德达博妥单抗(Datopotamab Deruxtecan) - 药物靶点：Top I x Trop-2_在研适应症：EGFR阳性非小细胞肺癌，ER阳性/HER2阴性乳腺癌，晚期非小细胞肺癌_专利_临床

概要

基本信息

药物类型

ADC

别名

Dato-DXd、Datopotamab Deruxtecan-dlnk、达妥维妥单抗

+ [11]

靶点

Top I x Trop-2

作用方式

抑制剂

作用机制

TOP1抑制剂(DNA拓扑异构酶I抑制剂)、Trop-2抑制剂(肿瘤相关钙信号传感器2抑制剂)

治疗领域

肿瘤呼吸系统疾病皮肤和肌肉骨骼疾病+ [4]

在研适应症

EGFR阳性非小细胞肺癌ER阳性/HER2阴性乳腺癌晚期非小细胞肺癌+ [43]

非在研适应症

非小细胞肺癌 III期鳞状非小细胞肺癌

原研机构

Daiichi Sankyo Co., Ltd.

在研机构

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.

阿斯利康投资（中国）有限公司

+ [13]

非在研机构-

权益机构

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.Gustave Roussy, Cancer Campus, Grand Paris

最高研发阶段批准上市

首次获批日期

日本 (2024-12-27),

HR阳性/HER2阴性乳腺癌

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)

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结构/序列

使用我们的ADC技术数据为新药研发加速。

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Sequence Code 524309355L

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Sequence Code 524309356H

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关联

51

项与德达博妥单抗相关的临床试验

NCT07535437

/ Recruiting临床1/2期IIT

A Phase 1/2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy

The researchers are doing this study to find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. The researchers will test different doses of the Dato-DXd or osimertinib with an unchanging (fixed) dose of ivonescimab to find the best dose that causes few or mild side effects in participants. Once the dose is found the researchers will test ivonescimab with Dato-DXd or osimertinib in a new group of participants to see if it is effective in treating their NSCLC with an EGFR mutation.

开始日期2026-04-09

申办/合作机构

Memorial Sloan Kettering Cancer Center

[+1]

NCT07471776

/ Recruiting临床2期IIT

Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer

This study aims to evaluate whether ^68Ga-TROP2 PET/CT, combined with ^18F-FDG PET/CT, can predict the efficacy of anti-TROP2 antibody-drug conjugates in patients with advanced HER2-negative breast cancer. Baseline and dynamic imaging parameters will be used to develop prediction models (primary endpoint: AUC), and their associations with clinical outcomes and tumor TROP2 status will be explored.

开始日期2026-03-11

申办/合作机构

复旦大学

NCT07357597

/ Not yet recruiting临床4期

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)

This is a multicenter, open-label, single-arm study of prophylaxis for Dato-DXd-related stomatitis in eligible patients with metastatic or inoperable locally recurrent breast cancer or locally advanced or metastatic Epidermal Growth Factor Receptor-Mutated (EGFRm) non-small cell lung cancer.

开始日期2026-02-27

申办/合作机构

AstraZeneca PLC

[+1]

100 项与德达博妥单抗相关的临床结果

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100 项与德达博妥单抗相关的转化医学

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100 项与德达博妥单抗相关的专利（医药）

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124

项与德达博妥单抗相关的文献（医药）

2026-05-01·ANNALS OF PHARMACOTHERAPY

Targeting TROP2 Across Solid Tumors: The Clinical Profile and Role of Datopotamab Deruxtecan

Review

作者: Lucky, Rachel ; Thornburg, Lauren ; Halford, Zachery

Objective::

To evaluate the pharmacology, efficacy, safety, and clinical use of datopotamab deruxtecan (Dato-DXd), a recently approved trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC), in the treatment of advanced solid tumors.

Data sources::

A comprehensive English-language literature search was conducted on PubMed and ClinicalTrials.gov from January 2010 through September 2025 using the search terms datopotamab, datroway, breast cancer , or nonsmall cell lung cancer .

