德曲妥珠单抗(Fam-trastuzumab deruxtecan-NXKI) - 药物靶点：HER2 x Top I_在研适应症：胃癌，HER2阳性实体瘤，HR阳性/HER2低表达乳腺癌_专利_临床

概要

基本信息

药物类型

ADC

别名

Fam-trastuzumab deruxtecan、T-DXd、Trastuzumab deruxtecan

+ [15]

靶点

HER2 x Top I

作用方式

拮抗剂、抑制剂

作用机制

HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)、TOP1抑制剂(DNA拓扑异构酶I抑制剂)、ADCC(抗体依赖的细胞毒作用)

治疗领域

肿瘤消化系统疾病呼吸系统疾病+ [5]

在研适应症

胃癌HER2阳性实体瘤HR阳性/HER2低表达乳腺癌+ [66]

非在研适应症

HER2阳性尿路上皮癌HER2表达胃食管交界处腺癌脑膜癌病+ [1]

原研机构

Daiichi Sankyo Co., Ltd.

在研机构

Daiichi Sankyo Co., Ltd.

AstraZeneca PLCAstraZeneca AB

+ [8]

非在研机构-

权益机构

Merck & Co., Inc.

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.

+ [2]

最高研发阶段批准上市

首次获批日期

美国 (2019-12-20),

HER2阳性乳腺癌

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国)、孤儿药 (日本)、优先审评 (澳大利亚)、先驱策略 (日本)、孤儿药 (澳大利亚)、快速通道 (美国)

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结构/序列

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Sequence Code 18481L

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Sequence Code 44772H

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关联

190

项与德曲妥珠单抗相关的临床试验

NCT07126561

/ Not yet recruiting临床2期IIT

Phase II Open Label Trial of Trastuzumab Deruxtecan (Enhertu, DS-8210) in HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer Patients With an ECOG Performance Status of 2

Purpose: This clinical trial is designed to evaluate the safety and effectiveness of Trastuzumab Deruxtecan for patients with HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer. The goal is to determine how well this treatment works and to identify any potential side effects.
Who Can Participate: We are looking for Participants with histologically confirmed HER2 positive locally advanced unresectable and/or metastatic esophageal, gastric or GEJ adenocarcinoma with an ECOG PS of 2 and measurable disease according to RECIST 1.1 within 42 days prior to registration. Participants will be carefully screened to ensure they meet the study requirements.
What to Expect: Participants will undergo 6.4mg/kg, IV infusion of Trastuzumab deruxtucan over the course of the study. They will receive detailed information about the study and will have the opportunity to ask questions before deciding to participate. Informed consent will be obtained to ensure that participants understand the study's purpose, procedures, risks, and benefits.
Safety Monitoring: The health and safety of participants are our top priority. An Independent Data and Safety Monitoring Committee (DSMC) will regularly review the study data to ensure participant safety and to monitor for any adverse events. Any serious side effects will be reported and addressed promptly.
Benefits and Risks: While the study aims to provide potential benefits, such as improved treatment options for HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer there may also be risks involved. Participants will be informed of all possible risks before enrolling in the study.
Confidentiality: All personal information will be kept confidential, and data will be used only for research purposes.
Contact Information: For more information about this study, please contact PhaseIICRA@medicine.bsd.uchicago.edu

开始日期2026-11-01

申办/合作机构

The University of Chicago

NCT07137416

/ Recruiting临床1期IIT

Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors

This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving pidnarulex in combination with trastuzumab deruxtecan may be safe, tolerable and/or effective in treating patients with metastatic, unresectable, or locally advanced HER2-expressing breast cancer or other solid tumors.

