KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn:
* About the safety of MK-1084 and if people tolerate it when taken with other treatments
* How many people have the cancer respond (get smaller or go away) to the treatments

开始日期2026-03-23

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT07060807

/ Recruiting临床3期

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic.
* HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread
* HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2
* Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles
* Metastatic means the cancer has spread to other parts of the body
Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

开始日期2025-07-21

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT05620914

/ Withdrawn临床2期IIT

A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases

The purpose of this study is to determine if the study drug, patritumab deruxtecan (HER3-DXd), can be measured in brain tumor tissue after recieving one dose of patritumab deruxtecan before surgery.

开始日期2025-07-01

申办/合作机构

Duke University

[+1]

100 项与德帕瑞妥单抗相关的临床结果

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100 项与德帕瑞妥单抗相关的转化医学

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100 项与德帕瑞妥单抗相关的专利（医药）

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项与德帕瑞妥单抗相关的文献（医药）

2026-05-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Resistance mechanisms and post-trastuzumab deruxtecan (T-DXd) strategies in HER2+ and HER2-low breast cancer: From biology to clinical practice

Review

作者: Chen, Minna ; Xue, Wenwu ; Wen, Xiaofen ; Li, Xiaozhi ; Zeng, De ; Lin, Danxia ; Song, Junwei ; Wang, Wende ; Zhang, Weichun ; Shen, Jiaxin

Trastuzumab deruxtecan (T-DXd), a HER2-directed antibody-drug conjugate (ADC), has revolutionized the treatment landscape for HER2-positive and HER2-low breast cancer, offering unprecedented improvements in progression-free survival (PFS) and overall survival (OS). However, the emergence of resistance limits its long-term efficacy and highlights the need for rational post-progression strategies. This review summarizes current understanding of resistance mechanisms to T-DXd, including dynamic HER2 expression loss, dysregulation of DNA damage repair, tumor microenvironment remodeling, and immune evasion. Building upon these mechanistic insights, we explore therapeutic strategies following T-DXd resistance, including sequential ADCs with alternative targets or payloads, combinations with HER2-targeted tyrosine kinase inhibitors (TKIs), CDK4/6 or PARP inhibitors, endocrine therapy, and immunotherapy. Novel agents such as ARX788, patritumab deruxtecan, and Dato-DXd demonstrate promise in overcoming resistance through diversified mechanisms. Real-world data further support a "three-step strategy" involving ADC rechallenge after interim non-ADC therapies, offering a practical, mechanism-informed treatment model. This review provides a framework for precision-guided care in patients with advanced breast cancer and supports ongoing efforts to extend the therapeutic window beyond initial T-DXd benefit.

2026-02-01·CANCER TREATMENT REVIEWS

Intracranial activity of antibody-drug conjugates in advanced non-small cell lung cancer: What have we accomplished so far?

Review

作者: Remon, Jordi ; Hendriks, Lizza E L ; Huang, Derek De-Rui ; Cheo, Seng Wee ; Voon, Pei Jye ; Saw, Stephanie P L ; Addeo, Alfredo ; Li, Molly S C ; Menis, Jessica

Antibody-drug conjugates (ADCs) represent a rapidly evolving class of therapeutics in non-small cell lung cancer (NSCLC), offering targeted delivery of cytotoxic payloads to tumor cells while minimizing off-target toxicity. Although ADCs have demonstrated promising results in NSCLC, their efficacy in treating central nervous system (CNS) metastases has been uncertain due to concerns over blood-brain barrier (BBB) penetration and the lack of dedicated CNS-specific evaluations in clinical trials. However, emerging evidence challenges this paradigm. While earlier-generation ADCs such as T-DM1 exhibited limited CNS efficacy, newer ADCs employing optimized linkers and cytotoxins demonstrate more favorable efficacy and toxicity profiles. Selected agents, including trastuzumab deruxtecan, datopotamab deruxtecan and patritumab deruxtecan, have all shown intracranial responses in patients with advanced NSCLC with brain metastases (BM). Proposed mechanisms facilitating CNS activity include BBB disruption by BM, membrane-permeable and highly potent cytotoxic payloads, and bystander effects that enable tumor cell killing beyond the target antigen. Nevertheless, several limitations remain, including variability in trial designs, limited number of patients with untreated CNS disease, and a lack of CNS-specific endpoints. Given the high incidence of BM in NSCLC and their significant impact on patient outcomes, there is an urgent need to better understand the intracranial activity of ADCs and whether they can prevent the development of CNS metastases, especially as some of these ADCS are being tested in the curative-intent setting. This review synthesizes current evidence and highlights ongoing trials, with a focused examination of the evolving role of ADCs in the management of BM.

