Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.

Start Date27 Oct 2023

Sponsor / Collaborator

Itm Isotope Technologies Munich SE

NCT06045260

/ RecruitingPhase 2

"Receptor Radionuclide Therapy With 177Lu-DOTATOC (177Lu-edotreotide or 177Lu-octreotide) in SSTR Positive Patients: a Multicenter, Prospective, Phase II Trial"

Peptide receptor radionuclide therapy (PRRT) may be recommended in G1- G2 GEP-NET patients with disease progression on somatostatine analogues therapy (LUTATHERA®). However, there are several diseases, including neuroendocrine neoplasia not originating from the digestive tract, for which the efficacy of PRRT has already been demonstrated, but which are not currently within the indications of LUTATHERA and therefore cannot benefit from it (i.e. bronchopulmonary, ovarian, renal NETs and neuroendocrine carcinomas). Moreover, the role of PRRT is also accepted in Pheochromocytomas and paragangliomas (PPGLs), Meningiomas, but also as a salvage therapy in pre-treated NET pts, and other SSTR-positive malignancies (Lymphomas, Gliomas...). Least explored among radiopharmaceuticals for SSTR-positive tumors is 177Lu-DOTATOC. This study aims to investigate the efficacy and safety of lutetium (177Lu) edotreotide (Lu-Dotatoc) on all the above-mentioned diseases that could benefit from receptor radionuclide therapy. We believe that this study, which will involve only patients outside the indication of LUTATHERA, will expand the current knowledge of radionuclide receptor therapy with 177Lu- DOTATOC, particularly with regard to objective response and safety parameters, and may consolidate its in the management of these diseases.

Start Date13 Sep 2023

Sponsor / Collaborator-

100 Clinical Results associated with Lutetium (177Lu) edotreotide

100 Translational Medicine associated with Lutetium (177Lu) edotreotide

100 Patents (Medical) associated with Lutetium (177Lu) edotreotide

Literatures (Medical) associated with Lutetium (177Lu) edotreotide

01 Mar 2026·JOURNAL OF NUCLEAR MEDICINE

Targeted β ⁻ -Particle Plus Conversion and Auger-Electron Therapy with ¹⁶¹ Tb-Labeled Somatostatin Receptor Antagonist DOTA-LM3: A Phase 0 Study

Article

Author: McDougall, Lisa ; Müller, Cristina ; Schmid, David E ; Westerbergh, Frida ; Geistlich, Susanne ; van der Meulen, Nicholas P ; Christ, Emanuel ; Bernhardt, Peter ; Nicolas, Guillaume P ; Fani, Melpomeni ; Fricke, Julia G ; Favaretto, Chiara ; Wild, Damian ; Schibli, Roger ; Borgna, Francesca

