Lutetium Dotatate LU-177

2月27日，映恩生物宣布在2026年美国临床肿瘤学会泌尿生殖系统肿瘤研讨会（ASCO GU）上以海报形式公布了与BioNTech合作开发的靶向B7H3的抗体偶联药物（ADC）DB-1311/BNT324在转移性去势抵抗性前列腺癌（mCRPC）患者中的最新临床研究数据。本次报告的数据来自一项全球多中心1/2期临床研究。 截至2025年12月29日，共纳入146例既往接受过多线治疗的mCRPC患者，中位年龄为70岁，中位既往治疗线数为4线。其中，52例患者（超总人群1/3）既往接受过³⁷⁷Lu-PSMA-617放射配体治疗（Lu-177），该亚组人群中位既往治疗线数为5线，87%既往接受过紫杉烷类治疗，40%既往同时接受过多西他赛和卡巴他赛。 疗效方面，DB-1311在经多线治疗的mCRPC患者中展现出令人鼓舞的抗肿瘤活性。129例疗效可评估的患者中，中位影像学无进展生存期（rPFS）为11.3个月，中位总生存期（OS）为22.5个月。亚组分析显示，84例既往未接受过Lu 177的患者中位rPFS为13.6个月；45例既往接受过Lu 177的患者疗效与整体人群相当，中位rPFS同样为11.3个月，中位OS尚未达到。 安全性方面，DB-1311/BNT324延续既往的优异表现，未发生新的安全性信号。最常见的治疗相关不良事件（TRAE）为恶心及血液学相关事件，且主要为1–2级。在110例接受6mg/kg（每3周一次）DB-1311/BNT324治疗的患者中，22例（20.0%）发生3级TRAE，6例（5.5%）发生导致停药的TRAE，未发生导致死亡的TRAE，提示该药物具有可控且可管理的安全性特征。 映恩生物新闻稿表示，该研究代表B7H3 ADC可在既往接受过Lu-177治疗的mCRPC患者中展示出令人鼓舞的持久疗效。DB-1311/BNT324不仅为这类难治人群提供了新的治疗希望，其整体疗效数据也支持在更前线治疗中进一步探索。该公司将加速推进前线mCRPC全球三期临床试验（NCT07365995），以rPFS和OS为双主要终点，以期获得更坚实的临床数据，加快产品上市进程。 参考资料：[1]ASCO GU 2026 | 映恩生物在ASCO GU大会公布B7H3 ADC DB-1311/BNT324在转移性去势抵抗性前列腺癌中的最新临床研究数据.From https://mp.weixin.qq.com/s/Ac0Wrf9LqM7EztHKTy7J0Q 免责声明：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。

Dosimetry data from the Phase 3 ECLIPSE substudy demonstrated favorable organ radiation absorbed doses supporting administration of 7.4 GBq for up to six cycles BOSTON, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Curium, a world leading nuclear medicine company dedicated to using cutting-edge technology and innovative science to personalize diagnoses and treatments for patients with cancer, today announced the first dosimetry and pharmacokinetics (PK) data from a substudy of the ongoing pivotal Phase 3 ECLIPSE clinical trial (NCT05204927). The Phase 3 ECLIPSE clinical trial evaluates lutetium-177 (Lu-177) zadavotide guraxetan (a proprietary formulation of 177Lu-PSMA-I&T), an investigational prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior androgen receptor pathway inhibitor (ARPI). The data will be presented in a poster at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) taking place 26-28 February, 2026, in San Francisco, California. The nonrandomized PK/dosimetry substudy (n=26) was conducted as part of the ECLIPSE trial to evaluate the biodistribution and radiation absorbed dose of Lu-177 zadavotide guraxetan to organs of interest. Sakir Mutevelic, MD, Curium’s Chief Medical Officer said: “These data represent the first published dosimetry data for our investigational formulation of Lu-177 zadavotide guraxetan, with projected mean cumulative renal doses remaining low for a six-cycle treatment regimen, thus supporting a protocol amendment to increase from a maximum of four doses to six in the ECLIPSE trial. We will continue to evaluate the ECLIPSE clinical trial data with the goal of bringing this potential therapy to market for those living with mCRPC. This reinforces our long-term vision to treat 80 percent of cancers within the next 10-15 years.” Frankis Almaguel, MD, PhD, Assistant Professor, Medicine, Hematology/Oncology, Loma Linda University Health Cancer Center, and presenting author said: “These data reinforce the clinical utility of using dosimetry data to inform clinical trial protocol design, as well as identify organs at highest risk of radiation exposure.” A poster, Pharmacokinetics and Dosimetry of Lutetium Lu 177 Zadavotide Guraxetan in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): Results From the ECLIPSE Sub-study (Abstract #174), will be presented on Thursday, 26 February in Poster Session A: Prostate Cancer. The abstract is available here. ASCO GU attendees can learn more about Curium by visiting booth 11 during the symposium. About Curium Curium is a world leading global radiopharmaceutical company with proven expertise in the development, manufacturing and supply of radiopharmaceuticals that transform the way cancer is diagnosed and treated. Headquartered in Boston with offices around the world, Curium’s mission is to find new and better ways to diagnose and treat cancer. With a global footprint that extends to more than 70 countries, a skilled and dedicated team of over 3,000 employees, and four manufacturing sites, Curium is uniquely qualified to meet the significant supply and distribution of established products that underlie success in the radiopharmaceuticals market. Curium’s global leadership is embodied in a diverse and extensive portfolio of over 45 products, that advance patient care for a wide range of cancers. Curium’s pioneering legacy in nuclear medicine is the foundation of the company’s dedication to innovation and portfolio expansion to cancer therapeutics, particularly in neuroendocrine tumors and with a late-stage pipeline exploring opportunities in prostate cancer. To learn more, visit www.curiumpharma.com. Inquiries: Camilla CampbellVP, Head of Global Communicationscommunications@curiumpharma.com