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.

开始日期2025-01-01

申办/合作机构

ITM Solucin GmbH

NCT05918302

/ Recruiting临床3期IIT

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.

开始日期2023-10-27

申办/合作机构

Itm Isotope Technologies Munich SE

100 项与镥[177Lu]依多曲肽相关的临床结果

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100 项与镥[177Lu]依多曲肽相关的转化医学

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100 项与镥[177Lu]依多曲肽相关的专利（医药）

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项与镥[177Lu]依多曲肽相关的文献（医药）

2024-06-01·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

作者: Jentzen, Walter ; van Echteld, Cees J A ; Meckel, Marian ; Fendler, Wolfgang P ; Himmen, Stephan ; 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.

2024-01-01·Theranostics

Long-term Nephrotoxicity after PRRT: Myth or Reality

Article

作者: 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.

2023-07-01·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

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

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.

项与镥[177Lu]依多曲肽相关的新闻（医药）

2025-03-07

·氨基观察

拜耳寻求巨额融资；江苏吴中涉嫌骗取出口退税罪被起诉

氨基观察-创新药组原创出品作者 | 黄恺江苏吴中遇到了麻烦事。 3月7日，江苏吴中公告，公司全资子公司吴中进出口及原法定代表人、董事长杨锋因在2011年7月至2018年12月期间协助林锡钦等人实施骗取出口退税，被湖南省衡东县人民检察院以骗取出口退税罪（从犯）提起公诉。拜耳寻求巨额融资。 3月7日，拜耳宣布，公司正在寻求股东批准，计划发行新股，金额相当于其当前股本的35%，以便在需要迅速解决美国法律问题时获得资金。监事会主席指出，此次资本增资的收益将专门用于在解决美国诉讼期间加强资产负债表，而不是用于融资并购。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 市场速递 1）百奥泰生物研发副总辞职 3月6日，百奥泰生物公告，公司董事会于近日收到公司非独立董事、副总经理LIU CUIHUA（刘翠华）女士的书面辞职报告，LIUCUIHUA（刘翠华）女士因个人原因辞去公司第二届董事会董事、副总经理职务。 2）江苏吴中涉嫌骗取出口退税罪被起诉 3月7日，江苏吴中公告，公司全资子公司吴中进出口及原法定代表人、董事长杨锋因在2011年7月至2018年12月期间协助林锡钦等人实施骗取出口退税，被湖南省衡东县人民检察院以骗取出口退税罪（从犯）提起公诉。 / 02 / 资本信息 1）心通医疗2024年亏损额为3000万元-6000万元 3月7日，心通医疗发布业绩预告，预计2024年亏损额为3000万元-6000万元。 / 03 / 医药动态 1）望实智慧科技SWA1211片获临床许可 3月7日，据CDE官网，望实智慧科技SWA1211片获临床许可，拟开展治疗晚期实体瘤的研究。 2）圣因生物siRNA新药启动2期临床 3月7日，圣因生物宣布，靶向补体C3的小核酸（siRNA）药物SGB-9768注射液在中国正式启动2期临床试验，针对原发性IgA肾病患者、C3肾小球病患者和免疫复合物介导的膜增生性肾小球肾炎患者中。 / 04 / 器械跟踪 1）国内首家冻干三靶标肠癌甲基化检测试剂盒成功上市 3月7日，康为世纪宣布，自主研发生产的人类Septin9、SDC2和NDRG4基因甲基化检测试剂盒（荧光PCR法）获国家药品监督管理局颁发的《医疗器械注册证》。这是我国冻干肠癌甲基化检测试剂盒第一张三类注册证。 / 05 / 海外药闻 1）罕见眼科疾病新疗法获FDA批准 3月6日，Neurotech Pharmaceuticals宣布，FDA已批准Encelto（revakingene taroretcel-lwey）用于治疗2型黄斑毛细血管扩张症。该药是首个且唯一获得FDA批准的MacTel治疗药物。 2）阿斯利康胃癌围手术期PD-L1联合疗法优于标准治疗 3月7日，阿斯利康宣布，III期MATTERHORN研究结果显示，Imfinzi（度伐利尤单抗）联合标准治疗FLOT（氟尿嘧啶、亚叶酸钙、奥沙利铂和多西他赛）化疗作为可切除的早期和局部晚期（II期、III期、IVA期）的胃癌和胃食管交界处癌（GEJ）患者围手术期治疗方案，主要终点无事件生存期（EFS）具有统计学意义和临床意义的改善。MATTERHORN是首个证明免疫疗法联合治疗优于标准治疗的全球随机III期临床研究。 3）创新多肽偶联药物达3期临床主要终点 3月6日，ITM Isotope Technologies宣布，其专有的靶向放射性疗法177Lu-edotreotide（亦称ITM-11），在治疗无法手术切除的进展性1级或2级胃肠胰神经内分泌肿瘤患者的3期临床试验COMPETE中获得的积极结果。 4）拜耳寻求巨额融资 3月7日，拜耳宣布，公司正在寻求股东批准，计划发行新股，金额相当于其当前股本的35%，以便在需要迅速解决美国法律问题时获得资金。监事会主席指出，此次资本增资的收益将专门用于在解决美国诉讼期间加强资产负债表，而不是用于融资并购。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

