This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays.
The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC.
Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.

开始日期2026-01-01

申办/合作机构

Lineberger Comprehensive Cancer Center

[+1]

CTIS2024-516906-47-00

/ Recruiting临床2/3期

A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Participants with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who Progressed During or After Enfortumab Vedotin (EV) plus Pembrolizumab Combination Treatment. TROPION-Urothelial03 (TU03).

开始日期2025-11-28

申办/合作机构

Daiichi Sankyo, Inc.

NCT07291037

/ Recruiting临床3期

A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)

TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).

开始日期2025-10-31

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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项与德达博妥单抗相关的文献（医药）

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.

2026-02-01·CANCER TREATMENT REVIEWS

Clinical overview of trophoblast surface antigen 2 antibody-drug conjugates in non–small cell lung cancer

Review

作者: Naidoo, Jarushka ; Gadgeel, Shirish ; Mino-Kenudson, Mari ; Sethakorn, Nan ; Patel, Sandip Pravin

Lung cancer remains the leading cause of cancer-related death in the United States, with non-small cell lung cancer (NSCLC) accounting for most lung cancer cases. Improvements in first-line treatment with immuno-oncology and targeted therapies have been observed in patients with NSCLC, but benefits may be limited for those with advanced or metastatic NSCLC (mNSCLC). Following progression on frontline therapies, later-line therapies offer modest benefits and are associated with pronounced adverse effects. Accordingly, there is a need for new, more effective options to improve survival and quality of life. Trophoblast surface antigen 2 (TROP2) antibody-drug conjugates (ADCs) are a novel approach to address unmet treatment needs in NSCLC. There are 5 TROP2-directed ADCs currently under investigation for treatment of NSCLC: datopotamab deruxtecan, sacituzumab govitecan, sacituzumab tirumotecan, DB-1305, and SHR-A1921. Here, we provide an overview of the properties of each ADC as well as efficacy and safety data from clinical trials of patients with NSCLC with or without actionable genomic alterations (AGAs). The unique characteristics of each ADC and its components, particularly the linker chemistry and payload attributes, define the mechanism of action and subsequently influence dosing, efficacy, and safety. TROP2 ADCs have shown antitumor responses with a manageable safety profile in patients with mNSCLC in several ongoing and completed trials. Additional studies are required to understand how these agents can be effectively integrated into the treatment paradigm for lung cancer, taking into consideration sequential use of multiple ADCs, resistance mechanisms, combination therapies, and use in special populations.

2026-02-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

TROP-2–directed antibody–drug conjugates in advanced NSCLC: A systematic review and meta-analysis of efficacy, safety, and reconstructed survival outcomes

Review

作者: Siddiqui, Hafiza Tooba ; Rath, Shree ; Alam, Umama ; Ansab, Muhammad ; Desai, Aakash ; Burhan, Muhammad

INTRODUCTION:

Non-small cell lung cancer (NSCLC) represents the majority of lung cancer cases worldwide, with most patients diagnosed at advanced stages and limited by resistance to existing therapies. TROP-2, an epithelial cell surface glycoprotein overexpressed in many NSCLCs, has emerged as a promising therapeutic target for antibody-drug conjugates (ADCs). This study aims to systematically evaluate the efficacy and safety of TROP-2-directed ADCs in patients with advanced or metastatic NSCLC.

METHODS:

Electronic databases (PubMed, Embase, Clinical Trials and Cochrane Central) were searched up to November 2025 for studies reporting outcomes in advanced NSCLC patients treated with TROP-2-directed ADCs. Eligible studies included adult populations with advanced NSCLC that were treated with datopotamab deruxtecan, sacituzumab govitecan, or sacituzumab tirumotecan, and reported efficacy or safety outcomes. Pseudo-individual patient-level data for survival analyses were reconstructed from published Kaplan-Meier curves. Pooled effect sizes were estimated using random-effects meta-analytic models.

RESULTS:

Seven studies encompassing 1365 patients with advanced or metastatic NSCLC were included. The pooled median overall survival (OS) was 16.38 months (95 % CI: 11.17-22.96), and the median progression-free survival (PFS) was 6.08 months (95 % CI: 4.93-8.55). The objective response rate (ORR) across studies was 29 % (95 % CI: 19 %-39 %), with a disease control rate (DCR) of 79 % (95 % CI: 74 %-84 %). Subgroup analysis revealed patients with EGFR-mutated tumors had a significantly higher likelihood of response (risk ratio 1.70, 95 % CI: 1.11-2.61). Safety analysis showed treatment-emergent adverse events (TEAEs) in 98 % (95 % CI: 94 %-100 %), grade ≥ 3 TEAEs in 52 % (95 % CI: 38 %-67 %), and interstitial lung disease (ILD) in 9 % (95 % CI: 3 %-16 %).

