myelodysplastic syndrome was reported as related to ITM-11, the company said.After 20 years of building radioisotope expertise as a manufacturer and supplier, the German company has been pushing its own therapies into the clinic, with ITM-11 leading the charge. The company also has a phase 1 trial in children with SSTR-positive tumors ongoing, as well as a phase 3 study in lung and thymus neuroendocrine tumors.“These successful results validate our decision to design a pivotal phase 3 trial directly comparing a targeted radiopharmaceutical against a targeted molecular therapy … underscoring our commitment to improving the lives of people living with this challenging cancer,” ITM’s CEO Andrew Cavey, M.D., Ph.D., said in a release.“With this successful readout, [ITM-11] becomes the first drug candidate in ITM’s broad portfolio of early- to late-stage radiopharmaceuticals to deliver positive phase 3 results and progress towards NDA submission and commercial launch preparations,” Cavey added.

$ITM shares details of radiopharma\'s phase 3 win, reveals overall survival miss$

Phase 3Clinical ResultPhase 1

06 Mar 2025

·firstwordpharma.com

ITM fleshes out data for Phase III radiopharma success in neuroendocrine tumours

A radiopharmaceutical from ITM Isotope Technologies Munich reduced the risk of disease progression or death by 33% versus Novartis' targeted molecular therapy Afinitor (everolimus) in patients with gastroenteropancreatic neuroendocrine tumours (GEP-NETs). The outcome of the Phase III COMPETE study was first top-lined in January, with the announcement marking one of only a handful of wins for a radiopharmaceutical in a head-to-head trial. Detailed results were presented Thursday at the European Neuroendocrine Tumor Society (ENETS) annual meeting.The trial compared ITM-11 (177Lu-edotreotide) with Afinitor in 309 patients with inoperable, progressive Grade 1 or 2 somatostatin receptor (SSTR)-positive GEP-NETs. According to ITM, approximately 15% of people in each trial arm were treatment naïve, with the remaining 85% or so having received one prior therapy.Results showed that median progression-free survival (PFS) for ITM's therapeutic was 23.9 months, which was significantly and clinically better than the 14.1 months for Afinitor. In comparison, in the Phase III NETTER-2 trial, Novartis' peptide receptor radionuclide therapy Lutathera (lutetium Lu 177 dotatate) reduced the risk of disease progression or death by 72% as a first-line therapy for patients with SSTR-positive well-differentiated Grade 2/3 advanced GEP-NETs versus high-dose octreotide LAR alone, with median PFS in the two arms of 22.8 months and 8.5 months, respectively.ITM told FirstWord that the choice of Afinitor as a comparator in COMPETE was "backed by scientific evidence of efficacy and high clinical acceptance after market authorisation." The company suggested that this decision set "a higher standard for meeting the primary endpoint in more advanced grade tumours," adding that it hopes "physicians will recognise the higher threshold of our study design."FDA filing this year"These successful results validate our decision to design a pivotal Phase III trial directly comparing a targeted radiopharmaceutical against a targeted molecular therapy," CEO Andrew Carey said. Based on the findings, ITM plans to seek approval of ITM-11 in the US this year; however, the company told FirstWord that it is "currently prohibited" from filing in Europe until 2029 due to orphan drug designation on Lutathera.Top-line results also showed that interim median overall survival (OS) was 63.4 months for ITM-11. That was numerically higher than the 58.7 months seen with Afinitor, but not statistically significant at the current analysis. ITM noted that patients were allowed to start an alternative therapy after disease progression, "potentially confounding" the OS data."These data show unequivocal support for [ITM-11's] potential benefit in extending PFS," remarked study investigator Jaume Capdevila, adding that the radiopharmaceutical's "convenient dosing schedule and favourable safety results reinforce its potential as a compelling new treatment option."In COMPETE, patients were treated with ITM-11 every three months for up to four cycles, or with Afinitor daily for up to 30 months, or until disease progression. Meanwhile, ITM's therapy was well tolerated, with treatment-emergent adverse events occurring at a rate of 82.5%, compared with 97% for Afinitor. However, there was one Grade 2 event of myelodysplastic syndrome in the ITM-11 arm.Growing optionsNeuroendocrine tumours are one of the few cancers that have so far benefited from the approval of radiopharmaceuticals. Novartis currently markets Lutathera as a treatment for SSTR-positive GEP-NETs, while Sanofi also has skin in the game, having reached a deal last year to join forces with RadioMedix and Orano Med on the radioligand medicine AlphaMedix (212Pb-DOTAMTATE).Something that differentiates ITM from other players, however, is that it has worked in the radiopharma space for over 20 years and has manufacturing in-house. "Together, with our global isotopes manufacturing business, robust supply chain and experienced clinical and commercial team, we believe we are uniquely positioned as a standout leader in the fast-growing radiopharmaceutical industry," Carey said.ITM-11 — which combines the therapeutic β-emitting radioisotope lutetium-177 with the synthetic SSTR agonist edotreotide — is also being investigated in the Phase III COMPOSE trial in patients with well-differentiated, aggressive Grade 2 or 3 SSTR-positive GEP-NETs.