The goal of this phase 0 study was to determine the absorbed doses in tumors and relevant organs after a test injection of [¹⁶¹Tb]Tb-DOTA-LM3 and [¹⁷⁷Lu]Lu-DOTATOC in the same cohort of patients with grade 1 and 2 somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. Methods: In this randomized, crossover, prospective, single-center, open-label phase 0 study, 8 patients received 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3 and 1 GBq of [¹⁷⁷Lu]Lu-DOTATOC, with a 4-wk interval between injections. Quantitative SPECT/CT imaging was performed 3, 24, 72, and 168 h after administration of each radiopharmaceutical to calculate tumor and organ absorbed doses (3-dimensional dosimetry using a Monte Carlo-based ordered-subset expectation maximization algorithm). Results: After injection of 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3, SPECT/CT revealed excellent image quality with intense tumor uptake in all patients and a median of the mean effective tumor half-life of 103 h (range, 56-152 h) for [¹⁶¹Tb]Tb-DOTA-LM3 and 83 h (range, 30-122 h) for [¹⁷⁷Lu]Lu-DOTATOC (P = 0.012). The medians of the mean tumor absorbed doses of [¹⁶¹Tb]Tb-DOTA-LM3 and [¹⁷⁷Lu]Lu-DOTATOC were 36.6 Gy/GBq (range, 15-196 Gy/GBq) and 7.0 Gy/GBq (range, 2.4-14.2 Gy/GBq), respectively (P = 0.008). The median kidney and bone marrow absorbed doses were 2.4 Gy/GBq (range, 1.8-3.1 Gy/GBq) and 0.31 Gy/GBq (range, 0.24-0.48 Gy/GBq) for [¹⁶¹Tb]Tb-DOTA-LM3 and 0.6 Gy/GBq (range, 0.4-0.8 Gy/GBq) and 0.04 Gy/GBq (range, 0.03-0.06 Gy/GBq) for [¹⁷⁷Lu]Lu-DOTATOC, respectively (both P = 0.008). According to Common Terminology Criteria for Adverse Events version 5.0, grade 1-3 treatment-emergent adverse events occurred in 6 of 8 patients after administration of 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3. Conclusion: [¹⁶¹Tb]Tb-DOTA-LM3 showed a 7.6-fold-higher median tumor absorbed dose than that of [¹⁷⁷Lu]Lu-DOTATOC. The tumor-to-bone marrow absorbed dose ratio was in the same range for [¹⁶¹Tb]Tb-DOTA-LM3 as for [¹⁷⁷Lu]Lu-DOTATOC. The administration of 1 GBq of [¹⁶¹Tb]Tb-DOTA-LM3 was safe for all patients, without relevant adverse events.

01 Oct 2025·CLINICAL NUCLEAR MEDICINE

Feasibility of Single Time Point Dosimetry Application in 177Lu-DOTATATE/DOTATOC-treated Pediatric Neuroblastoma

Article

Author: Zheng, Fei ; Liu, Yuxuan ; Yang, Hao ; Li, Pengfei ; Wang, Han ; Sun, Xingyao ; Sun, Xiaorong ; Sun, Yingying

Background::

177Lu-DOTATATE/DOTATOC peptide receptor radionuclide therapy (PRRT) has demonstrated potential for treating pediatric neuroblastoma (NB), and in clinical practice can be measured dosimetry by multi–time point (MTP) dosimetry. However, the high workload and limited patient compliance associated with MTP restrict its application. Consequently, single time point (STP) dosimetry approaches have emerged as a promising alternative, though their effectiveness in pediatric populations has not been thoroughly investigated. This study aimed to assess the dosimetric determination of 177Lu-DOTATATE/DOTATOC in pediatric neuroblastoma patients to determine whether STP could serve as a viable replacement for MTP.

Patients and Methods::

A total of 24 pediatric NB patients who received 1 to 2 cycles of 177Lu-DOTATATE or 177Lu-DOTATOC underwent dosimetric measurement of lesions and critical organs using the 96 hours single time point (STPH) dosimetry method proposed by Hänscheid and colleagues. The results were compared with those obtained from standard MTP.

Results::

In patients treated with 177Lu-DOTATATE, the mean relative deviation absolute values of the STPH-calculated absorbed dose from MTP were <10% for lesions, kidneys, bone marrow, liver, and spleen, with Pearson correlation coefficients of 0.99, 0.93, 0.97, 0.84, and 0.84, respectively. In patients treated with 177Lu-DOTATOC, the mean relative deviation absolute values for kidneys, spleen, and bone marrow were <10%, with Pearson correlation coefficients of 0.97, 0.77, 0.35, 0.48, and 0.93 for lesions, kidneys, bone marrow, liver, and spleen, respectively.

Conclusions::

The findings confirm that the 96 hours STPH method can reliably replace MTP for dosimetric assessment in pediatric NB patients treated with 177Lu-DOTATATE and performed well in renal dosimetry for 177Lu-DOTATOC therapy.