CONCLUSION:

TROP-2-directed ADCs demonstrate meaningful efficacy in previously treated advanced NSCLC, especially among EGFR-mutant and non-squamous histology patients, with survival and response outcomes superior to traditional chemotherapy. However, high rates of adverse events, particularly ILD, necessitate close monitoring. Further randomized and biomarker-driven studies are warranted to refine patient selection and optimize the therapeutic potential of these agents.

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项与德达博妥单抗相关的新闻（医药）

2026-01-15

·知乎专栏

抗体偶联药物(ADC)制剂开发：核心要素解密与关键突破领域

在Antibody Therapeutics期刊上，药明合联偶联制剂开发团队发表了题为“Fundamental Properties and Principal Areas of Focus in Antibody-Drug Conjugates Formulation Development”[1]的综述论文。链接：。该论文首次全面综述并解析了全球已经上市的抗体偶联药物（ADC）的处方以及制剂策略，同时对早期制剂开发到最终药品生产全流程的研究重点进行了探讨，识别并分析了ADC制剂开发相较于裸抗的独特挑战并提出解决方案。值得关注的是，在目前已获批的17个ADC药物中，有15个为冻干制剂，ADC液体制剂开发存在挑战，主要源于ADC复杂的结构特性、独特的理化性质以及多样化的降解途径。此外，该综述还对ADC制剂开发的未来方向进行了展望，旨在推动这一革命性治疗模式的持续突破和创新。这篇综述论文主要内容包括如下几个方面：1.ADC制剂开发的关键点2.ADC制剂生产、储运和给药需要重点关注的关键点3.ADC稳定性的核心要素与制剂开发的挑战一、ADC制剂开发的关键点ADC制剂设计与开发需要关注分子可开发性、给药途径、剂型和剂量、药物相互作用和相容性研究、辅料和包材选择。分子可开发性：ADC可开发性评估是候选分子到成功药物的关键跨越。这一评估需要综合考虑抗体相关特性（比如：结构均一性、热稳定性、溶解性和靶点特异性）以及连接子-载荷的理化性质，并结合临床适应症和给药途径进行综合考量。研究人员通过优化连接子-载荷化学结构来改善ADC的粘度、溶解度和疏水性等理化性质，以提升皮下给药制剂的溶液稳定性。面对蛋白聚集和沉淀等浓度依赖性挑战（比如：戈沙妥珠单抗Sacituzumab govitecan（IMMU-132）及其相关化合物IMMU-130和IMMU-140），早期可开发性评估采用高通量筛选方法，在有限物料条件下评估多个候选分子，为后续的lead分子选择提供关键支持。给药途径：目前上市ADC药物均用于肿瘤适应症，且仅限于医疗机构内的静脉输注给药。由于载荷的局部沉积和毒性问题，其他给药途径在临床后期研究中应用较少。正在进行的ADC临床研究中，55%针对实体瘤，44%聚焦血液系统恶性肿瘤，1%探索非肿瘤适应症。随着ADC在慢性疾病领域的拓展和抗肿瘤药物皮下给药技术的发展，皮下注射作为替代方案脱颖而出。尽管Silverback公司的SBT6050（肿瘤）和AbbVie公司的ABBV-154（自身免疫疾病）等皮下制剂因疗效和安全性问题遭遇挫折，但该领域仍有不懈的探索者。例如：Heidelberg Pharma基于ATAC®平台的ADC（HDP-103）已披露积极的临床前结果，Alphamab公司的JSKN033——一种结合HER2靶向双表位ADC与PD-L1抑制剂的新型复方制剂，已推进至I/II期临床试验阶段。当前计划开发的Enhertu®皮下给药制剂，通过选择适中毒性的载荷以及优化的疏水性，与透明质酸酶ALT-B4联合开发成复方制剂。总之，生物制药行业对探索用于肿瘤和非肿瘤适应症的皮下ADC制剂的兴趣与日俱增，这一领域正迎来新的发展机遇。剂型和剂量：尽管液体制剂因其成本优势和便捷性，约三分之二的注射产品采用液体剂型。然而，ADC液体制剂相较于冻干往往面临更多稳定性挑战。上市17个ADC产品中，仅Elahere®和Akalux®两个产品是使用含有缓冲液、糖类和表面活性剂的液体剂型。ADC制剂开发需综合考虑裸抗稳定性、连接子和载荷的化学稳定性。随着创新连接子-载荷技术的发展和对各组分特性的深入理解，开发者需制定更加科学的制剂策略，实现剂型开发多样性。部分ADC剂量较低（Inotuzumab ozogamicin: 0.5 mg/m2, Moxetumomab pasudotox: 0.04 mg/kg, Loncastuximab tesirine: 0.075 mg/kg），可能会导致稀释过程中的吸附损失、聚集体增加和分析方法的挑战。通过使用静脉输液稳定剂，可在一定程度上缓解由载荷疏水性引起的表面吸附和稀释过程中的颗粒形成问题。药物相互作用和相容性研究：ADC与免疫治疗（ADC/IO）的联合策略已成为临床前和临床研究的重点。