开始日期2026-10-05

申办/合作机构

National Cancer Institute

NCT07553390

/ Not yet recruiting临床1期IIT

Phase 1b Study Of Allogeneic CAR TROP2/IL15 Transduced TGFBR2 KO CB NK-Cells (TRICK-NK) In Combination With Trastuzumab Deruxtecan (T-Dxd) In Treatment-Refractory Breast Cancers

The goal of this clinical research study is to find the highest tolerable dose of TGFBR-2 KO CD70 CAR NK (TRICK-NK) in combination with 2 doses of T-Dxd that can be given to participants who have advanced breast cancer. The safety of TRICK-NK will also be studied.
The goal of Part 1 (dose escalation) of this clinical research study is to find the highest tolerable dose of TRICK-NK (in combination with T-Dxd) that can be given to participants who have advanced breast cancer.
The goal of Part 2 (dose expansion) of this clinical research study is to learn if the dose of TRICK-NK found in Part 1 can help to control the disease.
The optional schedule optimization phase will test a shorter interval between the NK cell infusion and the first dose of T-Dxd.

开始日期2026-10-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与德曲妥珠单抗相关的临床结果

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100 项与德曲妥珠单抗相关的转化医学

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100 项与德曲妥珠单抗相关的专利（医药）

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1,066

项与德曲妥珠单抗相关的文献（医药）

2026-07-01·Value in Health Regional Issues

Budget Impact Analysis of Fam-Trastuzumab-Deruxtecan as a Second Line in Patients With HER2-Positive Metastatic Breast Cancer in Oman

Article

作者: Aljaber, Rana ; Al Froukh, Rawan F ; Al Hashar, Amna

OBJECTIVES:

Despite advancements, breast cancer remains a major global health and financial challenge. Trastuzumab-based therapies, particularly Fam-Trastuzumab-Deruxtecan (T-DXd), have shown superior outcomes, leading to its recommendation as a preferred second-line treatment. However, its high cost necessitates a budget impact analysis (BIA) to evaluate financial feasibility. This study assesses the 1-year budget impact of replacing Trastuzumab Emtansine (TDM1) with T-DXd for HER2+ metastatic breast cancer in an Omani cancer center.

METHODS:

A static BIA model was built based on National Institute for Health and Care Excellence template with adaptation as required. The model time horizon was 1 year then projected over another 2 years, using 2022 as the baseline year, adopting Omani healthcare-payer perspective. The analysis considered 2 scenarios: (1) TDM1 as the current formulary drug and (2) T-DXd is introduced instead of TDM1, assuming that treatment share would be 100%. One-way sensitivity analysis is performed to assess the model's robustness.

RESULTS:

The BIA demonstrated that replacing TDM1 with T-DXd for the eligible patients would lead to increase in the budget expenditure. Over a 3-year period, considering the provided assumptions and input data, the cumulative excess amount to €5 909 481.67. The primary contributing factors are the drug acquisition cost and the median treatment duration. The sensitivity analysis results suggest the model is robust to changes in adverse drug reaction costs, unlike changes in treatment duration and drug cost.

CONCLUSIONS:

Although T-DXd improves clinical outcomes, its adoption as a second-line treatment in Oman poses a substantial financial burden, necessitating careful budget planning to ensure long-term affordability.

2026-06-01·BREAST

Antibody–drug conjugate sequencing in HER2-positive metastatic breast cancer: Real-world outcomes of trastuzumab deruxtecan with and without prior T-DM1 exposure

Article

作者: Yazıcı, O ; Güney, B ; Sezer, A ; Türker, S ; Kaban, K ; Tunalı, D ; Selçukbiricik, F ; Demir, N ; Güney, G ; Altunok, O ; Laçin, Ş ; Yıldız, I ; Güren, A K ; Kıkılı, C I ; Köylü, B ; Yeşil Çınkır, H ; Bilici, A ; Çelik, E ; Bayoğlu, I V ; Deliktaş Onur, I ; Aykan, M B ; Bayram, E ; Göker, E ; Oruç, A ; Aksoy, S ; Erdem, D ; Ekinci, Ö B ; Gündüz, Ş ; Kemik, F ; Biter, S ; Molinas Mandel, N ; Akdoğan, O ; Yılmaz, M ; Seyyar, M ; Gürsu, R U ; Açıkel Yüksel, S D ; Çabuk, D ; Tünbekici, S ; Karadurmuş, N ; Yazıcı, M ; Majidova, N ; Korkmaz, T ; Başaran, G ; Özçelik, H ; Ateş, Ö ; Şahin, T K ; Kalem, A ; Güven, D C ; Tural, D ; Er, Ö ; Araz, M

BACKGROUND:

Optimal sequencing of trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd) in HER2 positive metastatic breast cancer (mBC) remains uncertain, and real-world evidence on the impact of prior T-DM1 exposure on subsequent T-DXd outcomes is limited.

