A Multicenter, Open-label, Non-comparative, Single-arm, Phase II Trial of Datopotamab Deruxtecan for Non-small Cell Lung Cancer Patients with Active Brain Metastases (The TUXEDO-5 Study)

This trial will study a type of advanced lung cancer that is defined as non-squamous non-small cell lung cancer (NSCLC) with active brain metastases (BMs). This type of cancer originates in peripheral lung tissue, which is composed of cancer cells that look different from normal lung cells when viewed under a microscope and is characterized by the presence of BMs, which indicates the spreading of such cancer cells into the brain. NSCLC tumors often have specific genetic alterations or mutations that drive their growth and are known as actionable genomic alterations (AGA). This trial will include patients with NSCLC tumors characterized by the presence or absence of such AGA. Patients will be treated with datopotamab deruxtecan (Dato-DXd), a Tumor-associated calcium signal transducer 2 (TROP2)-directed antibody drug conjugate (ADC) that works by targeting TROP2 protein that is differentially expressed in cancer cells. The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of Dato-DXd in patients who have NSCLC with active BMs. Dato-DXd efficacy will be determined by assessing the proportion of patients who experience a significant reduction in tumor size or whose cancer disappears completely, as determined at any timepoint during the study period by the investigators conducting the trial.

开始日期2025-04-01

申办/合作机构

Medica Scientia Innovation Research SL

[+1]

NCT06533826 / Not yet recruiting临床2期IIT

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2-low Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy

The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-low metastatic breast cancer.
The names of the study drugs involved in this study are:
* Datopotamab deruxtecan (a type of antibody drug conjugate)
* Trastuzumab deruxtecan (a type of antibody drug conjugate)

开始日期2025-01-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06564844 / Recruiting临床3期

A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

开始日期2024-10-15

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）

2025-12-01·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

作者: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Crescioli, Silvia ; Kaplon, Hélène ; Reichert, Janice M. ; Wang, Lin ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2024-12-01·NATURE MEDICINE

Datopotamab–deruxtecan plus durvalumab in early-stage breast cancer: the sequential multiple assignment randomized I-SPY2.2 phase 2 trial

Article

作者: Arora, Mili ; Boles, Sarah ; Moore, Brian ; DeMichele, Angela ; Brown-Swigart, Lamorna ; Boughey, Judy C. ; Falkson, Carla ; Onishi, Natsuko ; Parker, Catherine ; Huppert, Laura ; Symmans, W. Fraser ; Hirst, Gillian L. ; Rozenblit, Mariya ; Hirst, Gillian L ; Chen, Yunni Yi ; Rugo, Hope S ; Trivedi, Meghna S. ; Isaacs, Claudine ; Clark, Amy S ; van ’t Veer, Laura J. ; Chien, A. Jo ; Asare, Adam L ; LeStage, Barbara ; Davidian, Marie ; Boughey, Judy C ; Albain, Kathy S. ; Yau, Christina ; Howard, Frederick M. ; Wallace, Anne M ; Nangia, Chaitali ; Clark, Amy S. ; Asare, Adam L. ; Omene, Coral ; Matthews, Jeffrey B. ; Thomas, Brittani ; Norwood, Peter ; Beineke, Philip ; Hershman, Dawn L. ; Tsiatis, Butch ; Nanda, Rita ; Trivedi, Meghna S ; Matthews, Jeffrey B ; Williams, Nicole ; Sanford, Amy ; Elias, Anthony D. ; Wallace, Anne M. ; Beckwith, Heather ; Sanft, Tara ; Esserman, Laura J. ; Giridhar, Karthik ; Chien, A Jo ; Price, Elissa ; Jahan, Nusrat ; Perlmutter, Jane ; Elias, Anthony D ; Hylton, Nola M. ; Roussos Torres, Evanthia T. ; Thomas, Alexandra ; Hershman, Dawn L ; Yee, Douglas ; Shatsky, Rebecca A. ; van 't Veer, Laura J ; Li, Wen ; Howard, Frederick M ; Yeung, Kay ; Esserman, Laura J ; Blackwood, M Michele ; Albain, Kathy S ; Tseng, Jennifer ; Vaklavas, Christos ; Blackwood, M. Michele ; Stringer-Reasor, Erica ; Symmans, W Fraser ; Pohlmann, Paula ; Kalinsky, Kevin ; Shatsky, Rebecca A ; Hylton, Nola M ; Rugo, Hope S. ; Roussos Torres, Evanthia T ; Heditsian, Diane