2025-12-31·OncoImmunology

Patritumab deruxtecan induces immunogenic cell death

Article

作者: Sauvat, Allan ; Liu, Peng ; Cerrato, Giulia ; Zhao, Liwei ; Doffe, Flora ; Forveille, Sabrina ; Pan, Yuhong ; Kepp, Oliver ; Kroemer, Guido ; Leduc, Marion

Antibody-drug conjugates (ADCs) enable targeted delivery of cytotoxic payload to cancer cells. Here, we characterized the mode of action of the ADC patritumab deruxtecan, which is a monoclonal antibody specific for Erb-B2 Receptor Tyrosine Kinase 3 (ERBB3, best known as HER3) coupled to the topoisomerase-I inhibitor DXd. Patritumab deruxtecan decreased viability and induced the relocation of calreticulin fused to green fluorescent protein (CALR-GFP) to the periphery of human osteosarcoma U2OS cells engineered to express HER3 but not in their parental counterparts only expressing the CALR-GFP biosensor. Patritumab deruxtecan as well as its payload DXd induced various traits of immunogenic cell death (ICD) including antibody detectable calreticulin membrane exposure, exodus of high mobility group protein B1 (HMGB1), as well as the release of ATP into cell culture supernatants. Moreover, DXd causes rapid inhibition of DNA-to-RNA transcription, which is a key predictor for ICD. Mouse cancer cells treated with DXd were able to vaccinate syngeneic immunocompetent mice against tumor challenge. Tumor-free mice developed immune memory that led to the rejection of syngeneic tumors after rechallenge. In conclusion, patritumab deruxtecan is equipped with a cytotoxic payload that induces hallmarks of ICD in vitro and elicits antitumor immunity in vivo.

554

项与德帕瑞妥单抗相关的新闻（医药）

2026-02-27

·生物药观察

宜联在中国启动YL202的非小细胞肺癌关键III期临床研究

2026年2月18日，宜联生物靶向HER3的ADC药物 YL202/BNT326 (beruzatatug pelitecan)在clinicaltrail注册了非小细胞肺癌的关键III期临床研究（NCT07416994，YL202-CN-301-01）。该研究预计于 3 月启动，将在中国入组440 例既往接受过至少一种 EGFR-TKI和含铂化疗治疗后进展的EGFR突变非鳞状非小细胞肺癌患者。研究以PFS和OS为双主要终点，与多西他赛进行头对头对比。此前默沙东 / 第一三共的HER3-DXd（Patritumab deruxtecan）已经在二线 EGFR 突变非小细胞肺癌适应症折戟（三代TKI耐药患者），其 Herthena-Lung02 研究未能显示总生存期获益，且出现显著安全性问题，最终撤回了在美国的上市申请。参考文献Herthena-Lung02 2025ASCO.pptx 值得关注的是，此前YL202/BNT326曾因临床试验中观察到多起死亡事件，被FDA Partial Hold（NCT05653752）。不过暂停时间不长，在企业同意将剂量上限控制在3 mg/kg后，Partial Hold得以解除。本次III期临床拟用剂量为2 mg/kg Q3W。截至目前，公司尚未公布专门针对非小细胞肺癌的数据，但宜联生物在2024 年 ASCO上公布的初步数据中包含部分肺癌患者。Ⅰ 期结果显示：在＜3 mg/kg 剂量下，乳腺癌与肺癌患者的总体客观缓解率为 42%。 BioNTech 则更倾向于联合用药策略，正在探索将YL202/BNT326与管线中其他药物（如PD-L1/VEGF双抗药物BNT327）联用研究。一项针对相同人群（EGFR TKI 经治后 NSCLC）的 Ⅰ/Ⅱ 期联合研究预计将于今年晚些时候公布数据（NCT07070232）。除了YL202，恒瑞的同靶点ADC Ruzaltatug rezetecan（SHR-A2009）也已经启动同人群的临床III期研究（SHR-A2009-301）及一线非小细胞肺癌联用研究（联合阿美替尼 SHR-A2009-302）。百利天恒/BMS的HER3/EGFR 双靶点ADC BL-B01D1同样在该人群（三代TKI耐药患者）开展了全球临床III期研究（IZABRIGHT-Lung01），国内的临床III期研究已完成患者招募（BL-B01D1-301）。 PS：BL-B01D1和HER3-DXd都要求三代TKI耐药，YL202和SHR-A2009仅要求TKI耐药，不知道患者人群差异如何，欢迎医学专家留言解惑。关注小编不迷路

