AstraZeneca’s Tagrisso (osimertinib)​ has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT).

阿斯利康（AstraZeneca）的Tagrisso（osimertinib）已在美国被批准用于治疗不可切除的III期表皮生长因子受体突变（EGFRm）非小细胞肺癌（NSCLC）的成年患者，这些患者的疾病在同期或序贯铂类放化疗（CRT）期间或之后没有进展。

Tagrisso is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations, as detected by a FDA-approved test..

经FDA批准的测试检测，Tagrisso适用于外显子19缺失或外显子21（L858R）突变的患者。。

The approval follows a Priority Review by the Food and Drug Administration (FDA) that was based on results from the LAURA Phase III trial, which were presented during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine..

美国食品和药物管理局（FDA）根据LAURA III期临床试验的结果进行了优先审查，该试验在2024年美国临床肿瘤学会（ASCO）年会的全体会议上提交，同时发表在《新英格兰医学杂志》上。。

Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001) as assessed by blinded independent central review. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo. .

通过盲法独立中央审查评估，与安慰剂相比，Tagrisso将疾病进展或死亡风险降低了84%（风险比0.16；95%置信区间0.10-0.24；p＜0.001）。Tagrisso治疗的患者中位无进展生存期（PFS）为39.1个月，安慰剂组为5.6个月。。

Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.

在目前的分析中，总体生存（OS）结果仍然不成熟。该试验继续评估OS作为次要终点。

Each year in the US, there are more than 200,000 people diagnosed with lung cancer, and 80-85% of these patients are diagnosed with NSCLC, the most common form of lung cancer.1-3 Approximately 15% of NSCLC patients in the US have EGFR mutations.4 Nearly one in five people diagnosed with NSCLC has an unresectable tumour.5.

在美国，每年有超过200000人被诊断出患有肺癌，其中80-85%的患者被诊断出患有NSCLC，这是最常见的肺癌形式[1-3]。美国约有15%的NSCLC患者有EGFR突变[4]。近五分之一的NSCLC患者患有不可切除的肿瘤。

Suresh Ramalingam, MD, Executive Director of Winship Cancer Institute of Emory University, Atlanta, US, and principal investigator in the trial, said: “This approval represents a major breakthrough for patients with Stage III, EGFR-mutated lung cancer who will now have the opportunity to benefit from osimertinib.

美国亚特兰大埃默里大学Winship癌症研究所执行主任兼该试验首席研究员Suresh Ramalingam医学博士说：“这项批准代表了III期EGFR突变肺癌患者的重大突破，他们现在有机会从osimertinib中受益。

Patients treated with osimertinib lived without disease progression by more than three years in the LAURA trial, and this impressive benefit underscores the importance of diagnosing and testing lung cancer patients as early as possible.”.

在LAURA试验中，接受osimertinib治疗的患者在没有疾病进展的情况下存活了三年多，这一令人印象深刻的益处强调了尽早诊断和检测肺癌患者的重要性。”。

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “The approval of Tagrisso for patients with Stage III, unresectable EGFR-mutated non-small cell lung cancer addresses a critical need for patients with these mutations who have never had the option of targeted therapy before.

阿斯利康肿瘤业务部门执行副总裁戴夫·弗雷德里克森（DaveFredrickson）表示：“Tagrisso对III期不可切除的EGFR突变非小细胞肺癌患者的批准解决了这些突变患者的迫切需求，这些突变患者以前从未有过靶向治疗的选择。

The results of the LAURA trial show the powerful impact Tagrisso can make as backbone therapy in this disease, and with this approval, patients across all stages of EGFR-mutated non-small cell lung cancer can now benefit.”.

LAURA试验的结果表明，Tagrisso可以作为这种疾病的主要治疗方法，并且有了这一批准，EGFR突变的非小细胞肺癌各个阶段的患者现在都可以受益。”。

The safety and tolerability of Tagrisso in the LAURA trial was consistent with its established profile and no new safety concerns were identified.

Tagrisso在LAURA试验中的安全性和耐受性与其既定的概况一致，没有发现新的安全问题。

Tagrisso is approved for patients with EGFR mutations in the 1st-line metastatic setting as a monotherapy and in combination with chemotherapy, and as an adjuvant treatment for early-stage disease. Tagrisso is currently under review with regulatory authorities in other countries around the world for this indication..

Tagrisso被批准用于一线转移环境中EGFR突变的患者，作为单一疗法和联合化疗，以及作为早期疾病的辅助治疗。。。

Lung cancer

肺癌

Each year, an estimated 2.4 million people are diagnosed with lung cancer globally.6 Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.6 Lung cancer is broadly split into NSCLC and small cell lung cancer.2 The majority of all NSCLC patients are diagnosed with advanced disease.7.

每年，全球估计有240万人被诊断出患有肺癌。肺癌是男性和女性癌症死亡的主要原因，约占所有癌症死亡人数的五分之一。肺癌大致分为非小细胞肺癌和小细胞肺癌。所有非小细胞肺癌患者中，大多数被诊断为晚期疾病。

Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.4,8-9 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.

