A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F

The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.

开始日期2026-03-11

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT07227597

/ Recruiting临床1/2期

A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer

Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body.
A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy.
* Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing.
* Immunotherapy is a treatment that helps the immune system fight cancer.
Gocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate.
* T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells.
* A T-cell is a type of white blood cell, which are cells that help the body fight infection.
* An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The goals of this study are to learn:
* About the safety of combining gocatamig and I-DXd and if people tolerate them together
* If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away

开始日期2026-01-29

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

CTR20252497

/ Recruiting临床3期

一项在转移性去势抵抗性前列腺癌（mCRPC）受试者中比较Ifinatamab Deruxtecan与多西他赛的III期、开放标签研究（IDeate-Prostate01）

在前线转移性去势抵抗性前列腺癌（mCRPC）受试者中比较Ifinatamab Deruxtecan与多西他赛的有效性和安全性

开始日期2025-08-21

申办/合作机构

默沙东研发（中国）有限公司

[+2]

100 项与 Ifinatamab deruxtecan 相关的临床结果

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100 项与 Ifinatamab deruxtecan 相关的转化医学

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100 项与 Ifinatamab deruxtecan 相关的专利（医药）

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项与 Ifinatamab deruxtecan 相关的文献（医药）

2026-12-31·mAbs

Antibodies to watch in 2026

Review

作者: Pinto, Kieran ; Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Chenoweth, Alicia ; Hsu, Yu-Shin

The Antibodies to Watch article series provides annual updates on commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. Since the first article was published in 2010, the late-stage pipeline has grown from 26 antibody therapeutics to over 200, while during the same time numerous molecules in late-stage studies either transitioned to regulatory review and were approved or were terminated. In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab. As antibody therapeutics development is a global enterprise, we also discuss trends in annual first approvals granted to antibody therapeutics in any country since 2010, stratified by the antibody's country of origin, documenting the notable increases in the total number of first approvals and those approved first in China. Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by their therapeutic area, mechanism of action, format, and country of origin. Our data show that the development and approval period were typically ~6 years, but on average this period was shorter for China-originated products.

2026-02-01·JOURNAL OF CLINICAL ONCOLOGY

Ifinatamab Deruxtecan in Patients With Extensive-Stage Small Cell Lung Cancer: Primary Analysis of the Phase II IDeate-Lung01 Trial

Article

作者: Tang, Mei ; Singh, Jasmeet ; Johnson, Melissa L. ; Hann, Christine L. ; Qian, Meng ; Paz-Ares, Luis ; Rocha, Pedro ; Nishio, Makoto ; Ahn, Myung-Ju ; Sakai, Tetsuya ; Girard, Nicolas ; Hayashi, Hidetoshi ; Kim, Yu Jung ; Rudin, Charles M. ; Godard, Juliette ; Hu, Haichuan

PURPOSE:

Treatment options for patients with recurrent or progressive extensive-stage small cell lung cancer (ES-SCLC) are limited. This phase II trial evaluated the efficacy and safety of ifinatamab deruxtecan (I-DXd), a B7 homolog 3–directed antibody-drug conjugate, in patients with previously treated ES-SCLC.

METHODS:

Patients were randomly assigned to receive I-DXd 8 or 12 mg/kg intravenously once every 3 weeks in part 1 (dose optimization) and received I-DXd 12 mg/kg in part 2 (extension). The primary end point was objective response rate (ORR) by blinded independent central review per RECIST, version 1.1.

RESULTS:

Overall, 183 patients received I-DXd: 88 in part 1 (8 mg/kg, n = 46; 12 mg/kg, n = 42) and 95 in part 2. The median number of previous lines of treatment was two. In the total 12-mg/kg group from parts 1 and 2 (n = 137), the confirmed ORR was 48.2% (95% CI, 39.6 to 56.9), median duration of response was 5.3 (95% CI, 4.0 to 6.5) months, median time to response was 1.4 (range, 1.0-8.1) months, median progression-free survival was 4.9 (95% CI, 4.2 to 5.5) months, and the 9-month overall survival estimate was 59.1%. Any-grade treatment-related adverse events (TRAEs) occurred in 89.8% of patients (grade ≥3, 36.5%). The most common TRAEs were nausea (43.1%), anemia (34.3%), and neutropenia (34.3%). TRAEs associated with treatment discontinuation and death were reported in 9.5% and 4.4% of patients, respectively. Treatment-related interstitial lung disease (ILD) as determined by the ILD adjudication committee was reported in 12.4% of patients (grade ≥3, 4.4%).