临床3期ASCO会议抗体药物偶联物临床结果

2026-02-25

·集思广JSG咨询

225药讯第一三共U31402-277/HER3-DXd治疗局部晚期或转移性实体瘤的II期研究 GSK的1类新药利奈昔巴特片上市申请获得受理

第一三共U31402-277/HER3-DXd治疗局部晚期或转移性实体瘤的II期研究成功在中国完成首例受试者给药 2026年2月25日，U31402-277研究是一项HER3-DXd治疗局部晚期或转移性实体瘤的II 期、多中心、多队列、开放性、概念验证研究。 U31402-277研究的主要疗效终点是经研究者评估的客观缓解率（ORR）。次要终点包括治疗的安全性和耐受性等。荣昌生物的泰它西普间质性肺病的III期临床试验 2026年2月24日，荣昌生物的泰它西普（TACI, Fc融合蛋白）正式启动了一项中国境内针对间质性肺病的III期临床试验（试验编号：CTR20260545）。该试验名称为“泰它西普注射液治疗结缔组织病相关间质性肺疾病患者的III期临床试验”，计划在中国多个地区开展，目标入组患者人数为260人。本临床试验的研究药物为泰它西普。主要终点为第52周时用力肺活量（FVC，单位：mL）较基线的变化值。百济神州启动了一项关于BG-A3004I期临床试验 2026年2月24日，百济神州启动了一项关于BG-A3004（其他用途，尚未获批）的中国境内I期临床试验，旨在评估该药物在皮肤病（斑秃、皮肤扁平苔藓、白癜风等）患者及健康受试者中的安全性、耐受性、药代动力学、免疫原性以及药效学特征。该试验为随机、双盲、安慰剂对照组成的首次人体研究，试验编号为CTR20260646，总目标入组人数为78人。该临床试验的试验药品为BG-A3004。本研究的主要终点为：评估受试者在治疗期间发生的不良事件和严重不良事件的数量（包括实验室检查、生命体征监测及心电图分析）。 Sanofi启动了一项国际多中心的三期临床试验 2026年2月24日，Sanofi启动了一项国际多中心的三期临床试验，研究duvakitug（TL1A单克隆抗体）在中度至重度活动性溃疡性结肠炎患者中的疗效与安全性。该试验的注册号为CTR20260389，属于随机、双盲、安慰剂对照的导入治疗临床研究，计划在全球范围内多中心开展，目标入组患者人数为980人。本次临床试验的研究药物为duvakitug。主要研究终点为第12周时，依据修订版Mayo评分（mMS）达到临床缓解的患者比例。东阳光提交的靶向尼帕病毒（NiV）G蛋白的单克隆抗体新药HEC-648注射液临床试验申请东阳光药获悉，国家药品监督管理局药品审评中心（CDE）正式受理宜昌东阳光长江药业股份有限公司提交的靶向尼帕病毒（NiV）G蛋白的单克隆抗体新药HEC-648注射液临床试验申请（IND）。东阳光药表示，该药物源自中国科学院武汉病毒研究所的科研成果，研究团队以尼帕病毒表面囊膜蛋白G蛋白为靶点，基于噬菌体展示技术进行高效筛选和优化，获得了能够同时强效中和尼帕病毒马来西亚株（NiV-M）、尼帕病毒孟加拉株（NiV-B）及其近亲亨德拉病毒（HeV）的人源单克隆抗体。其作用机制为通过特异性、高亲和力结合病毒G蛋白，阻断病毒与宿主细胞受体的结合，从而抑制病毒的感染。康方生物申报的1类新药曼多奇单抗注射液上市申请获得受理 2026年2月25日，中国国家药监局药品审评中心(CDE)官网公示显示，康方生物申报的1类新药曼多奇单抗注射液上市申请获得受理。公开资料显示，曼多奇单抗(研发代号:AK120)是康方生物自主研发的新型人源化抗IL-4Rα(白介素-4受体a)单克隆抗体。曼多奇(AK120)是一款新型人源化IL-4Ra单克隆抗体IL-4Ra是促炎性细胞因子工-4(白介素-4)、I-13(介素-13)受体的共同亚基，曼多奇通过与IL-4Ra特异性结合以阻断I-4与I-13介导的信号通路，抑制相关免疫炎症反应的发生与发展。圣因生物SGB-9768(C3 siRNA)再获FDA孤儿药资格认定 2026年2月24日，圣因生物宣布其自主研发的在研药物SGB-9768获得美国FDA授予的孤儿药资格，用于治疗免疫复合物介导的膜增生性肾小球肾炎(IC-MPGN)。 SGB9768现已获得针对IC-MPGN和C3G两项适应症的孤儿药资格。赛诺菲和再生元共同宣布度普利尤单抗获得FDA批准新适应症 2026年2月24日，赛诺菲和再生元共同宣布度普利尤单抗获得FDA批准新适应症，用于治疗患有变应性真菌性鼻-鼻窦炎（AFRS）且有鼻窦手术史的6岁及以上儿童和成人患者。