德曲妥珠单抗(Fam-trastuzumab deruxtecan-NXKI) - 药物靶点：HER2 x TOP1_在研适应症：HER2阳性胃腺癌，HR阳性/HER2阳性乳腺癌，HER2突变型非小细胞肺癌_专利_临床

概要

基本信息

药物类型

ADC

别名

Fam-trastuzumab deruxtecan、T-DXd、Trastuzumab deruxtecan

+ [13]

靶点

HER2 x TOP1

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)

治疗领域

肿瘤消化系统疾病呼吸系统疾病+ [5]

在研适应症

HER2阳性胃腺癌HR阳性/HER2阳性乳腺癌HER2突变型非小细胞肺癌+ [48]

非在研适应症

晚期胃食管交界处腺癌HER2阳性尿路上皮癌尿路上皮癌

原研机构

Daiichi Sankyo Co., Ltd.

在研机构

Daiichi Sankyo Co., Ltd.

Daiichi Sankyo, Inc.

AstraZeneca PLC

+ [8]

非在研机构

台湾第一三共股份有限公司

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

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

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序列信息

Sequence Code 18481L

来源: *****

Sequence Code 44772H

来源: *****

关联

133

项与德曲妥珠单抗相关的临床试验

NCT06364410 / Recruiting临床1期IIT

Phase 1 Study of Trastuzumab Deruxtecan (DS-8201a) in Combination With Azenosertib (ZN-c3) in HER2-Expressing/Amplified Cyclin E-Amplified Gastric/Gastroesophageal Junction Cancer and Other Solid Tumors With HER2 Expression

This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive and cyclin E amplified gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. 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 cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone.

开始日期2025-07-07

申办/合作机构

National Cancer Institute

NCT06585969 / Not yet recruiting临床3期IIT

A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer

The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative metastatic breast cancer

开始日期2025-05-01

申办/合作机构

Danish Breast Cancer Cooperative Group

NCT06680596 / Not yet recruiting临床2期IIT

A ctDNA Screening Program in Patients With HR+, HER2 Low Metastatic Breast Cancer for Detection of High-risk Relapse Patients on Any CDK4/6 Inhibitor Followed by a Single Arm Phase II Trial of Trastuzumab-deruxtecan in Patients With Persistent ctDNA After 1 Month of Treatment With Endocrine Therapy Combined With CDK4/6 Inhibitor

After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the efficacy of trastuzumab deruxtecan in terms of progression-free survival (PFS).

开始日期2025-03-30

申办/合作机构

UNICANCER

[+2]

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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683

项与德曲妥珠单抗相关的文献（医药）

2025-01-01·Current cancer drug targets

Twenty-four-month Progression-free Survival in HER2-amplified Advanced Gastric Cancer with Brain Metastases after Trastuzumab Deruxtecan Treatment: A Case Report and Literature Review

作者: Xu, Min ; Zhang, Haibo

Background::

Trastuzumab deruxtecan (T-DXd) has shown promising outcomes as a second or subsequent-line treatment for human epidermal growth factor-2 (HER2)-positive advanced gastric or gastroesophageal junction cancer.

Case Presentation::

We reported a 49-year-old male patient with stage IV HER2-amplified gastric cancer. Despite extensive pretreatments, including first-line trastuzumab plus FOLFOX, second-- line trastuzumab plus FOLFOX, followed by traditional Chinese medicine, third-line nivolumab plus trastuzumab, fourth-line pyrotinib plus paclitaxel and five hepatic arterial chemoembolization procedures, and fifth-line pembrolizumab plus nab-paclitaxel and thoracic radiotherapy, the patient experienced disease progression. In April 2021, T-DXd was initiated as the sixth-line therapy in combination with radiotherapy for brain metastases. After one treatment cycle, the patient achieved a partial response. T-DXd was discontinued in August 2022 due to recurrent anemia attributed to cardiac stenosis-related bleeding.

Conclusion::

The condition of the patient remained stable until May 2023, indicating a progression- free survival of over 24 months. This case suggests that T-DXd may offer long-term clinical benefits in patients with HER2-amplified advanced gastric cancer with brain metastases.

