Tagrisso demonstrated strong overall survival benefit in the ADAURA Phase III trial for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer

2023年3月9日07:05 GMT
 

第一项III期试验证明在这种辅助设置下生存获益
 

ADAURA III期临床试验的高水平阳性结果显示，澳门在线赌城娱乐的药物治疗效果良好 Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), 一个关键的次要端点, 与安慰剂相比，早期IB患者的辅助治疗效果更好, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

In May 2020澳门在线赌城娱乐宣布 Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in this setting. In 2022年9月最新结果显示，患者的平均生存时间为近5年半.

根据ADAURA试验方案, 接受安慰剂治疗的转移性疾病复发患者有机会接受开放标签治疗 Tagrisso.

Roy S. Herbst, MD, PhD, 耶鲁癌症中心和斯迈洛癌症医院副主任兼肿瘤内科主任, New Haven, 康涅狄格, ADAURA III期临床试验的首席研究员, said: “These new survival data for osimertinib reinforce the unprecedented ADAURA disease-free survival results and confirm its potential to extend patients’ lives 在早期疾病中. The ADAURA results provide powerful evidence that osimertinib offers the best possible care for patients with early-stage EGFR-mutated non-small cell lung cancer who historically faced high rates of recurrence and previously had no targeted options after surgery.”

Susan Galbraith，肿瘤学研究中心执行副总裁&D, 澳门在线赌城娱乐, said: “The ADAURA trial brought the first targeted medicine to patients with early-stage EGFR-mutated non-small cell lung cancer. 今天，这些令人兴奋的总体生存结果证实了佐剂的有效性 Tagrisso as the standard of care in this setting and reinforce the importance of early diagnosis and testing for EGFR mutation in lung cancer.”

的安全性和耐受性 Tagrisso 在ADAURA试验中，没有出现新的安全性问题.

这些新的ADAURA OS结果在早期可切除的设置增加了广泛的证据体 Tagrisso in EGFRm NSCLC which has now shown a statistically significant and clinically meaningful OS benefit in both the early adjuvant and late-stage metastatic settings. 这些数据将在即将召开的医学会议上公布.

每年估计有2个.全球有200万人被诊断为肺癌，其中80-85%的患者被诊断为非小细胞肺癌, 最常见的肺癌.^1-3 Approximately 25-30% of all patients with NSCLC are diagnosed early enough to have surgery with curative intent.^4‑5 Further, 73%的IB期患者和56-65%的II期患者将存活5年.⁶ 对于IIIA期和IIIB期患者，这一比例分别降至41%和24%, 反映出大量未满足的医疗需求.⁶

澳门在线赌城娱乐有几个正在进行的注册试验，重点是测试 Tagrisso 在肺癌早期阶段, 包括新辅助可切除设置(NeoADAURA), 在IA2-IA3期辅助切除设置(ADAURA2), 以及III期局部晚期不可切除的情况(LAURA).

Tagrisso 是否在90多个国家被批准用于治疗早期肺癌, 包括在美国, EU, 中国和日本, 更多的全球监管审查正在进行中. Tagrisso is also approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, EU, China, 日本和许多其他国家.

澳门在线赌城娱乐 has a comprehensive portfolio of approved and potential new medicines in 发展 for patients with lung cancer. 除了这些结果，公司今天还宣布了来自于 爱琴海III期试验 of Imfinzi (durvalumab) in combination with neo辅助化疗 before surgery and as adjuvant monotherapy after surgery in Stage IIA-IIIB resectable NSCLC.

Notes

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 The majority of all NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.^4‑5 Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition.^7‑8

对于可切除肿瘤的患者, 尽管完全切除肿瘤并进行辅助化疗，大多数患者最终仍复发.⁹

在美国和欧洲大约有10-15%的NSCLC患者, 亚洲30-40%的患者有EGFRm.^10-12 These patients are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which block the cell-signalling pathways that drive the growth of tumour cells.¹³

ADAURA
ADAURA是一个随机的, 双盲, 安慰剂对照, 全球III期临床试验辅助治疗682例IB期患者, II, IIIA肿瘤完全切除后的EGFRm, 由医生和病人自行决定, 辅助化疗. 患者接受了 Tagrisso 80mg每日一次口服片剂或安慰剂，服用3年或直至疾病复发.

该试验在20多个国家的200多个中心进行, 包括美国在内, Europe, 南美, 亚洲和中东. The primary endpoint was DFS in Stage II和IIIA患者 and key secondary endpoints included DFS in Stage IB, II和IIIA患者, 以及主要人群和总体人群的OS.

虽然最初预计将在2022年读取主要数据，但试验数据却推迟了 早期的报道 following a recommendation from an Independent Data Monitoring Committee (IDMC) based on its determination of overwhelming efficacy.

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)已用于治疗近700例,澳门在线赌城娱乐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.

除了调查 Tagrisso 在早期疾病中, 澳门在线赌城娱乐 is also studying the medicine in combination with chemotherapy in locally advanced and metastatic EGFRm NSCLC (FLAURA2). The Company is also researching ways to address tumour mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, 以及SAFFRON III期试验, 哪些测试 Tagrisso 与savolitinib合用, an oral, 有效和高选择性的MET TKI, 以及其他潜在的新药.

澳门在线赌城娱乐治疗肺癌
澳门在线赌城娱乐 is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, 同时也在推动科学的发展，以改善耐药和高级环境的结果. 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 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与Daiichi Sankyo合作; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

澳门在线赌城娱乐是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 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门在线赌城娱乐 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门在线赌城娱乐.com 并在Twitter上关注公司 @澳门在线赌城娱乐.

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