Study selection and data extraction::

Evidence was gathered from clinical trials, relevant articles, guidelines, abstracts, and package inserts.

Data synthesis::

Dato-DXd received accelerated approval by the Food and Drug Administration (FDA) in 2025 for hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer, and epidermal growth factor receptor (EGFR)-mutant nonsmall cell lung cancer (NSCLC). In the TROPION-Breast01 trial, Dato-DXd demonstrated superior efficacy with a response rate of 36.4% versus 22.9% for chemotherapy and median progression-free survival of 6.9 versus 4.9 months. In NSCLC, TROPION-Lung01 showed a response rate of 26.4% with Dato-DXd compared with 12.8% with docetaxel. For the approved EGFR-mutant NSCLC indication, the TROPION-Lung05 trial demonstrated a response rate of 35.8% with Dato-DXd. Treatment-related adverse events included stomatitis, nausea, alopecia, and ocular events, with interstitial lung disease/pneumonitis representing the most clinically significant safety concern.

Relevance to patient care and clinical practice::

The TROP2-directed ADC appears to be a viable therapeutic alternative for select patients with previously treated HR+/HER2– breast cancer or EGFR-mutant NSCLC after progression on targeted therapy.

Conclusions::

Dato-DXd offers a promising treatment option for heavily pretreated patients with HR+/HER2– breast cancer and EGFR-mutant NSCLC, providing meaningful clinical benefit with a manageable safety profile. Optimal sequencing and positioning within the rapidly shifting ADC landscape requires further investigation.

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: Xue, Wenwu ; Chen, Minna ; 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.

2026-05-01·ANNALS OF ONCOLOGY

Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive, HER2-negative breast cancer: final overall survival analysis of the phase III TROPION-Breast01 study

Article

作者: Jhaveri, K ; Lu, Y-S ; Hamilton, E ; Martínez Jañez, N ; Pistilli, B ; Bardia, A ; Wang, S ; Pernas, S ; Khan, S ; Borges, G ; Tsurutani, J ; Hattori, M ; Rugo, H S ; Rubini Liedke, P E ; Cescon, D W ; Kalinsky, K ; De Laurentiis, M ; Carroll, D ; Im, S-A ; Xu, B

BACKGROUND:

The TROPION-Breast01 study (NCT05104866) demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS) by blinded independent central review (BICR) with the trophoblast cell-surface antigen 2-directed antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd) versus investigator's choice of chemotherapy (ICC) in patients with previously treated, inoperable/metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. In this article, we report results from the final overall survival (OS) analysis.

PATIENTS AND METHODS:

Patients with inoperable/metastatic HR-positive/HER2-negative breast cancer, who had disease progression on endocrine therapy and for whom endocrine therapy was unsuitable, and had received one to two prior lines of chemotherapy in the inoperable/metastatic setting were randomly assigned in a 1 : 1 ratio to Dato-DXd (6 mg/kg every 3 weeks) or ICC (eribulin/capecitabine/vinorelbine/gemcitabine). Dual primary endpoints were PFS by BICR and OS.

RESULTS:

At data cut-off, median follow-up was 22.8 months. OS for the Dato-DXd versus ICC arm did not reach statistical significance (hazard ratio 1.01, 95% confidence interval 0.83-1.22, P = 0.9445). Use of ADCs (trastuzumab deruxtecan and sacituzumab govitecan) as subsequent therapy was imbalanced: 12.3% in the Dato-DXd arm versus 24.0% in the ICC arm. Secondary efficacy endpoints (PFS by investigator assessment, objective response rate, duration of response, disease control rate at 12 weeks, time to first and second subsequent therapy or death, and time to second progression or death) continued to favor Dato-DXd at this final analysis. The overall safety profile of Dato-DXd remained favorable compared with ICC, and no new safety signals were observed with longer follow-up.