2024-12-10·JOURNAL OF CLINICAL ONCOLOGY

Human Epidermal Growth Factor Receptor 2 Pan Tumor Indication for Trastuzumab Deruxtecan

Article

作者: Mau-Sørensen, Morten ; Lænkholm, Anne-Vibeke ; Jørgensen, Jan Trøst ; Egebjerg, Kristian

2024-12-05·NEW ENGLAND JOURNAL OF MEDICINE

Trastuzumab Deruxtecan after Endocrine Therapy in Metastatic Breast Cancer

Article

作者: Ke, Jun ; Begbie, Natasha ; Hu, Xichun ; Bardia, Aditya ; Saura, Cristina ; Curigliano, Giuseppe ; Patel, Gargi ; O'Shaughnessy, Joyce A ; Lévy, Christelle ; Sohn, Joohyuk ; Yonemori, Kan ; Dent, Rebecca ; Wildiers, Hans ; Zhang, Qingyuan ; Biganzoli, Laura ; Im, Seock-Ah ; Pierga, Jean-Yves ; Barrios, Carlos H ; Jacot, William

BACKGROUND:

Outcomes in patients with hormone receptor-positive metastatic breast cancer worsen after one or more lines of endocrine-based therapy. Trastuzumab deruxtecan has shown efficacy in patients with metastatic breast cancer with low expression of human epidermal growth factor receptor 2 (HER2) after previous chemotherapy.

METHODS:

We conducted a phase 3, multicenter, open-label trial involving patients with hormone receptor-positive metastatic breast cancer with low HER2 expression (a score of 1+ or 2+ on immunohistochemical [IHC] analysis and negative results on in situ hybridization) or ultralow HER2 expression (IHC 0 with membrane staining) who had received one or more lines of endocrine-based therapy and no previous chemotherapy for metastatic breast cancer. Patients were randomly assigned in a 1:1 ratio to receive trastuzumab deruxtecan or the physician's choice of chemotherapy. The primary end point was progression-free survival (according to blinded independent central review) among the patients with HER2-low disease. Secondary end points included progression-free survival among all the patients who had undergone randomization, overall survival, and safety.

RESULTS:

Of the 866 patients who underwent randomization, 713 had HER2-low disease, and 153 had HER2-ultralow disease. Among the patients with HER2-low disease, the median progression-free survival was 13.2 months (95% confidence interval [CI], 11.4 to 15.2) in the trastuzumab deruxtecan group and 8.1 months (95% CI, 7.0 to 9.0) in the chemotherapy group (hazard ratio for disease progression or death, 0.62; 95% CI, 0.51 to 0.74; P<0.001); the results were consistent in the exploratory HER2-ultralow population. Data for overall survival were immature. Adverse events of grade 3 or higher occurred in 52.8% of the patients in the trastuzumab deruxtecan group and in 44.4% of those in the chemotherapy group. Adjudicated interstitial lung disease or pneumonitis occurred in 49 patients (11.3%; three events were grade 5 in severity) and in 1 patient (0.2%; grade 2), respectively.

CONCLUSIONS:

Among patients with hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer who had received one or more lines of endocrine-based therapy, treatment with trastuzumab deruxtecan resulted in longer progression-free survival than chemotherapy. No new safety signals were identified. (Funded by AstraZeneca and Daiichi Sankyo; DESTINY-Breast06 ClinicalTrials.gov number, NCT04494425.).

2,614

项与德曲妥珠单抗相关的新闻（医药）

22 小时之前

·PRNewswire

BioView Presents Promising Results from Their Joint Liquid Biopsy Development Project