CONCLUSION:

I-DXd 12 mg/kg once every 3 weeks showed promising efficacy in patients with previously treated ES-SCLC. The observed safety profile was consistent with previous reports, with no new safety signals identified.

2025-11-01·BIOCHIMICA ET BIOPHYSICA ACTA-REVIEWS ON CANCER

The evolving landscape of antibody-drug conjugates in small cell lung cancer: From research progress to clinical application

Review

作者: Zhang, Chenyue ; Wang, Haoyu ; Wang, Haiyong

Antibody-drug conjugates (ADCs), one of the emerging developing classes of antitumor drugs, have transformed the therapeutic paradigm in oncology. It stands out due to its properties of boasting the strength of both chemotherapy and targeted therapy. In small cell lung cancer (SCLC), ADC has also demonstrated its potential and appealing effect. Clinical trials of ADCs in SCLC are currently in full swing. While ADC has brought some encouraging results so far, several obstacles have been encountered, such as drug resistance, drug toxicities and the difficulty in the selection of patients benefiting from ADCs. Thus, a deepened and comprehensive understanding of the fundamental researches, as well as summarization of ADC development in SCLC might offer us some enlightenment and solutions to these tricky issues. Therefore, in the present review, we elaborate on the structure and mechanism of ADC, clinical trials conducted in SCLC. Additionally, we also outline the obstacles and propose future directions of ADC in SCLC, highlighting its in-depth research and prospective application in SCLC.

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项与 Ifinatamab deruxtecan 相关的新闻（医药）