Sequential adaptive trial designs can help accomplish the goals of personalized medicine, optimizing outcomes and avoiding unnecessary toxicity. Here we describe the results of incorporating a promising antibody-drug conjugate, datopotamab-deruxtecan (Dato-DXd) in combination with programmed cell death-ligand 1 inhibitor, durvalumab, as the first sequence of therapy in the I-SPY2.2 phase 2 neoadjuvant sequential multiple assignment randomization trial for high-risk stage 2/3 breast cancer. The trial includes three blocks of treatment, with initial randomization to different experimental agent(s) (block A), followed by a taxane-based regimen tailored to tumor subtype (block B), followed by doxorubicin-cyclophosphamide (block C). Subtype-specific algorithms based on magnetic resonance imaging volume change and core biopsy guide treatment redirection after each block, including the option of early surgical resection in patients predicted to have a high likelihood of pathologic complete response, which is the primary endpoint assessed when resection occurs. There are two primary efficacy analyses: after block A and across all blocks for six prespecified HER2-negative subtypes (defined by hormone receptor status and/or response-predictive subtypes). In total, 106 patients were treated with Dato-DXd/durvalumab in block A. In the immune-positive subtype, Dato-DXd/durvalumab exceeded the prespecified threshold for success (graduated) after block A; and across all blocks, pathologic complete response rates were equivalent to the rate expected for the standard of care (79%), but 54% achieved that result after Dato-DXd/durvalumab alone (block A) and 92% without doxorubicin-cyclophosphamide (after blocks A + B). The treatment strategy across all blocks graduated in the hormone-negative/immune-negative subtype. No new toxicities were observed. Stomatitis was the most common side effect in block A. No patients receiving block A treatment alone had adrenal insufficiency. Dato-DXd/durvalumab is a promising therapy combination that can eliminate standard chemotherapy in many patients, particularly the immune-positive subtype.ClinicalTrials.gov registration: NCT01042379 .

757

项与德达博妥单抗相关的新闻（医药）

8 小时之前

·Antibody Research

阿斯利康和第一三共撤回 TROP2-DXD提交的上市申请

▎追溯 2024年12月24日，阿斯利康和第一三共宣布自愿撤回在欧盟提交的datopotamab deruxtecan（Dato-DXd）营销授权申请（MAA），该药物用于治疗局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）成年患者，该申请基于TROPION-Lung01三期临床试验。撤回 MAA 的决定是根据欧洲药品管理局 (EMA) 人用药品委员会的反馈做出的。阿斯利康和第一三共将继续努力将 datopotamab deruxtecan 带给欧盟的肺癌患者，使他们能够从中受益，并致力于通过我们强大的临床开发计划释放这种药物在肺癌治疗中的潜力，该计划包括在不同肺癌环境中进行的七项关键试验。阿斯利康和第一三共基于TROPION-Breast01三期临床试验在欧盟提出的 datopotamab deruxtecan 用于治疗激素受体 (HR) 阳性、HER2 阴性转移性乳腺癌的申请仍在审查中。 Datopotamab deruxtecan 是一种专门设计的 TROP2 导向 DXd 抗体药物偶联物 (ADC)，由第一三共发现，并由阿斯利康和第一三共联合开发。阿斯利康在2024 WCLC公布TROPION-Lung01临床研究，同时也在ASCO杂志上发表文章“Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non–Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study”，公开其临床数据。该临床研究共有299名患者和305名患者分别被随机分配接受Dato-DXd或多西他赛治疗。Dato-DXd组的中位无进展生存期（PFS）为4.4个月（95% CI, 4.2至5.6），多西他赛组为3.7个月（95% CI, 2.9至4.2）（危险比 [HR], 0.75 [95% CI, 0.62至0.91]；P = 0.004）。中位总生存期（OS）分别为12.9个月（95% CI, 11.0至13.9）和11.8个月（95% CI, 10.1至12.8）（HR, 0.94 [95% CI, 0.78至1.14]；P = 0.530）。未达到统计学意义。在预设的非鳞状组织学亚组中，中位PFS分别为5.5个月对比3.6个月（HR, 0.63 [95% CI, 0.51至0.79]），中位OS分别为14.6个月对比12.3个月（HR, 0.84 [95% CI, 0.68至1.05]）。在鳞状组织学亚组中，中位PFS分别为2.8个月对比3.9个月（HR, 1.41 [95% CI, 0.95至2.08]），中位OS分别为7.6个月对比9.4个月（HR, 1.32 [95% CI, 0.91至1.92]）。欢迎加入我的知识星球，可提供专业的免费咨询。公众号已经建立读者实名讨论微信群，可以添加微信（zhuisu2210）后进群，添加时请主动注明姓名、企业、职位。