该药物是AFRS领域首个针对性治疗药物。 FDA此次批准主要基于III期LIBERTY-AFRS-AIMS研究的积极结果。该研究（n=62）评估了度普利尤单抗（200mg或300mg，每2周1次或每4周1次）对比安慰剂治疗AFRS的有效性和安全性。结果显示，第24周，度普利尤单抗组患者的鼻窦混浊评分较安慰剂组降低5.45分（p<0.0001）；第52周，度普利尤单抗组患者的鼻窦混浊评分改善了50%，而安慰剂组仅改善10%（经安慰剂组校正后，-7.36分，p<0.0001）。 GSK的1类新药利奈昔巴特片上市申请获得受理 2月25 日，CDE官网显示，GSK的1类新药利奈昔巴特片上市申请获得受理。利奈昔巴特(Linerixibat)是一种口服 IBAT 抑制剂，通过抑制胆汁酸再摄取，减少血液循环中的多种瘙痒介质。 PBC 是一种胆汁淤积性肝病，其肝脏胆汁流出受阻。达石药业宣布其与美国新锐生物制药企业Slate Medicines, Inc.（下称“Slate Medicines”）达成独家授权合作 2026年2月25日，达石药业宣布其与美国新锐生物制药企业Slate Medicines, Inc.（下称“Slate Medicines”）达成独家授权合作，将公司自主研发的、潜在同类最佳的、靶向垂体腺苷酸环化酶激活多肽(PACAP)的单克隆抗体DS009（Slate Medicines命名为SLTE-1009）的全球（大中华区除外）临床开发及商业化权利独家许可给对方，用于偏头痛等头痛疾病的预防治疗。 DS009成为我国首个“出海”的原研非阿片类生物镇痛药。君实生物宣布与德琪医药达成战略合作 2026年2月25日，君实生物宣布与德琪医药达成战略合作，双方将共同探索君实生物自主研发的JS207(抗PD-1/VEGF双特异性抗体)与德琪医药的 ATG-037(口服CD73小分子抑制剂) 在中国大陆肿瘤患者中的联合治疗协同潜力。 JS207是君实生物自主研发的重组人源化抗PD-1和VEGF双特异性抗体，在临床前及临床研究中均显示出令人鼓舞的抗肿瘤活性及可控的安全性特征。在2025年欧洲肿瘤内科学会亚洲年会(ESMOAsia)壁报展示中，JS207单药治疗在多种实体瘤中展现出积极疗效，其中接受一线治疗的 62例PD-L1阳性非小细胞肺痘(NSCLC)患者客观缓解率(ORR)达到58.1%，疾病控制率(DCR)达到87.1%。普递瑞(Prodegre)完成天使+轮融资:打造差异化蛋白降解与互作的多机制创新引擎，攻克CNS与炎症难成药靶点致力于CNS与炎症相关疾病开发，构建差异化蛋白降解与互作药物的平台型生物科技公司普递瑞(Prodegre)今日宣布完成数千万元天使+轮融资，由复容投资旗下复旦大学生医药转化基金(以下简称“三复基金”)领投，公司核心团队持续跟投加注。本轮融资将重点用于加速Prodegre ATLASIM平台研发，推动帕金森病关键致病蛋白a-synuclein降解剂的首个剂型IND申报与口服优化工作。普递瑞基于以靶点为中心、多机制驱动的研发战略，自主构建了Prodegre ATLASIM差异化蛋白降解与互作平台。易慕峰生物、维眸生物递交港交所IPO 日前，易慕峰生物和维眸生物根据港交所第18A章寻求上市。易慕峰生物于2020年成立的创新型细胞治疗公司，瞄准全球与中国CAR-T市场。核心产品：IMC002（靶向CLDN18.2），是全球临床进度第二的实体瘤CAR-T疗法，已进入III期临床试验。其他管线：拥有潜在同类首创的IMC001（靶向EpCAM）及新一代体内CAR-T平台（iMAGIC）。财务状况：处于研发投入期，持续亏损，面临高研发成本及临床不确定性等风险。上市目的：根据港交所第18A章（未盈利生物科技公司）寻求上市，募集资金主要用于推进核心产品IMC002的开发及商业化。维眸生物于2016年成立的专注眼科领域的生物科技企业。核心产品：VVN461（高剂量，JAK1/TYK2抑制剂滴眼液），用于治疗非感染性前葡萄膜炎，已进入III期临床；VVN001（LFA-1拮抗剂滴眼液），用于治疗中重度干眼症，已进入III期临床。其他管线：拥有多项针对眼表及眼底疾病的临床阶段候选药。财务状况：处于研发投入期，尚未盈利。上市目的：根据港交所第18A章寻求上市，募集资金主要用于核心产品的全球临床开发及注册。云雷屯，君子以经纶。

