[Translation] A prospective, randomized, controlled, open-label, multicenter trial evaluating the efficacy, safety, and patient-reported outcomes of 177Lu-edotreotide peptide receptor radionuclide therapy (PRRT) compared with best standard therapy in patients with well-differentiated aggressive grade 2 and 3 somatostatin receptor-positive (SSTR+) neuroendocrine tumors of gastrointestinal or pancreatic origin (COMPOSE)

在高分化侵袭性2级（G2）和3级（G3）GEP-NETs患者中确认177Lu-依多曲肽PRRT的有效性和安全性

[Translation]

To confirm the efficacy and safety of 177Lu-edotreotide PRRT in patients with well-differentiated aggressive grade 2 (G2) and grade 3 (G3) GEP-NETs

Start Date11 Feb 2025

Sponsor / Collaborator

ITM Solucin GmbH

[+1]

NCT06441331

/ Not yet recruitingPhase 1

A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).

The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to <18 years of age with somatostatin receptor (SSTR)-positive tumors.

Start Date01 Jan 2025

Sponsor / Collaborator

ITM Solucin GmbH

NCT05918302

/ RecruitingPhase 3IIT

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

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 Jun 2024·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Safety and Efficacy ofPara-Aminohippurate Coinfusion for Renal Protection During Peptide Receptor Radiotherapy in Patients with Neuroendocrine Tumors

Article

Author: Jentzen, Walter ; van Echteld, Cees J A ; Meckel, Marian ; Himmen, Stephan ; Fendler, Wolfgang P ; Coelho, Marta ; Fragoso Costa, Pedro ; Sraieb, Miriam ; Herrmann, Ken ; Moraitis, Alexandros ; Kersting, David

Para-aminohippurate, also known as p-aminohippuric acid (PAH), is used clinically to measure effective renal plasma flow. Preclinically, it was shown to reduce ¹⁷⁷Lu-DOTATOC uptake in the kidneys while improving bioavailability compared with amino acid (AA) coinfusion. We report the safety and efficacy of PAH coinfusion during peptide receptor radiotherapy in patients with neuroendocrine tumors. Methods: Twelve patients with metastatic or unresectable gastroenteropancreatic neuroendocrine tumors received ¹⁷⁷Lu-DOTATOC in 33 treatment cycles. Either 8 g of PAH or a mixture of 25 g of arginine and 25 g of lysine were coinfused. Safety was assessed by monitoring laboratory data, including hematologic and renal data, as well as electrolytes obtained before and 24 h after treatment. For radiation dosimetry, whole-body scans were performed at 1, 24, and 48 h and a SPECT/CT scan was performed at 48 h, along with blood sampling at 5 min and 0.5, 2, 4, 24, and 48 h after administration. Absorbed dose estimations for the kidneys and bone marrow were performed according to the MIRD concept. Results: In 15 treatment cycles, PAH was coinfused. No changes in mean creatinine level, glomerular filtration rate, and serum electrolytes were observed before or 24 h after treatment when using PAH protection (P ≥ 0.20), whereas serum chloride and serum phosphate increased significantly under AA (both P < 0.01). Kidney-absorbed dose coefficients were 0.60 ± 0.14 Gy/GBq with PAH and 0.53 ± 0.16 Gy/GBq with AA. Based on extrapolated cumulative kidney-absorbed doses for 4 cycles, 1 patient with PAH protection and 1 patient with AA protection in our patient group would exceed the 23-Gy conservative threshold. The bone marrow-absorbed dose coefficient was 0.012 ± 0.004 Gy/GBq with PAH and 0.012 ± 0.003 Gy/GBq with AA. Conclusion: PAH is a promising alternative to AA for renal protection during peptide receptor radiotherapy. Further research is required to systematically investigate the safety profile and radiation dosimetry at varying PAH plasma concentrations.