除inotuzumab ozogamicin和Moxetumomab pasudotox外，几乎所有获批ADC都在开展与免疫检查点调节剂的联合试验，可通过联合给药（co-administration）和复方制剂（co-formulation）两种形式实现给药。Co-administration的相容性研究主要集中在临床使用过程，由于缺乏与其他药物的化学或物理相容性数据，通常不建议使用同一输液系统。而co-formulation的开发则需要全面评估长期稳定性和潜在的药物相互作用，以透明质酸酶为基础的复方制剂开发就是典型案例，需要确保酶组分不影响ADC的释药机制、关键质量属性和安全性，同时ADC制剂也需维持酶的活性，实现两者的稳定共存。辅料和包材的选择：上市ADC制剂常用的辅料系统，包括缓冲液、冻干保护剂和表面活性剂。缓冲液包括组氨酸、MES、柠檬酸盐、磷酸盐、Tris、琥珀酸盐和醋酸盐，pH范围为5.0~8.0。 Mylotarg®、Besponsa®和Trodelvy®采用相对较高的pH值（pH7.5, pH8.0和pH6.5）以保护分子中酸敏感的化学键。冻干工艺因其能维持长期储存过程中ADC分子完整性并减少载荷提前释放，仍是大多数ADC的首选策略。冻干过程中的冷冻和干燥应力可能导致蛋白变性，通常选用具有适中玻璃化转变温度（Tg’）的糖类作为冻干保护剂。创新辅料的应用为ADC制剂开发带来新机遇。先进的容器密封系统为ADC制剂提供了针对性解决方案，等离子体脉冲化学气相沉积和烘烤涂层等表面改性技术可改善冻干雾化和溶液残留问题。对于光敏药物，可采用棕色西林瓶和避光标签来提供保护，例如：Mylotarg®, Besponsa®, Enhertu®, Akalux®, Datroway®等5款ADC选用了棕色西林瓶作为包材。二、ADC制剂生产、储运和给药的关键点ADC生产工艺开发中，首要目标是建立稳健的工艺，持续交付质量合格的产品。抗体药物偶联比（DAR值）是关键质量指标，直接影响ADC疗效、安全性和稳定性。由于ADC最终产品通常是具有不同偶联比的混合物，且载荷多为高细胞毒性化合物，因此需要建立更高的生产标准和严格的控制措施。基于产品安全（降低交叉污染风险）和职业暴露限值（OEL）的考虑，ADC制剂生产通常采用一次性塑料耗材。对于直接接触ADC的塑料组件系统产生工艺相关可提取物，USP<1665>建议采用标准化提取方案，包含了酸性、碱性和有机提取溶剂。鉴于ADC结构特殊性，在储存和运输过程中需控制温度，以防止游离药物的释放和降解产物形成。适宜的原液容器密封系统可有效降低质量影响，适宜的选项包括可耐受-90℃的聚碳酸酯（PC）和高密度聚乙烯（HDPE）瓶、脆化温度为-40℃的聚对苯二甲酸乙二酯共聚物（PETG）瓶以及用于低温储存的乙烯-醋酸乙烯酯（EVA）袋。ADC药物被列入2024年NIOSH危险药物清单中。封闭系统转移装置（CSTD）在配制和给药过程中可提供关键保护，其使用需测试理化相容性和剂量回收率。关键评估点包括：机械应力和设备润滑剂产生的颗粒、吸附和死体积导致的药物损失，以及潜在的蛋白聚集问题。值得注意的是，输液组件中0.2 µm在线过滤器的使用对于维持USP<787>规定的颗粒水平至关重要。三、ADC稳定性的核心要素与制剂开发的挑战ADC结构的复杂性要求我们在制剂开发中特别关注其独特的稳定性问题。如图1所示，ADC稳定性研究可从多个维度分析，包括裸抗、连接子和载荷等单个组分的稳定性，以及整个偶联组装体的稳定性。裸抗：尽管ADC与裸抗具有相似的二级和三级结构，但ADC通常表现出较低的构象稳定性和胶体稳定性。与裸抗相比，ADC具有更低的溶解温度，对热应力更敏感。此外，偶联位点周围疏水性增加，导致更高的聚集倾向。离子强度可影响ADC的盐溶/盐析行为，高离子浓度会减弱电荷排斥力，增加蛋白-蛋白相互作用。ADC分子同时也会保留抗体的化学降解性质，包括脱酰胺、异构化、断裂和氧化。连接子：作为裸抗和载荷的桥梁，连接子需要在循环系统中保持稳定，同时在特定条件下实现可控释放。连接子稳定性可分为药物-连接子不稳定性和抗体-连接子不稳定性。上市ADC产品中，无论是可切割还是不可切割连接子，均存在一定程度的不稳定性。例如，某ADC在15℃液态储存2个月后，游离药物释放可达总药量的5% ~ 6%。载荷：ADC制剂开发中需关注光稳定性、疏水性和降解特性。偶联方式：偶联技术已从传统的赖氨酸酰胺偶联、半胱氨酸马来酰亚胺烷基化，发展到非天然氨基酸工程、二硫键重桥接、酶促偶联和糖连接等多种创新方法。不同的偶联方式带来不同的稳定性。DAR值和药物负载分布是ADC产品质量的关键。研究表明，高DAR值ADC在高离子强度盐环境中更易形成可溶性和不溶性聚集体。图1 ADC稳定性的核心要素与制剂开发的挑战参考文献： 1. Lili Wen, Yuanyuan Zhang, Chenxi Sun, Shawn Shouye Wang, Yuhui Gong, Chunyuan Jia, Jianjun Luo. Fundamental Properties and Principal Areas of Focus in Antibody-Drug Conjugates Formulation Development. Antibody Therapeutics. 2025. 8 (2): 99-110.关于药明合联药明合联生物技术有限公司 (股票代码：)是全球领先的生物偶联药合同研究、开发和生产企业（CRDMO），专注于提供抗体偶联药物(ADC)等生物偶联药端到端服务，涵盖抗体或其他偶联药中间体、连接子/化学有效载荷、偶联原液及制剂等研发和GMP生产领域。更多信息，请查询：。