Results Presented at the Prestigious AACR International Liquid Biopsy Conference TEL AVIV, Israel, Dec. 18, 2024 /PRNewswire/ -- BioView Ltd. (TASE: BIOV), a company developing advanced medical imaging systems for cancer cell detection, traded on the Tel Aviv Stock Exchange, today announced the completion of the first stage of its joint project with a partner from the UK. The companies presented results from their collaborative liquid biopsy development effort at the prestigious AACR International Liquid Biopsy Conference. The two companies are co-developing an innovative liquid biopsy test to detect HER2 genetic amplification and protein expression in circulating tumor cells (CTCs) collected from the blood of metastatic breast cancer (MBC) patients. The kit combines a microfluidic CTC enrichment system together with BioView's advanced AI based automated imaging and analysis technology, offering a practical and safer methodology compared to traditional tissue biopsies for repeated patient examination. CTCs, cancerous cells released from primary tumors or metastases into the bloodstream, can be analyzed using a simple blood test. This approach enables HER2 status monitoring without the risks and complications associated with tissue biopsies. Additionally, it provides a more comprehensive representation of HER2 expression in both primary and metastatic tumors, unlike tissue biopsies which are confined to specific tumor regions. Promising Results and Key Insights The study analyzed blood samples from 43 metastatic breast cancer patients. Notably, three out of five patients initially classified as HER2-negative via tissue biopsy were later identified as HER2-positive using the liquid biopsy test. These findings highlight the test's potential as a complementary tool to tissue biopsies, enabling real-time monitoring of HER2 status changes post-diagnosis and improving treatment decisions. According to the U.S. National Institutes of Health (NIH), approximately 81% of breast cancer patients are HER2-negative at initial diagnosis. Studies indicate this status may change over time. Liquid biopsy blood tests can enable real-time monitoring of such patients, identifying those who may benefit from targeted HER2 therapies like Herceptin or Enhertu. Expert Commentary Dr. Chassidy Johnson, Chief Scientist at BioView, stated: "The results from our joint development presented at the AACR conference mark a significant milestone. They underscore the analytical power of our test to identify diverse HER2 expressions and its potential to identify patients who could benefit from advanced HER2-targeted therapies." For more information: Gilad Mandel [email protected] SOURCE BioView Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AACR会议临床结果

2024-12-18

·医药地理

从上市到销售，ADC发展步入新周期

近期ADC（抗体偶联药物）领域消息不断，两款药物新进2024年医保目录、映恩生物与GSK达成独家授权协议、首个靶向CD19的替朗妥昔单抗获批，涵盖研发、上市、准入等多个环节。获批分析基于Pharma-ONE中国上市药品数据库，截至2024.12.11，共有11个ADC产品获批。从2020年起，每年都至少有1个ADC获批上市，分布较为平均，同时2024年批准数量创新高，11月下旬至12月上旬捷报频传，短短两周时间内市场迎来3个新成员。从企业角度分析，目前获批的大部分都是进口，只有2个国产（维迪西妥单抗、芦康沙妥珠单抗），而后备研发力量正不断提速，例如恒瑞医药SHR-A2102纳入拟突破性治疗名单等；从靶点角度分析，HER2出现频率最高，2020、2021、2023均有药物涉足；从适应症角度分析，除2021年外每年都有1个乳腺癌相关的产品获批，主要靶点为HER2或TROP2。图1 国内ADC产品每年获批数量统计医保分析基于Pharma-ONE医保目录数据库，已有5个ADC纳入了2024年国家医保目录，新增2个、续约3个。除了2023年外，医保目录自2021年起每个版本均新增ADC相关产品，国产的维迪西妥单抗以最短的准入时长首个进入目录，以平均准入时长1/3的速度在当年引起广泛热议。后续进入目录的ADC均耗时较长，普遍高于均值40%-60%，主要是由于早期未参加谈判或首次谈判未成功。另一方面，4个ADC在历经2023年目录的颗粒无收后，维泊妥珠单抗和德曲妥珠单抗在今年选择提前降价，并争取到新版医保目录的二席之地；奥加伊妥珠单抗和戈沙妥珠单抗如果能在2025年继续坚持，则准入跨度至少超过3年。图2 重点ADC产品谈判准入时长对比（准入时长=谈判新增通用名的医保公示时间-产品最早上市时间，2025*预测仅供参考）销售分析基于PDB药物综合数据库国内全渠道放大市场，统计所有ADC销售情况，可以发现，在2020年至2024上半年的周期内，产品数量稳步增长，除了戈沙妥珠单抗外，其他均于获批当年进入市场。进一步分析2024上半年7个ADC产品的市场占比，德曲妥珠单抗表现亮眼，因其价格力压前辈成为该领域金额TOP1；如果按照数量进行统计，则首个获批的恩美曲妥珠单抗及首个进入医保目录的维迪西妥单抗更具优势，两者相加超过60%。另外，无论是金额还是数量，奥加伊妥珠单抗和戈沙妥珠单抗都未表现出显著的市场需求，再加上高昂的价格，导致其连续两年都折戟国家医保目录。图3 国内全渠道放大市场ADC金额格局变化（2020、2022、2024H1）图4 国内全渠道放大市场ADC数量格局变化（2020、2022、2024H1）渠道分析基于PDB药物综合数据库和RPDB药品零售数据库，统计2024年医保ADC的渠道分布，进一步深挖全渠道同期市场。恩美曲妥珠单抗在院端优势较大，而随着德曲妥珠单抗的进一步降价，将继续保持该优势；线下零售药店则是另一番景象，德曲妥珠单抗占据明显优势，虽然医保执行后药店会同步调价，但数量效应影响更大。图5 医保ADC产品在不同终端的市场格局对比（以金额计，院端放大2024H1，线下药店放大2024Q1-Q3） END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

