基于TROPION-Lung01和TROPION-Breast01 III期试验结果的并行应用表明，澳门葡京网赌游戏和第一三共的datopotamab deruxtecan显著提高了无进展生存期. 两种癌症的化疗
欧洲药品管理局(EMA)已经批准了澳门葡京网赌游戏(澳门葡京网赌游戏)和第一三共制药的datopotamab deruxtecan (Dato-DXd)治疗两种癌症的两项上市许可申请(MAAs). 一种MAA用于治疗局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)的成人患者，这些患者在先前治疗后需要全身治疗. 另一种MAA用于治疗不可切除或转移性激素受体(HR)阳性的成人患者, her2阴性(IHC 0, IHC 1+或IHC 2+/ISH-)乳腺癌，已进展，不适合内分泌治疗，并接受了至少一种额外的全身治疗.
验证确认了申请的完成，并开始了EMA人用药品委员会的科学审查过程. 应用程序是基于数据从枢纽 TROPION-Lung01 and TROPION-Breast01 在2023年欧洲肿瘤医学学会大会的两次总统专题讨论会上提出了III期试验.
Datopotamab deruxtecan是由第一三共制药公司发现并由澳门葡京网赌游戏和第一三共制药公司联合开发的一种特异性工程的trop2导向的DXd抗体药物偶联物(ADC).
Susan Galbraith，肿瘤学研究中心执行副总裁&D, 澳门葡京网赌游戏, 他说:“澳门葡京赌博游戏的目标是让datopotamab deruxtecan改善并取代传统化疗治疗多种癌症. 今天，澳门葡京赌博游戏在肺癌和乳腺癌应用的双重验证使这一潜在药物朝着重新定义欧洲两种最常见癌症患者的治疗期望迈出了有意义的一步.”
Ken Takeshita，医学博士，全球主管，R&D, 第一三共制药, 他说:“EMA的验证是将这种trop2导向的抗体药物偶联物引入欧洲非鳞状肺癌和hr阳性患者的重要第一步, her2阴性乳腺癌. 这一消息是基于澳门葡京赌博游戏最近在美国监管方面取得的进展, where our lung cancer application has been accepted and our breast cancer application is underway, 强调澳门葡京赌博游戏致力于通过开发新药来改变护理标准，以帮助世界上尽可能多的患者."
datopotamab deruxtecan用于肺癌和乳腺癌的其他监管申请正在美国和全球范围内进行.
Notes
晚期非小细胞肺癌
Nearly 500,000 lung cancer cases were diagnosed in Europe in 2022.1 NSCLC is the most common type of lung cancer, accounting for about 80% of cases.1 Approximately 70% and 30% of NSCLC tumours are of nonsquamous or squamous histology, respectively.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 几十年来,, chemotherapy has been the last treatment available for patients with advanced NSCLC, 尽管效果有限，而且已知有副作用.3,4,5
hr阳性乳腺癌
More than 500,000 breast cancer cases were diagnosed in Europe in 2022.6 HR-positive, her2阴性乳腺癌是最常见的亚型, 占确诊病例的65%以上.7 乳腺癌被认为是hr阳性, HER2阴性是指肿瘤雌激素和/或孕激素受体检测呈阳性，HER2阴性(以IHC的HER2评分为0), IHC 1+或IHC 2+/ISH-).7,8 该亚型乳腺癌的标准初始治疗是内分泌治疗，但大多数晚期患者会产生耐药性, 强调需要更多的选择.9,10
TROP2
TROP2是一种在多种实体肿瘤中广泛表达的蛋白, 包括大多数NSCLC和hr阳性, her2阴性乳腺癌病例.11,12 High TROP2 expression is associated with increased tumour progression and poor survival.12,13 There is currently no TROP2-directed ADC approved for the treatment of lung cancer.14,15
TROPION-Lung01
TROPION-Lung01是一种全球性的, randomised, 多中心, 开放标签III期试验评估datopotamab deruxtecan与docetaxel在局部晚期或转移性NSCLC患者中的疗效和安全性，伴有或不伴有可操作的基因组改变，需要在先前治疗后进行全身治疗. 具有可操作的基因组改变的患者以前接受过基于铂的化疗和批准的靶向治疗. Patients without known actionable genomic alterations were previously treated, 组合的或顺序的, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
TROPION-Lung01的双重主要终点是通过盲法独立中心评价(BICR)评估的无进展生存期(PFS)和总生存期(OS)。. 关键次要终点包括研究者评估的PFS, 客观反应率, 反应持续时间(DoR), 响应时间, disease control rate (DCR) as assessed by both BICR and investigator, and safety. TROPION-Lung01 enrolled approximately 600 patients in Asia, Europe, 北美和南美. 欲知详情，请浏览 临床试验.gov.
TROPION-Breast01
TROPION-Breast01是一种全球性的, randomised, 多中心, 开放标签III期试验评估datopotamab deruxtecan与研究者选择的单药化疗(eribulin)的有效性和安全性, 卡培他滨, vinorelbine or gemcitabine) in patients with unresectable or metastatic HR-positive, her2阴性(IHC 0, IHC 1+或IHC 2+/ISH-)乳腺癌，经研究者评估进展不适合内分泌治疗，且因不可切除或转移性疾病已接受至少一种额外的全身治疗.