Phase 3Clinical ResultOligonucleotideOrphan Drug

100 Deals associated with 68Ga-Edotreotide

External Link

KEGG	Wiki	ATC	Drug Bank
-	68Ga-Edotreotide	V09IX	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Neuroendocrine Tumors	United States	UNIV IOWA HOSPS AND CLINICS PET IMAGING CENTER	21 Aug 2019
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	European Union	Advanced Accelerator Applications SA	08 Dec 2016
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	Liechtenstein	Advanced Accelerator Applications SA	08 Dec 2016
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	Norway	Advanced Accelerator Applications SA	08 Dec 2016
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	Iceland	Advanced Accelerator Applications SA	08 Dec 2016
Gastro-Enteropancreatic Neuroendocrine Tumor	-	Itm Isotope Technologies Munich SE	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	-	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Nov 2023
Endocarditis, Bacterial	Phase 2	France	Centre Hospitalier Regional de Nancy	16 May 2022
Carcinoid Tumor	Phase 1	United States	University of Iowa	01 Sep 2015
Somatostatinoma	Phase 1	United States	Icahn School of Medicine at Mount Sinai	01 Dec 2014
Carcinoid Tumor	Discovery	United States	University of Iowa	01 Sep 2015
Medulloblastoma	Discovery	United States	University of Iowa	01 Sep 2015
Neuroblastoma	Discovery	United States	University of Iowa	01 Sep 2015
Somatostatin Receptor-Positive Neuroendocrine Tumor	Discovery	United States	University of Iowa	21 Feb 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05448157 (RGS GEP-NET, Pubmed)	Phase 2	Neuroendocrine Tumors 68Ga-DOTA-TOC	20	68Ga-DOTA-TOC	xkcqsiashn(wrcqxhlzaa) = anwphkkigk ogxoryofcd (zemyfeebha ) View more	Positive	23 Apr 2024
THU036 (ENDO2023)	Not Applicable	Cushing Syndrome ACTH	44	68Ga-DOTATOC PET/CT	gwphguwlkw(slvzxpwoxc) = zpxzdxvdhx dduopsgqgi (wzpwonmobe ) View more	Negative	05 Oct 2023
				68 Ga-DOTATOC (Pituitary MRI)	gwphguwlkw(slvzxpwoxc) = jwkyukqvxa dduopsgqgi (wzpwonmobe ) View more
EANM2021	Not Applicable	Neuroendocrine Tumors	84	68 Ga-DOTATOC (SRETVwb)	shpuuxbscq(rmwrwfaroj) = nxdspdznqg ufesjypxeh (xabsywgqzn )	-	24 Sep 2021
				68 Ga-DOTATOC (TLSREwb)	ejsygugzra(yhnxmhtfiq) = jgvawtbqrl euflooolkr (vqfloakzdn )
NCT01869725 (CTgov)	Phase 2	Somatostatinoma \| Neuroblastoma \| Medulloblastoma	68	contrast-enhanced magnetic resonance imaging+indium In 111 pentetreotide+gallium Ga 68-edotreotide	munfpkqkdw(gjazpobbfz) = emdwydbpzv kuuzyyqsxq (lvtgovgree, gdodyiairy - mudwfmmqpm) View more	-	22 Sep 2021
SNMMI2021	Not Applicable	-	-	68 Ga-DOTA-TOC (Patients with normal serum glucose level)	pdoodpgzag(lvoanuwsqi) = etmwuorzar mgdsxkvveq (cypmqrztjf, 5.238)	-	18 May 2021
NCT01619865 (GA-68, CTgov)	Phase 1/2	Carcinoid Tumor \| Neuroblastoma \| Medulloblastoma \| Somatostatin Receptor-Positive Neuroendocrine Tumor	223	68Ga-DOTATOC PET/CT	pajzlzasxs(pzbjfaewqx) = pcjurzqxfa xwvapmyzyg (wybzxooccg, xtqcclsssm - ymqclcwgiq) View more	-	02 Feb 2021
EANM2020	Not Applicable	Paraganglioma \| Pheochromocytoma	33	68 Ga-DOTATOC68Ga-DOTATOC (68 Ga-DOTATOC-PET/CT)	bynmgmncxw(ojjowwizot) = sjqsvbnzzb pfzwqktnvf (wghbvdhxro ) View more	Positive	18 Sep 2020
				18 F-DOPA68Ga-DOTATOC (18 F-DOPA-PET/CT)	bynmgmncxw(ojjowwizot) = hjoxklbqsh pfzwqktnvf (wghbvdhxro ) View more
EANM2019	Not Applicable	Neuroendocrine Tumors 68 Ga DOTATOC PET/CT	35	68 Ga DOTATOC PET/CT	zdpeqyeodt(gwavgvkmri) = phmjoinokz clsbitauzp (kupbpcpdkq ) View more	-	18 Sep 2019
				68 Ga DOTATOC (CT)	zdpeqyeodt(gwavgvkmri) = fbjkitrclq clsbitauzp (kupbpcpdkq )
NCT03136328 (CTgov)	Phase 3	Neuroendocrine Tumors	11	68Ga-DOTATOC	siifsdvvpx(eejhdqhsrc) = immfbssrzw bsoneyihcj (gmuvsiwtei, rwacprvavs - smavspvouc) View more	-	30 Jan 2019
SNMMI2018	Not Applicable	-	-	68 Ga-DOTATOC (Galli Eo® 68Ge/68Ga generator)	jhtrcpndov(yapfrykkwc) = aovbslpteu ascmaybtvb (tmsxhuzhmq ) View more	-	23 May 2018
				68 Ga-DOTATOC (GRP 3V synthesizer)	jhtrcpndov(yapfrykkwc) = skboxyzfvl ascmaybtvb (tmsxhuzhmq ) View more

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