2026-02-25

·医脉通肿瘤科

破局前行：中国新型ADC开启乳腺癌精准治疗新篇章

引言 2026年2月11日，乳腺癌抗体偶联药物（ADC）专题研讨下半场会议在内蒙古医科大学附属医院白俊文教授的主持下拉开帷幕。此次会议由北京大学肿瘤医院邵彬教授与中国医科大学附属第一医院陈波教授共同担任主席，汇聚北京、辽宁、内蒙古等多地肿瘤领域资深专家，围绕ADC类药物的前沿进展及HER2靶向新型ADC药物的临床应用展开深入研讨。邵彬教授在开场致辞中指出，本次会议以ADC药物研究进展与临床应用为核心议题，旨在通过专题报告与专家对话，推动学术成果向临床实践的有效转化。陈波教授在致辞中强调，ADC药物已成为肿瘤诊疗领域的热点方向，尤其在乳腺癌治疗中，覆盖HER2高表达、低表达及多种分子分型，应用场景从晚期拓展至早期干预，为临床带来更多选择的同时，也引发新的决策思考。他高度肯定本次会议内容的系统性与前瞻性，认为在年末节点举办此类学术交流意义重大。本次会议为岁末年初肿瘤领域为数不多的跨区域学术交流平台，内容紧凑、议题聚焦，为ADC药物规范化应用与个体化决策注入新的思路与动力。中国医科大学附属第一医院石晶教授以《破局前行——中国新型ADC开启乳腺癌探索之路》为题，围绕瑞康曲妥珠单抗（1811）的药物设计、临床数据与定位策略展开深度剖析，直击ADC药物研发同质化背景下的临床决策痛点。随后，中国人民解放军总医院李瑛教授、大会主席陈波教授与邵彬教授就国产ADC的差异化优势、耐药机制与临床排兵布阵展开热烈讨论，将会议推向新的高度。一、同质化时代的冷思考：从“百花齐放”到“择一而行” “当下ADC药物的研发看似百花齐放，实则真正的差异化品类并不多。”石晶教授开宗明义，直指HER2靶向ADC领域的核心困境。靶点与载荷的高度同质化——1811、8201、A166等多款ADC均以曲妥珠单抗为抗体骨架，搭载拓扑异构酶Ⅰ抑制剂为载荷，连接子均为可裂解设计。这种结构上的高度相似性，注定其临床定位将面临激烈竞争，且交叉耐药几乎不可避免。石晶教授进一步提出关键推论：ADC药物的耐药机制，大概率以“载荷耐药”为主，而非“靶点耐药”。这一判断基于阿斯利康旗下8201与DS-7300的有限研究数据——两款药物载荷完全相同，若8201耐药后DS-7300疗效不佳，则载荷耐药假说得证。她预测，待DS-7300上市后，临床实践将很快给出明确答案。 “同质化注定了这类药物未来大概率只能择一使用。”这一论断，为临床排兵布阵提供了底层逻辑支撑。二、1811与8201：高度相似下的差异化破局石晶教授系统对比了1811与8201的药物结构与临床数据，得出两个核心观点：结构高度相似，各有设计巧思。两款药物抗体均为曲妥珠单抗，连接子均为基于半胱氨酸残基的可裂解连接子，载荷均为拓扑异构酶抑制剂。唯一差异在于DAR值：8201为7.4–7.6，1811为6。但1811通过旁观者效应优化、载荷体内稳定性提升，有效弥补了DAR值的理论劣势。临床数据高度趋同，疗效并驾齐驱。 I期研究：1811在HER2低表达患者中的无进展生存期（PFS）达11个月，在HER2阳性患者中的PFS约22个月，两者相差一倍——这一特征与8201的DB01研究如出一辙。 III期研究：1811头对头对比TKI联合卡培他滨，中位PFS达30.6个月（研究者评估33个月），风险比（HR）=0.21，客观缓解率（ORR）为81%。这一数据与8201的DB03研究高度相似。入组患者中帕妥珠单抗经治比例超70%，内脏转移占比76%，真实反映当前HER2阳性晚期乳腺癌二线治疗的临床画像。 “从疗效数据看，1811与8201的表现极其相似，未来临床中大概率只能择一使用。”石晶教授的观点清晰而坚定。三、国产ADC的临床价值锚点：脑转移与安全性李瑛教授进一步阐释了1811的差异化优势，为临床选择提供具体场景指引。结构创新带来理论优势。 1811的载荷相较于DS-7300多一个环丙基结构，半数抑制浓度（IC50）更低，肿瘤杀伤作用更强；同时亲脂性与膜通透性更优，理论上对脑转移病灶更具穿透潜力。脑转移数据令人惊艳。尽管HB01研究中脑转移患者入组比例偏低（<5%），但在RAIN研究中，1811针对活动性脑转移患者的颅内ORR达84%，远高于8201系列研究60%左右的水平。这一差异若经后续研究证实，将成为1811的重要临床定位锚点。安全性更可控。 8201的间质性肺病（发生率15.43%，存在致死风险）与显著消化道反应，是临床使用的核心顾虑。1811的3级以上血液学毒性虽发生率较高（>70%），但临床处理方案成熟，医生驾驭经验丰富；间质性肺病发生率仅约3%，远低于8201。李瑛教授指出：“对于既往有肺间质病变病史或高风险患者，1811的安全优势尤为突出。” 四、临床排兵布阵：从“疗效优先”到“全程管理” 陈波教授总结两点核心思考：耐药机制决定序贯策略。若耐药以载荷耐药为主导，则前序ADC药物耐药后，更换不同载荷的ADC或非ADC方案才是合理路径；同一载荷的ADC序贯使用，大概率无法打破耐药困局。这一认知将深刻影响未来ADC药物的研发方向与临床布局。毒副作用影响治疗完成度。 8201纳入医保后临床可及性大幅提升，但部分患者因毒副作用无法完成全疗程治疗，甚至有患者反馈“不适感比T-DM1更明显”。在疗效相近的前提下，选择毒副作用更可控的药物，保障患者完成规范疗程，是实现最终生存获益的关键。邵彬教授在总结中强调：“将疗效更优、不良反应更小的药物前移，让患者能够耐受、能够坚持，才是临床决策的核心逻辑。” 结语本次乳腺癌ADC药物专题研讨，从机制辨析到数据对照，从临床定位到全程管理，完成了一次对中国新型ADC药物价值的深度审视。1811与8201的高度相似性，既是挑战，也是契机——在疗效并驾齐驱的背景下，脑转移疗效优势、安全性可控性、医保可及性将成为临床选择的现实支点。正如石晶教授所言：“评判ADC药物的临床价值，不能仅看结构，最终要以临床数据为核心依据。”中国新型ADC已凭借扎实的研究证据与独特的差异化优势，在乳腺癌治疗版图中站稳一席之地。未来，随着更多头对头研究与真实世界证据的积累，这场关于“择一而行”的临床决策，将拥有更坚实的循证依托。审核：Squid 排版：Chipsy 执行：Squid 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