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

Beyond similarities: overall survival and prognostic insights from [¹⁷⁷Lu]Lu-DOTATOC therapy in neuroendocrine tumors

Article

Author: Wetz, Christoph ; Ruhwedel, Tristan ; Rogasch, Julian ; Steinhagen, Peter ; Galler, Markus ; Amthauer, Holger ; Schatka, Imke

Abstract:

Purpose:

Therapy with [177Lu]Lu-DOTATATE is well established for neuroendocrine tumors (NET), but its production generates [177mLu], raising concerns about waste disposal due to its longer half-life. In contrast, [177mLu] is not formed during [177Lu]Lu-DOTATOC production. However, data on overall survival (OS) and prognostic factors for [177Lu]Lu-DOTATOC remain limited, and its efficacy compared to [177Lu]Lu-DOTATATE is uncertain. This study aimed to analyze OS and radiological response in NET patients treated with [177Lu]Lu-DOTATOC.

Methods:

Monocentric, retrospective analysis of 141 patients with NET (grading: 21% G1, 71% G2, 4% G3, 4% grading unknown; primary: 48% small intestine (SI-NET); 27% pancreas (P-NET); 9% colon/rectum; 1% stomach, 7% lung; 9% CUP-NET) receiving PRRT with [177Lu]Lu-DOTATOC. Cox and logistic regression were used to identify prognostic factors for OS or risk of primary progression.

Results:

Death from any cause was observed in 85 of 141 patients (60.3%). Median OS was 55.2 months (SI NET G1-G2: 62.7 months; P-NET G1-G2: 41.2 months; NET G3: 26.3 months). Multivariable Cox regression identified baseline De Ritis Ratio (p < 0.001), ALP (p < 0.001), CgA (p < 0.001) and prior therapy with mTOR-inhibitors (p = 0.005) as significant prognostic factors of OS. Overall response rate was 12% and disease control rate was 72%. In multivariable logistic regression, primary tumor location (p = 0.04) and CgA (p = 0.01) were significant prognostic factors for higher risk of primary progression.

Conclusion:

The analysis of OS from routine clinical practice shows that PRRT with [177Lu]Lu-DOTATOC is an effective treatment option for NET patients, while generating minimal [177mLu]. The evaluated prognostic factors could help to identify patients who particularly benefit from shorter follow-up intervals.

News (Medical) associated with Lutetium (177Lu) edotreotide

05 Mar 2026

·www.biospace.com

ITM Announces Phase 3 COMPETE Trial Post-Hoc Subgroup Analyses with n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) in Patients with Pancreatic Neuroendocrine Tumors at ENETS 2026 Conference