siRNA并购高管变更临床2期

2025-03-07

·创鉴汇

“不止罕见”，2024年至今167家罕见病创新药公司获融资！

▎药明康德内容团队编辑第18个国际罕见病日刚刚过去，今年的主题“不止罕见”不仅呼吁社会关注这一群体的多元面貌，更提醒我们——在医学与创新的共同推动下，罕见病的“解法”正加速破冰。罕见病的治疗和新药研发虽荆棘密布，但也不乏大型药企投入与新兴力量的突围，资金与创新的碰撞，正为全球3亿罕见病患者推开一扇扇希望之窗。回顾2024年至今，全球至少有167家罕见病创新药公司获得融资。值得关注的亮点包括：跨国药企支持共建创新生态：投资机构中不乏大型药企的身影，如百时美施贵宝（BMS）参与Attralus B轮融资以及COUR Pharmaceuticals A轮融资、诺华（Novartis）支持FundaMental Pharma种子轮融资，大型药企深度参与构建管线协同。 AI与大数据重塑药物发现：AI驱动的新药研发公司融资活跃，如剂泰医药C轮融资1亿美元、Manas AI获2460万美元种子轮融资、Model Medicines获1475万美元资金支持，技术覆盖靶点预测、分子设计及临床优化。细胞与基因疗法（CGT）备受关注：得益于技术成熟度提升，多家CGT疗法研发公司获得融资。细胞疗法如Kyverna Therapeutics IPO筹得3.67亿美元、Sonoma Biotherapeutics的Treg细胞疗法获4500万美元，基因疗法如Tune Therapeutics和Beacon Therapeutics分别获1.75亿美元和1.7亿美元B轮融资。 Kyverna Therapeutics成功登陆纳斯达克 Kyverna Therapeutics是一家临床阶段的细胞疗法研发公司，致力于为自身免疫性疾病和炎症疾病研发新疗法。其治疗平台结合T细胞工程和合成生物学技术，可抑制和消除导致疾病的自身反应性免疫细胞。Kyverna Therapeutics的候选管线KYV-101及其异构体KYV-201是一种CAR-T细胞疗法，旨在治疗B细胞介导的自身免疫性疾病。KYV-101特异性地靶向CD19，这是一种在B细胞表面表达的蛋白，参与各类恶性肿瘤及自身免疫性疾病如重症肌无力、僵人综合征和系统性硬化等罕见病。该药物获得了美国FDA授予的快速通道资格，用于治疗重症肌无力和多发性硬化。 2024年2月，Kyverna Therapeutics宣布完成3.19亿美元的超额IPO。 GondolaBio获3亿美元A轮融资 GondolaBio是BridgeBio Pharma公司成立的一家新公司。BridgeBio Pharma公司将把针对红细胞生成性原卟啉症、α-1抗胰蛋白酶缺乏症和结节性硬化症等罕见病的早期临床期和临床前项目转移到GondolaBio公司并由其继续进行开发。 8月，公司在Viking Global Investors LP、Patient Square Capital、红杉资本（Sequoia Capital）等投资机构的支持下成立并获得3亿美元的分期融资。 Zenas BioPharma连续完成两轮融资 Zenas成立于2021年，致力于开发免疫治疗药物。公司主要管线Obexelimab是一种双功能单克隆抗体，旨在同时靶向CD19和FcγRIIb，以抑制B细胞、浆母细胞和表达CD19的浆细胞的活性。