2026-02-25

·第一三共中国

Patritumab deruxtecan治疗实体瘤概念性验证2期研究HERTHENA-PanTumor01 (U31402-277)在中国启动

2026年2月25日，U31402-277/HER3-DXd 治疗局部晚期或转移性实体瘤的II 期研究成功在中国完成首例受试者给药！这标志着该研究迈出了重要的第一步。我们期待与各方继续紧密合作，加速HER3-DXd的临床开发进程。研究团队将全力以赴，高质量、高效率地推进HER3-DXd的临床开发，期待早日将这一创新疗法带给中国的晚期实体瘤患者。关于U31402-277临床研究 U31402-277研究是一项HER3-DXd 治疗局部晚期或转移性实体瘤的II 期、多中心、多队列、开放性、概念验证研究。U31402-277研究的主要疗效终点是经研究者评估的客观缓解率（ORR）。次要终点包括治疗的安全性和耐受性等。更多研究相关信息，可登陆https://clinicaltrials.gov及http://www.chinadrugtrials.org.cn网站查询。关于肺癌/乳腺癌/胃癌肺癌是全球最常见癌症和癌症相关死亡的主要原因之一。2022年全球估计有250万例新发肺癌病例（占所有新发癌症病例的12.4%）和180 万例肺癌相关死亡病例（占全球癌症死亡病例的18.7%）。1非小细胞肺癌（NSCLC）占所有肺癌的80%-85%。在Non-AGA的晚期或转移性NSCLC患者中，全身化疗仍是一线治疗的主要选择。ICI 和PBC 治疗期间出现疾病进展的患者可选择的治疗方案有限，且获益较为短暂，NonAGA NSCLC 患者亟需更有效且可耐受的治疗方案。一项已发表的回顾性流行病学研究显示，83%的 NSCLC 患者的肿瘤细胞表达 HER3。2ERBB3/HER3 癌基因在肺癌细胞中过表达，且较高的HER3 表达水平与较差的预后相关3。乳腺癌是全球女性中发病率最高的恶性肿瘤，也是女性癌症相关死亡的首要原因。4HR+/HER2-乳腺癌占所有病例的70%，发病率显著高于其他亚型，5年OS率随分期下降，远处转移患者仅约30%。5 HER3高表达（IHC 2+/3+）见于30%-45%的乳腺癌患者，与较差的生存预后相关。6, 7, 8, 9评价 HER-3 表达水平有助于识别预后较差的患者亚群，在这些患者中进一步评价靶向HER-3 抗肿瘤药物治疗转移性乳腺癌的有效性。胃癌是全球第五大常见癌症。近年来，免疫检查点抑制剂（ICI）联合化疗的引入改善了转移性胃癌患者一线治疗的治疗前景。10纳武利尤单抗联合化疗，帕博利珠单抗联合氟嘧啶类药物和含铂化疗（PBC）可作为一线治疗方案。11, 12含曲妥珠单抗或德曲妥珠单抗方案也可作为HER2阳一线治疗或二线治疗方案。13, 14 关于HER3 HER3是EGFR受体酪氨酸激酶家族的成员之一，与细胞的异常增殖和存活有关。15据估计，大约83%的NSCLC肿瘤表达HER3蛋白，可能与转移发生率增加、生存率下降和对标准治疗的耐药性有关。16, 17, 18 　　关于Patritumab deruxtecan Patritumab deruxtecan (HER3-DXd, U3-1402) 是第一三共肿瘤管线中DXd ADC之一。采用第一三共专有的DXd ADC技术设计，由人源化HER3抗体与拓扑异构酶I抑制剂有效载荷，通过稳定的可裂解四肽连接子组合而成。　　关于第一三共与默沙东合作第一三共与默沙东于2023年10月达成全球合作，共同开发并商业化 Patritumab Deruxtecan (HER3-DXd)、Ifinatamab Deruxtecan (I-DXd)和Raludotatug deruxtecan (R-DXd)，且第一三共拥有日本市场独家权益，第一三共将全权负责生产和供应。2024年08月，合作协议扩展到MK-6070，双方将共同在全球范围内开发和商业化该药物，且默沙东拥有日本市场独家权益。默沙东将全权负责MK-6070的生产和供应。　　　关于第一三共第一三共是一家为社会可持续发展做贡献的创新型全球医疗保健公司，致力于发现、开发和提供新的标准疗法，以提高世界各地患者的生活质量。第一三共专注制药行业120余年，凭借其世界一流的科学和技术，为癌症、心血管疾病和其他医疗需求远未得到满足的疾病患者研发新的治疗方法和创新药物。如欲了解更多信息，请访问www.daiichisankyo.com。参考文献： 1.Filho AM, Laversanne M, Ferlay J, Colombet M, Piñeros M, Znaor A, Parkin DM, Soerjomataram I, Bray F. The GLOBOCAN 2022 cancer estimates: Data sources, methods, and a snapshot of the cancer burden worldwide. Int J Cancer. 2025 Feb 3;156(7):1336-1346. 2.Scharpenseel H, Hanssen A, Loges S, et al. EGFR and HER3 expression in circulating tumor cells and tumor tissue from non-small cell lung cancer patients. Sci Rep. 2019;9(1):7406. 3.Ocana A, Vera-Badillo F, Seruga B, et al. HER3 overexpression and survival in solid tumors: a meta-analysis. J Natl Cancer Inst. 2013; 105(4):266-73. 