01 Jan 2024·Theranostics

Long-term Nephrotoxicity after PRRT: Myth or Reality

Article

Author: Yu, Fei ; Zhang, Jingjing ; Baum, Richard P ; Schuchardt, Christiane ; Fan, Xin ; Jakobsson, Vivianne ; Chen, Xiaoyuan

Rationale: The kidneys are commonly considered as the potential dose-limiting organ for peptide receptor radionuclide therapy (PRRT), making the risk of nephrotoxicity a primary concern. This retrospective analysis with prospective documentation and long-term follow-up aims to assess the risk of nephrotoxicity after PRRT in a large cohort of patients with neuroendocrine neoplasms (NENs) treated at our institution over the past 18 years. Methods: A total of 1361 NEN patients treated with 1-10 cycles of ¹⁷⁷Lu-DOTA-TOC/-NOC/-TATE, ⁹⁰Y-DOTA-TOC/-NOC/-TATE, DUO-PRRT (sequential administration of ⁹⁰Y- and ¹⁷⁷Lu-), or TANDEM-PRRT (combination of ⁹⁰Y- and ¹⁷⁷Lu- on the same day concomitantly) were included in this analysis. All parameters were prospectively documented in a structured database comprising over 250 items per patient and retrospectively analyzed. Kidney function, including serum creatinine, blood urea nitrogen, cGFR, and electrolytes, was evaluated before each PRRT cycle and during follow-up. Restaging was regularly performed at 6-month intervals until death. Treatment-related adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0). Results: Between 2000 and 2018, a total of 5409 cycles of PRRT were administered to 1361 NEN patients. Follow-up after complete treatment was available for 1281 patients receiving 4709 cycles of PRRT, with a median follow-up time of 69.2 months (interquartile range, 32.8-110.5 months) and a maximum follow-up time of 175 months. Baseline creatinine levels were normal in 1039/1281 (81.1%) subjects, while grade 1 (G1) renal insufficiency was present in 221/1281 (17.3%) prior to PRRT. G2 was present in 19/1281 (1.5%), and G3 in 2/1281 (0.2%). After treatment, the proportion of G3/G4 grade patients only increased from 0.2% to 0.7%. Mean creatinine levels increased from a baseline of 0.90 ± 0.30 to 1.01 ± 0.57 mg/L (80.0 ± 26.7 to 89.4 ± 50.8 μmol/L) after treatment. In our main analysis cohort of 1244 patients (4576 cycles), 200 patients experienced an increase in CTCAE creatinine grade. Age, number of treatment cycles, type of radionuclides, and length of follow-up time were the main factors affecting CTCAE creatinine grading after treatment. When comparing the subgroups treated with different radionuclides, the risk of nephrotoxicity after ⁹⁰Y treatment alone and the ⁹⁰Y/¹⁷⁷Lu combination group was higher than after ¹⁷⁷Lu treatment alone. In the ⁹⁰Y treatment subgroup, the two significant risk factors for an increased CTCAE creatinine grade were identified to be age (≥60) and a long follow-up time. Conclusions: This retrospective analysis with prospective documentation in a large cohort of 1281 NEN patients receiving 4709 cycles of PRRT co-administered with renal protection, treated through the individualized approach at a single institution over 18 years, did not reveal any evidence of long-term PRRT-related renal toxicity. The results of our study suggest that with the use of proper renal protection, nephrotoxicity due to PRRT is more likely a myth than a reality.

01 Jul 2023·Journal of nuclear medicine : official publication, Society of Nuclear Medicine

¹⁶¹Tb-DOTATOC Production Using a Fully Automated Disposable Cassette System: A First Step Toward the Introduction of ¹⁶¹Tb into the Clinic.

Article

Author: Landolt, Stefan ; van der Meulen, Nicholas P ; Grundler, Pascal V ; Talip, Zeynep ; Sepini, Lebogang ; Köster, Ulli ; Schibli, Roger ; Geistlich, Susanne ; Müller, Cristina ; Favaretto, Chiara