临床结果ASCO会议抗体药物偶联物临床3期

10 小时之前

·PipelineReview

Datopotamab Deruxtecan Application in the EU for Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer Voluntarily Withdrawn

TOKYO, Japan & MUNICH, Germany I December 24, 2024 I Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have voluntarily withdrawn the marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) based on the TROPION-Lung01 phase 3 trial. The decision to withdraw the MAA was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). Daiichi Sankyo and AstraZeneca will continue to work to bring datopotamab deruxtecan to patients with lung cancer in the EU who can benefit and are committed to unlocking the potential of this medicine in lung cancer through our robust clinical development program which includes seven pivotal trials in various lung cancer settings. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca. Daiichi Sankyo and AstraZeneca’s application in the EU for datopotamab deruxtecan for the treatment of hormone receptor (HR) positive, HER2 negative metastatic breast cancer based on the TROPION-Breast01 phase 3 trial remains under review. About TROPION-Lung01 TROPION-Lung01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan versus docetaxel in adult patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations who require systemic therapy following prior treatment. Patients with actionable genomic alterations were previously treated with an approved targeted therapy and platinum-based chemotherapy. Patients without known actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. The dual primary endpoints of TROPION-Lung01 are progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS). Key secondary endpoints include investigator-assessed PFS, objective response rate, duration of response, time to response, and disease control rate as assessed by both BICR and investigator, and safety. TROPION-Lung01 enrolled approximately 600 patients in Asia, Europe, North America, Oceania and South America. For more information visit ClinicalTrials.gov . Primary PFS results and interim OS results from TROPION-Lung01 were presented at the 2023 ESMO (#ESMO23) Congress. Final OS results were presented at IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC24) and simultaneously published in the Journal of Clinical Oncology in September 2024. About Advanced Non-Small Cell Lung Cancer Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. 1 In Europe, nearly 500,000 lung cancer cases were diagnosed in 2022. 1 Lung cancer is broadly split into small or non-small cell lung cancer, the latter accounting for about 80% of cases. 2 While immunotherapy and targeted therapies have improved outcomes in the first-line setting, most patients eventually experience disease progression and receive chemotherapy. 3,4,5 For decades, chemotherapy has been the last treatment available for patients with advanced NSCLC, despite limited effectiveness and known side effects. 3,4,5 TROP2 is a protein broadly expressed in the majority of NSCLC tumors. 6 There is currently no TROP2 directed ADC approved for the treatment of lung cancer. 7,8 About Datopotamab Deruxtecan (Dato-DXd) Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, datopotamab deruxtecan is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Additional regulatory submissions in breast cancer are under review in China, Japan, the U.S. and other regions. Datopotamab deruxtecan has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) NSCLC with disease progression on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. Daiichi Sankyo and AstraZeneca have submitted a Biologics License Application for datopotamab deruxtecan for this potential indication. About the Datopotamab Deruxtecan Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple negative breast cancer and HR positive, HER2 low or negative breast cancer. The program includes seven phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating datopotamab deruxtecan as a monotherapy and in combination with other anticancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc., Rahway, N.J. USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . References 1 World Health Organization. Global Cancer Observatory: Lung. Accessed December 2024. 2 American Cancer Society. Key Statistics for Lung Cancer . Accessed December 2024. 3 Chen R, et al. J Hematol Oncol . 2020:13(1):58. 4 Majeed U, et al. J Hematol Oncol . 2021;14(1):108. 5 Pircher A, et al. Anticancer Research . 2020;70(5):287-294. 6 Mito R, et al. Pathol Int . 2020;70(5):287-294. 7 American Cancer Society. Targeted Drug Therapy for Non-Small Cell Lung Cancer . Accessed December 2024. 8 Rodríguez-Abreau D, et al. Ann Onc . 2021 Jul;32(7): 881-895. SOURCE: Daiichi Sankyo