4.Arnold M, Morgan E, Rumgay H, et al. Current and future burden of breast cancer: Global statistics for 2020 and 2040[J]. The Breast, 2022, 66: 15-23. 5.Female Breast Cancer Subtypes - Cancer Stat Facts [Internet]. SEER. [cited 2025 May 14]. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html 6.Ocana A, Vera-Badillo F, Seruga B, et al. HER3 overexpression and survival in solid tumors: a meta-analysis. J Natl Cancer Inst. 2013; 105(4):266-73. 7.Chiu CG, Masoudi H, Leung S, Voduc DK, Gilks B, Huntsman DG, Wiseman SM. HER-3 overexpression is prognostic of reduced breast cancer survival: a study of 4046 patients. Ann Surg. 2010 Jun;251(6):1107-16 8.Fuchs IB, Siemer I, Bühler H, Schmider A, Henrich W, Lichtenegger W, Schaller G, Kuemmel S. Epidermal growth factor receptor changes during breast cancer metastasis. Anticancer Res. 2006 Nov;26(6B):4397-4401 9.Witton CJ, Reeves JR, Going JJ, Cooke TG, Bartlett JM. Expression of the HER1-4 family of receptor tyrosine kinases in breast cancer. J Pathol. 2003 Jul;200(3):290-7 10.Janjigian YY, Shitara K, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021; 398(10294):27-40. 11.Janjigian YY, Shitara K, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021; 398(10294):27-40. 12.Ryu MH, et al. 178P KEYNOTE-859 update: Pembrolizumab + chemotherapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer. Ann Oncol. 2024 Dec;35(Suppl 6):S1473-S1474. 13.Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010; 376(9742):687-97. 14.Shitara K, Bang YJ, Iwasa S, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020; 382(25):2419-30. 15.Mishra R, Patel H, Alanazi S, et al. HER3 signaling and targeted therapy in cancer[J]. Oncology reviews, 2018, 12(1): 355. 16.Zhang Y L, Yuan J Q, Wang K F, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis[J]. Oncotarget, 2016, 7(48): 78985. 17.Müller-Tidow C, Diederichs S, Bulk E, et al. Identification of metastasis-associated receptor tyrosine kinases in non–small cell lung cancer[J]. Cancer research, 2005, 65(5): 1778-1782. 18.Scharpenseel H, Hanssen A, Loges S, et al. EGFR and HER3 expression in circulating tumor cells and tumor tissue from non-small cell lung cancer patients[J]. Scientific reports, 2019, 9(1): 7406. 声明: 1.本材料不用于任何推广目的，相关信息亦不应作为治疗或使用建议。如有相关问题请咨询医疗卫生专业人士。 2.本文涉及未在中国获批的产品或适应症，第一三共不推荐任何未获批药品/适应症的使用。

