Tagrisso demonstrated overwhelming efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung 癌症 in 劳拉 Phase III trial

First EGFR inhibitor 和 targeted treatment to demonstrate
progression-free survival benefit in Stage III setting
 

Positive high-level results from the 劳拉 Phase III trial showed 澳门在线赌城娱乐’s Tagrisso (osimertinib)对不可切除肿瘤患者的无进展生存期(PFS)有统计学意义和高度临床意义的改善, III期表皮生长因子受体突变(EGFRm)非小细胞肺癌(NSCLC)在放化疗(CRT)后与安慰剂后的比较.

Overall survival (OS) data showed a favourable trend for Tagrisso, although data were not mature at the time of this analysis. The trial will continue to assess OS as a secondary endpoint.

每年估计有2.全球有400万人被诊断为肺癌，其中80-85%的患者被诊断为非小细胞肺癌, the most common form of lung 癌症.^1-3 Approximately 10-15% of NSCLC patients in the US 和 欧洲, 以及亚洲30-40%的患者, 有EGFR突变.^4-7 超过六分之一的NSCLC患者被诊断为无法切除的III期疾病(15%)。.⁸

苏雷什Ramalingam, MD, Executive Director of Winship Cancer Institute of Emory University, 亚特兰大, US, 和 principal investigator in the trial, 他说:“这些结果代表了egfr突变的III期肺癌患者的重大进展，这些患者有很高的早期进展和扩散到大脑的倾向, 和 在哪里 no targeted therapy is available. 劳拉显示，奥西替尼可以提供有效的临床益处，并可能成为III期疾病患者的第一种靶向治疗选择.”

Susan Galbraith, Executive Vice President, 肿瘤学 R&D, 澳门在线赌城娱乐, 他说:“这些极具影响力的结果进一步巩固了劳拉试验在早期肺癌治疗方面的潜力 Tagrisso as the backbone therapy for EGFR-mutated lung 癌症. These data together with the ADAURA data, 强调尽早诊断和治疗肺癌患者的必要性.”  

的安全性和耐受性 Tagrisso 在劳拉试验中，没有发现新的安全性问题 Tagrisso maintenance treatment following CRT.

这些数据将在即将召开的医学会议上提交，并与全球监管机构共享.

此外, Tagrisso plus chemotherapy was recently approved in the US based on the F劳拉2 III期试验.

作为澳门在线赌城娱乐持续致力于尽早治疗肺癌患者的一部分, Tagrisso 也正在NeoADAURA III期临床试验中进行新辅助研究，预计今年晚些时候会有结果, 和 in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

笔记

肺癌
肺癌 is the leading cause of 癌症 death among both men 和 women, accounting for about one-fifth of all 癌症 deaths.¹ 肺癌 is broadly split into NSCLC 和 small cell lung 癌症.² The majority of all NSCLC patients are diagnosed with advanced disease.⁶

EGFRm NSCLC患者对egfr -酪氨酸激酶抑制剂(EGFR-TKI)治疗特别敏感，EGFR-TKI阻断了驱动肿瘤细胞生长的细胞信号通路.¹⁰

劳拉
劳拉是随机的, 双盲, 安慰剂对照, 的多中心, global Phase III trial in patients with unresectable, 确诊铂基CRT后疾病未进展的NSCLC III期EGFRm. 患者接受了 Tagrisso 80mg once daily oral tablets until disease progression, unacceptable toxicity or other discontinuation criteria were met. Upon progression, patients in the placebo arm were permitted to be treated with Tagrisso.

The trial enrolled 216 patients in more than 145 centres across more than 15 countries, 包括在美国, 欧洲, 南美洲和亚洲. This is the analysis of the primary endpoint of PFS. The trial is ongoing 和 will continue to assess the secondary endpoint of OS.

Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, 包括 against central nervous system metastases. Tagrisso (40mg 和 80mg once-daily oral tablets) has been used to treat more than 800,000 patients across its indications worldwide 和 澳门在线赌城娱乐 continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

Tagrisso 在包括美国、欧盟、中国和日本在内的100多个国家被批准为单一疗法. 其中包括局部晚期或转移性EGFRm NSCLC患者的一线治疗, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, 和 adjuvant treatment of early-stage (IB, II和IIIA) NSCLC EGFRm, 在哪里 Tagrisso recently demonstrated a statistically significant 和 clinically meaningful OS benefit.

T在这里 is an extensive body of evidence supporting the use of Tagrisso 在非小细胞肺癌EGFRm中. Tagrisso 唯一的靶向治疗是改善两种早期疾病患者的预后吗 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. 

该公司还在通过SAVANNAH和ORCHARD II期试验研究解决肿瘤耐药机制的方法, 以及SAFFRON III期试验, 哪些测试 Tagrisso 加上savolitinib, 口服, potent 和 highly selective MET TKI, as well as other potential new medicines.

澳门在线赌城娱乐治疗肺癌
澳门在线赌城娱乐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, 同时也在推动科学的发展，以改善耐药和高级环境的结果. By defining new therapeutic targets 和 investigating innovative approaches, the Company aims to match medicines to the patients 谁 can benefit most.

该公司的综合产品组合包括领先的肺癌药物和下一波创新, 包括 Tagrisso 和 艾瑞莎 (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 和 combinations across diverse mechanisms of action.

澳门在线赌城娱乐 is a founding member of the Lung Ambition Alliance, 一个致力于加速创新并为肺癌患者提供有意义改善的全球联盟, 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, following the science to underst和 癌症 和 all its complexities to discover, develop 和 deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging 癌症s. 正是通过持续的创新，澳门在线赌城娱乐建立了行业中最多样化的产品组合和管道之一, 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 has the vision to redefine 癌症 care 和, 有一天,, eliminate 癌症 as a cause of death.

澳门在线赌城娱乐
澳门在线赌城娱乐 (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, 发展, 和 commercialisation of prescription medicines in 肿瘤学, 罕见疾病, 和澳门第一赌城在线娱乐, 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 和 follow the Company on social media @澳门在线赌城娱乐.

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参考文献

艾德里安·坎普
公司秘书
澳门在线赌城娱乐