CONCLUSIONS:

TROPION-Breast01 met its dual primary endpoint of PFS by BICR. While there was no statistically significant improvement in the dual primary endpoint of OS with Dato-DXd versus ICC, subsequent ADC treatment may have affected OS results. The totality of efficacy and safety data supports Dato-DXd as a new treatment option for patients with previously treated, inoperable/metastatic HR-positive/HER2-negative breast cancer.

1,762

项与德达博妥单抗相关的新闻（医药）

2026-05-08

·Firstwordpharma

Daiichi to pay compensation of over $480M to CMOs

Daiichi Sankyo said Friday that it will pay compensation to contract manufacturing organisations (CMOs) totalling JPY 75.7 billion ($483 million) after scaling back capacity for its antibody-drug conjugate (ADC) business. The company will also record an impairment charge of JPY 19.3 billion related to its own manufacturing plant in Odawara, Japan.Last month, Daiichi delayed the release of its 2025 fiscal results as it needed more time to review supply plans for its oncology portfolio and development pipeline "in light of rapidly changing business conditions." That disclosure, although downplayed by analysts, led to a 10% drop in the drugmaker's shares. On Friday, Daiichi explained that the issues stem from contracts signed with CMOs that were based on earlier estimates for its ADC business, which includes Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan), as well as development-stage assets such as patritumab deruxtecan (HER3-DXd). The company said that initial estimates "expanded significantly" beyond its previous plans, leading to a policy of securing manufacturing capacity "sufficient to cover maximum demand." Daiichi indicated that this involved long-term contracts with CMOs — including setting minimum purchase obligations — as well as investing in its own manufacturing capacity. However, given setbacks in its ADC business — mainly due to the postponed launch of HER3-DXd — Daiichi said that it has been forced to adjust its needs. "Based on the results of each clinical trial for the ADC portfolio, revisions to the target patients populations and delays in product launch timelines led to a reduction in the original demand forecast," the company explained.As an initial response, Daiichi recorded a CMO compensation fee of JPY12.7 billion in its second-quarter results, as well as inventory valuation losses of JPY 4.6 billion. The drugmaker has subsequently moved to a new supply plan, which incorporates risk adjustment.As such, Daiichi said "a gap has emerged between the new supply plan and the minimum purchase obligations stipulated in the contracts with CMOs." The company noted that while the short-term impact of this has been recorded as an expense in fiscal year 2025, no provision has been made for the medium- to -long-term implication due to the "high level of uncertainty."($1 = JPY 156.66741675)

抗体药物偶联物财报

2026-05-07

·FierceBiotech

From drug development to M&A, Big Pharmas showcase AI’s ‘measurable impact’