100 项与德帕瑞妥单抗相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
EGFR突变的非小细胞肺癌	申请上市	美国	Merck & Co., Inc.	2023-12-22
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2023-12-22
HR阳性乳腺癌	临床3期	美国	Merck Sharp & Dohme LLC	2025-10-17
HR阳性乳腺癌	临床3期	中国	Merck Sharp & Dohme LLC	2025-10-17
HR阳性乳腺癌	临床3期	日本	Merck Sharp & Dohme LLC	2025-10-17
HR阳性乳腺癌	临床3期	阿根廷	Merck Sharp & Dohme LLC	2025-10-17
HR阳性乳腺癌	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2025-10-17
HR阳性乳腺癌	临床3期	巴西	Merck Sharp & Dohme LLC	2025-10-17
HR阳性乳腺癌	临床3期	加拿大	Merck Sharp & Dohme LLC	2025-10-17
HR阳性乳腺癌	临床3期	智利	Merck Sharp & Dohme LLC	2025-10-17

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临床结果

适应症

分期

评价

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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


NCT06686394 (HERTHENA-Breast01, ESMO_ASIA2025)	临床1/2期	晚期 HER2 阳性乳腺癌 HER2+ \| HER3-expressing	81	HER3-DXd + trastuzumab	壓觸遞廠夢齋鬱構壓願(製繭鑰壓範鬱夢糧鏇鹹) = The geometric mean ratios (GMRs) for Ctrough were within 71.9–104.5% for HER3-DXd ADC, 71.4–106.4% for total HER3-DXd antidrug antibody, and 79.0–90.3% for free DXd payload across all comparisons. The 90% CIs for AUC24s were 83.0–109.2% for HER3-DXd ADC, 80.6–110.8% for total HER3-DXd antidrug antibody, and 84.4–106.0% for free DXd payload. 壓蓋願構積膚淵鬱憲鬱 (範膚淵憲鹹願顧範繭鏇 )	积极	2025-12-05
NCT06686394 (HERTHENA-Breast01, ESMO_ASIA2025)	临床1/2期	晚期 HER2 阳性乳腺癌 HER2+ \| HER3-expressing	81	HER3-DXd + trastuzumab + pertuzumab		积极	2025-12-05
NCT05865990 (TUXEDO-3, Pubmed \| Lancet Oncol)	临床2期	脑转移瘤	21	Patritumab deruxtecan (HER3-DXd) 5·6 mg/kg	遞壓繭夢顧顧顧膚憲淵(築齋壓繭顧選膚夢廠齋) = 築網夢鏇襯顧糧醖鬱窪夢餘餘衊壓憲鬱醖廠蓋 (範繭蓋膚壓鏇鏇繭廠簾 ) 更多	积极	2025-11-01
NCT05865990 (TUXEDO-3, Pubmed \| Lancet Oncol)	临床2期	非小细胞肺癌	20	Patritumab deruxtecan (HER3-DXd) 5·6 mg/kg	齋鹽範糧壓廠淵鑰廠鹽(網襯積觸鑰顧齋憲衊顧) = neutropenia in three (15%) patients and febrile neutropenia in two (10%). 膚衊顧觸齋獵憲夢獵繭 (顧鹽網遞遞積獵憲簾淵 ) 更多	积极	2025-11-01