抗体药物偶联物临床结果CSCO会议

2026-01-14

·FiercePharma

JPM26: AstraZeneca's $80B revenue target 'very much within reach,' CFO says

The number of new molecules or in-market drugs with late-stage label expansion programs has grown to 37 at AstraZeneca in 2025, compared with 27 in 2021. AstraZeneca’s $80 billion revenue target for 2030 is “very much within reach,” Chief Financial Officer Aradhana Sarin said at the J.P. Morgan Healthcare Conference Tuesday.“If we have the same success rate this year as we had last year of our phase 3s, then I think the confidence increases even further,” she said.Within the drugmaker's oncology portfolio alone, AZ had 10 positive phase 3 readouts last year, which gave the company “a lot of cards that we get to play between now and 2030,” oncology business chief Dave Fredrickson said at the event.The number of new molecules or in-market drugs with late-stage label expansion opportunities at AstraZeneca grew to 37 in 2025 compared with 27 in 2021, according to a presentation by Sarin. At the same time, the non-risk-adjusted value per indication of those meds has also increased to about $1.3 billion in 2025 from about $700 million previously.As Sarin noted, analysts’ projections for AZ in 2030 have risen to match that $80 billion target, versus a consensus estimate of $67 billion when the company first floated the goal in May 2024.Within the oncology portfolio, Fredrickson suggested the PD-L1 inhibitor Imfinzi will likely be AZ’s largest oncology medicine by sales “in the midterm period” thanks to a series of new indications such as perioperative gastric cancer. But perhaps more important is the upcoming phase 3 Avanza readout for AZ and Daiichi Sankyo’s TROP2 ADC Datroway and Imfinzi in first-line metastatic non-small cell lung cancer (NSCLC).“We have very little sales of Imfinzi in stage 4 lung cancer, so this would be a really nice opportunity to grow into that setting,” Fredrickson said.If that effort is successful, Imfinzi would supplant Tagrisso, which has been AZ’s largest oncology product for a long time. In the first nine months of 2025, Tagrisso’s sales grew 10% year over year to nearly $5.4 billion, while Imfinzi’s haul jumped 25%, reaching $4.3 billion.“That doesn’t mean Tagrisso is not going to be doing well,” Fredrickson added. “It’s just because I think Imfinzi has got more engines to grow off of.” As the longtime EGFR inhibitor king, Tagrisso is facing a threat from Johnson & Johnson’s combination of Rybrevant and Lazcluze, which beat the AZ med in a head-to-head phase 3 in first-line EGFR-mutant NSCLC.“We’re continuously looking for opportunities to raise the bar and beat Tagrisso right now,” Fredrickson said. “The near- and mid-term opportunities to do that are through Tagrisso combinations.”The phase 3 Flaura2 trial recently showed that Tagrisso’s combination with chemo could help first-line patients live longer than Tagrisso alone. The readout spurred an interest among doctors to favor the combo, instead of Tagrisso monotherapy, for most patients, according to Fredrickson.Beyond chemotherapy, AZ is weighing whether to add Datroway to Tagrisso in the front-line setting.“Ideally, we’d like to be able to bring in other ADC combos with Tagrisso into the space as well,” Fredrickson said.Outside of oncology, analysts have high hopes for AZ’s Ionis-partnered transthyretin amyloidosis (ATTR) drug Wainua, which is expected to read out phase 3 ATTR-cardiomyopathy data in the second half of 2026. The Cardio-TTRansform trial is the largest ever done in ATTR-CM, and, perhaps more importantly, it could have data on whether Wainua works on top of Pfizer’s blockbuster Vyndamax (tafamidis).AZ boasts a strong presence in cardiovascular disease, including with Farxiga, and its experimental hypertension drug baxdrostat is under FDA priority review with a decision expected in the second quarter. AZ was among the first large pharma companies to have signed a most-favored-nation drug pricing deal with the Trump administration.“I think one of the things that we were encouraged by with the administration [is] that the administration understood the nuanced aspects of ensuring that life sciences continue to be competitive and robust within the United States,” Sarin said, “and that meant a phased approach to the work that we're doing.”That phased approach lies in the fact that beginning in 2026, MFN is going to first touch Medicaid, which according to Sarin represents only a low-single-digit percentage of global sales for AZ over time.“It will grow to represent multiple channels of business and multiple medicines, but it gives us the opportunity to plan to get towards that and to offset by increasing funding for innovation across the globe as the U.S. prices come down,” Sarin said.