抗体药物偶联物上市批准引进/卖出医药出海

2024-12-18

·UmabsDB

第一三共研发日上的新分子

Umabs DB作为目前全球最全面的抗体药物专业数据库，收录全球近10000个从临床前到商业化阶段抗体药物，涉及靶点1600+，涉及疾病种类2400+，研发机构2900+，覆盖药物蛋白序列、专利和临床等多种专业信息。Umabs DB药物数据库已正式开放上线，可访问www.umabs.com注册享受7天免费试用。 2024年12月16-17日，第一三共召开2024年的研发日活动，介绍了公司的管理策略、财务预测、未来展望、研发信息以及一些特定的研发项目。从临床进展来看，第一三共此前主要依靠5款DXd ADC药物在商业化、临床以及商业拓展方面取得了巨大的成功，一己之力改变了下一代ADC药物研发的格局，当前第一三共将依靠五款现有ADC不断拓展临床应用，同时投入更多新型疗法的分子。乳腺癌方面，以HER2 ADC药物Enhertu为基石，不断拓展应用范围，从HER2阳性到低表达，到三阴乳腺癌，到HR阳性等多中人群，同时也逐步从后期到一线，一线到辅助治疗，多范围覆盖乳腺癌治疗。肺癌方面，同样如此，依靠TROP2 ADC和B7-H3 ADC，在非小细胞肺癌和小细胞肺癌多个阶段进行疗法探索。新分子方面，第一三共此前就介绍了MUC1的ADC药物DS-3939进展，这也是第六款DXD ADC药物，MUC1为肿瘤特异性相关靶点，在多种实体瘤中均有所表达。 DS-2243为一款NYESO的TCR双抗，根据UmabsDB数据库的记录，今年10月第一三共已经在clinical trials网站上，登记了一项NY-ESO TCR疗法药物DS-2243a，在滑膜肉瘤和非小细胞肺癌等多种实体瘤HLA-A2亚型患者中，启动一项1期临床试验NCT06644755，该临床于2024年11月启动，计划入组人数为150例。此外第一三共还介绍了最新研发更新、临床进展、转化研究和ADC制造与供应相关主题，并进行相关问题的交流，相关问答罗列如下： Q1. How will Dato-DXd and HER3-DXd be positioned in EGFR-mutatednon-small cell lung cancer (NSCLC)? Can they be used sequentially? A: Both agents offer efficacy with distinct safety profiles, allowingphysicians to tailor treatment. Studies are ongoing to understand DXdresistance mechanisms (target-vs. payload-related) to inform potentiasequential use strategies and maximize patient benefit. Q2. What are the advantages of the PBD payload, and why was Claudin6 chosen as the first target? A: The PBD payload provides an alternative to overcome DXd resistanceand allows sequencingflexibility,enhancing treatment options. Claudin6 was selected due to its relevance as a tumor antigen in cancers withhigh unmet needs,including gastric, ovarian, lung, and germ cell tumors 03.When will the OCS analysis results from the AVANZAR study beavailable,and what are the plans for the second-line pivotal trial? A: A pivotal second-line study will evaluate Dato-DXd against docetaxelinTROP2 QCS-positive patients with non-squamous NsCLC. This trial isexpected to begin soon. For the AVANZAR study, a pre-specified QCsanalysis will assess the efficacy of Dato-DXd, and the results areanticipated in the second half of 2025. Q4.ls QCS-NMR specific to non-squamous NsCLc? Can it be applied toother tumor types? A: The QCS-NMR biomarker was specifically optimized for use in non-squamous NSCLC.While its application to squamous NSCLC and othertumor types is being explored, no definitive data is currently available forthese populations. Q5.Beyond conventional lHC and QCS, are there