Obexelimab的临床开发计划包括正在进行的针对罕见病IgG4相关疾病的3期注册性临床试验，该疗法已经在五项包括198名受试者的临床试验中显示出显著的临床疗效和安全性，尤其是在自身免疫性疾病方面。 2024年5月，公司完成2亿美元的C轮融资，并在9月成功登陆纳斯达克。 ITM获1.88亿欧元融资 Isotope Technologies Munich（ITM）是一家放射性药物研发公司，致力于为难治性肿瘤提供新型放射性分子精准治疗和诊断。公司将放射性同位素与能够治疗一系列肿瘤的靶向分子相结合，研发精准肿瘤学产品管线。目前，ITM公司已有多条放射性核素疗法（TRT）进入临床阶段。其中，核心管线ITM-11（edotreotide）是一种肽类药物，能特异性地靶向神经内分泌肿瘤受体，其使用无载体添加 (no carrier added, nca) 的镥-177进行标记。目前ITM-11已经进入临床3期试验阶段，针对胃肠胰神经内分泌肿瘤（GEP-NETs）的治疗。 2024年6月，ITM宣布完成1.88亿欧元融资，旨在推动创新放射性药物管线研发，并为公司用于治疗胃肠胰神经内分泌肿瘤的3期候选药物ITM-11做好商业准备。此外，ITM还将利用这笔资金提高其Lutetium-177和Actinium-225的生产能力，扩大其医用放射性同位素的产线，为其全球供应网络提供备受需要的放射性同位素资源。康霈生技成功IPO上市康霈生技（Caliway Biopharmaceuticals）主要开发用于治疗目的的新型小分子药物。旗下重要候选药物CBL-514是一款可以破坏注射部位脂肪细胞的潜在“first-in-class”小分子疗法。该药物已取得在临床2期试验CBL-0201EFP的积极顶线结果，显示CBL-514在改善橘皮组织严重程度方面具有统计学和临床显著的疗效。同时公司正在积极拓展CBL-514用于治疗多种适应症，包括罕见病德库姆病的治疗。 2024年10月，公司成功IPO上市，募集资金64亿新台币。 Abcuro获2亿美元C轮融资 Abcuro是一家致力于研发免疫疗法治疗自身免疫性疾病和癌症的临床阶段生物技术公司，新型抗体是公司研究的重点。其核心药物管线Ulviprubart是一款靶向KLRG1的在研单抗疗法，能够选择性地清除具有高细胞毒性的T细胞，同时保留初始T细胞、调节性T细胞和中枢记忆T细胞。该药物设计用于治疗由高细胞毒性T细胞介导的疾病，包括包涵体肌炎以及T细胞大颗粒淋巴细胞性白血病（T-LGLL）。美国FDA和欧洲药品管理局（EMA）均已授予Ulviprubart治疗体肌炎的孤儿药资格。 2025年2月，Abcuro宣布完成总额达2亿美元的C轮融资。所得资金将用于完成评估Ulviprubart治疗包涵体肌炎疗效与安全性的注册性2/3期MUSCLE临床试验。读者们请星标⭐创鉴汇，第一时间收到推送免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文由药明康德内容团队根据公开资料整理编辑，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转发/复制至其他平台。转发授权请在「创鉴汇」微信公众号留言联系我们。更多数据内容推荐点击“在看”，分享创鉴汇健康新动态

