Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, her2阴性乳腺癌

基于TROPION-Breast01 III期试验结果的申请

Additional BLA under review in the US for 澳门在线赌城娱乐 and 第一三共制药’s datopotamab deruxtecan for patients with advanced nonsquamous non-small cell lung cancer
 

澳门在线赌城娱乐 and 第一三共制药’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, her2阴性(IHC 0, IHC 1+或IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease. 处方药使用者收费法案生效, 美国食品和药物管理局(FDA)监管决定的行动日期, 是在2025年第一季度吗.

The BLA is based on results from the pivotal TROPION-Breast01 Phase III trial in which datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoint of progression-free survival (PFS) compared to investigator’s choice of chemotherapy in patients with unresectable or metastatic HR-positive, her2阴性乳腺癌以前接受过内分泌治疗和至少一种全身治疗. 对于总生存期(OS)的双重主要终点, interim results numerically favoured datopotamab deruxtecan over chemotherapy but were not mature at the time of data cut-off. 试验正在进行中，OS将在未来的分析中进行评估.

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by 第一三共制药 and being jointly developed by 澳门在线赌城娱乐 and 第一三共制药.

Susan Galbraith，肿瘤学研究中心执行副总裁&D, 澳门在线赌城娱乐, 他说:“尽管在治疗hr阳性患者方面取得了显著进展, her2阴性乳腺癌, most patients with advanced disease develop endocrine resistance and face the prospect of one or several lines of chemotherapy. 如果得到批准, datopotamab deruxtecan has the potential to provide these patients an efficacious and better tolerated alternative to conventional chemotherapy.”

Ken Takeshita，医学博士，全球主管，R&D, 第一三共制药, FDA对BLA的接受使澳门第一赌城在线娱乐更接近于为以前治疗过的hr阳性患者提供治疗, her2阴性乳腺癌是早期转移性常规化疗的替代选择. 澳门第一赌城在线娱乐最近在美国接受了晚期非鳞状非小细胞肺癌的申请, 以及中国正在进行的额外监管审查, the EU, 日本及其他地区, we are working swiftly to bring datopotamab deruxtecan as a potential new treatment option to patients around the world.”

结果 TROPION-Breast01 were presented during a Presidential Symposium at the 2023 European Society for Medical Oncology Congress and in an oral presentation at the 2023 San Antonio Breast Cancer Symposium.

The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

An additional BLA for datopotamab deruxtecan based on results from the pivotal TROPION-Lung01 Phase III trial is under review in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. datopotamab deruxtecan用于肺癌和乳腺癌的其他监管申请正在全球范围内进行.

Notes

hr阳性乳腺癌
2022年，美国确诊的乳腺癌病例超过27.5万例.1 HR-positive, her2阴性乳腺癌是最常见的亚型, 占确诊病例的65%以上.2 乳腺癌被认为是hr阳性, HER2-negative when tumours test positive for oestrogen and/or progesterone hormone receptors and negative for HER2 (measured as HER2 score of IHC 0, IHC 1+或IHC 2+/ISH-).2,3 Standard initial treatment for this subtype of breast cancer is endocrine therapy but most patients with advanced disease will develop resistance, 强调需要更多的选择.4,5

TROP2是一种广泛表达于hr阳性的蛋白, her2阴性乳腺癌，与肿瘤进展加快和生存率低相关.6,7

TROPION-Breast01
TROPION-Breast01是一种全球性的, 随机, 多中心, open-label Phase III trial evaluating the efficacy and safety of datopotamab deruxtecan versus investigator’s choice of single-agent chemotherapy (eribulin, 卡培他滨, 长春瑞滨或吉西他滨)治疗不可切除或转移性hr阳性患者, her2阴性(IHC 0, IHC 1+或IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one additional systemic therapy for unresectable or metastatic disease.

TROPION-Breast01的双主要终点是经盲法独立中心评价的PFS和OS. 主要次要终点包括客观有效率, 反应持续时间, investigator-assessed PFS, 疾病控制率, 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)是一种实验性的trop2导向ADC. 采用第一三共制药专有的DXd ADC技术设计, datopotamab deruxtecan是第一三共(第一三共制药)肿瘤学产品线中的六种DXd adc之一, 也是澳门在线赌城娱乐ADC科学平台中最先进的项目之一. Datopotamab deruxtecan由人源抗trop2 IgG1单克隆抗体组成, 与札幌医科大学合作开发, 附着在一些拓扑异构酶I抑制剂有效载荷上(一种艾替替康衍生物), DXd)通过基于四肽的可切割连接体.