The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. 关键的次要终点包括ORR, DoR, investigator-assessed PFS, DCR, 到第一次后续治疗的时间和安全性. TROPION-Breast01在非洲招募了700多名患者, Asia, Europe, 北美和南美. 欲知详情，请浏览 临床试验.gov.
Dato-DXd (Dato-DXd)
Dato-DXd (Dato-DXd) is an investigational TROP2-directed ADC. Designed using 第一三共制药’s proprietary DXd ADC Technology, datopotamab deruxtecan is one of six DXd ADCs in the oncology pipeline of 第一三共制药, and one of the most advanced programmes in 澳门葡京网赌游戏’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, 与札幌医科大学合作开发, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd)通过基于四肽的可切割连接体.
一项名为TROPION的综合开发项目正在全球范围内进行，有超过14项试验评估datopotamab deruxtecan治疗多种癌症的疗效和安全性, 包括非小细胞肺癌, 三阴性乳腺癌和hr阳性, her2阴性乳腺癌. 在TROPION项目之外, datopotamab deruxtecan also is being evaluated in novel combinations in several ongoing trials.
第一三共合作
澳门葡京网赌游戏 and 第一三共制药 entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 和datopotamab deruxtecan July 2020, except in Japan where 第一三共制药 maintains exclusive rights for each ADC. 第一三共制药 is responsible for the manufacturing and supply of Enhertu 和datopotamab deruxtecan.
澳门葡京网赌游戏在肿瘤学
澳门葡京网赌游戏 is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, 开发并向患者提供改变生活的药物.
The Company’s focus is on some of the most challenging cancers. 正是通过持续的创新，澳门葡京网赌游戏建立了行业中最多样化的产品组合和管道之一, with the potential to catalyse changes in the practice of medicine and transform the patient experience.
澳门葡京网赌游戏的愿景是重新定义癌症治疗和, one day, 消除癌症作为死亡原因.
澳门葡京网赌游戏
澳门葡京网赌游戏(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, science-led biopharmaceutical company that focuses on the discovery, 发展, 以及肿瘤学处方药的商业化, 罕见疾病, 和澳门葡京赌博游戏, 包括心血管, Renal & 新陈代谢和呼吸 & Immunology. 总部设在剑桥, UK, 澳门葡京网赌游戏 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门葡京网赌游戏.com 并在社交媒体上关注公司 @澳门葡京网赌游戏.
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References
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2. 国家癌症研究所. SEER Cancer Statistics Factsheets: Lung and Bronchus Cancer, 2015. 可以在: http://seer.cancer.gov/archive/csr/1975_2012/results_merged/sect_15_lung_bronchus.pdf. 获取于2024年3月.
3. 陈锐，等. Emerging therapeutic agents for advanced non-small cell lung cancer. 血液学杂志. 2020;13(1):58.
4. Majeed U，等. Targeted therapy in advanced non-small cell lung cancer: current advances and future trends. [J]血液学. 2021;14(1):108.
5. Pircher A等人. 多西紫杉醇治疗非小细胞肺癌(NSCLC)——一项关注症状改善的观察性研究. 抗癌的研究. 2020;70(5): 287-294.
6. Globocan 2022. Europe. 可以在: http://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf. 获取于2024年3月.
7. 国家癌症研究所. SEER癌症统计数据:女性乳腺癌亚型. 可以在: http://seer.cancer.gov/statfacts/html/breast-subtypes.html. 获取于2024年3月.
8. Iqbal N，等. Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications. Mol Biol Int. 2014;852748.
9. 林敏，等. Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer. J Cancer. 2020; 10.7150/jca.48944.
10. Lloyd M R，等. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor-positive, HER2-negative Breast Cancer and Emerging Therapeutic Opportunities. 临床癌症研究中心. 2022; 28(5): 821-30.
11. Goldenberg D等. The emergence of trophoblast cell-surface antigen 2 (TROP-2) as a novel cancer target. Oncotarget. 2018;9(48): 28989-29006.
12. Mito R，等. Clinical impact of TROP2 in non-small lung cancers and its correlation with abnormal p53 nuclear accumulation. Pathol Int. 2020;70(5): 287-294.
13. Vidula N，等. Sacituzumab govitecan: Antibody-drug conjugate in triple negative breast cancer and other solid tumours. 乳腺癌治疗. [j] .中国科学:自然科学;2009 (3):569-575.
14. Rodríguez-Abreau D，等. 培美曲塞加铂联合或不联合派姆单抗治疗先前未治疗的转移性非鳞状NSCLC患者:KEYNOTE-189协议指定的最终分析. Ann Onc. 2021年7月，32(7):881-895.
15. 美国癌症协会. 非小细胞肺癌的靶向药物治疗. 可以在: http://www.cancer.org/cancer/types/lung-cancer/treating-non-small-cell/targeted-therapies.html. 获取于2024年3月.
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