抗体药物偶联物

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。

2026-02-19

·BioSpace

ENHERTU® Type II Variation Application Validated in the EU as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer

Based on DESTINY-Breast05 phase 3 trial results, which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1 If approved, Daiichi Sankyo and AstraZeneca’s ENHERTU has the potential to become a new standard of care in this early breast cancer setting TOKYO & MUNICH--(BUSINESS WIRE)--The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU ® (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The application is based on data from the DESTINY-Breast05 phase 3 trial presented at the 2025 European Society for Medical Oncology (#ESMO25) Congress and subsequently published in The New England Journal of Medicine . In the trial, ENHERTU demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) versus trastuzumab emtansine (T-DM1) in patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy. “Patients who have residual invasive disease despite neoadjuvant therapy face a heightened risk of recurrence and are in need of better options following neoadjuvant treatment and surgery,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “This validation in the EU is an important step toward bringing ENHERTU to eligible patients earlier in the treatment journey to help reduce the risk of disease recurrence and progression to metastatic disease.” Additional regulatory submissions for ENHERTU also are underway in the EU, including in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer based on data from DESTINY-Breast09 and for previously treated HER2 positive unresectable or metastatic solid tumors based on data from DESTINY-PanTumor02 , DESTINY-CRC02 and DESTINY-Lung01 . About DESTINY-Breast05 DESTINY-Breast05 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus T-DM1 in patients with HER2 positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy. The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomization until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed disease-free survival. Other secondary endpoints include overall survival, distant recurrence-free interval, brain metastases-free interval and safety. DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov . About Post Neoadjuvant Treatment for HER2 Positive Early Breast Cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally. 1 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually, with more than 144,000 deaths. 1 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer. 2 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer. 2 Approximately one in five cases of breast cancer is considered HER2 positive. 3 For patients with HER2 positive early breast cancer, achieving pathologic complete response (pCR) with neoadjuvant treatment is the earliest indicator of improved long-term survival. 4 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence. 5,6,7,8,9 Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death and current treatment options have shown limited impact on central nervous system recurrence. 10 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%. 11 Post-neoadjuvant therapy represents a key opportunity to minimize the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients. 12,13 About ENHERTU ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial. ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 , DESTINY-Gastric02 and/or DESTINY-Gastric04 trials. ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02 , DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the ENHERTU Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY ® in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU and DATROWAY, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit . ________________________________ References 1 World Health Organization. Breast Fact Sheet . Accessed February 2026. 2 Cheng X, et al. Genes . 2024;15(7):903. 3 Tarantino P, et al. Ann Oncol . 2023;34(8):645-659. 4 Spring LM, et al. Clin Cancer Res . 2020;26(12):2838-2848. 5 Schneeweiss A, et al. Ann Oncol . 2013;24(9):2278-2284. 6 Swain SM, et al. Ann Oncol . 2018;29(3):646-653. 7 Huober J, et al. J Clin Oncol . 2022;40(25):2946-2956. 8 Masuda N, et al. Breast Cancer Res Treat . 2020;180(1):135-146. 9 Gao HF, et al. Presented at ASCO Annual Meeting 2025. 10 Geyer CE, et al. N Engl J Med . 2025;392(3):249-257. 11 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer. Accessed February 2026. 12 von Minckwitz G, et al. N Engl J Med . 2019;380(7):617-628. 13 Zaborowski AM and Wong SM. BJS . 2023;110(7):765-772. Contacts Media Contacts: Global: Jennifer Brennan Daiichi Sankyo, Inc. jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) EU: Simone Jendsch-Dowé Daiichi Sankyo Europe GmbH simone.jendsch-dowe@daiichisankyo.com +49 (89) 78080 (office) Japan: Daiichi Sankyo Co., Ltd. DS-PR_jp@daiichisankyo.com Investor Relations Contact: DaiichiSankyoIR_jp@daiichisankyo.com

