首次证实EGFR抑制剂和靶向治疗
III期无进展生存获益
来自劳拉 III期临床试验的高水平阳性结果显示，澳门葡京网赌游戏的药物治疗效果良好 Tagrisso (osimertinib) demonstrated a statistically significant 和 highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung 癌症 (NSCLC) after chemoradiotherapy (CRT) compared to placebo after CRT.
总生存期(OS)数据显示有利的趋势 Tagrisso, 虽然在进行分析时数据还不成熟. 该试验将继续评估OS作为次要终点.
每年估计有2.4 million people are diagnosed with lung 癌症 globally with 80-85% of patients diagnosed with NSCLC, 最常见的肺癌.1-3 在美国和欧洲大约有10-15%的NSCLC患者, 以及亚洲30-40%的患者, 有EGFR突变.4-7 更多的 than one in six patients with NSCLC are diagnosed with unresectable Stage III disease (15%).8
苏雷什Ramalingam, MD, 埃默里大学温希普癌症研究所执行主任, 亚特兰大, US, 也是试验的主要研究者, said: “These results represent a major advance for patients with Stage III EGFR-mutated lung 癌症 谁 have a high propensity for early progression 和 spread to the brain, 在没有靶向治疗的地方. 劳拉 shows osimertinib can provide impactful clinical benefit 和 could become the first targeted treatment option for patients with Stage III disease.”
Susan Galbraith，肿瘤学研究中心执行副总裁&D, 澳门葡京网赌游戏, said: “These highly impactful results for the 劳拉 trial in this potentially curative early lung 癌症 setting further entrench Tagrisso 作为egfr突变肺癌的主要治疗方法. 这些数据与ADAURA数据一起, reinforce the imperative to diagnose 和 treat patients with lung 癌症 as early as possible.”
的安全性和耐受性 Tagrisso in the 劳拉 trial was consistent with its established profile 和 no new safety concerns were reported with Tagrisso CRT后的维持治疗.
The data will be presented at a forthcoming medical meeting 和 shared with global regulatory authorities.
此外, Tagrisso 基于F劳拉2 III期临床试验，加化疗最近在美国获得批准.
As part of 澳门葡京网赌游戏’s ongoing commitment to treating patients as early as possible in lung 癌症, Tagrisso is also being investigated in the neoadjuvant setting in the NeoADAURA III期试验 with results expected later this year, 以及ADAURA2 III期临床试验中早期辅助切除组.
笔记
肺癌
肺癌是男性和女性癌症死亡的主要原因, 占所有癌症死亡人数的五分之一.1 肺癌大致分为非小细胞肺癌和小细胞肺癌.2 大多数非小细胞肺癌患者被诊断为晚期疾病.6
Patients with EGFRm NSCLC are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which blocks the cell-signalling pathways that drive the growth of tumour cells.10
劳拉
劳拉是随机的, 双盲, 安慰剂对照, 的多中心, 全球III期临床试验中不可切除的患者, Stage III EGFRm NSCLC 谁se disease has not progressed following definitive platinum‑based CRT. 患者接受了 Tagrisso 80mg每日一次口服片剂，直至疾病进展, 符合不可接受的毒性或其他停药标准. 在进展后，安慰剂组的患者被允许接受治疗 Tagrisso.
该试验在超过15个国家的145个中心招募了216名患者, 包括在美国, 欧洲, 南美洲和亚洲. 这是对PFS主要终点的分析. 该试验正在进行中，并将继续评估OS的次要终点.
Tagrisso
Tagrisso (osimertinib)是第三代, 在非小细胞肺癌中具有临床活性的不可逆EGFR-TKI, 包括对抗中枢神经系统的转移. Tagrisso (40毫克和80毫克，每日一次口服片剂)已用于治疗超过800例,澳门葡京网赌游戏将继续探索其在全球的适应症 Tagrisso 作为跨阶段EGFRm NSCLC患者的一种治疗方法.
Tagrisso is approved as monotherapy in more than 100 countries 包括在美国, EU, China 和 Japan. These include for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, 局部晚期或转移性EGFR T790M突变阳性的NSCLC, 早期IB的辅助治疗, II和IIIA) NSCLC EGFRm, 在哪里 Tagrisso 最近证明了统计学意义和临床意义的OS获益.
有大量的证据支持使用 Tagrisso 在非小细胞肺癌EGFRm中. Tagrisso is the only targeted therapy to improve patient outcomes in both early-stage disease in the ADAURA III期试验 和晚期疾病 F劳拉 III期试验 和 F劳拉2 III期试验.
The Company is also researching ways to address tumour mechanisms of resistance through the SAVANNAH 和 ORCHARD Phase II trials, 以及SAFFRON III期试验, 哪些测试 Tagrisso 加上savolitinib, 口服, 有效和高选择性的MET TKI, 以及其他潜在的新药.
澳门葡京网赌游戏治疗肺癌
澳门葡京网赌游戏 is working to bring patients with lung 癌症 closer to cure through the detection 和 treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant 和 advanced settings. 通过定义新的治疗靶点和研究创新方法, 公司的目标是将药物匹配到最能受益的患者.
The Company’s comprehensive portfolio includes leading lung 癌症 medicines 和 the next wave of innovations, 包括 Tagrisso 和 艾瑞莎 (吉非替尼); Imfinzi (durvalumab)和 Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) 和 datopotamab deruxtecan in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines 和 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 和 deliver meaningful improvements for people with lung 癌症, 包括治疗之外的.
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 癌症 in every form, 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 澳门葡京网赌游戏 has built one of the most diverse portfolios 和 pipelines in the industry, with the potential to catalyse changes in the practice of medicine 和 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, 有一天,, 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, 以科学为主导的澳门葡京赌博游戏公司，专注于发现, 发展, 以及肿瘤学处方药的商业化, 罕见疾病, 和澳门葡京赌博游戏, 包括心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门葡京网赌游戏 operates in over 100 countries 和 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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参考文献
1. 世界卫生组织. 国际癌症研究机构. 肺部情况说明. 可以在: http://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. 2024年2月访问.
2. LUNGevity基金会. 肺癌的种类. 可以在: http://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. 2024年2月访问.
3. 美国癌症协会. 肺癌是什么? 可以在: http://www.cancer.org/cancer/lung-cancer/about/what-is.html#:~:text=About%2080%25%20to%2085%25%20of,(outlook)%20are%20often%20similar. 2024年2月访问.
4. Knight SB等. 肺癌早期检测的进展与展望. 开放杂志. 2017;7(9): 170070.
5. Keedy VL，等. American Society of Clinical 肿瘤学 Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J .临床肿瘤学. 2011:29;2121-27.
6. 张勇，等. The prevalence of EGFR mutation in patients with non-small cell lung 癌症: a systematic review 和 meta-analysis. Oncotarget. 2016;7(48).
7. Szumera-Ciećkiewicz A，等. 11例细胞学和组织学样本EGFR突变检测. 非小细胞肺癌:一个润色剂, 欧洲发病率的单机构研究和系统评价. 临床经验病理学. 2013:6;2800-12.
8. Cerner 癌症impact数据库.2023年10月生效.
9. Keedy六世, 等. American Society of Clinical 肿瘤学 Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J .临床肿瘤学. 2011:29;2121-27.
10. 埃里森G, 等. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods 和 Their Use for Analysis of Tumour Tissue 和 Cytology Samples. 临床病理学. 2013:66;79-89.
11. 交叉哒。 等. AZD9291, 一个不可逆的EGFR TKI, 克服t790m介导的肺癌对EGFR抑制剂的耐药. 癌症越是加大. 2014;4(9):1046-1061.
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