临床3期优先审批

2026-01-14

·肿瘤界

年终盘点 | 2025年NMPA批准了哪些抗肿瘤新药？

点击蓝字关注我们前言随着抗肿瘤药物研发的持续推进，新药的批准上市不仅为临床医生提供了对抗肿瘤的新武器，也为患者带来了更高效、更安全的治疗方案。回顾2025年，中国国家药品监督管理局（NMPA）批准的抗肿瘤新药及新适应症数量再创新高，分别涵盖肺癌、乳腺癌、消化系统肿瘤、血液系统肿瘤、泌尿系统肿瘤、妇科肿瘤等多个瘤种。本文按癌种对获批新药进行了分类整理，以飨读者。肺癌马来酸美凡厄替尼片（商品名：迈瑞东）用于具有表皮生长因子受体（EGFR）外显子21（L858R）置换突变的局部晚期或转移性非小细胞肺癌成人患者的一线治疗宗艾替尼片（商品名：圣赫途）单药适用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌成人患者地罗阿克片（商品名：轩菲宁）单药适用于未经过间变性淋巴瘤激酶（ALK）抑制剂治疗的ALK阳性的局部晚期或转移性非小细胞肺癌患者的治疗注射用瑞康曲妥珠单抗（商品名：艾维达）单药适用于治疗存在HER2（ERBB2）激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌成人患者枸橼酸戈来雷塞片（商品名：艾瑞凯）用于至少接受过一种系统性治疗的鼠类肉瘤病毒癌基因（KRAS）G12C突变型的晚期非小细胞肺癌成人患者利厄替尼片（商品名：奥壹新）用于既往经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂治疗时或治疗后出现疾病进展,并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性非小细胞肺癌成人患者乳腺癌库莫西利胶囊（商品名：赛坦欣）用于既往接受内分泌治疗后出现疾病进展的激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性的局部晚期或转移性乳腺癌成人患者，与氟维司群联合治疗注射用博度曲妥珠单抗（商品名：舒泰莱）用于既往接受过一种或一种以上抗HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌患者注射用德达博妥单抗（商品名：达卓优）用于治疗既往接受过内分泌治疗且在晚期疾病阶段接受过至少一线化疗的不可切除或转移性的HR阳性、HER2阴性（IHC 0、IHC 1+或IHC 2+/ISH-）乳腺癌成人患者酒石酸泰瑞西利胶囊（商品名：康美纳）联合氟维司群，适用于既往接受内分泌治疗后进展的HR阳性、HER2阴性局部晚期或转移性成年乳腺癌患者枸橼酸伏维西利胶囊（商品名：复妥宁）联合氟维司群，适用于既往接受内分泌治疗后出现疾病进展的HR阳性、HER2阴性复发或转移性成年乳腺癌患者盐酸来罗西利片（商品名：汝佳宁）用于HR阳性、HER2阴性局部晚期或转移性乳腺癌成人患者：与芳香化酶抑制剂联合使用作为初始内分泌治疗；与氟维司群联合用于既往接受内分泌治疗后疾病进展的患者吡洛西利片（商品名：轩悦宁）用于HR阳性、HER2阴性晚期或转移性乳腺癌成人患者：与氟维司群联合用于既往接受内分泌治疗后出现疾病进展的患者；单药用于既往转移性阶段接受过两种及以上内分泌治疗和一种化疗后出现疾病进展的患者卡匹色替片（商品名：荃科得）联合氟维司群用于转移性阶段至少接受过一种内分泌治疗后疾病进展，或在辅助治疗期间或完成辅助治疗后12个月内复发的HR阳性、HER2阴性且伴有一种或多种PIK3CA/AKT1/PTEN改变的局部晚期或转移性乳腺癌成人患者伊那利塞片（商品名：伊赫莱）联合哌柏西利和氟维司群,适用于内分泌治疗耐药（包括在辅助内分泌治疗期间或之后出现复发）、PIK3CA突变、HR阳性、HER2阴性的局部晚期或转移性乳腺癌成人患者妇科肿瘤注射用苏维西塔单抗（商品名：恩泽舒）苏维西塔单抗联合紫杉醇、多柔比