Median progression-free survival (PFS) in pancreatic neuroendocrine tumor (P-NET) patients was 24.5 months on 177 Lu-edotreotide arm vs. 14.7 months on everolimus arm Objective response rate (ORR) was higher across the majority of P-NETs subgroups Krakow, Poland, March 5, 2026 – ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, today presented post-hoc subgroup analyses of the ITM-11 Phase 3 COMPETE trial in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In patients with pancreatic neuroendocrine tumors (P-NETs), data showed that n.c.a. 177 Lu-edotreotide (ITM-11) prolonged progression-free survival (PFS) and achieved higher objective response rates (ORR) when compared to everolimus. Data were presented by Thomas Walter, MD, PhD, professor of gastroenterology, Hospices Civil of Lyon, France, in a mini-oral presentation and in an accompanying poster at the 23 rd Annual Meeting of the European Neuroendocrine Tumor Society (ENETS), held March 4-6, 2026 in Krakow, Poland. As previously announced at ENETS 2025 , the COMPETE trial met its primary endpoint of PFS (23.9 vs. 14.1 months; p=0.022; HR 0.67, 95% CI [0.48, 0.95]). At ESMO 2025 , ITM announced that COMPETE also met a key secondary endpoint of ORR (21.9% vs 4.2%, p<0.0001) in patients with GEP-NETs. The COMPETE study enrolled a total of 309 GEP-NET patients, including 178 (57.6%) patients with P-NETs randomized 2:1 to either 177 Lu-edotreotide (n=119) or everolimus (n=59). Of the 178 P-NET patients, 150 (84.3%) had non-functional tumors, meaning they did not produce hormones causing clinical symptoms, and 28 (15.7%) had functional tumors, in which excess hormone production can cause symptoms such as hypoglycemia (insulinoma), or diarrhea and peptic ulcer (Zollinger Elison syndrome). Key findings in the P-NETs population showed: Median PFS was longer in the 177 Lu-edotreotide arm compared to everolimus (24.5 months vs. 14.7 months; p=0.114; HR 0.70, 95% CI [0.45, 1.09]) and ORR in the 177 Lu-edotreotide arm was 33.3% vs. 3.6% in everolimus arm. ORR in the 177 Lu-edotreotide arm was ≥ 30% in P-NET patients with non-functional disease, across all patients regardless of line of therapy and Ki-67 index. This includes 38.1% ORR in P-NET patients with non-functional disease and 34.2% ORR in patients with a Ki-67 index ≥10%. Median overall survival was numerically longer in the 177 Lu-edotreotide arm compared to everolimus (65.7 months vs. 49.3 months) at the time of analyses; data continue to mature with ongoing five-year follow up. The overall safety pro P-NET patients receiving 177 Lu-edotreotide compared to everolimus was similar or potentially improved, and included fewer serious adverse events (SAEs) (29.1% vs. 43.1%). Lower incidence of adverse events suspected to be related to the study drug was seen in the 177 Lu-edotreotide arm vs. everolimus arm (83.8% vs. 96.6%). “Given that the data on peptide receptor radionuclide therapy in pancreatic NETs has been limited to date, we are encouraged by the activity of 177 Lu-edotreotide observed in this prespecified exploratory subgroup of patients with Grade 1 or 2 pancreatic NETs, who represented approximately 58% of trial participants,” said Thomas Walter, MD, PhD, professor of gastroenterology, Hospices Civil of Lyon, France. “These additional results from our Phase 3 COMPETE trial provide important insights into treatment options for patients with pancreatic NETs, and further enhance the robust clinical data of 177 Lu-edotreotide,” said Dr. Celine Wilke, chief medical officer of ITM . 177 Lu-edotreotide (ITM-11) is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. ENETS Oral Presentation Details Title : 177 Lu-edotreotide for the Treatment of Pancreatic Neuroendocrine Tumours: A Subgroup Analysis from the COMPETE Study Date and Time : March 5, 2026, 11:00 am-12:30 pm CET Session; 11:50-11:57 am CET Oral Presentation Session and Room Number: Clinical Science, Session 2B: Abstract session; Theatre Hall (S2) Presenter: Thomas Walter, PhD, MD, Professor of Gastroenterology, Hospices Civil of Lyon, France The e-poster will be accessible to registered participants during the event and available on after the conference. About the COMPETE Trial The COMPETE trial (NCT03049189) evaluated 177 Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular standard-of-care therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177 Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177 Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors. 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 of medical radioisotopes. 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 outcome and quality of life. ITM Contacts: Corporate Communications Kathleen Noonan/Julia Westermeir Phone: +49 89 329 8986 1500 Email: communications@itm-radiopharma.com Investor Relations Ben Orzelek Phone: +49 89 329 8986 1009 Email: investors@itm-radiopharma.com Attachment ITM Announces Phase 3 COMPETE Trial Post-Hoc Subgroup Analyses with n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) in Patients with Pancreatic Neuroendocrine Tumors at ENETS 2026