免疫疗法细胞疗法IPO快速通道基因疗法

2025-03-07

·PipelineReview

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

临床结果临床3期孤儿药快速通道临床2期

100 项与镥[177Lu]依多曲肽相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
SSTR阳性胃肠胰神经内分泌肿瘤	临床3期	中国	远大医药（中国）有限公司	2025-02-11
SSTR阳性胃肠胰神经内分泌肿瘤	临床3期	中国	ITM Solucin GmbH	2025-02-11
肺神经内分泌肿瘤	临床3期	法国	Itm Isotope Technologies Munich SE	2023-10-27
肺神经内分泌肿瘤	临床3期	意大利	Itm Isotope Technologies Munich SE	2023-10-27
肺神经内分泌肿瘤	临床3期	西班牙	Itm Isotope Technologies Munich SE	2023-10-27
生长抑素受体阳性神经内分泌肿瘤	临床3期	法国	Itm Isotope Technologies Munich SE	2023-10-27
生长抑素受体阳性神经内分泌肿瘤	临床3期	意大利	Itm Isotope Technologies Munich SE	2023-10-27
生长抑素受体阳性神经内分泌肿瘤	临床3期	西班牙	Itm Isotope Technologies Munich SE	2023-10-27
胸腺肿瘤	临床3期	法国	Itm Isotope Technologies Munich SE	2023-10-27
胸腺肿瘤	临床3期	意大利	Itm Isotope Technologies Munich SE	2023-10-27

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03049189 (COMPETE, Company_Website) 人工标引	临床3期	胃肠胰神经内分泌肿瘤	309	ITM-11	淵簾壓顧觸鬱觸憲膚製(壓繭積艱衊選醖顧鬱鬱) = ITM-11 demonstrating clinically relevant and statistically significant benefit in PFS compared to everolimus 壓夢鹹繭製構餘網糧餘 (鑰蓋鏇夢蓋製衊齋鑰鏇 ) 达到	积极	2025-01-28
				Everolimus
NCT04194125 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	神经内分泌肿瘤	21	177Lu DOTATOC+ CAPTEM	選憲鑰艱網鏇鑰廠窪製(鏇鬱鹽餘壓鑰膚鹽簾鹽) = 憲夢鏇鹽選鏇鏇艱醖簾築願壓蓋鹹積艱醖糧選 (廠製製窪廠夢鹽壓簾鹽, 16.0 ~ NR) 更多	积极	2023-10-22
				177Lu DOTATOC+ CAPTEM (panNET)	選憲鑰艱網鏇鑰廠窪製(鏇鬱鹽餘壓鑰膚鹽簾鹽) = 糧願齋繭鬱構觸顧獵鹽築願壓蓋鹹積艱醖糧選 (廠製製窪廠夢鹽壓簾鹽, 14.0 ~ NR)
SNMMI2023	N/A	胃肠胰神经内分泌肿瘤	-	4 cycles of PRRT	鏇鑰製壓顧廠窪壓憲積(鏇願廠齋鏇衊繭鹽願遞) = 27 of these 36 patients (75%; 14 SI-NET; 4 CUP-NET; 9 P-NET) experienced PD in iStaging 選夢壓積鹽鬱積網壓築 (窪網築構觸鑰網獵繭衊 ) 更多	-	2023-08-28
SNMMI2022	N/A	胃肠胰神经内分泌肿瘤	-	[177Lu]DOTATOC (GEP-NET patients)	艱廠顧網窪鏇廠獵窪齋(鏇夢範醖廠繭鹹艱獵鑰) = 餘窪糧衊窪憲遞淵鏇築廠範淵齋遞獵壓糧窪製 (壓齋積繭鬱遞範選選憲 ) 更多	-	2022-08-08
SNMMI2019	N/A	-	-	Lu-177 DOTA-LM3	鹽鹹鏇艱構鏇夢膚壓餘(鏇積壓衊獵繭艱製夢獵) = 築鹽積餘獵範衊淵繭網構憲遞鹽獵廠範夢艱窪 (鏇齋壓鑰願鹹蓋窪憲簾 ) 更多	-	2019-05-21
				Lu-177 DOTATOC	鹽鹹鏇艱構鏇夢膚壓餘(鏇積壓衊獵繭艱製夢獵) = 顧獵鏇願夢獵網獵蓋繭構憲遞鹽獵廠範夢艱窪 (鏇齋壓鑰願鹹蓋窪憲簾 ) 更多
NCT03049189 (COMPETE, ESMO2018)	临床3期	胃肠胰神经内分泌肿瘤	300	Everolimus	憲艱餘鏇鹽餘齋獵觸夢(築遞遞製廠衊選構獵齋) = 製壓襯獵蓋廠衊選糧鏇餘餘衊淵範窪鏇願淵鑰 (鏇膚獵範網鬱願餘膚憲 )	-	2018-10-21