星脂质体或拓扑替康用于铂耐药后接受过不超过1种系统治疗的成人复发性卵巢癌、输卵管癌或原发性腹膜癌的治疗苹果酸法米替尼胶囊（商品名：艾比特）联合注射用卡瑞利珠单抗用于既往接受含铂化疗治疗失败但未接受过贝伐珠单抗治疗的复发或转移性宫颈癌患者塞纳帕利胶囊（商品名：派舒宁）用于晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者在一线含铂化疗达到完全缓解或部分缓解后的维持治疗前列腺癌氘恩扎鲁胺软胶囊（商品名：海纳安）用于接受醋酸阿比特龙及化疗后出现疾病进展，且既往未接受新型雄激素受体抑制剂的转移性去势抵抗性前列腺癌（mCRPC）成人患者胆道癌注射用泽尼达妥单抗（商品名：百赫安）用于既往接受过全身治疗的HER2高表达（IHC3+）的不可切除局部晚期或转移性胆道癌患者头颈部肿瘤菲诺利单抗注射液（商品名：安佑平）与含铂化疗联合用于复发性和/或转移性头颈部鳞状细胞癌的一线治疗注射用维贝柯妥塔单抗（商品名：美佑恒）用于治疗既往经至少二线系统化疗和PD-1/PD-L1抑制剂治疗失败的复发/转移性鼻咽癌的成人患者腱鞘巨细胞瘤盐酸匹米替尼胶囊（商品名：贝捷迈）用于治疗手术切除可能会导致功能受限或出现较严重并发症的症状性腱鞘巨细胞瘤（TGCT）成年患者血液系统肿瘤普基奥仑赛注射液（商品名：普利得凯）用于治疗3-21岁CD19阳性的难治或复发（首次缓解12个月后复发需经挽救化疗）的急性B淋巴细胞白血病患者泽美妥司他片（商品名：艾瑞璟）用于既往接受过至少1线系统性治疗的复发或难治外周T细胞淋巴瘤成人患者雷尼基奥仑赛注射液（商品名：恒凯莱）用于治疗经过二线或以上系统性治疗后成人复发或难治性大B细胞淋巴瘤，包括弥漫性大B细胞淋巴瘤非特指型、滤泡性淋巴瘤转化的弥漫性大B细胞淋巴瘤、伴MYC和BCL2重排的高级别B细胞淋巴瘤、高级别B细胞淋巴瘤非特指型利沙托克拉片（商品名：利生妥）用于既往经过至少包含布鲁顿酪氨酸激酶（BTK）抑制剂在内的一种系统治疗的成人慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者注射用盐酸伊吡诺司他（商品名：贝特琳）单药适用于既往接受过至少两线系统性治疗的复发或难治性弥漫性大B细胞淋巴瘤成人患者盐酸吉卡昔替尼片（商品名：泽普平）用于中危或高危原发性骨髓纤维化（PMF）、真性红细胞增多症继发性骨髓纤维化（PPV-MF）和原发性血小板增多症继发性骨髓纤维化（PET-MF）的成人患者，治疗疾病相关脾肿大或疾病相关症状其他佐来曲替尼片（商品名：宜诺欣）用于符合下列条件的成人和12岁以上青少年实体瘤患者：经充分验证的检测方法诊断为携带神经营养酪氨酸受体激酶（NTRK）融合基因且不包括已知获得性耐药突变，患有局部晚期、转移性疾病或手术切除可能导致严重并发症的患者，以及无满意替代治疗或既往治疗失败的患者芦沃美替尼片（商品名：复迈宁）用于朗格汉斯细胞组织细胞增生症（LCH）和组织细胞肿瘤成人患者；2岁及2岁以上伴有症状、无法手术的丛状神经纤维瘤（PN）的I型神经纤维瘤病（NF1）儿童及青少年患者注射用磷罗拉匹坦帕洛诺司琼（商品名：瑞坦宁）用于预防成人高度致吐性化疗（HEC）引起的急性和迟发性恶心和呕吐注射用阿格司亭α（商品名：迈粒生）用于成年非髓性恶性肿瘤患者在接受容易引起发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时，降低以发热性中性粒细胞减少症为表现的感染发生率以上获批信息均源自“国家药品监督管理局”官网。推荐阅读 ● 年终盘点 | 2024年各癌种NMPA适应证获批情况一览 ● 年终盘点 | 2023年NMPA批准了哪些抗肿瘤新药？ ● 2022新药盘点丨肿瘤领域NMPA获批新药汇总声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：医脉通肿瘤科编辑：Lagertha 审核：素问