¹⁶¹Tb is an interesting radionuclide for application in the treatment of neuroendocrine neoplasms' small metastases and single cancer cells because of its conversion and Auger-electron emission. Tb has coordination chemistry similar to that of Lu; therefore, like ¹⁷⁷Lu, it can stably radiolabel DOTATOC, one of the leading peptides used for the treatment of neuroendocrine neoplasms. However, ¹⁶¹Tb is a recently developed radionuclide that has not yet been specified for clinical use. Therefore, the aim of the current work was to characterize and specify ¹⁶¹Tb and to develop a protocol for the synthesis and quality control of ¹⁶¹Tb-DOTATOC with a fully automated process conforming to good-manufacturing-practice guidelines, in view of its clinical use. Methods: ¹⁶¹Tb, produced by neutron irradiation of ¹⁶⁰Gd in high-flux reactors followed by radiochemical separation from its target material, was characterized regarding its radionuclidic purity, chemical purity, endotoxin level, and radiochemical purity (RCP) in analogy to what is described in the European Pharmacopoeia for no-carrier-added ¹⁷⁷Lu. In addition, ¹⁶¹Tb was introduced into a fully automated cassette-module synthesis to produce ¹⁶¹Tb-DOTATOC, as used for ¹⁷⁷Lu-DOTATOC. The quality and stability of the produced radiopharmaceutical in terms of identity, RCP, and ethanol and endotoxin content were assessed by means of high-performance liquid chromatography, gas chromatography, and an endotoxin test, respectively. Results: ¹⁶¹Tb produced under the described conditions showed, as the no-carrier-added ¹⁷⁷Lu, a pH of 1-2, radionuclidic purity and RCP of more than 99.9%, and an endotoxin level below the permitted range (175 IU/mL), indicating its appropriate quality for clinical use. In addition, an efficient and robust procedure for the automated production and quality control of ¹⁶¹Tb-DOTATOC with clinically applicable specifications and activity levels, that is, 1.0-7.4 GBq in 20 mL, was developed. The radiopharmaceutical's quality control was also developed using chromatographic methods, which confirmed the product's stability (RCP ≥ 95%) over 24 h. Conclusion: The current study demonstrated that ¹⁶¹Tb has appropriate features for clinical use. The developed synthesis protocol guarantees high yields and safe preparation of injectable ¹⁶¹Tb-DOTATOC. The investigated approach could be translated to other DOTA-derivatized peptides; thus, ¹⁶¹Tb could be successfully applied in clinical practice for radionuclide therapy.

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

09 Apr 2025

·www.globenewswire.com

Barbara Weber, M.D., Elected to ITM Supervisory Board

Garching / Munich, Germany, April 09, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the election of Barbara Weber, M.D., to its Supervisory Board, effective May 01, 2025. The election occurred at ITM’s Extraordinary General Meeting. Dr. Weber is the President, Chief Executive Officer and Founder of Tango Therapeutics (Nasdaq: TNGX). She has over 25 years of executive and research and development leadership experience in biotech, venture capital and at major pharmaceutical companies, including Novartis (NYSE: NVS) and GlaxoSmithKline (NYSE: GSK). ITM’s Supervisory Board and the company overall will benefit from Dr. Weber’s deep expertise as it advances its lead Phase 3 candidate, n.c.a. 177Lu-edotreotide (ITM-11), and continues advancing its radiopharmaceutical pipeline and medical radioisotope manufacturing business. “Dr. Weber’s impressive track record in building transformative oncology biotech companies speaks volumes for her business acumen and her dedication to improving the lives of people living with cancer. Her profound industry and scientific knowledge, including her demonstrated ability to bring novel compounds through the clinic to FDA approval, will be an invaluable asset to ITM,” said Udo J. Vetter, Chairman of the Supervisory Board of ITM. “The expansion of our Supervisory Board and its insights ensures that ITM is optimally positioned to continue accelerating the growth of its radiopharmaceutical pipeline and medical radioisotope business.” Dr. Weber is a physician-scientist with a distinguished clinical and academic career and extensive leadership expertise in global pharmaceutical development. As the President, Chief Executive Officer and Founder of Tango Therapeutics, she led the company’s transition to being publicly listed and the development of its precision oncology product candidates based on the genetic principle of synthetic lethality. As a Venture Partner at Third Rock Ventures, she led teams in creating new oncology drug discovery companies, including Tango Therapeutics, Neon Therapeutics (acquired by BioNTech (Nasdaq: BNTX)) and Relay Therapeutics (Nasdaq: RLAY). “As a physician and business executive devoted to fighting cancer, I recognize the significant potential of targeted radiopharmaceutical therapy to improve the precision oncology treatment paradigm and outcomes for patients. I look forward to working with ITM’s Supervisory Board and Leadership Team as the company plans an NDA submission for ITM-11 and expands its pipeline with various promising alpha- and beta-emitting radioisotopes coupled with novel targeting agents,” said Dr. Weber. Prior to her tenure at Third Rock Ventures, Dr. Weber was Senior Vice President, Oncology Translational Medicine at Novartis and Vice President, Oncology Discovery and Translational Medicine at GlaxoSmithKline, where she was instrumental in leading clinical studies and obtaining FDA approvals for numerous drugs including Zykadia®, Kisqali®, Vijoice® and Promacta®. Dr. Weber received her Doctor of Medicine from the University of Washington and has been affiliated with the University of Pennsylvania, Yale University and the Dana-Farber Cancer Institute. She is a member of the Board of Directors at Tango Therapeutics, Revolution Medicines Inc. (Nasdaq: RVMD), Parabilis Medicines and Sesame Therapeutics. About ITM Isotope Technologies Munich SEITM, 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 outcome and quality of life. www.itm-radiopharma.com ITM ContactCorporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.com Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@itm-radiopharma.com Attachments 20250409_Barbara Weber, M.D., Elected to ITM Supervisory Board Barbara Weber, M.D., Elected to ITM Supervisory Board