临床3期临床结果上市批准引进/卖出突破性疗法

10 小时之前

·医药魔方Info

阿斯利康/第一三共自愿撤回在欧盟提交的Dato-DXd非鳞NSCLC上市申请

12月24日，阿斯利康和第一三共基于III期TROPION-Lung01研究结果，已自愿撤回在欧盟提交的datopotamab deruxtecan（Dato-DXd，德曲妥珠单抗）用于治疗局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）成人患者的上市许可申请（MAA）。此次撤回MAA的决定是基于欧洲药品管理局（EMA）人用药品委员会（CHMP）的反馈得出的。阿斯利康和第一三共将继续努力，将Dato-DXd带给欧盟肺癌患者，并致力于通过临床开发计划挖掘该药物在肺癌治疗中的潜力，该计划涵盖了在不同肺癌环境中进行的七项关键临床研究。阿斯利康和第一三共基于III期TROPION-Breast01研究结果，在欧盟提交的Dato-DXd用于治疗激素受体（HR）阳性、HER2阴性转移性乳腺癌的申请仍在审评中。 Dato-DXd是一种在研靶向TROP2的抗体偶联药物（ADC）。该药物采用第一三共独有的DXd ADC技术开发，是第一三共肿瘤研发管线中的六种DXd ADC之一，也是阿斯利康ADC科学平台中最先进的项目之一。Dato-DXd由一种人源化抗TROP2 IgG1单克隆抗体组成，并通过基于四肽的可裂解连接子与多个拓扑异构酶I抑制剂有效载荷（一种艾沙替康衍生物，即DXd）结合。美国FDA已授予Dato-DXd突破性疗法认定，用于治疗既往接受过表皮生长因子受体（EGFR）酪氨酸激酶抑制剂和含铂化疗治疗后疾病进展的局部晚期或转移性EGFR突变型（EGFRm）非小细胞肺癌（NSCLC）成人患者。阿斯利康和第一三共已就该潜在适应症提交了Dato-DXd的生物制品许可申请（BLA）。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

突破性疗法临床3期抗体药物偶联物引进/卖出

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

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
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
HR阳性/HER2阴性乳腺癌	申请上市	欧盟	Daiichi Sankyo Co., Ltd.	2024-03-04
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
非小细胞肺癌Ⅰ期	临床3期	美国	AstraZeneca PLC	2024-10-15
非小细胞肺癌Ⅰ期	临床3期	日本	AstraZeneca PLC	2024-10-15
非小细胞肺癌Ⅰ期	临床3期	比利时	AstraZeneca PLC	2024-10-15

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临床结果

适应症

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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