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

10 条最早获批的记录,

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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

10 条进展最快的记录,

后查看更多信息

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	中国	Baxter Oncology GmbH	2025-12-22
三阴性乳腺癌	申请上市	中国	Daiichi Sankyo Europe GmbH	2025-12-22
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2024-11-12
EGFR突变的非小细胞肺癌	申请上市	美国	AstraZeneca PLC	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

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


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	艱網淵選膚範選鬱壓鏇(鹹憲網醖繭製衊淵遞鏇) = 糧鹹醖選構壓壓鏇憲遞簾憲膚獵夢簾鹹顧壓簾 (範淵顧積艱鹹齋製築範, 0.7 ~ not reached) 更多	积极	2025-12-10
				Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV (ADC-naïve patients)	艱網淵選膚範選鬱壓鏇(鹹憲網醖繭製衊淵遞鏇) = 獵憲醖醖顧餘選衊鏇顧簾憲膚獵夢簾鹹顧壓簾 (範淵顧積艱鹹齋製築範 ) 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)	夢窪鬱選鬱醖鑰遞網製(鹽願廠鑰壓壓齋淵顧齋) = 簾襯鏇夢鏇糧襯積簾憲壓醖獵顧膚窪壓顧糧鑰 (餘糧鏇鏇壓襯鏇觸製艱, 19.8 ~ 25.6) 更多	积极	2025-10-17
				Investigator’s choice of chemotherapy (ICC)	夢窪鬱選鬱醖鑰遞網製(鹽願廠鑰壓壓齋淵顧齋) = 憲築襯憲壓憲獵觸遞餘壓醖獵顧膚窪壓顧糧鑰 (餘糧鏇鏇壓襯鏇觸製艱, 16.0 ~ 21.8) 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	選餘鹹膚遞膚觸廠獵淵 \| 範糧餘蓋憲蓋選夢艱築(襯壓顧衊網窪構網壓顧) = 壓蓋襯獵遞簾醖觸遞鏇鏇蓋鑰網醖積齋齋窪獵 (糧獵醖蓋遞壓憲窪範顧, 10.5 ~ 27.3) 更多	积极	2025-10-17
				Dato-DXd + durvalumabDurvalumab (PD-L1-high)	範糧餘蓋憲蓋選夢艱築 \| 襯齋衊築鑰淵鹹鹹鹹遞(範觸蓋襯獵糧觸選夢艱) = 積壓廠蓋願膚蓋觸糧願簾範願蓋鏇繭範壓餘廠 (鹽艱餘鹹構製衊觸網願, 64.5 ~ 93.0) 更多
NCT05489211 (TROPION-PanTumor03, ESMO2025)	临床2期	局部晚期尿路上皮癌二线 \| 一线	40	Dato-DXd + rilvegostomig (1L population)	艱簾鑰築顧淵艱獵憲糧(夢鬱艱顧廠鹽築觸糧網) = 網鹹窪鑰範願鹽觸鏇簾獵淵鑰選繭淵鹽製鑰餘 (繭積鏇積壓積鹹製遞鬱 ) 更多	积极	2025-10-17
				Dato-DXd + rilvegostomig (2L population)	艱簾鑰築顧淵艱獵憲糧(夢鬱艱顧廠鹽築觸糧網) = 艱網鬱簾衊鹽襯簾鬱襯獵淵鑰選繭淵鹽製鑰餘 (繭積鏇積壓積鹹製遞鬱 ) 更多