AstraZeneca CEO Pascal Soriot said using AI is \"delivering real, measurable impact today, right across our value chain.\"\n From shrinking drug development timelines to scouting potential acquisitions, the recent run of first-quarter earnings results marked a shift for Big Pharma from AI hype to explaining how the technology is being applied in practice.AstraZeneca dedicated a slide in its April 29 earnings presentation to showcasing what it has already achieved—as well as clarifying some bold ambitions. The U.K.-based drugmaker has developed its own open-source generative AI framework, dubbed Reinvent, which has halved the time needed to identify molecular structures that could become potential new medicines.The Reinvent program is “fundamentally changing the speed at which we can move from concept to lead molecules,” AstraZeneca CEO Pascal Soriot told journalists on an earnings call.Meanwhile, the company has continued to use its algorithm platform—known as quantitative continuous scoring, or QCS—to identify patients most likely to respond to treatment. QCS is designed to evaluate digitized images of patient tissue samples to quantify targets on the surface of tumor cells as well as inside the cells themselves.Specifically, QCS is being used to assess non-small cell lung cancer patients who are most likely to benefit from treatment in a phase 3 study of the TROP2-directed antibody drug conjugate Datroway.When it comes to manufacturing, AstraZeneca hopes its AI Development Agent will ultimately halve chemistry, manufacturing and controls (CMC) development time. The agentic system could shake up synthetic drug development by harnessing simulations, data and in-house expertise.“AI is transforming our ways of working and is already embedded end-to-end across AstraZeneca, from discovery and development to commercial operations through to healthcare delivery,” Soriot said.“This is not a future ambition,” the CEO added. “AI is delivering real, measurable impact today, right across our value chain.”The technology will remain central to AstraZeneca’s push toward its goal of reaching $80 billion in revenue by 2030.Over at fellow U.K.-based pharma GSK, CEO Luke Miels told journalists that the “number one priority for the usage of AI is the innovation dimension.”“We’re using it to look at process, cost control and elements like that—but that is typically an off-the-shelf solution,” Miels said on an April 29 earnings call with journalists.“The proprietary effort, and where we\'re putting our best AI people, is on the R&D component, particularly at the earliest stage—the translational part,” he added.While the company is exploring the use of AI in designing medicines, Miels pointed out that the technology is also being aligned with GSK’s recent M&A strategy of picking up potential rivals to established blockbusters.“The key thing is looking more broadly at where could that medicine be developed? Where could it be used that maybe the broader world may not have spotted?” he said. “That becomes very important, not only with our own internal programs, but even more important with business development, because that\'s a way that we could identify value that may not be fully reflected in that company or that product,” Miels added. ‘Broadening the use of AI tools’ Over at Bristol Myers Squibb, CEO Chris Boerner, Ph.D., listed “broadening the use of AI tools” alongside greater use of automation in the lab as ways the U.S. pharma is investing in its core R&D infrastructure.The company has set a target of using AI to halve the time taken to select targets and design molecules while “applying greater rigor so that only the most differentiated molecules advance in late development,” Boerner said on an April 30 earnings call with analysts.When it comes to the later stages of drug development, BMS is already using AI to streamline clinical operations, shorten development timelines and improve quality oversight over time, the CEO said.“We expect these efforts to deliver a 30% reduction in cycle times versus just a few years ago,” Boerner added, pointing to a March deal with Faro to scale AI-powered workflows across clinical trial design, drafting, validation and optimization. BMS wasn’t the only Big Pharma on the hunt for AI-powered partnerships in recent months. Novo Nordisk followed in the footsteps of Sanofi and Eli Lilly by striking its own pact with OpenAI in April, with the ambition of integrating AI “globally from drug discovery to commercial operations.”Novo’s announcement came days after OpenAI unveiled a new reasoning model, dubbed GPT-Rosalind, specifically designed to support research in biology, drug discovery and translational medicine. The model is now available as a research preview in ChatGPT, Codex and the API for customers through OpenAI’s trusted access program.Meanwhile, Merck & Co. picked Google Cloud for its own AI partner. As part of an investment valued at up to $1 billion, Merck will get access to the tech giant\'s agentic AI platform across its R&D operations, manufacturing, commercial teams and corporate functions.Speaking to analysts on an April 30 earnings call, Merck CEO Robert Davis framed the Google Cloud deal within the broader context of a partnership with Tempus AI to accelerate the discovery of precision medicine biomarkers, as well as a collaboration to access Mayo Clinic laboratory results, medical imaging, clinical notes and molecular data to support the validation of AI models for drug discovery.“These efforts support improved productivity across our organization and create a real opportunity to advance the innovation in our pipeline with greater speed and with a higher likelihood of ultimately reaching patients,” Davis explained.