METHODS:

We conducted a multicenter, retrospective cohort study across 21 oncology centers in Türkiye including consecutive adults with HER2 positive mBC who received at least one cycle of T-DXd between 2020 and 2025. Patients were classified as T-DM1 pretreated or T-DM1 naive at T-DXd initiation. The primary endpoint was progression free survival (PFS); secondary endpoints included objective response rate (ORR), duration of response (DOR), and overall survival (OS). To address confounding by indication, we applied stabilized inverse probability of treatment weighting (IPTW) based on prespecified clinical covariates and assessed covariate balance using standardized mean differences.

RESULTS:

Among 218 patients treated with T-DXd, 137 (62.8%) had received prior T-DM1 and 81 (37.2%) were T-DM1 naive. The ORR was 71.9%, including 15.2% complete and 56.7% partial responses. Median DOR in the overall cohort was 20.96 months (95% CI, 15.71-26.22). In the IPTW-weighted analysis, prior T-DM1 exposure was associated with significantly shorter PFS: 12.1 months (95% CI, 10.3-20.5) versus 26.0 months (95% CI, 18.9 - not reached) in T-DM1 naive patients (IPTW-weighted log-rank p = 0.006). Prior T-DM1 remained independently associated with higher progression risk (HR 1.99, 95% CI 1.09 - 3.62; p = 0.02). Median OS was 18.9 months (95% CI, 17.2-not reached) in T-DM1 pretreated patients and not reached in T-DM1 naive patients; the IPTW-weighted OS hazard ratio did not reach statistical significance (HR 1.80, 95% CI 0.86-3.79; p = 0.12).

CONCLUSIONS:

Trastuzumab deruxtecan demonstrated substantial real-world activity after prior T-DM1 exposure, but PFS was significantly shorter compared with T-DM1 naive patients, even after rigorous adjustment for measured confounding. These findings highlight the clinical relevance of antibody drug conjugate sequencing and support prospective studies to define the optimal positioning of T-DXd in HER2 positive mBC treatment algorithms.

2026-06-01·ESMO Gastrointestinal Oncology

Methodological limitations in interpreting the efficacy of trastuzumab deruxtecan by CLDN18.2 status in single-arm studies

Letter

作者: Yoshimura, Kenichi

5,838

项与德曲妥珠单抗相关的新闻（医药）

2026-05-11

·Firstwordpharma

Daiichi aims for $14.6B in oncology sales by 2030

Daiichi Sankyo on Monday outlined ambitions to generate annual sales from its cancer drugs of more than JPY 2.3 trillion ($14.6 billion) by 2030 and become a global top five oncology company by 2035. The targets form part of a new five-year plan unveiled by Daiichi alongside its delayed financial results for fiscal year 2025.The company said that its oncology portfolio — led by the antibody-drug conjugates (ADCs) Enhertu and Datroway — pulled in JPY 608.8 billion ($3.9 billion) in fiscal year 2025, representing growth of 31.3%. Meanwhile, overall sales rose 12.6% to JPY 2.1 trillion ($13.4 billion), which is targeted to grow to more than JPY 3 trillion ($19.1 billion) in 2030. Daiichi hopes to continue this strong performance through the launch of 20 new indications across five medicines by 2030, as it aims to "maximise the value" of its ADC portfolio and broader oncology pipeline. The company noted that it expects "five practice-changing launches" across its ADC portfolio this year, including four new breast cancer indications for Enhertu and Datroway, as well as a first-ever launch in small-cell lung cancer for ifinatamab deruxtecan."We plan to expand our leadership into lung cancer where there are more than 10 new indication launches planned for this tumour type across our portfolio over the next five years," said Ken Keller, global head of Daiichi's oncology business.Earlier ambitions for Daiichi's ADC assets — particularly the Merck & Co.-partnered patritumab deruxtecan (HER3-DXd) — have recently come back to haunt the Japanese drugmaker, leading to compensation of over $480 million to contract manufacturing organisations amid a glut of excess manufacturing capacity.Having now adjusted its manufacturing needs, Daiichi is also advancing research behind new ADCs with novel cytotoxic and immunological payloads."We aim to further accelerate the speed of development of our pipeline assets through increasing the efficiency of clinical development processes, including leveraging the latest digital and artificial intelligence tools as well as enhancing our biomarker capabilities for better patient selection strategies," explained John Tsai, global R&D head.Daiichi indicated that it will employ "a breakthrough generating technology (BGT) approach, a platform-based drug discovery model, designed to deliver innovative medicines to patients faster and with a higher probability of success." Using this, by 2030, the company aims to identify additional BGTs, which may consist of multi-specific antibodies, targeted protein degradation and siRNA.