NCT05374512 (TROPION-Breast02, Company_Website) 人工标引	临床3期	转移性三阴性乳腺癌一线 Hormone Receptor Negative \| HER2 Negative	-	Datroway	築鹽壓網遞鹽糧觸蓋廠(醖構艱淵鹹蓋醖醖顧觸) = Datroway demonstrated a statistically significant and clinically meaningful improvement for overall survival compared to investigator's choice of chemotherapy. 鹹壓糧選築範淵鹹襯獵 (壓糧壓壓蓋糧鑰醖積願 ) 更多	积极	2025-10-06
				chemotherapy
NCT04656652 (TROPION-Lung 01 \| TROPION-Lung01, CTgov)	临床3期	转移性非小细胞肺癌	605	DS-1062a (DS-1062a 6.0 mg/kg)	積憲憲鏇製簾襯構製醖(觸壓艱糧醖廠積憲艱選) = 鹹醖壓齋顧淵製廠願選廠觸壓衊構繭艱憲壓鏇 (製蓋鬱膚艱築鬱齋獵簾, 襯製齋蓋網廠廠構範製 ~ 網鏇簾網繭構鹽壓壓獵) 更多	-	2025-07-23
				Docetaxel (Docetaxel 75 mg/m^2)	積憲憲鏇製簾襯構製醖(觸壓艱糧醖廠積憲艱選) = 憲鹹壓簾齋夢膚鑰憲蓋廠觸壓衊構繭艱憲壓鏇 (製蓋鬱膚艱築鬱齋獵簾, 憲鏇壓獵鹽憲餘鑰觸獵 ~ 夢鑰顧鹹糧簾壓簾衊糧) 更多
NCT04484142 \| NCT04656652 (TROPION-Lung01, FDA_CDER) 人工标引	N/A	EGFR突变的非小细胞肺癌 EGFR Mutation	114	DATROWAY (DATROWAY TL05)	構鑰衊獵願糧鏇糧願獵(獵顧窪齋築艱獵淵齋選) = 壓夢獵蓋製鏇積醖構蓋窪顧蓋壓製範鏇淵積鏇 (鹽衊繭醖襯製鹽繭構築, 34 ~ 57) 更多	积极	2025-06-23
				DATROWAY (DATROWAY TL01)	構鑰衊獵願糧鏇糧願獵(獵顧窪齋築艱獵淵齋選) = 築觸膚蓋獵繭餘構築顧窪顧蓋壓製範鏇淵積鏇 (鹽衊繭醖襯製鹽繭構築, 27 ~ 61) 更多
NCT04526691 (TROPION-Lung02, ASCO2025) 人工标引	临床1期	晚期非小细胞肺癌一线	96	Datopotamab deruxtecan + pembrolizumab	餘鬱獵夢構範艱窪鹹壓(鑰鑰衊鑰廠範糧願壓觸) = 膚糧醖願醖獵膚餘鑰遞蓋構顧鹹衊壓醖艱製構 (選衊憲衊構壓窪齋鹹選 ) 更多	积极	2025-05-30
				Datopotamab deruxtecan + pembrolizumab + platinum chemotherapy	餘鬱獵夢構範艱窪鹹壓(鑰鑰衊鑰廠範糧願壓觸) = 遞顧鏇範夢蓋鑰獵衊艱蓋構顧鹹衊壓醖艱製構 (選衊憲衊構壓窪齋鹹選 ) 更多
ASCO2025	N/A	转移性非小细胞肺癌 Anti-TROP-2	-	Datopotamab deruxtecan (Dato-DXd)	齋遞鹽願範夢膚餘餘鬱(壓鏇積範鹽膚醖獵鹹鑰) = 廠鑰簾壓遞遞積鑰蓋廠鏇鹹鏇積鏇艱顧衊網積 (艱獵鹽艱膚鏇夢醖鬱醖 ) 更多	不佳	2025-05-30
				Sacituzumab govitecan (SG)	齋遞鹽願範夢膚餘餘鬱(壓鏇積範鹽膚醖獵鹹鑰) = 窪鏇構廠簾築鏇鏇鏇觸鏇鹹鏇積鏇艱顧衊網積 (艱獵鹽艱膚鏇夢醖鬱醖 ) 更多
NCT04612751 (TROPION-Lung04 (cohort 5), ASCO2025)	临床1期	转移性非小细胞肺癌一线 PD-L1 tumor proportion score [TPS]	40	Dato-DXd + rilvegostomig	觸淵網壓觸蓋蓋窪選鹹(憲淵衊鬱鏇醖構襯憲窪) = 鑰製淵積築衊鏇觸淵醖鬱壓簾憲衊選願艱窪構 (襯壓範繭鹹製糧遞醖蓋, 40.9 ~ 73.0) 更多	积极	2025-05-30