财报

2026-05-07

·医路相伴-罕见突变肺癌科普

肺癌ROS1基因融合突变临床诊疗

——精准靶向治疗的科学进展与应用实践一、ROS1基因突变的分子机制及流行病学特征 1）ROS1基因定位于人类染色体6q22，其编码的受体酪氨酸激酶在正常细胞分化中发挥调控作用。当染色体易位导致ROS1基因与其他基因（常见伴侣基因：CD74、SLC34A2、EZR）发生融合时，将构成致癌驱动突变。临床研究证实： - 发生率：占非小细胞肺癌(NSCLC)的1-2%（中国年新发病例约7,500-8,500例） - 高危人群：非吸烟者（>70%）、<50岁年轻患者（中位诊断年龄49.3岁） - 病理特征：98.7%见于腺癌亚型，胸膜转移发生率可达42.6% 2）国际肺癌研究协会(IASLC)2023年统计显示：未行基因检测的晚期肺腺癌患者中，约0.8%漏诊ROS1融合突变【1】二、检测方式 ROS1 融合推荐使用 IHC、FISH、qRT-PCR、NGS（二代测序）检测。IHC 检测仅用于初筛，阳性结果需采用其他方法验证；FISH 是 ROS1 融合检测的「金标准」，但易漏检 GOPC-ROS1 融合；基于 DNA 和 RNA 的二代测序均可用于 ROS1 融合基因检测，但 DNA 二代测序检测 ROS1 融合易发生漏检。 1. 金标准检测：基于RNA的二代测序（NGS）可检出22种融合变异亚型 2. 替代方案：组织样本不足时采用液体活检（灵敏度82.3%，特异性98.1%） 3. 诊断时效性：从送检至报告平均周期应≤10个工作日三、分层治疗策略目前，NCCN 指南推荐恩曲替尼、克唑替尼、瑞普替尼、塞瑞替尼用于一线治疗携带 ROS1 融合突变的 NSCLC 患者。国际和国内指南首选推荐使用新一代的ROS1靶向药物进行一线治疗。它们相比老一代药物，效力更强，且能更好地穿透血脑屏障，预防和治疗脑转移。 CSCO 指南推荐恩曲替尼、克唑替尼用于 IV 期 ROS1 融合阳性 NSCLC 一线治疗（I 级推荐）。 1）首选药物（第一梯队）： 1. 恩曲替尼 · 优势：高效、入脑能力强。对于已发生脑转移的患者，颅内病灶控制率非常高。对原发灶的控制效果也非常出色。 · 研究数据：在关键临床试验中，恩曲替尼治疗初治的ROS1阳性患者，客观缓解率（ORR）可达80%以上，中位无进展生存期（PFS）显著延长。 2. 洛拉替尼 · 优势：入脑能力极强，被认为是目前所有ROS1抑制剂中入脑效果最好的药物之一。对于预防和治疗脑转移效果卓越。它对多种耐药突变也有效。 · 研究数据：在临床试验中，无论是初治还是经治患者，洛拉替尼都显示出极高的全身和颅内疗效。 3. 克唑替尼 · 背景：这是第一个被批准用于ROS1阳性肺癌的靶向药，具有里程碑意义。 · 现状：由于其入脑能力相对较弱（脑转移控制效果较差），以及后续有更优的药物出现，目前已通常不作为一线首选，但在某些情况下（如药物可及性问题）仍可使用。一线治疗总结：对于新确诊的ROS1阳性晚期肺腺癌患者，应优先考虑使用恩曲替尼或洛拉替尼作为初始治疗。 2）耐药后的治疗策略（后线治疗）靶向药在使用一段时间（通常1-2年）后会出现耐药，导致疾病进展。此时，策略如下： 1. 全面评估病情 · 再次活检：对进展的病灶进行穿刺活检，进行基因检测，明确具体的耐药突变类型。 · 液体活检：如果组织活检困难，可以通过抽血进行ctDNA检测，也能帮助发现耐药机制。 2. 根据耐药机制选择后续方案 · 如果出现特定耐药突变（如G2032R等）： · 洛拉替尼：如果一线未使用，后线使用可能有效。 · 他雷替尼：一种新一代的ROS1/TRK抑制剂，对包括G2032R在内的多种常见耐药突变显示出良好活性，是目前后线治疗的重要选择。 · 瑞普替尼：另一款高效的新一代ROS1抑制剂，对多种耐药突变有效，已获国际批准。 · 如果未发现明确耐药突变或出现旁路激活： · 可以考虑更换其他作用机制的化疗。 · 可考虑抗血管生成药物（如贝伐珠单抗）联合化疗。 · 免疫治疗：单药效果在ROS1阳性患者中普遍不佳，通常不作为优先选择，但可与化疗联合在特定情况下尝试。 3. 耐药机制与应对方案主要耐药类型： 1. 守门突变（Gatekeeper mutations）：G2032R（占耐药病例53.7%） 2. 旁路激活（Bypass activation）：EGFR/KRAS通路激活（18.2%） 3. 组织学转化（Histologic transformation）：腺癌向小细胞癌转化（8.4%）临床解决方案： - G2032R突变采用NGS指导的三代药物序贯治疗 - KRAS G12C共突变联合Sotorasib治疗（临床研究ORR 41.3%） - 转化型小细胞癌采用依托泊苷+铂类化疗四、未来研究方向 1. 新靶点药物开发 - 双特异性抗体KN026（I期临床ORR 62.5%） - 抗体偶联药物DS-1062a（临床前模型脑转移清除率93.1%） 2. 免疫联合治疗 - PD-1抑制剂联合洛拉替尼（临床试验NCT04807122） - TIL细胞疗法治疗耐药患者（上海肺科医院研究CR率24.3%） 3. 中国原研突破 - 科伦药业A400（靶向G2032R突变，I期ORR 83%） - 恒瑞医药SHR-1905（c-MET/ROS1双靶点，获CDE突破性疗法）五、生存数据更新根据中国胸部肿瘤研究协作组（CTONG）1707研究，ROS1阳性患者经规范靶向治疗后： - 3年总生存率：71.3%（vs 化疗组 23.8%） - 5年生存率：62.1%（vs 历史对照 5.2%）六、结论 ROS1融合突变作为临床可干预的驱动基因，其诊疗体系的规范化实施显著改善了患者预后。持续的药物研发与精准耐药管理策略，正推动晚期肺癌向慢性病管理模式的转化。 1.J Thorac Oncol 2023;18:S12 1. Chinese Society of Clinical Oncology (CSCO) NSCLC Guidelines 2024 2. NMPA Drug Approval Database [DB/OL] 2024-07 3. National Cancer Center Annual Report 2023