抗体药物偶联物

2026-05-11

·小药说药

卵巢癌药物市场的现状与未来

-01- 引言卵巢癌是美国女性癌症相关死亡的第六大原因。它在早期基本上是无症状的，导致大多数患者在晚期才被诊断出来。大多数（90%）卵巢恶性肿瘤起源于上皮，并按组织学分类，包括浆液性、粘液性、子宫内膜样和透明细胞癌。高级浆液性卵巢癌根据它们是否携带BRCA1和BCRA2突变进行细分，这些突变发生在10-15%的卵巢癌中。 -02- 一、目前的治疗方法在早期（I-II期），辅助化疗是具有高风险病理特征患者的标准护理，卡铂和紫杉醇治疗可降低复发风险。低风险I期肿瘤通常仅通过手术进行治疗，有高治愈率。晚期（III-IV期）的治疗模式包括细胞减灭术、卡铂和紫杉醇化疗（作为新辅助剂和/或佐剂）以及对一些患者的维持治疗。具有高肿瘤负荷或IV期的患者也可接受贝伐单抗治疗。在BRCA1/2突变状态和同源重组缺陷（HRD）的指导下，PARP抑制剂已经改变了一线维持治疗。奥拉帕尼是BRCA1/2突变肿瘤的标准治疗方法，建议与贝伐单抗联合治疗HRD阳性肿瘤。在2025年对III期PRIMA试验的最终总体生存数据进行审查后，Niraparib现在仅限于治疗HRD阳性肿瘤。Rucaparib被指定为一线维护选择，无论BRCA或HRD状态如何，但仅在欧洲获得批准。贝伐单抗维持治疗是已经开始抗血管生成治疗的患者或HRD阴性疾病患者的替代方案。在疾病复发时，铂敏感和铂耐药之间的区别是临床决策的核心。铂敏感复发——通常定义为至少六个月的无铂间隔期——通常用基于铂的联合方案治疗，如卡铂加紫杉醇、卡铂加吉西他滨或卡铂加阿霉素脂质体，并在选定的患者中加入贝伐单抗。由于PARP抑制剂在一线的广泛使用，这种情况下的维护选项变得越来越有限，这减少了PARP抑制剂再次干预的机会；因此，贝伐单抗仍然是继铂类治疗反应后的主要维持治疗。抗铂卵巢癌的定义是在最后一次服用铂后六个月内复发，由于预后不良和对现有疗法的反应持久性有限，这是一个有大量临床需求的领域。治疗主要依赖于连续的非铂类单一药物，如聚乙二醇化脂质体阿霉素、紫杉醇、拓扑替康或吉西他滨，加上贝伐单抗，可以适度改善贝伐单抗初治患者的无进展生存率。美国食品药品监督管理局于2026年3月批准了relacorilant，这是一种第一类选择性糖皮质激素受体拮抗剂，与nab-paclitaxel联合使用，为复发性抗铂卵巢癌症提供了一种机制上独特的生物标志物识别治疗选择。它适用于接受过最多三种先前治疗的患者，包括贝伐单抗。靶向治疗也扩大了对生物标志物定义的复发性抗铂癌症患者的治疗。抗体偶联药物（ADC）mirvetuximab soravtansine是高叶酸受体-α（FRα）表达患者的标准治疗方法，正在进行的III期试验（GLORIOSA）中与贝伐单抗联合评估。PD-1抑制剂pembrolizumab与紫杉醇联合使用，联合或不联合贝伐单抗，适用于PDL1阳性肿瘤（联合阳性评分，CPS≥1；美国食品药品监督管理局于2026年批准）。Avutometinib加defactinib，一种RAF/MEK和FAK抑制剂组合，被批准用于KRAS-突变的复发性低级别浆液性癌症，一种罕见的亚型（上皮肿瘤<5%）。该组合在2025年获得了美国食品药品监督管理局的加速批准，继续批准取决于在验证性试验中确认临床效益。 -03- 二、新兴疗法癌症III期管线在过去三年中大幅扩张，目前主要由具有不同分子靶点的ADC主导，如下表所示。三种FRα导向的ADC—— rinatabart sesutecan (Genmab), sofetabart mipitecan (Eli Lilly) 和torvutatug samrotecan (AstraZeneca) ——正在治疗复发性铂耐药性疾病的III期试验中进行评估。尽管这些药物与mirvetuximab soravtansine具有相似的作用机制，但它们正在未经选择的人群中进行研究，而不管FRα的表达如何，这可能会扩大它们的用途。