Executive ChangePhase 3

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

100 Deals associated with Lutetium (177Lu) edotreotide

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
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	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
Somatostatin Receptor-Positive Neuroendocrine Tumor	Phase 3	France	Itm Isotope Technologies Munich SE	27 Oct 2023
Somatostatin Receptor-Positive Neuroendocrine Tumor	Phase 3	Italy	Itm Isotope Technologies Munich SE	27 Oct 2023
Somatostatin Receptor-Positive Neuroendocrine Tumor	Phase 3	Spain	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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03049189 (COMPETE, Company_Website \| NEWS) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	309	ITM-11	dedidjogws(rbbeftwoge) = jmtkliuask buhzokhniv (nogtdpjsxu ) Met View more	Positive	28 Jan 2025
NCT03049189 (COMPETE, Company_Website \| NEWS) Manual	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	309	Everolimus	dedidjogws(rbbeftwoge) = gdzduhyomt buhzokhniv (nogtdpjsxu ) Met View more	Positive	28 Jan 2025
NCT04194125 (ESMO 12023 \| ESMO 22023) Manual	Phase 2	Neuroendocrine Tumors	21	177Lu DOTATOC+ CAPTEM	bceymndabp(tczvawbivg) = gcefknxgvu wpsfnhzmhw (verbjbrxei, 16.0 - NR) View more	Positive	22 Oct 2023
NCT04194125 (ESMO 12023 \| ESMO 22023) Manual	Phase 2	Neuroendocrine Tumors	21	177Lu DOTATOC+ CAPTEM (panNET)	bceymndabp(tczvawbivg) = vacrqtpktw wpsfnhzmhw (verbjbrxei, 14.0 - NR)	Positive	22 Oct 2023
SNMMI2023	Not Applicable	Gastro-Enteropancreatic Neuroendocrine Tumor	-	4 cycles of PRRT	ndkfeugkdl(ruhyhejfwh) = 27 of these 36 patients (75%; 14 SI-NET; 4 CUP-NET; 9 P-NET) experienced PD in iStaging eazbycakhy (fxobajbqpz ) View more	-	28 Aug 2023
SNMMI2022	Not Applicable	Gastro-Enteropancreatic Neuroendocrine Tumor	-	[177Lu]DOTATOC (GEP-NET patients)	dpagwbkbzn(jlahsscbrj) = ptsaswprcn bahchtpezr (agdxbuuagf ) View more	-	08 Aug 2022
SNMMI2019	Not Applicable	-	-	Lu-177 DOTA-LM3	hnywixocah(uerfezttlq) = tnbnjpzjyj dpbdrhmnhq (whddthiopb ) View more	-	21 May 2019
SNMMI2019	Not Applicable	-	-	Lu-177 DOTATOC	hnywixocah(uerfezttlq) = zlgnhmicfh dpbdrhmnhq (whddthiopb ) View more	-	21 May 2019
NCT03049189 (COMPETE, ESMO2018)	Phase 3	Gastro-Enteropancreatic Neuroendocrine Tumor	300	Everolimus	vpertbdtve(dtboenqvbd) = ewjuictdau hzscxwzkxm (zknpzcsucn )	-	21 Oct 2018

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