100 项与德达博妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16410

研发状态

批准上市

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适应症	国家/地区	公司	日期
EGFR阳性非小细胞肺癌	美国	Daiichi Sankyo, Inc.	2025-06-23
ER阳性/HER2阴性乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	2025-05-20
晚期非小细胞肺癌	加拿大	AstraZeneca Canada, Inc.	2025-03-01
HR阳性/HER2阴性乳腺癌	日本	Daiichi Sankyo Co., Ltd.	2024-12-27

未上市

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适应症	最高研发状态	国家/地区	公司	日期
三阴性乳腺癌	申请上市	美国	AstraZeneca PLC	2025-02-03
三阴性乳腺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2025-02-03
EGFR突变的非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-11-12
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2024-11-12
局部晚期非鳞状非小细胞肺癌	申请上市	美国	Daiichi Sankyo, Inc.	2024-02-19
局部晚期非鳞状非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-02-19
转移性非鳞状非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-02-19
转移性非鳞状非小细胞肺癌	申请上市	美国	Daiichi Sankyo, Inc.	2024-02-19
膀胱癌	临床3期	美国	Daiichi Sankyo Co., Ltd.	2025-09-26
膀胱癌	临床3期	中国	Daiichi Sankyo Co., Ltd.	2025-09-26

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临床结果

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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