临床3期临床结果引进/卖出上市批准抗体药物偶联物

100 项与 Ifinatamab deruxtecan 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
转移性前列腺腺癌	临床3期	美国	Merck Sharp & Dohme LLC	2025-06-23
转移性前列腺腺癌	临床3期	中国	Merck Sharp & Dohme LLC	2025-06-23
转移性前列腺腺癌	临床3期	日本	Merck Sharp & Dohme LLC	2025-06-23
转移性前列腺腺癌	临床3期	阿根廷	Merck Sharp & Dohme LLC	2025-06-23
转移性前列腺腺癌	临床3期	澳大利亚	Merck Sharp & Dohme LLC	2025-06-23
转移性前列腺腺癌	临床3期	奥地利	Merck Sharp & Dohme LLC	2025-06-23
转移性前列腺腺癌	临床3期	巴西	Merck Sharp & Dohme LLC	2025-06-23
转移性前列腺腺癌	临床3期	智利	Merck Sharp & Dohme LLC	2025-06-23
转移性前列腺腺癌	临床3期	哥伦比亚	Merck Sharp & Dohme LLC	2025-06-23
转移性前列腺腺癌	临床3期	捷克	Merck Sharp & Dohme LLC	2025-06-23

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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


NCT06644781 (IDeate-Esophageal01, ESMO_ASIA2025)	临床3期	转移性食管鳞状细胞癌二线 B7 homolog 3 (B7-H3)	474	Ifinatamab deruxtecan (I-DXd) 12 mg/kg	餘構遞窪鏇齋衊製構積(膚簾選鬱繭願廠顧鹹淵) = 膚醖鹹構襯築鹹鹽鹽襯鑰鏇壓憲艱鹹衊夢簾壓 (襯鹽鹹壓鬱網積壓窪網 ) 更多	积极	2025-12-05
				Investigator’s choice of chemotherapy (paclitaxel, docetaxel, or irinotecan)	餘構遞窪鏇齋衊製構積(膚簾選鬱繭願廠顧鹹淵) = 鹹觸鹽鹽築遞鏇遞網壓鑰鏇壓憲艱鹹衊夢簾壓 (襯鹽鹹壓鬱網積壓窪網 )
NCT05280470 (IDeate-Lung01, ESMO2025) 人工标引	临床2期	广泛期小细胞肺癌	137	I-DXd 12 mg/kg (with BL BM)	艱構鏇憲網窪淵構醖醖(築蓋鏇蓋鹽齋齋範鏇夢) = 網膚簾衊齋醖範範艱餘餘築糧遞餘遞簾膚膚餘 (繭鑰獵獵鑰鹹範顧遞鏇, 33.7 ~ 59.0) 更多	积极	2025-10-18
				I-DXd 12 mg/kg (No prior brain RT for BL BM)	艱構鏇憲網窪淵構醖醖(築蓋鏇蓋鹽齋齋範鏇夢) = 製鬱構鑰餘獵鏇遞夢齋餘築糧遞餘遞簾膚膚餘 (繭鑰獵獵鑰鹹範顧遞鏇, 37 ~ 77) 更多
NCT06780085 (KEYMAKER-U01, ESMO2025)	临床2期	转移性非小细胞肺癌	240	R-DXd 5.6 mg/kg Q3W	獵構繭醖獵範餘醖鑰蓋(顧獵獵夢憲選製築製選) = 觸遞蓋鹹積窪餘願鬱選夢選淵窪夢壓鏇鬱選艱 (鹹繭夢廠糧鹽獵構觸鏇 )	积极	2025-10-17
				I-DXd 12 mg/kg Q3W	獵構繭醖獵範餘醖鑰蓋(積鏇淵壓網廠膚構選築) = 鏇鹹遞構鏇壓製鑰鏇構製積網繭積遞構醖製鹽 (積顧顧繭鏇觸鏇糧鬱壓 ) 更多