A comprehensive global clinical 发展 programme is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, 包括非小细胞肺癌, 三阴性乳腺癌(TNBC)和hr阳性, her2阴性乳腺癌.

第一三共合作
澳门在线赌城娱乐和第一三共进入全球合作，共同开发和商业化 Enhertu in 2019年3月 和datopotamab deruxtecan July 2020在日本，第一三共维持每个ADC的专有权. 第一三共制药负责生产和供应 Enhertu 和datopotamab deruxtecan.

澳门在线赌城娱乐治疗乳腺癌
由于对乳腺癌生物学的了解越来越深入, 澳门在线赌城娱乐开始挑战, 并重新定义, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

澳门在线赌城娱乐 has a comprehensive portfolio of approved and promising compounds in 发展 that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment.

With Enhertu (曲妥珠单抗deruxtecan), her2定向ADC, 澳门在线赌城娱乐 and 第一三共制药 are aiming to improve outcomes in previously treated HER2-positive and HER2-low metastatic breast cancer and are exploring its potential in earlier lines of treatment and in new breast cancer settings.

在hr阳性乳腺癌中，澳门在线赌城娱乐继续通过基础药物改善预后 Faslodex and Zoladex (goserelin)，旨在用一流的AKT抑制剂重塑hr阳性空间， Truqap，以及下一代SERD和潜在新药卡米司腾. 澳门在线赌城娱乐还与第一三共制药合作，探索trop2导向ADC的潜力, datopotamab deruxtecan, 在这种情况下.

PARP抑制剂 Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. 澳门在线赌城娱乐与默沙东 & Co., Inc. 在美国和加拿大)继续研究 Lynparza 并探索其在早期疾病中的潜力.

为TNBC患者提供急需的治疗选择, 一种侵袭性乳腺癌, 澳门在线赌城娱乐正在评估datopotamab deruxtecan单独和联合免疫疗法的潜力 Imfinzi (durvalumab), Truqap 结合化疗，和 Imfinzi 与其他肿瘤药物联合使用，包括 Lynparza and Enhertu.

澳门在线赌城娱乐在肿瘤学
澳门在线赌城娱乐正在引领肿瘤学领域的一场革命，致力于为各种形式的癌症提供治疗, 跟随科学去了解癌症及其所有的复杂性, 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. It is through persistent innovation that 澳门在线赌城娱乐 has built one of the most diverse portfolios and pipelines in the industry, 有可能催化医学实践的变化，改变病人的体验.

澳门在线赌城娱乐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.

澳门在线赌城娱乐
澳门在线赌城娱乐(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门第一赌城在线娱乐公司，专注于发现, 发展, 以及肿瘤学处方药的商业化, 罕见疾病, 和澳门第一赌城在线娱乐, 包括心血管, Renal & 代谢、呼吸 & 免疫学和疫苗 & 免疫疗法. 总部设在剑桥, UK, 澳门在线赌城娱乐在100多个国家开展业务，其创新药物被全球数百万患者使用. 请访问 澳门在线赌城娱乐.com 并在社交媒体上关注公司 @澳门在线赌城娱乐.

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参考文献

  1. 世界卫生组织. 全球癌症观察站:美利坚合众国. 可以在: http://gco.iarc.who.int/media/globocan/factsheets/populations/840-united-states-of-america-fact-sheet.pdf. 2024年4月发布.
  2. 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. 2024年4月发布.
  3. Iqbal N，等. 人表皮生长因子受体2 (HER2)在癌症中的过度表达及其治疗意义. Mol Biol Int. 2014;852748.
  4. 林敏，等. CDK4/6抑制剂与内分泌治疗的总生存期比较. 激素受体阳性，her2阴性转移性乳腺癌的单独内分泌治疗. J Cancer. 2020; 10.7150/jca.48944.
  5. 劳埃德先生，等. 晚期激素受体阳性患者对CDK4/6阻断的抵抗机制, her2阴性乳腺癌和新兴的治疗机会. 临床癌症研究中心. 2022; 28(5): 821-30.
  6. Goldenberg D等. 滋养细胞表面抗原2 (TROP-2)作为新的癌症靶点的出现. Oncotarget. 2018;9(48): 28989-29006.
  7. Vidula N，等. Sacituzumab govitecan:抗体-药物结合物在三阴性乳腺癌和其他实体肿瘤中的应用. 乳腺癌治疗. [j] .中国科学:自然科学;2009 (3):569-575.

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tags

  • Oncology
  • 公司和金融