NCT06172478 (HERTHENA-PanTumor01, Pubmed \| Future Oncol)	临床2期	晚期恶性实体瘤	100	Patritumab deruxtecan (HER3-DXd)	遞繭窪選糧襯鏇壓構繭(鬱蓋醖遞憲顧窪鏇範選) = 窪願選廠遞艱憲餘遞遞觸壓糧壓獵鏇鏇艱膚繭 (憲顧蓋醖襯餘齋淵遞夢 ) 更多	积极	2025-10-21
NCT04965766 (ICARUS-BREAST01, Pubmed \| Nat Med)	临床2期	晚期乳腺癌 HR+ \| HER2-	99	Patritumab deruxtecan	範淵淵網鑰鏇衊醖餘齋(製遞遞構選壓鬱獵膚蓋) = 顧網淵壓廠鏇網網選構鹹製遞構鬱範顧淵鏇齋 (鏇膚膚鑰願遞願鏇蓋艱, 44.8 ~ 62.1)	积极	2025-10-01
NCT03260491 (Pubmed \| J Clin Oncol) 人工标引	临床1期	非小细胞肺癌	47	HER3-DXd	廠襯壓襯觸觸鑰餘鑰鏇(繭獵網築築窪積廠廠選) = 構廠衊廠夢願觸憲餘膚鹽鑰醖鑰繭窪蓋膚鑰蓋 (鏇膚繭艱艱製範窪築鹹, 15.6 ~ 42.6) 更多	积极	2025-06-24
NCT05338970 (HERTHENA-Lung02, ASCO2025) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Exon 19 Deletion \| EGFR L858R	586	Patritumab deruxtecan (HER3-DXd)	網鏇鹹壓鏇艱構夢顧範(繭範選積構淵鹹餘網願) = 艱餘壓夢鑰鏇夢廠膚願憲範範淵淵築糧遞鬱獵 (鏇齋顧醖繭艱觸夢鏇糧, 5.5 ~ 6.8) 更多	积极	2025-05-30
NCT05338970 (HERTHENA-Lung02, ASCO2025) 人工标引	临床3期	EGFR突变的非小细胞肺癌 EGFR Exon 19 Deletion \| EGFR L858R	586	Platinum-based chemotherapy (PBC)	網鏇鹹壓鏇艱構夢顧範(繭範選積構淵鹹餘網願) = 蓋窪築糧鬱衊夢廠顧願憲範範淵淵築糧遞鬱獵 (鏇齋顧醖繭艱觸夢鏇糧, 5.0 ~ 5.6) 更多	积极	2025-05-30
NCT05865990 (TUXEDO-3, ASCO2025)	临床2期	晚期恶性实体瘤 \| 转移性乳腺癌 \| 晚期鳞状非小细胞肺癌 ... HER3 更多	61	HER3-DXd 5.6 mg/kg	淵糧壓鹹觸選鑰鑰壓遞(鑰膚繭餘簾積夢壓窪膚) = 夢獵繭網鬱醖衊築廠糧壓廠獵獵糧鹹鬱範範願 (網鹽願鏇鏇網網壓選膚 )	积极	2025-05-30
NCT04479436 (CTgov)	临床2期	转移性结直肠癌	40	Patritumab Deruxtecan (Cohort 1: HER3 High (IHC 3+, 2+))	醖襯鬱遞夢艱顧膚壓醖 = 廠糧襯選簾製襯構鹽製襯鏇憲夢網餘築遞築齋 (積夢顧齋鬱窪選選範醖, 鑰鬱願鏇襯廠淵鏇夢鹹 ~ 鑰衊鑰餘鹽繭艱鏇艱艱) 更多	-	2025-05-18
NCT04479436 (CTgov)	临床2期	转移性结直肠癌	40	Patritumab Deruxtecan (Cohort 2: HER3 Low/Negative (IHC 1+, 0))	醖襯鬱遞夢艱顧膚壓醖 = 鏇艱膚網夢積築衊鹹淵襯鏇憲夢網餘築遞築齋 (積夢顧齋鬱窪選選範醖, 鹹餘簾構憲壓網網襯淵 ~ 選遞淵積築憲願鹹夢選) 更多	-	2025-05-18
NCT05569811 (SOLTI VALENTINE, ESMO_BC2025)	临床2期	HR阳性/HER2阴性乳腺癌新辅助 HER3	122	HER3-DXd	餘壓鬱憲製鏇壓窪夢膚(艱蓋衊膚糧獵顧餘蓋築) = 鹽齋窪簾壓築網夢獵醖醖鏇鬱醖鏇鬱簾鏇製構 (鹹鬱醖壓構觸獵窪艱鬱 )	积极	2025-05-14
NCT05569811 (SOLTI VALENTINE, ESMO_BC2025)	临床2期	HR阳性/HER2阴性乳腺癌新辅助 HER3	122	HER3-DXd + letrozole	餘壓鬱憲製鏇壓窪夢膚(艱蓋衊膚糧獵顧餘蓋築) = 鏇遞醖艱壓選鹹鹹鬱淵醖鏇鬱醖鏇鬱簾鏇製構 (鹹鬱醖壓構觸獵窪艱鬱 )	积极	2025-05-14