additional biomarkerscritical for ADC development? A: While lHC works for some ADCs like T-DXd, it proved insufficient fo!Dato-DXd.To improve precision, digital and computational pathologyquantify target expression and its intracellular distribution. Otherbiomarkers are under investigation but remain in the early stages Q6. Are there plans to consolidate ADC manufacturing into a singlelocation for efficiency? A: While consolidating production into one location might appear moreefficient, we prioritize risk mitigation.Diversifying manufacturingprocesses across in-house facilities and CDMOs ensures greaterresilience,minimizing disruptions from potential risks. 更多有关抗体的研发格局、具体信息、专利及临床等动态进展，敬请访问Umabs DB全球数据库（www.umabs.com）查阅。拓展阅读：盘前大跌20%：affimed更新EGFR/CD16a双抗非小细胞肺癌二期临床数据科伦启动B7H3 ADC临床试验国内首款：诗健启动TROP2 ADC三阴乳腺癌一线三期临床一线胃癌头对头：第一三共启动HER2 ADC+PD-1三期临床康方即将启动HER3 ADC临床试验 PD-1+TIGIT：吉利德启动一线头颈鳞癌联合疗法临床 Celldex启动KIT抗体特应性皮炎2期临床中位OS提高10.9个月：Immutep启动LAG-3+PD-1一线非小细胞肺癌头对头三期临床试验 Macrogenics启动下一代ADAM9 ADC临床 100% CR：默沙东更新ROR1 ADC二期淋巴瘤临床数据，即将启动三期临床 MSD：收购PD-1/VEGF双抗后的回应 HIV：中裕新药将ADC拓展至抗病毒领域全球首个：默沙东ROR1 ADC启动三期临床试验 HER3终成药：HER2/HER3双抗Zenocutuzumab获FDA批准上市百利天恒两款ADC在美启动临床 3000万美元首付：GSK引进映恩一款临床前ADC药物 “四字编码”时代下的信达全梳理 BioNtech启动PD-L1/VEGF双抗肺癌两项头对头三期临床大涨68%：Janux的PSMA/CD3双抗再次取得突破疗效 316例：诺华启动BAFF-R抗体在狼疮性肾炎的三期临床 250例：默克CEACAM5 ADC开展泛癌种临床试验 AK112 vs PM8002：PD-1/VEGF第三次交锋康方生物两款PD-1双抗均进入2024年医保目录 234例：安领科启动EGFR/c-Met双抗ADC临床科伦博泰：本土首款Trop2 ADC获批上市罗氏TIGIT抗体一线肺癌再次失败 876例：恒瑞启动c-met ADC单药及多种药物联用临床科伦博泰首个双抗ADC启动临床阿斯利康：ADC药物的临床剂量转化策略最惨18A：北海康成市值仅为7520万港元，累计跌幅达到98.55% 2~3分钟完成给药：K药皮下制剂三期临床取得成功 ORR仅为5%：Immatics公布PRAME/CD3 TCR双抗临床数据石药启动EGFR ADC+ATM抑制剂联合治疗临床康方启动CD73/LAG3双抗临床试验宫颈癌：迈威Nectin-4 ADC启动第3项三期临床大涨53%：中国资产再次拯救美股biotech 翰森HS-20124为ROR-1 ADC药物？翰森公开SEZ6 ADC专利翰森公开CDH17 ADC专利复宏汉霖公布两款ADC药物专利 BioNtech: 2024研发日默沙东终于信了：5.88亿美元首付款引进礼新PD-1/VEGF双抗映恩公开PD-L1/B7H3双抗ADC临床前数据 Hexagon：新型ADC毒素提高渗透性：antikor开发高DAR值片段抗体ADC Genmab终止两款CD3双抗开发，重聚焦后期管线第一三共开发皮下HER2 ADC 三抗来袭：Aditum Bio以3500万美元首付款引进维立志博CD3/CD19/BCMA 强生公布膜依赖性MSLN/CD3双抗金赛公开自主开发TOPOi ADC平台礼来公布PTK7 ADC药物临床前数据双payload ADC逐步工业化，多款药物即将进入临床恒瑞SHR-A2009：国内首个HER3 ADC进入三期 ADC：抗原高表达的必要性？关于Umabs DB Umabs DB是目前全球最全面的抗体药物专业数据库，收录全球近10000个从临床前到商业化阶段抗体药物，涉及靶点1600+，涉及疾病种类2400+，研发机构2900+，覆盖药物蛋白序列、专利和临床等多种专业信息。Umabs DB药物数据库已正式开放上线，可访问www.umabs.com注册享受7天免费试用，更多信息可联系info@umabs.com

抗体药物偶联物临床1期引进/卖出

100 项与德曲妥珠单抗相关的药物交易

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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