Rinatabart sesutecan和sofetabart mipitecan也正在接受复发性铂敏感性疾病的评估。Rinatabart sesutecan正在RAINFOL-04试验中作为二线维持治疗进行评估，无论是否使用贝伐单抗，而sofetabart mipitecan正在FRAmework-01试验中进行研究，其中一部分纳入了接受贝伐单抗治疗的铂类敏感患者。 Sacituzumab-tirumotecan，一种TROP2靶向ADC，目前正在两项III期试验中评估，无论是否使用贝伐单抗，用于复发性对铂敏感的卵巢癌。它正在被研究作为二线维持疗法（TroFuse-022试验）和HRD阴性疾病的一线维持疗法（TroFuse-021试验）。Trastuzumab deruxtecan是一种HER2靶向ADC，也被评估为表达HER2的BRCA野生型患者的一线维持治疗，有或没有贝伐单抗。 Raludotatug deruxtecan靶向钙粘蛋白-6（CDH6），后者在65%以上的上皮性卵巢癌中表达。在复发性铂耐药性疾病的II/III期试验（REJOICE-Ovarian01）中，正在对其进行评估，并根据CDH6表达对患者进行分层。GSK-5733584（GSK）靶向B7-H4，B7-H4在90%以上的卵巢癌中过表达，ADC也在这种情况下进行评估。除了ADC，INCB-123667（Incyte）是一种小分子细胞周期蛋白依赖性激酶2抑制剂，正在研究复发性铂耐药性卵巢癌。NP-G2-044（Novita Pharmaceuticals）是一种领先的fascin抑制剂，正在与聚乙二醇化脂质体阿霉素联合使用进行评估；其II/III期试验（ULTIMUS-1）也在该人群中进行。Olvimulogene nanivacirepvec（Genelux）是一种溶瘤病毒免疫疗法，也正在该人群中进行评估。相比之下，在疾病过程的早期，有几种药物也正在开发中。IMNN-001（Imunon）是一种基于质粒的DNA载体，编码通过纳米颗粒递送系统递送的白细胞介素-12，正在与新诊断的晚期卵巢癌症的（新）辅助化疗联合研究（OVATION-3试验）。Oregovomab（CanariaBio）是一种靶向CA125的单克隆抗体，在这种情况下也正在与化疗联合进行评估。然而，其试验（FLORA-5）排除了BRCA1/2突变或HRD阳性肿瘤的参与者。 -04- 三、卵巢癌的药物市场根据Clarivate Disease Landscape&Forecast，2025年卵巢癌药物在主要市场的销售总额为39.2亿美元，预计2034年将达到73.7亿美元，主要受高价ADC的批准和标签扩展的推动。 2025年，PARP抑制剂是卵巢癌症最畅销的药物类别（19.7亿美元），其中奥拉帕尼在类别销售额中所占份额最大。然而，由于成本较低的仿制药的预期进入，预计到2034年，这类药物在主要市场的销售额将稳步下降。相比之下，预计到2034年，ADC将成为最畅销的药物类别（47.4亿美元），占市场总销售额的近65%。在这一类别中，Trastuzumab deruxtecan预计将成为主要产品，2034年的预计销售额为11亿美元，反映出其有望扩展到一线维护用途，尽管其使用可能会受到其他疗法的竞争和生物标志物限制的影响。最近的市场进入者提供了急需的治疗选择，并满足了临床需求；然而，他们的销售效果预计不会太大。Avutometinib和defactinib仅限于一种罕见的卵巢癌症亚型，而relacorilant和pembrolizumab预计主要用于符合条件的患者较少的晚期环境。参考资料： The ovarian cancer drug market. Nat Rev Drug Discov. 2026 May 8 公众号已建立“小药说药专业交流群”微信行业交流群以及读者交流群，扫描下方小编二维码加入，入行业群请主动告知姓名、工作单位和职务。