Phase 3Clinical ResultOligonucleotide

13 Nov 2025

·www.globenewswire.com

ITM Announces FDA Acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a. 177Lu-edotreotide (ITM-11) in Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Prescription Drug User Fee Act (PDUFA) goal date set for August 28, 2026 Garching / Munich, Germany, November 13, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) completed its filing review and accepted the company’s New Drug Application (NDA) for n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide). 177Lu-edotreotide is ITM’s proprietary, synthetic, targeted radiotherapeutic investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026. “The FDA’s acceptance of our NDA is an important regulatory milestone in advancing this new radiopharmaceutical treatment option for patients with GEP-NETs,” said Dr. Celine Wilke, chief medical officer of ITM. “In the Phase 3 COMPETE trial, 177Lu-edotreotide demonstrated extended PFS, a straightforward dosing regimen, and a favorable safety profile, supporting its potential to improve the current treatment paradigm. We look forward to working closely with the FDA toward potential approval.” The NDA submission for 177Lu-edotreotide is supported by results from the Phase 3 COMPETE study, a prospective, randomized, controlled, open-label trial that enrolled 309 patients with inoperable, progressive Grade 1 or Grade 2 GEP-NETs as a first- or second-line treatment. The trial met its primary endpoint, revealing a significantly longer median mPFS in patients treated with agent 177Lu-edotreotide compared to everolimus, a targeted molecular therapy. Patients treated with 177Lu-edotreotide also demonstrated a significantly higher ORR compared to everolimus. “This milestone reflects more than 20 years of leadership and dedication to advancing the radiopharmaceutical field, built on our global isotope manufacturing, clinical expertise, and pipeline of targeted therapeutics and diagnostics,” said Dr. Andrew Cavey, chief executive officer of ITM. “Above all, we are driven by a single focus: making a real difference for people living with hard-to-treat cancers.” About the COMPETE Trial The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors. 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 of medical radioisotopes. 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 outcome and quality of life. www.itm-radiopharma.com ITM Contact Corporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.comInvestor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@itm-radiopharma.com Attachment 20251113_ITM Press Release FDA NDA Acceptance ITM 11

Phase 3Clinical ResultNDAOligonucleotide

25 Oct 2025

·www.globenewswire.com

ITM Announces Analyses from Phase 3 COMPETE Data Showing Higher Objective Response Rates with n.c.a. 177Lu-edotreotide (ITM-11) vs. Everolimus Across Subgroups of Patients with GEP-NETs at NANETS 2025 Annual Symposium