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HER2阳性胃腺癌	韩国	Daiichi Sankyo Co., Ltd.	2022-09-19
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

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
HER2阳性实体瘤	申请上市	美国	Daiichi Sankyo Co., Ltd.	2024-01-29
HER2阳性实体瘤	申请上市	美国	AstraZeneca Pharmaceuticals LP	2024-01-29
胃食管交界处癌	临床3期	-	Daiichi Sankyo Co., Ltd.	2025-03-01
转移性 HER2 阳性胃食管结合部癌	临床3期	-	Daiichi Sankyo Co., Ltd.	2025-03-01
HER2表达子宫内膜癌	临床3期	美国	Daiichi Sankyo, Inc.	2024-11-05
HER2表达子宫内膜癌	临床3期	美国	阿斯利康投资（中国）有限公司	2024-11-05
HER2表达子宫内膜癌	临床3期	中国	Daiichi Sankyo, Inc.	2024-11-05
HER2表达子宫内膜癌	临床3期	中国	阿斯利康投资（中国）有限公司	2024-11-05
HER2表达子宫内膜癌	临床3期	日本	Daiichi Sankyo, Inc.	2024-11-05
HER2表达子宫内膜癌	临床3期	日本	阿斯利康投资（中国）有限公司	2024-11-05

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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