NCT05104866 (TROPION-Breast01, ESMO_ASIA2024) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌 Hormone Receptor Positive \| HER2 Negative	83	Datopotamab deruxtecan (Dato-DXd) (China cohort)	繭齋壓膚構繭醖繭製網(窪網齋艱鬱願蓋積獵範) = 夢壓窪餘積簾願蓋選選願製積廠廠觸鏇顧襯膚 (範網築願鑰積觸憲範積 ) 更多	积极	2024-12-07
				Chemotherapy (capecitabine/eribulin/gemcitabine/vinorelbine) (China cohort)	繭齋壓膚構繭醖繭製網(窪網齋艱鬱願蓋積獵範) = 積繭顧顧淵壓鏇獵蓋鏇願製積廠廠觸鏇顧襯膚 (範網築願鑰積觸憲範積 ) 更多
NCT04484142 \| NCT04656652 (TROPION-Lung01, ESMO_ASIA2024) 人工标引	N/A	EGFR突变的非小细胞肺癌 EGFR Mutation	117	Dato-DXd	鹽遞獵衊蓋蓋製簾齋願(鹽衊網製憲築簾獵獵鬱) = 夢繭襯鬱鬱憲壓網繭築鹹選齋積網鏇鏇範鏇鏇 (顧壓鬱鹽獵壓顧製選壓, 34 ~ 52) 更多	积极	2024-12-06
				Dato-DXd (TROPION-Lung05)	鹽遞獵衊蓋蓋製簾齋願(鹽衊網製憲築簾獵獵鬱) = 網壓鏇獵醖顧顧鹹鏇艱鹹選齋積網鏇鏇範鏇鏇 (顧壓鬱鹽獵壓顧製選壓, 32 ~ 55) 更多
NCT05104866 (TROPION-Breast01, NEWS) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌 HER2 Negative \| Hormone Receptor Positive	700	Dato-DXd （6.0mg/kg）	範廠鹽衊鹽艱鬱選顧齋(選蓋蓋窪遞齋蓋觸憲築): HR = 0.84 (95% CI, 0.62 ~ 1.14) 未达到	不佳	2024-09-23
				研究者选择的单药化疗
NCT05104866 (ESMO2024)	临床3期	HR阳性/HER2阴性乳腺癌	-	Investigator’s choice of chemotherapy (ICC)	艱蓋憲廠築膚衊糧願憲(淵壓觸齋鏇壓艱淵餘顧) = 簾糧衊築積積簾願淵醖壓鏇襯鬱築繭願淵廠醖 (築襯選鹽夢壓選淵醖願 )	-	2024-09-16
NCT05489211 (ESMO2024) 人工标引	临床2期	卵巢癌 \| 子宫内膜癌	75	Dato-DXd 6 mg/kg IV Q3W	願艱襯餘製鏇蓋範顧廠(壓鑰壓襯繭鬱夢簾醖鏇) = 鹹齋鹹構衊餘壓鑰選積鹽廠繭鹽糧繭構繭遞鹽 (繭鹽簾選齋選襯製醖願 ) 更多	积极	2024-09-15
				Dato-DXd (Ovarian)	願艱襯餘製鏇蓋範顧廠(壓鑰壓襯繭鬱夢簾醖鏇) = 膚獵遞廠觸餘鏇膚網淵鹽廠繭鹽糧繭構繭遞鹽 (繭鹽簾選齋選襯製醖願 ) 更多
NCT04656652 (TROPION-LUNG01, ESMO2024) 人工标引	临床3期	晚期肺非鳞状非小细胞癌二线 \| 三线	468	Datopotamab deruxtecan (Dato-DXd) 6 mg/kg	憲壓範膚糧遞蓋獵壓齋(遞鹹鹹膚繭遞膚鹹繭窪) = 獵鏇鬱糧選蓋蓋繭鏇選膚蓋窪蓋構鹽鏇襯艱壓 (夢鏇積壓廠鹹鹽鹹膚願, 2.9 ~ 5.9) 更多	积极	2024-09-14
				Docetaxel (DTX) 75 mg/m2	憲壓範膚糧遞蓋獵壓齋(遞鹹鹹膚繭遞膚鹹繭窪) = 製蓋膚鑰窪艱網網築糧膚蓋窪蓋構鹽鏇襯艱壓 (夢鏇積壓廠鹹鹽鹹膚願, 1.5 ~ 4.6) 更多
NCT05104866 (TROPION-Breast01, Pubmed \| J Clin Oncol) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌二线 \| 三线 Hormone Receptor Positive \| HER2 Negative	732	Datopotamab deruxtecan (Dato-DXd)	鑰繭鹽鹽糧壓鑰壓網餘(繭鑰範鬱獵簾鏇願餘製): HR = 0.84 (95% CI, 0.62 ~ 1.14) 更多	积极	2024-09-12
				Investigator's choice of chemotherapy (ICC)
NCT04656652 (TROPION-Lung01, WCLC2024) 人工标引	临床3期	非小细胞肺癌二线 \| 三线	604	Datopotamab deruxtecan	糧蓋鹹蓋網製淵觸膚壓(糧夢壓積繭觸憲簾糧鬱) = 範憲糧製構願夢糧鬱鹽簾簾鹽襯選遞範鹹蓋壓 (簾獵壓繭觸構廠鹽簾繭, 11.0 ~ 13.9) 未达到更多	不佳	2024-09-09
				Docetaxel	糧蓋鹹蓋網製淵觸膚壓(糧夢壓積繭觸憲簾糧鬱) = 鬱繭窪鬱窪壓壓顧選蓋簾簾鹽襯選遞範鹹蓋壓 (簾獵壓繭觸構廠鹽簾繭, 10.1 ~ 12.8) 未达到更多
NCT04656652 (TROPION-Lung01, Pubmed \| J Clin Oncol) 人工标引	临床3期	非小细胞肺癌二线	604	Datopotamab deruxtecan 6 mg/kg	壓壓餘壓餘簾選衊遞鏇(憲廠鹽膚夢鬱選鑰鏇顧) = 糧願廠鬱顧構願壓淵簾範襯齋淵憲齋壓餘範構 (顧願鬱鑰膚顧鏇顧夢憲, 11.0 ~ 13.9) 更多	积极	2024-09-09
				Docetaxel 75 mg/m2	壓壓餘壓餘簾選衊遞鏇(憲廠鹽膚夢鬱選鑰鏇顧) = 鏇膚膚積淵網餘顧鑰衊範襯齋淵憲齋壓餘範構 (顧願鬱鑰膚顧鏇顧夢憲, 10.1 ~ 12.8) 更多
NCT04656652 (TROPION-Lung01, Company_Website) 人工标引	临床3期	非鳞状非小细胞肺癌	-	datopotamab deruxtecan (nonsquamous NSCLC)	醖鏇遞淵衊構衊觸憲糧(壓餘鏇壓衊顧餘願憲蓋) = In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy. 餘醖廠鏇網簾網積網範 (築窪壓構蓋繭願繭鬱夢 )	积极	2024-05-27
				docetaxel (nonsquamous NSCLC)