TOKYO & MUNICH--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have voluntarily withdrawn the marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or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..

东京和慕尼黑--（商业新闻短讯）--第一三共（东京证交所：4568）和阿斯利康（LSE/STO/Nasdaq：AZN）已经自愿撤回了达托单抗-德鲁替康（Dato-DXd）在欧盟的上市授权申请（MAA），该申请基于TROPION-Lung01 3期试验，用于治疗局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）的成年患者。。

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..

撤回MAA的决定是根据欧洲药品管理局（EMA）人类使用药品委员会的反馈信息做出的。Daiichi Sankyo和AstraZeneca将继续致力于为欧盟肺癌患者带来达托帕单抗deruxtecan，这些患者可以受益，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中的潜力，该计划包括在各种肺癌环境中的七项关键试验。。

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.

Datopotamab deruxtecan是由Daiichi Sankyo发现并由Daiichi Sankyo和AstraZeneca联合开发的特异性工程TROP2定向DXd抗体-药物偶联物（ADC）。

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.

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About TROPION-Lung01

关于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.

TROPION-Lung01是一项全球性，随机，多中心，开放标签的3期临床试验，评估达托单抗-德鲁替康与多西紫杉醇在成人局部晚期或转移性非小细胞肺癌患者中的疗效和安全性，无论是否有可行的基因组改变，需要在事先治疗后进行全身治疗。

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..

。没有已知可行基因组改变的患者先前曾同时或顺序接受铂类化疗和PD-1或PD-L1抑制剂治疗。。

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的双重主要终点是通过盲法独立中央评估（BICR）和总生存期（OS）评估的无进展生存期（PFS）。关键的次要终点包括BICR和研究者评估的研究者评估的PFS，客观缓解率，缓解持续时间，缓解时间和疾病控制率以及安全性。。

TROPION-Lung01 enrolled approximately 600 patients in Asia, Europe, North America, Oceania and South America. For more information visit ClinicalTrials.gov.

TROPION-Lung01在亚洲，欧洲，北美，大洋洲和南美招募了大约600名患者。有关更多信息，请访问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..

TROPION-Lung01的主要PFS结果和中期OS结果在2023年ESMO（#ESMO23）大会上发表。最终的OS结果发表在国际肺癌研究协会（WCLC24）主办的IASLC 2024年世界肺癌会议上，并于2024年9月同时发表在《临床肿瘤学杂志》上。。

About Advanced Non-Small Cell Lung Cancer

关于晚期非小细胞肺癌

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.

2022年全球诊断出近250万例肺癌病例。在欧洲，2022年诊断出近50万例肺癌病例。肺癌大致分为小细胞肺癌或非小细胞肺癌，后者约占病例的80%。虽然免疫治疗和靶向治疗在一线治疗中改善了预后，但大多数患者最终会经历疾病进展并接受化疗[3,4,5]。几十年来，化疗一直是晚期非小细胞肺癌患者可用的最后一种治疗方法，尽管疗效有限，副作用已知[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

TROP2是一种在大多数NSCLC肿瘤中广泛表达的蛋白质[6]。目前还没有TROP2指导的ADC被批准用于治疗肺癌[7,8]

About Datopotamab Deruxtecan (Dato-DXd)

关于达托帕马·德鲁克斯坦（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（Dato DXd）是一种研究性TROP2指导的ADC。datopotamab deruxtecan使用Daiichi Sankyo专有的DXd ADC技术设计，是Daiichi Sankyo肿瘤学管道中的六个DXd ADC之一，也是阿斯利康ADC科学平台中最先进的程序之一。

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..

Datopotamab deruxtecan由与札幌医科大学合作开发的人源化抗TROP2 IgG1单克隆抗体组成，通过基于四肽的可切割接头连接到许多拓扑异构酶I抑制剂有效载荷（exatecan衍生物DXd）。。

Additional regulatory submissions in breast cancer are under review in China, Japan, the U.S. and other regions.

中国、日本、美国和其他地区正在审查有关乳腺癌的其他监管文件。

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.

达托单抗-德鲁替康已被美国食品和药物管理局授予突破性治疗指定，用于治疗局部晚期或转移性表皮生长因子受体突变（EGFR突变）NSCLC的成年患者，这些患者在用EGFR酪氨酸激酶抑制剂（TKI）和铂类化疗治疗时或治疗后疾病进展。

Daiichi Sankyo and AstraZeneca have submitted a Biologics License Application for datopotamab deruxtecan for this potential indication..

Daiichi Sankyo和AstraZeneca已经提交了datopotamab deruxtecan的生物制剂许可证申请，用于这种潜在的适应症。。

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..

一项全面的全球临床开发计划正在进行中，超过20项试验评估了达托单抗deruxtecan在多种癌症中的疗效和安全性，包括NSCLC，三阴性乳腺癌和HR阳性，HER2低或阴性乳腺癌。该计划包括7项肺癌3期临床试验和5项乳腺癌3期临床试验，评估达托单抗-德鲁替康作为单一疗法以及在各种情况下与其他抗癌治疗相结合。。

About the Daiichi Sankyo and AstraZeneca Collaboration

关于第一三共和阿斯利康的合作

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..

第一三共与阿斯利康于2019年3月达成全球合作，共同开发ENHERTU，并于2020年7月将其商业化，但在日本，第一三共对每个ADC拥有专有权。Daiichi Sankyo负责ENHERTU和datopotamab deruxtecan的制造和供应。。

About the ADC Portfolio of Daiichi Sankyo

关于第一三共的ADC投资组合

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.

Daiichi Sankyo ADC组合由七个临床开发中的ADC组成，这些ADC由Daiichi Sankyo内部发现的两个不同的ADC技术平台精心打造而成。

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.

临床开发中最深入的ADC平台是Daiichi Sankyo的DXd ADC技术，其中每个ADC由单克隆抗体组成，通过基于四肽的可切割接头连接到许多拓扑异构酶I抑制剂有效载荷（exatecan衍生物，DXd）。。

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..

Patritumab deruxtecan（HER3 DXd）是一种HER3定向的ADC，ifinatamab deruxtecan（I-DXd）是一种B7-H3定向的ADC，raludotatug deruxtecan（R-DXd）是一种CDH6定向的ADC，正在与美国新泽西州拉威的默克公司（Merck＆Co.，Inc.）联合开发和全球商业化。DS-3939是一种TA-MUC1定向的ADC，由第一三共开发。。

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.

第二个Daiichi Sankyo ADC平台由连接到修饰的吡咯并苯并二氮杂卓（PBD）有效载荷的单克隆抗体组成。DS-9606是一种CLDN6定向的PBD ADC，是利用该平台进行临床开发的几个计划ADC中的第一个。

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.

Datopotamab deruxtecan，ifinatamab deruxtecan，patritumab deruxtecan，raludotatug deruxtecan，DS-3939和DS-9606是尚未在任何国家批准用于任何适应症的研究药物。安全性和有效性尚未确定。

About Daiichi Sankyo

关于第一三共

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.

Daiichi Sankyo是一家创新的全球医疗保健公司，致力于社会的可持续发展，发现、开发和提供新的护理标准，以丰富世界各地的生活质量。拥有120多年的经验，第一三共利用其世界一流的科学和技术，为癌症，心血管疾病和其他医疗需求未得到满足的疾病患者创造新的模式和创新药物。

For more information, please visit www.daiichisankyo.com..

欲了解更多信息，请访问www.daiichisankyo.com。。

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References

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