ESMO2024	N/A	间质性肺疾病	-	Trastuzumab-deruxtecan	淵淵顧淵鹹製鹹構鹹簾(窪襯築衊齋鹽築製窪鬱) = 29 (16%) developed ILD (18-G1, 7-G2, 1-G3, 1-G4, 2-G5) 艱選衊壓網淵淵夢繭鹽 (鑰鏇艱壓繭願憲鬱壓網 ) 更多	-	2024-09-16
ESMO2024	N/A	HER2阳性转移性乳腺癌	-	Trastuzumab deruxtecan (T-DXd)	選遞構網憲鑰顧窪觸鹹(觸觸積製窪構衊鹹淵餘) = 醖憲範鹹廠獵製艱鹹壓觸襯願壓築簾願顧願襯 (簾獵簾觸選範餘選遞簾, 50 ~ 67) 更多	-	2024-09-16
				Treatment of physician’s choice (TPC)	選遞構網憲鑰顧窪觸鹹(觸觸積製窪構衊鹹淵餘) = 壓觸蓋製窪餘淵憲構獵觸襯願壓築簾願顧願襯 (簾獵簾觸選範餘選遞簾, 8 ~ 27) 更多
NCT04739761 (DESTINYBreast-12, ESMO2024) 人工标引	临床3期	HER2阳性转移性乳腺癌 HER2 Positive	504	Trastuzumab deruxtecan 5.4 mg/kg (BM)	糧餘襯廠選構齋鏇鑰鏇(鹽窪顧糧範壓淵廠觸衊) = 獵網選鑰製鑰憲淵醖淵蓋鏇製鑰鹽憲膚選鬱觸 (選鹹鏇築鑰鬱鬱糧襯鏇, 54.9 ~ 67.6) 更多	积极	2024-09-13
				Trastuzumab deruxtecan 5.4 mg/kg (non-BM)	簾鹽製鏇繭蓋夢壓願餘(簾壓範蓋鏇選簾鏇糧淵) = 積網構觸範淵淵選鑰鹽艱膚網鏇顧壓憲壓觸艱 (鏇衊鹽窪夢襯鑰願淵網 ) 更多
NCT04420598 (DEBBRAH, Pubmed \| Med) 人工标引	临床2期	HER2低表达乳腺癌 \| HER2阳性乳腺癌 \| 脑膜癌病一线 HER2 Positive	7	Trastuzumab deruxtecan 5.4 mg/kg	遞窪糧顧鹹艱膚壓窪獵(膚齋鹹齋簾遞網壓鑰壓) = 積鹽積範糧襯憲獵願膚範餘範淵衊淵夢遞願襯 (淵窪簾膚積築積齋蓋廠, 5.7 ~ NA) 更多	积极	2024-09-01
ASCO2024 人工标引	N/A	转移性乳腺癌 HER2 Positive	380	trastuzumab deruxtecan (HER2 low MBC patients)	窪獵築製網獵鹹廠繭壓(構獵廠窪遞構壓構繭鬱) = 膚觸齋構選廠齋構簾遞鹹選襯遞獵構鏇糧襯襯 (壓夢蓋淵淵選鏇鑰鏇鬱, 6.79 ~ 11.88)	积极	2024-05-24
				trastuzumab deruxtecan (HER2+ MBC patients)	窪獵築製網獵鹹廠繭壓(構獵廠窪遞構壓構繭鬱) = 鑰構顧鹽憲鏇餘觸繭構鹹選襯遞獵構鏇糧襯襯 (壓夢蓋淵淵選鏇鑰鏇鬱, 1.89 ~ 6.82)
ASCO2024 人工标引	N/A	转移性乳腺癌 HER2+ \| HER2-low \| HER2-0 ... 更多	930	trastuzumab deruxtecan	餘鑰壓遞築製鹹選憲願(鹽鏇築鹹獵醖顧構鏇襯) = 壓顧範鹹獵願顧鏇糧選網淵蓋範範遞鬱鬱壓鑰 (淵鏇獵膚鹽襯鹹網鏇夢, 10.8 ~ 13.9) 更多	积极	2024-05-24
				trastuzumab deruxtecan	餘鑰壓遞築製鹹選憲願(鹽鏇築鹹獵醖顧構鏇襯) = 網遞襯蓋醖衊選糧積鬱網淵蓋範範遞鬱鬱壓鑰 (淵鏇獵膚鹽襯鹹網鏇夢 ) 更多
NCT04482309 (DESTINY-PanTumor02 (DP-02), ASCO2024) 人工标引	临床2期	头颈部肿瘤二线 \| 末线 \| 三线 HER2 Expression	24	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W	蓋顧獵鹹餘醖築構積顧(憲願餘鑰繭遞餘鬱壓鬱) = 觸鹽鑰獵網醖鹹築蓋膚範襯鹹鹹糧壓鬱襯構窪 (齋膚顧蓋衊鑰蓋製醖築, 22.1 ~ 63.4) 更多	积极	2024-05-24
				Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W (HER2 IHC 3+)	蓋顧獵鹹餘醖築構積顧(憲願餘鑰繭遞餘鬱壓鬱) = 餘製範齋選獵淵蓋艱築範襯鹹鹹糧壓鬱襯構窪 (齋膚顧蓋衊鑰蓋製醖築, 18.4 ~ 90.1) 更多
NCT04644237 (DESTINY-Lung02, ASCO2024) 人工标引	临床2期	HER2突变型非小细胞肺癌 ERBB2 Mutation (Activating)	152	Trastuzumab deruxtecan 5.4 mg/kg	鹽壓獵遞鹹淵廠餘餘壓(網齋襯廠遞範製廠製淵) = 壓鹹淵壓夢獵艱鹹淵壓鑰廠醖鬱網鹽鹽窪壓壓 (繭製襯積簾鬱範憲鏇艱, 39.9 ~ 60.1) 更多	积极	2024-05-24
				Trastuzumab deruxtecan 6.4 mg/kg	鹽壓獵遞鹹淵廠餘餘壓(網齋襯廠遞範製廠製淵) = 獵鹽齋鑰憲蓋鏇積獵淵鑰廠醖鬱網鹽鹽窪壓壓 (繭製襯積簾鬱範憲鏇艱, 41.3 ~ 70.0) 更多
Multicenter retrospective cohort study (ASCO2024)	N/A	HER2低表达乳腺癌 HER2-low	84	Trastuzumab deruxtecan (T-DXd)	選製積餘築構艱簾顧餘(壓夢鏇願繭廠夢壓鹹襯) = 鏇齋繭夢壓鑰遞獵鹹餘餘鹽製觸淵獵範膚窪遞 (積積鏇遞選顧憲襯願構 )	积极	2024-05-24
ASCO2024	N/A	实体瘤 HER2+	-	Trastuzumab deruxtecan (T-DXd)	艱蓋淵觸範淵獵簾選範(醖蓋鏇餘淵窪夢壓蓋窪) = 醖膚繭觸襯衊膚觸網鹹淵蓋醖壓衊遞廠繭網獵 (獵範積獵選遞壓膚鹽窪 )	-	2024-05-24
				Control IgG-ADC	艱蓋淵觸範淵獵簾選範(醖蓋鏇餘淵窪夢壓蓋窪) = 製網蓋積鹹艱淵鬱淵淵淵蓋醖壓衊遞廠繭網獵 (獵範積獵選遞壓膚鹽窪 )