2026-05-11

·BioSpace

Daiichi takes $850M charge, axes facility investment as ADC demand forecast falls

iStock, agung fatria While Daiichi Sankyo brought in $13.4 billion in 2025, setbacks forced the company to update its antibody-drug conjugate forecast, pushing demand below the minimum supply agreed upon with CMOs and prompting the cancellation of an in-house investment. Daiichi Sankyo took a financial hit and axed plans to add manufacturing capacity after reassessing demand for its antibody-drug conjugates. On Monday, the company reported 133.2 billion Japanese yen ($850 million) in temporary expenses in its fourth-quarter results. In all, Daiichi recorded 153 billion Japanese yen ($970 million) in temporary expenses for 2025. Daiichi made 2.1 trillion Japanese yen ($13.4 billion) last year. Daiichi forewarned investors about the expenses on Friday, when it revealed that a review—which delayed its financial earnings last month—had identified charges associated with its use of contract manufacturing organizations (CMOs) and a planned expansion of in-house capabilities. Daiichi attributed the charges to shifts in forecast demand for its antibody-drug conjugates (ADCs). Initial demand for the company’s ADC portfolio, which is led by the AstraZeneca-partnered blockbuster Enhertu, exceeded expectations, leading the company to partner with CMOs to secure capacity. Prioritizing supply continuity, Daiichi struck long-term deals with CMOs that included minimum purchase obligations and dedicated production lines. The terms reflected the limitations of Daiichi’s in-house capacity and the restricted number of CMOs capable of handling ADCs, the company said. Clinical trial data, changes to the target patient populations and product launch timeline delays led Daiichi to reassess its demand for ADCs. The company recorded charges related to the reassessment earlier in its financial year. After another assessment, Daiichi concluded that its ADC forecast demand is below minimum purchase obligations stipulated in its agreements with CMOs. The company recorded a 75.7 billion Japanese yen ($480 million) CMO compensation fee associated with the demand shortfall. Further charges could follow, with Daiichi yet to recognize provisions related to a potential medium- to long-term demand shortfall because of the high level of uncertainty. Daiichi has pulled back from plans to add internal capacity in light of its revised ADC demand forecast, according to the earnings presentation. Previously, the company planned to invest in ADC equipment at a plant in Odawara, Japan. However, the review led Daiichi to scrap the planned investment, triggering a 19.3 billion Japanese yen ($120 million) charge. The CMO compensation and losses related to the cancelation of the Odawara site investment were the main drivers of temporary expenses in Daiichi’s fourth-quarter and full-year results. That figure includes two write-downs of Datroway inventories, plus one write-down for another candidate, HER3-DXd. Breast cancer AstraZeneca, Daiichi Sankyo’s ADC Wins First Approval Despite Mixed Data Datroway, formerly known as Dato-DXd, significantly improved median progression-free survival in a Phase III study but failed to do so for overall survival. January 21, 2025 · 2 min read · Tristan Manalac Read more Datroway received FDA approval early last year for certain types of breast cancer. However, the AstraZeneca-partnered, TROP2-directed ADC suffered clinical setbacks on its route to market. Datroway sales hit 47.6 billion Japanese yen ($300 million) in Daiichi’s 2025 financial year, a figure the company aims to more than double in 2026. The ADC is yet to near the highs of Enhertu, which generated sales of 698.4 billion Japanese yen ($4.5 billion).