Austin, Texas, October 25, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, announced analyses data from its Phase 3 COMPETE trial in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Results showed consistently higher objective response rates (ORR) and longer progression-free survival (PFS) across subgroups in patients treated with n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide) compared to everolimus, reinforcing its previously reported efficacy profile. Data were shared by study investigator, Jaume Capdevila, MD, PhD, in both oral and poster presentations at the 2025 North American Neuroendocrine Tumor Society (NANETS) Annual Multidisciplinary NET Medical Symposium, held October 23-25, 2025, in Austin, Texas.As previously announced at ENETS 2025, the COMPETE trial, which included a total of 309 patients randomized to either 177Lu-edotreotide (n=207) or everolimus (n=102), met its primary endpoint of progression-free survival, or PFS, (23.9 vs. 14.1 months; p=0.022; HR 0.67, 95% CI [0.48, 0.95]). At ESMO 2025, ITM announced that the COMPETE trial also met a key secondary endpoint of objective response rate (ORR) (21.9% vs 4.2%, p<0.0001).In this analysis of the COMPETE trial presented at NANETS 2025, the key findings showed: ORR was higher in patients in the 177Lu-edotreotide arm vs. everolimus across subgroups, including those with pancreatic NETs, Grade 1 tumors, Grade 2 tumors, and those who had received prior therapy (2nd line); post-hoc analysisAlthough data is still maturing, there was a preliminary trend of longer median overall survival (OS) in the 177Lu-edotreotide arm vs. everolimus in most patient subgroups ORR and OS Subgroup Analyses Based on Blinded Independent Central Review (BICR): Phase 3 COMPETE Trial177Lu-edotreotide (n=207 patients) vs. everolimus (n=102 patients) Objective Response Rate (ORR); post-hoc analysis Overall Survival (OS) Primary Tumor OriginGastroenteric NETPancreatic NET 6.0 % v. 5.0%33.3% v. 3.6% 63.4 months v. 58.7 months(p value = 0.799)65.7 months v. 49.3 months(p value=0.263) Tumor Grade 1Grade 1Grade 2 15.8% v. 3.3%28.3% v. 3.1% NR2 v. NR(p value=0.702)56.7 months vs. 41.4 months(p value=0.082) Prior Medical TherapyTreatment-naïve (1st line)Prior therapy (2nd line) 17.9% v. 5.9%22.5% v. 3.8% 57.4 months v. NR(p value= 0.016)63.4 months v. 43.4 months(p value=0.018) 1Central assessment according to WHO classification, 2Not reached “We are encouraged by the positive trends we see in PFS extension and higher ORR for 177Lu-edotreotide compared to everolimus in these patient subgroups. These results strengthen the existing data set for Lu-edotreotide’s potential as a new therapeutic option for people living with inoperable GEP-NETs,” said Dr. Capdevila, senior medical oncologist at Vall d'Hebron University Hospital, Barcelona. ITM also announced real-world clinical and meta-analysis data in patients with a range of neuroendocrine tumors at NANETS.In early October, ITM presented dosimetry data from the COMPETE trial at the European Association of Nuclear Medicine (EANM) Annual Congress in Barcelona, Spain. The data showed that 177Lu-edotreotide delivered targeted radiation to tumors while minimizing exposure to healthy tissue, supporting its efficacy and safety profile.“These additional subgroup data reinforce and extend evidence from the COMPETE Phase 3 trial, supporting 177Lu-edotreotide’s potential as a promising radiopharmaceutical therapy for neuroendocrine tumors if approved,” said Dr. Andrew Cavey, chief executive officer of ITM. Oral Presentation DetailsTitle: Efficacy of 177Lu-edotreotide vs everolimus in patients with grade 1 or grade 2 GEP-NETs: Phase 3 COMPETE trial (post hoc subgroup analyses)Date and Time: October 24, 2025, 3:35-4:50 pm Central Time Session: Part II Featured Abstracts| Access to New Treatments - How can we bring innovative treatments to patients more quickly and effectively? Presenter: Jaume Capdevila, MD, PhD, senior researcher, department of Medical Oncology, Vall d'Hebron University Hospital & Vall d'Hebron Institute of OncologyPoster Presentation Details:Title: Efficacy of 177Lu-edotreotide vs everolimus in patients with grade 1 or grade 2 GEP-NETs: Phase 3 COMPETE trial (post hoc subgroup analyses)Date and Time: Friday, October 24, 5:15-6:30 pm Central TimeSession: NANETS Poster TourPresenter: Dr. Jaume Capdevila, Vall d'Hebron University Hospital, Barcelona. Title: First-line Treatment with 177Lu-edotreotide ([177Lu]Lu-DOTATOC) in patients with NETs: a Swiss NET Registry AnalysisDate and Time: Friday, October 24, 5:15-6:30 pm Central TimeSession: NANETS Poster Tour Presenter: Dr. Guillaume Nicolas, University Hospital BaselTitle: Efficacy and safety of 177Lu-edotreotide ([177Lu]Lu-DOTATOC) for the treatment of neuroendocrine tumors (NETs) – a systematic literature review (SLR) and meta-analysisDate and Time: Friday, October 24, 5:15-6:30 pm Central TimeSession: NANETS Poster TourPresenter: Dr. Julia G Fricke, University Hospital BaselAbout the COMPETE TrialThe COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is also being evaluated in COMPOSE, a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors.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 of medical radioisotopes. 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 outcome and quality of life. www.itm-radiopharma.comITM Contacts:Corporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.comInvestor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@itm-radiopharma.com Attachment 20251025_ITM_NANETS 2025 COMPETE