ESMO_ELCC2026	N/A	肺腺癌	56	Datopotamab deruxtecan (Dato-DXd)	窪齋選網遞襯遞鬱憲繭(餘蓋獵齋鬱襯鹹淵範鏇) = Most common reported adverse events were stomatitis (69%, 21% were 3°), keratitis (18%, all were ≤2°), pneumonitis (10%, all were ≤ 2°), and anemia (8%, all were ≤2°). 壓糧簾壓鹹鏇鑰獵齋鹹 (遞糧鹽簾構糧簾鹽鏇鬱 ) 更多	积极	2026-03-25
				Datopotamab deruxtecan (Dato-DXd) (ECOG PS 0-1)
ESMO_ELCC2026	N/A	转移性非小细胞肺癌	43	Datopotamab deruxtecan	艱壓壓蓋網繭衊積遞鏇(鑰艱窪網廠夢鬱積築鏇) = 鹹餘壓壓積鑰遞積艱鹽餘糧衊網鏇襯齋製窪襯 (淵製顧鏇鹹餘鏇簾鑰鹹 ) 更多	积极	2026-03-25
NCT03944772 (ORCHARD, ESMO_ELCC2026)	临床1期	EGFR突变的非小细胞肺癌 EGFR-mutated	185	Dato-DXd (TROP2 NMR+)	蓋餘窪糧鬱窪願餘蓋製(網醖餘觸網觸獵艱觸壓) = 衊衊範憲網築範餘製積廠膚衊鹹鬱壓獵鑰襯襯 (遞鬱鏇蓋蓋鹽襯襯獵鑰 ) 更多	不佳	2026-03-25
				Dato-DXd (TROP2 NMR-)	蓋餘窪糧鬱窪願餘蓋製(網醖餘觸網觸獵艱觸壓) = 遞壓淵憲選衊鬱鑰範願廠膚衊鹹鬱壓獵鑰襯襯 (遞鬱鏇蓋蓋鹽襯襯獵鑰 ) 更多
NCT07129993 (TROPION-Urothelial03, ASCO_GU2026)	临床2/3期	转移性尿路上皮癌	630	Datopotamab deruxtecan + platinum chemotherapy	壓鹽淵製顧範鹹鑰範繭(鹹製網鏇繭廠觸齋簾餘) = 醖衊簾積壓範膚積簾遞積壓築襯觸網築顧夢鏇 (願願憲鬱觸鹽網壓遞襯 )	积极	2026-02-26
				Gemcitabine + platinum chemotherapy	餘艱餘顧築襯齋顧範遞(製網鏇憲鏇醖淵獵積選) = 鏇廠顧齋獵衊餘蓋鏇獵積鬱繭獵遞製築製憲壓 (範鏇蓋艱衊醖憲齋範鏇, 7.7 ~ 11.3)
NCT05104866 (TROPION-Breast01, CTgov)	临床3期	转移性HER2阴性乳腺癌	732	Dato-DXd	壓蓋遞廠鏇淵夢糧齋獵(願醖鹹鏇願鬱鏇淵蓋鑰) = 願觸醖夢選積選選糧膚廠鬱築廠選膚觸網衊獵 (簾網選鑰壓鑰構網網窪, 鹹蓋襯鹹積鑰蓋衊醖膚 ~ 範襯糧範襯齋鑰鏇廠襯) 更多	-	2026-02-04
NCT06357533 (TROPION-Lung10, Pubmed \| Front Oncol)	临床3期	非小细胞肺癌一线 PD-L1 expression	675	Datopotamab deruxtecan + Rilvegostomig	鏇襯窪築壓衊鹹艱艱艱(醖夢簾願廠艱鹽糧衊獵) = 網構醖艱遞製糧膚構鑰壓窪醖積鏇觸蓋觸觸製 (鹽蓋糧選艱艱製範製襯 ) 更多	积极	2026-01-26