抗体药物偶联物上市批准临床3期财报临床结果

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外链

KEGG	Wiki	ATC	Drug Bank
-	德曲妥珠单抗	L01XC	DB14962

研发状态

批准上市

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适应症	国家/地区	公司	日期
胃癌	印度	AstraZeneca PLC	2025-10-07
HER2阳性实体瘤	英国	Daiichi Sankyo UK Ltd.	2025-04-09
HR阳性/HER2低表达乳腺癌	美国	Daiichi Sankyo Co., Ltd.	2025-01-28
HR阳性/HER2阳性乳腺癌	韩国	Daiichi Sankyo Co., Ltd.	2022-09-19
HER2突变型非小细胞肺癌	美国	Daiichi Sankyo, Inc.	2022-08-11
HER2阳性胃腺癌	澳大利亚	AstraZeneca Pty Ltd.	2021-10-08
HER2低表达乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	2021-10-08
转移性乳腺癌	加拿大	AstraZeneca Canada, Inc.	2021-04-15
HER2阳性胃食管结合部腺癌	美国	Daiichi Sankyo, Inc.	2021-01-15
HER2阳性胃癌	日本	Daiichi Sankyo Co., Ltd.	2020-09-25
HER2阳性乳腺癌	美国	Daiichi Sankyo, Inc.	2019-12-20

未上市

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适应症	最高研发状态	国家/地区	公司	日期
实体瘤	临床3期	美国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	中国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	日本	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	澳大利亚	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	巴西	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	法国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	以色列	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	意大利	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	韩国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	西班牙	Daiichi Sankyo, Inc.	2025-12-23

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临床结果

适应症

分期

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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