NCT05280470 (IDeate-Lung01, WCLC2025)	临床2期	广泛期小细胞肺癌二线 \| 三线 \| 末线 B7-H3	137	Ifinatamab Deruxtecan (I-DXd) 12 mg/kg (second-line (23.4%) + third-line (54.7%) + fourth-line (21.9%))	繭繭鬱製艱齋構憲衊壓(顧壓簾壓廠窪願鬱襯鑰) = 淵襯築繭齋鑰構顧夢簾淵積範窪網積鏇選衊艱 (艱鏇積顧選鏇壓衊鬱鬱, 39.6 ~ 56.9) 更多	积极	2025-09-09
NCT05280470 (IDeate-Lung01, WCLC2025 \| NEWS) 人工标引	临床2期	广泛期小细胞肺癌二线 \| 末线 \| 三线	137	Ifinatamab deruxtecan (I-DXd) 12 mg/kg every 3 weeks	窪壓鏇積築醖餘願觸顧(餘觸壓淵醖艱膚衊憲糧) = 構願鹹繭醖築糧製願夢網獵夢蓋夢鑰襯觸廠製 (鏇夢襯衊艱醖衊願壓鬱, 39.6 ~ 56.9) 更多	积极	2025-09-07
				Ifinatamab deruxtecan (I-DXd) 12 mg/kg every 3 weeks (2nd-line)	窪壓鏇積築醖餘願觸顧(餘觸壓淵醖艱膚衊憲糧) = 鹽糧顧構鏇製範繭窪構網獵夢蓋夢鑰襯觸廠製 (鏇夢襯衊艱醖衊願壓鬱, 37.7 ~ 73.6) 更多
NCT05280470 (ESMO2024)	临床2期	广泛期小细胞肺癌	-	Ifinatamab deruxtecan 8 mg/kg	夢鹹願鏇鬱觸網獵憲獵(鏇鬱築壓壓蓋壓餘壓願) = 35% had Grade ≥3 TEAEs (47% in pts without BL BM) 繭鑰鑰艱築範膚齋窪鹽 (艱製壓廠憲窪蓋獵廠範 ) 更多	-	2024-09-14
				Ifinatamab deruxtecan 12 mg/kg
NCT06362252 (IDeate-Lung03, ESMO2024)	临床1/2期	广泛期小细胞肺癌一线 \| 维持 B7 homolog 3 (B7-H3)	149	I-DXd 12 mg/kg + atezo maintenance	範鹹築網窪繭遞顧鏇觸(鬱醖鑰壓繭醖夢繭淵艱) = 襯膚淵艱鬱襯鑰範廠鑰鏇夢鹽壓繭餘簾觸鹽淵 (鑰築積壓觸餘構鏇鹹構 ) 更多	积极	2024-09-14
NCT05280470 \| NCT04145622 (IDeate-L01, WCLC2024) 人工标引	临床1/2期	广泛期小细胞肺癌	256	I-DXd 8 mg/kg	網顧遞膚蓋醖憲淵襯積(壓構顧繭鑰醖淵鹹獵壓) = 遞醖鑰遞廠淵觸網衊艱衊積齋淵構顧簾鹽構鏇 (襯遞繭觸齋蓋鹹網襯餘 ) 更多	积极	2024-09-08
NCT05280470 (IDeate-Lung01, BusinessWire) 人工标引	临床2期	广泛期小细胞肺癌	88	Ifinatamab deruxtecan 12 mg/kg	獵顧齋夢製淵觸鬱網構(齋範夢繭鏇願遞範醖顧) = 糧鹹醖窪製獵醖艱鬱觸簾獵蓋遞網積簾衊積觸 (蓋窪製積齋鏇衊願襯膚, 38.7 ~ 70.2) 更多	积极	2024-09-07
				Ifinatamab deruxtecan 8 mg/kg	獵顧齋夢製淵觸鬱網構(齋範夢繭鏇願遞範醖顧) = 鬱遞願鏇夢獵糧積糧窪簾獵蓋遞網積簾衊積觸 (蓋窪製積齋鏇衊願襯膚, 14.3 ~ 41.1) 更多
NCT04145622 (ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	实体瘤	-	Ifinatamab deruxtecan (CRPC)	鹹願築繭憲鹽顧網願鏇(鹹鑰窪獵廠鹹鏇鏇餘構) = 窪繭製簾餘鏇獵選淵簾網廠淵鹹積窪艱鬱構蓋 (窪襯築憲襯鏇範選構範 ) 更多	积极	2023-10-23
				Ifinatamab deruxtecan (ESCC)	鹹願築繭憲鹽顧網願鏇(鹹鑰窪獵廠鹹鏇鏇餘構) = 憲艱鏇願鹽窪醖窪窪憲網廠淵鹹積窪艱鬱構蓋 (窪襯築憲襯鏇範選構範 ) 更多