Phase 3Clinical ResultOligonucleotide

100 Deals associated with Lutetium (177Lu) edotreotide

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Gastro-Enteropancreatic Neuroendocrine Tumor	NDA/BLA	United States	Itm Isotope Technologies Munich SE	14 Nov 2025
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	China	ITM Solucin GmbH	11 Feb 2025
SSTR positive Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 3	China	Grand Pharmaceutical (China) Co., Ltd.	11 Feb 2025
Neuroendocrine neoplasm of lung	Phase 3	Belgium	Itm Isotope Technologies Munich SE	27 Oct 2023
Neuroendocrine neoplasm of lung	Phase 3	France	Itm Isotope Technologies Munich SE	27 Oct 2023
Neuroendocrine neoplasm of lung	Phase 3	Italy	Itm Isotope Technologies Munich SE	27 Oct 2023
Neuroendocrine neoplasm of lung	Phase 3	Spain	Itm Isotope Technologies Munich SE	27 Oct 2023
Thymus Neoplasms	Phase 3	Belgium	Itm Isotope Technologies Munich SE	27 Oct 2023
Thymus Neoplasms	Phase 3	France	Itm Isotope Technologies Munich SE	27 Oct 2023
Thymus Neoplasms	Phase 3	Italy	Itm Isotope Technologies Munich SE	27 Oct 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03049189 (COMPETE, Company_Website) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor Second line \| First line Somatostatin Receptor Positive	309	177Lu-edotreotide	ietfpaznjr(zphoxcnjhs) = akymsuihom vcisloaooa (iebgpyrana ) Met View more	Positive	25 Oct 2025
				Everolimus	ietfpaznjr(zphoxcnjhs) = zfctnmiuur vcisloaooa (iebgpyrana ) Met View more
NCT03049189 (COMPETE, Company_Website \| ESMO2025) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor Second line \| First line Somatostatin Receptor Positive	309	177Lu-edotreotide	cxfrwzpjad(njxpqncjbu) = ltngzvodfx lszioumspu (uihsetjnuu ) View more	Positive	18 Oct 2025
				Everolimus	cxfrwzpjad(njxpqncjbu) = pbalwvobut lszioumspu (uihsetjnuu ) View more
NCT03049189 (COMPETE, ESMO2025)	Phase 3	somatostatin receptor positive \| Ki-67 ≤20%	309	177Lu-edotreotide	cvlznkciwj(keocbgsqhr) = agbdxqsfwf gyzynfzjia (pbjuezqzvn ) View more	Positive	17 Oct 2025
				Everolimus	cvlznkciwj(keocbgsqhr) = nhhwtkhyii gyzynfzjia (pbjuezqzvn ) View more
NCT03049189 (COMPETE, EANM2025 \| GlobeNewswire) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	309	177Lu-edotreotide (ITM-11)	bwrxgivauz(bthtophxxi) = twocfctlim oywepaldgd (rypupoimqo ) Met View more	Positive	08 Oct 2025
				Everolimus	bwrxgivauz(bthtophxxi) = nxrqjzgbou oywepaldgd (rypupoimqo ) Met View more
NCT03049189 (COMPETE, Company_Website \| NEWS) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	309	ITM-11	jhgpebywku(rqqcrsgpdi) = dzuqlalcnz hbmrsflcpu (mgerldoslp ) Met View more	Positive	28 Jan 2025
				Everolimus	jhgpebywku(rqqcrsgpdi) = actjtnfjuz hbmrsflcpu (mgerldoslp ) Met View more
NCT04194125 (ESMO 12023 \| ESMO 22023) Manual	Phase 2	Neuroendocrine Tumors	21	177Lu DOTATOC+ CAPTEM	onviafekal(jutlqjytoi) = vpfybyqrxq okkdlybqld (hbpbyubcog, 16.0 - NR) View more	Positive	22 Oct 2023
				177Lu DOTATOC+ CAPTEM (panNET)	onviafekal(jutlqjytoi) = jwquymqknz okkdlybqld (hbpbyubcog, 14.0 - NR)
SNMMI2023	Not Applicable	Gastro-Enteropancreatic Neuroendocrine Tumor	-	4 cycles of PRRT	fymorakztf(mwvwtblweo) = 27 of these 36 patients (75%; 14 SI-NET; 4 CUP-NET; 9 P-NET) experienced PD in iStaging yxqhhyuqut (vzirsmkmxl ) View more	-	28 Aug 2023
NCT03049189 (COMPETE, ESMO2018)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	300	Everolimus	mbhpihdgty(aziqwzmgar) = sommidvdxv xchwbwmmcv (zrtzctiqxv )	-	21 Oct 2018

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