NCT07151586 (ALTER, AACR2026)	临床2期	三阴性乳腺癌 HER2-low	260	Alternating sacituzumab-govitecan and trastuzumab-deruxtecan	蓋鹹獵鹹糧餘範選簾製(鏇鹹廠憲夢廠蓋選淵觸) = 選壓觸範願鹽觸壓構積選鬱繭壓衊蓋餘網餘網 (窪膚鏇淵築獵窪淵觸鹽 ) 更多	积极	2026-04-21
				Sacituzumab-govitecan	蓋鹹獵鹹糧餘範選簾製(鏇鹹廠憲夢廠蓋選淵觸) = 鹹製夢構繭鬱艱淵淵鏇選鬱繭壓衊蓋餘網餘網 (窪膚鏇淵築獵窪淵觸鹽 ) 更多
NCT04379596 (DESTINY-Gastric03, AACR2026)	临床1/2期	食管腺癌 \| HER2阳性胃癌 \| 胃食管交界处腺癌一线 HER2-positive	30	trastuzumab deruxtecan + rilvegostomig + fluoropyrimidine (HER2-positive gastric cancer, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma)	選顧齋願蓋遞遞獵選遞(選顧觸衊蓋鏇鏇鹹築夢) = 鹹蓋遞餘鑰膚繭壓襯餘艱遞範蓋衊獵網簾積網 (艱築壓壓夢選網構網製 ) 更多	积极	2026-04-21
AACR2026	N/A	HER2阳性卵巢癌 \| HER2表达子宫内膜癌 HER2 expressing	33	Trastuzumab deruxtecan	夢獵構範衊蓋築鏇襯鑰(醖醖獵夢網獵顧構淵壓) = 繭襯鑰遞醖選窪餘鹽餘夢積網衊窪夢鏇齋獵襯 (齋獵蓋簾糧廠繭鬱築觸 ) 更多	积极	2026-04-20
				Trastuzumab deruxtecan (Ovarian cancer)	夢獵構範衊蓋築鏇襯鑰(醖醖獵夢網獵顧構淵壓) = 衊構糧廠構壓憲顧蓋鬱夢積網衊窪夢鏇齋獵襯 (齋獵蓋簾糧廠繭鬱築觸 ) 更多
AACR2026	N/A	转移性结直肠癌二线 HER2-amplified \| MSS	3,734	trastuzumab deruxtecan	鑰鹽鹽窪醖衊鏇衊鏇膚(獵顧網鏇遞鹹遞糧窪衊): HR = 1.14 (95.0% CI, 1.05 ~ 1.24), P-Value = 0.0024 更多	积极	2026-04-19
				Standard Chemotherapy
ESMO_ELCC2026	N/A	转移性非小细胞肺癌二线 ERBB2 altered	5	Trastuzumab deruxtecan	製願廠憲願膚遞壓範膚(鑰鹽顧淵網憲選鹹製鑰) = No ILD/pneumonitis 遞窪糧範構獵遞餘鹹積 (淵築餘遞廠窪糧夢膚醖 ) 更多	积极	2026-03-25
ESMO_TAT2026	N/A	HER2-positive \| ERBB2-mutated	61	Trastuzumab deruxtecan (ERBB2 mutations)	鹽淵艱鑰製遞獵壓願鬱(憲簾願壓築網窪觸廠窪) = 糧膚範廠衊願衊積製壓壓簾壓鹽願遞鹽選憲觸 (願鏇簾獵糧構憲糧膚壓 ) 更多	积极	2026-03-16
				Trastuzumab deruxtecan (HER2 IHC 3+)	鹽淵艱鑰製遞獵壓願鬱(憲簾願壓築網窪觸廠窪) = 鏇夢襯鬱壓鹹顧糧蓋壓壓簾壓鹽願遞鹽選憲觸 (願鏇簾獵糧構憲糧膚壓 ) 更多
NCT05744375 (TRANSCENDER, CTgov)	临床2期	局部晚期乳腺癌 \| HER2阳性转移性乳腺癌	2	Trastuzumab deruxtecan	鹽網餘膚壓網醖憲衊鹽 = 窪醖鏇窪觸構夢願醖蓋製網襯淵鑰醖製淵遞顧 (廠鏇膚選鹽構蓋獵齋餘, 蓋壓遞簾鹽廠鏇獵觸選 ~ 淵鏇壓遞餘繭衊選糧壓) 更多	-	2026-03-12
ESMO_SRC2026	N/A	实体瘤	9	Trastuzumab deruxtecan	範醖齋鬱憲顧觸襯構繭(顧願鏇壓壓齋積壓廠顧) = 範製網顧製製製製範網壓願範憲壓獵築顧築構 (獵齋獵繭廠獵範醖醖淵 )	积极	2026-03-09
NCT06989112 (DESTINY-Endometrial01, ESGO2026)	临床3期	复发性子宫内膜癌一线 HER2-expressing \| mismatch repair-proficient (pMMR)	600	trastuzumab deruxtecan + rilvegostomig	餘蓋壓醖衊簾憲鬱廠蓋(鹽淵窪膚鹹鹹積壓淵餘) = 糧餘顧餘製築獵淵醖選簾夢願窪願鬱夢範願繭 (糧築簾鏇鑰積鏇壓遞壓, 24.9 ~ NR) 更多	积极	2026-02-28
				trastuzumab deruxtecan + pembrolizumab	襯淵繭餘築選積選夢選(簾鏇膚齋鬱淵鬱壓淵觸) = 蓋積醖範構艱蓋鑰顧衊獵窪製築遞顧網膚糧窪 (觸餘觸繭鏇構襯窪獵鹽, 8.3 ~ 16.5) 更多
NCT04482309 (DESTINY-PanTumor02 (DP-02), ASCO_GU2026)	临床2期	膀胱癌 HER2-expressing	41	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W	簾簾遞醖鹽憲願淵顧膚(顧築積艱網鹽構選壓淵) = 鹽夢繭簾蓋鏇構窪餘製襯齋遞壓糧觸蓋願淵簾 (齋鑰鏇壓遞簾夢積膚糧, 26.3 ~ 57.9) 更多	积极	2026-02-26
				Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W (HER2 IHC 3+)	簾簾遞醖鹽憲願淵顧膚(顧築積艱網鹽構選壓淵) = 糧製襯鑰膚鑰獵製願齋襯齋遞壓糧觸蓋願淵簾 (齋鑰鏇壓遞簾夢積膚糧, 29.9 ~ 80.2) 更多