				Rilvegostomig	鏇襯窪築壓衊鹹艱艱艱(醖夢簾願廠艱鹽糧衊獵) = 觸鬱壓餘鏇鏇衊艱夢積壓窪醖積鏇觸蓋觸觸製 (鹽蓋糧選艱艱製範製襯 ) 更多
NCT06564844 (TROPION-Lung12, Pubmed \| J Thorac Cardiovasc Surg)	临床3期	非小细胞肺癌Ⅰ期辅助 ctDNA-positive	660	Datopotamab deruxtecan + Rilvegostomig	餘選衊醖鹽艱膚膚選築(鹽鑰廠廠網構範鏇觸蓋) = 網膚選廠遞積夢範網選鑰繭簾獵觸顧蓋夢遞壓 (鬱繭繭糧窪構鹽憲觸顧, 30.6 ~ NR) 更多	积极	2026-01-01
				Standard of Care	顧餘鹹選製艱遞鹽夢衊(醖網餘壓積夢鏇淵範齋) = 獵膚繭願顧鹽願鬱製選餘窪齋鑰鹹範衊壓網衊 (憲淵鬱襯廠襯廠膚積觸 )
NCT06176261 (DATO-BASE, SABCS 12025 \| SABCS 22025)	临床2期	HER2 阴性乳腺癌 \| 脑膜肿瘤 HER2-negative	10	Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV	獵鑰遞夢遞簾膚網齋網(齋餘襯築繭醖鑰繭艱構) = 鏇願膚膚繭鬱網積醖憲淵壓網糧網遞繭鹽顧蓋 (襯壓遞壓艱艱構窪壓遞, 0.7 ~ not reached) 更多	积极	2025-12-10
				Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV (ADC-naïve patients)	獵鑰遞夢遞簾膚網齋網(齋餘襯築繭醖鑰繭艱構) = 簾廠築鹽鑰窪艱憲願衊淵壓網糧網遞繭鹽顧蓋 (襯壓遞壓艱艱構窪壓遞 ) 更多
NCT03742102 (BEGONIA, ESMO2025) 人工标引	临床1/2期	三阴性乳腺癌一线 HER2 Negative \| HR Negative	95	Dato-DXd + durvalumab	獵糧淵艱鬱範艱鹹窪廠 \| 憲襯廠襯選積積憲窪艱(鑰夢範鹽範鏇憲鏇糧鑰) = 夢鹽廠壓鹹艱衊繭淵餘糧糧選願遞網醖繭鬱醖 (糧鹽繭鏇鏇廠憲觸願獵, 10.5 ~ 27.3) 更多	积极	2025-10-17
				Dato-DXd + durvalumabDurvalumab (PD-L1-high)	憲襯廠襯選積積憲窪艱 \| 範築積鬱艱糧齋蓋構憲(遞夢鹹鏇築顧醖鹽餘廠) = 範窪襯襯繭憲遞鏇獵鬱鏇築觸選觸選鬱蓋遞夢 (範壓窪構遞築廠築簾選, 64.5 ~ 93.0) 更多
NCT05374512 (TROPION-Breast02, ESMO2025) 人工标引	临床3期	三阴性乳腺癌一线 HR Negative \| HER2 Negative	644	Dato-DXd (6 mg/kg IV Q3W)	襯蓋蓋齋鑰簾選構壓衊(鹹窪蓋積鏇鹹繭獵積衊) = 廠獵鹹鹹鑰夢觸鹹顧鹹製遞簾糧築憲鬱醖構構 (築餘壓選糧襯夢醖衊齋, 19.8 ~ 25.6) 更多	积极	2025-10-17
				Investigator’s choice of chemotherapy (ICC)	襯蓋蓋齋鑰簾選構壓衊(鹹窪蓋積鏇鹹繭獵積衊) = 廠積選積淵壓艱壓膚齋製遞簾糧築憲鬱醖構構 (築餘壓選糧襯夢醖衊齋, 16.0 ~ 21.8) 更多