Datopotamab deruxtecan showed clinically meaningful overall survival improvement vs. chemotherapy in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase III trial

这份公告包含内幕消息

在整个试验人群中, 生存结果在数值上有利于澳门葡京网赌游戏和第一三共制药的datopotamab deruxtecan，但没有达到统计学意义

TROPION-Lung01先前达到了双重主要终点
总体试验人群的无进展生存期

结果支持目前正在审查的申请
包括美国和欧盟在内的全球监管机构
 

High-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which previously met the dual primary endpoint of progression-free survival (PFS), 在接受至少一种既往治疗的局部晚期或转移性非小细胞肺癌(NSCLC)患者的总体试验人群中，与多西他赛相比，Dato-DXd在数值上更受青睐. Survival results did not reach statistical significance in the overall trial population. 在预先指定的非鳞状NSCLC患者亚组中, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, 目前的标准治疗化疗.

The final analysis of OS builds on the positive progression-free survival (PFS) results presented 在2023年欧洲医学肿瘤学会大会上，该会议显示datopotamab deruxtecan在总体试验人群中显示了统计学上显著的PFS改善，在非鳞状NSCLC患者中显示了临床意义上的PFS益处. 在TROPION-Lung01, 根据肿瘤组织学入组的患者在治疗组中是平衡的，并且与实际发病率一致，大约75%的患者患有非鳞状NSCLC.1,2

datopotamab deruxtecan在TROPION-Lung01中的安全性与之前的分析一致，与多西他赛相比，由于不良事件而减少剂量或停药的情况更少, 也没有发现新的安全隐患. No new interstitial lung disease events of any grade were adjudicated as drug-related.

Susan Galbraith，肿瘤学研究中心执行副总裁&D, AstraZeneca, Datopotamab deruxtecan是唯一一种与多西他赛相比，显示出先前治疗过的非鳞状非小细胞肺癌患者有临床意义的生存改善的研究性疗法, which has long been unsurpassed in this post-targeted treatment and post-immunotherapy setting. 这些结果加强了datopotamab deruxtecan在晚期肺癌治疗中取代传统化疗的潜力，并强调了澳门葡京赌博游戏对正在进行的一线肺癌临床试验评估该疗法的信心.”

Ken Takeshita，医学博士，全球主管，R&D, 第一三共制药, datopotamab deruxtecan的总生存期的改善与先前报道的有临床意义的无进展生存期相结合, 与多西他赛相比，总疗效增加了一倍以上，疗效持续时间延长，这表明这种trop2导向的抗体药物偶联物可能成为晚期非鳞状非小细胞肺癌患者的重要新治疗方法. 这些数据将支持澳门葡京赌博游戏与全球监管机构正在进行的讨论，以尽快将datopotamab deruxtecan带给患者，并标志着为癌症患者创造新的护理标准又向前迈进了一步.”

Datopotamab deruxtecan是由第一三共制药公司发现并由AstraZeneca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.

这些数据将在即将召开的医学会议上提交，并将支持目前正在全球审查的监管申请, 包括在美国和欧盟，用于治疗先前接受过全身治疗的局部晚期或转移性非鳞状NSCLC成年患者.

Notes

晚期非小细胞肺癌
Nearly 2.2022年，全球诊断出500万例肺癌病例.3 NSCLC is the most common type of lung cancer, accounting for about 80% of cases.4 Approximately 75% and 25% of NSCLC tumours are of nonsquamous or squamous histology, respectively.1  While immunotherapy and targeted therapies have improved outcomes in the 1st-line setting, most patients eventually experience disease progression and receive chemotherapy.5-7 For decades, 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.5-7

TROP2 is a protein broadly expressed in the majority of NSCLC tumours.8 There is currently no TROP2-directed ADC approved for the treatment of lung cancer.9,10

TROPION-Lung01
TROPION-Lung01是一种全球性的, randomised, 多中心, open-label Phase III trial evaluating the efficacy and safety of datopotamab deruxtecan (6.0mg/kg) vs多西他赛(75mg/m)2)适用于局部晚期或转移性非小细胞肺癌的成年患者，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, 并发或顺序, 铂基化疗和PD-1或PD-L1抑制剂.

通过盲法独立中心评价(BICR)和OS评估TROPION-Lung01的双主要终点为PFS. 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, 响应时间, BICR和研究者评估的疾病控制率, and safety.

TROPION-Lung01 enrolled approximately 600 patients in Asia, Europe, North America and South America. 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. 采用第一三共制药专有的DXd ADC技术设计, 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 AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanised 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.

一项全面的全球临床开发计划正在进行中，有20多项试验评估datopotamab deruxtecan治疗多种癌症的有效性和安全性, 包括非小细胞肺癌, 三阴性乳腺癌和hr阳性, her2阴性乳腺癌.

第一三共合作
AstraZeneca 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.

澳门葡京网赌游戏治疗肺癌
澳门葡京网赌游戏正致力于通过早期疾病的检测和治疗，使肺癌患者更接近治愈, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso (osimertinib)和 Iressa (吉非替尼); Imfinzi (durvalumab)和 Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) 和datopotamab deruxtecan collaboration with 第一三共制药; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

澳门葡京网赌游戏是Lung Ambition Alliance的创始成员之一, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, 包括治疗之外的.

澳门葡京网赌游戏在肿瘤学
AstraZeneca 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.

该公司专注于一些最具挑战性的癌症. 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.

AstraZeneca
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 & 代谢与呼吸 & Immunology. 总部设在剑桥, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 sotanomc.net 并在社交媒体上关注公司 @AstraZeneca.

Contacts
For details on how to contact the 投资者关系 Team, please click here. 对于“媒体联系人”，单击 here.

References

  1. 国家癌症研究所. 癌症统计资料: 肺癌和支气管癌，1975-2017. 2024年5月发布.
  2. Ahn M-J, et al. Dato-DXd (Dato-DXd) vs doxetaxel治疗先前治疗的晚期/转移性(adv/met)非小细胞肺癌(NSCLC): TROPION-Lung01随机3期研究结果. Presented at: ESMO Congress 2023, 20-24 October 2023; Madrid, Spain. LBA12.
  3. 世界卫生组织. 全球癌症观测站:肺. 可以在: http://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. 2024年5月发布.
  4. Cancer.net. 肺癌-非小细胞:统计. 可以在: http://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics#:~:text=NSCLC%20is%20the%20most%20common,be%20diagnosed%20with%20lung%20cancer. 2024年5月发布.
  5. Chen R, et al. Emerging therapeutic agents for advanced non-small cell lung cancer. [J]血液学. 2020;13(1):58.
  6. Majeed U, et al. Targeted therapy in advanced non-small cell lung cancer: current advances and future trends. [J]血液学. 2021;14(1):108.
  7. 退却, et al. 多西紫杉醇治疗非小细胞肺癌(NSCLC) -一项以症状改善为重点的观察性研究. 抗癌的研究. 2013;33(9):3831-3836.
  8. Mito R, et al. Clinical impact of TROP2 in non‐small lung cancers and its correlation with abnormal p53 nuclear accumulation. Pathol Int. 2020;70(5):287-294.
  9. Rodriguez-Abreau D, et al. 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. [j]; 2011;32(7): 881-895.
  10. 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. 2024年5月发布.

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公司秘书
澳门葡京网赌游戏

 

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  • Oncology
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