美国和欧洲约有10-15%的NSCLC患者和亚洲30-40%的患者患有EGFRm NSCLC[4,8-9]。EGFRm NSCLC患者对EGFR酪氨酸激酶抑制剂（EGFR-TKI）的治疗特别敏感，它阻断了驱动肿瘤细胞生长的细胞信号通路。

LAURA

LAURA

LAURA is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial in patients with unresectable, Stage III EGFRm NSCLC whose disease has not progressed following definitive platinum-based CRT. Patients were treated with Tagrisso 80mg once-daily oral tablets until disease progression, unacceptable toxicity or other discontinuation criteria were met.

LAURA是一项随机，双盲，安慰剂对照，多中心，全球III期临床试验，用于不可切除的III期EGFRm NSCLC患者，其疾病在确定的铂类CRT后尚未进展。患者每天服用一次Tagrisso 80mg口服片剂，直到疾病进展，不可接受的毒性或其他停药标准得到满足。

Upon progression, patients in the placebo arm were offered treatment with Tagrisso..

进展后，安慰剂组患者接受了Tagrisso治疗。。

The trial enrolled 216 patients in more than 145 centres across more than 15 countries, including in the US, Europe, South America and Asia. This is the analysis of the primary endpoint of PFS. The trial is ongoing and will continue to assess the secondary endpoint of OS.

该试验在包括美国、欧洲、南美和亚洲在内的15个国家的145多个中心招募了216名患者。这是对PFS主要终点的分析。该试验正在进行中，将继续评估操作系统的次要终点。

Tagrisso

Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat nearly 800,000 patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC..

Tagrisso（osimertinib）是第三代不可逆EGFR-TKI，在NSCLC中具有已证实的临床活性，包括抗中枢神经系统（CNS）转移。Tagrisso（40mg和80mg，每日一次口服片剂）已被用于治疗全球近800000名患者的适应症，阿斯利康继续探索Tagrisso作为EGFRm NSCLC多个阶段患者的治疗方法。。

There is an extensive body of evidence supporting the use of Tagrisso as standard of care in EGFRm NSCLC. Tagrisso improved patient outcomes in early-stage disease in the ADAURA Phase III trial, locally advanced disease in the LAURA Phase III trial, late-stage disease in the FLAURA Phase III trial, and with chemotherapy in the FLAURA2 Phase III trial. .

有大量证据支持使用Tagrisso作为EGFRm NSCLC的护理标准。Tagrisso改善了ADAURA III期试验中早期疾病的患者预后，LAURA III期试验中的局部晚期疾病，FLAURA III期试验中的晚期疾病以及FLAURA2 III期试验中的化疗。。

As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the neoadjuvant setting in the NeoADAURA Phase III trial with results expected later this year and in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial..

作为阿斯利康持续致力于尽早治疗肺癌患者的一部分，Tagrisso也正在NeoADAURA III期试验的新辅助治疗中进行调查，预计今年晚些时候会有结果，ADAURA2 III期试验的早期辅助可切除治疗也会有结果。。

The Company is also researching ways to address tumour mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, and the SAFFRON Phase III trial, which test Tagrisso plus Orpathys (savolitinib), an oral, potent and highly selective MET TKI, as well as other potential new medicines.

该公司还正在研究通过SAVANNAH和ORCHARD II期试验以及SAFFRON III期试验解决肿瘤耐药机制的方法，该试验测试了口服，有效且高度选择性的MET-TKI Tagrisso plus Orpathys（savolitinib）以及其他潜在的新药。

AstraZeneca in lung cancer

阿斯利康治疗肺癌

AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, 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..

阿斯利康正在努力通过早期疾病的检测和治疗，使肺癌患者更接近治愈，同时也推动了科学的界限，以改善耐药和晚期环境中的结果。通过定义新的治疗目标和研究创新方法，该公司旨在将药物与最能受益的患者相匹配。。

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo; savolitinib in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action..

该公司的综合投资组合包括领先的肺癌药物和下一波创新，包括Tagrisso和Iressa（吉非替尼）；Imfinzi（durvalumab）和Imjudo（tremelimumab）；Enhertu（曲妥珠单抗deruxtecan）和达托帕单抗deruxtecan与Daiichi Sankyo合作；savolitinib与HUTCHMED合作；以及跨越不同行动机制的潜在新药和组合管道。。

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.

阿斯利康是肺癌雄心联盟的创始成员，该联盟是一个全球联盟，致力于加速创新，为肺癌患者提供有意义的改善，包括治疗和其他治疗。

AstraZeneca in oncology

阿斯利康肿瘤学

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, develop and deliver life-changing medicines to patients.

阿斯利康（AstraZeneca）正在领导一场肿瘤学革命，致力于为各种形式的癌症提供治疗，遵循科学理解癌症及其复杂性，发现、开发并向患者提供改变生命的药物。

The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

该公司专注于一些最具挑战性的癌症。正是通过不断的创新，阿斯利康建立了行业内最多样化的投资组合和渠道之一，有可能促进医学实践的变化并改变患者的体验。

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

阿斯利康的愿景是重新定义癌症护理，并有一天消除癌症作为死亡原因。

AstraZeneca

阿斯利康

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.

阿斯利康（LSE/STO/Nasdaq:AZN）是一家全球科学领先的生物制药公司，专注于肿瘤学，罕见病和生物制药（包括心血管，肾脏和代谢以及呼吸和免疫学）处方药的发现，开发和商业化。

Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide.

阿斯利康的创新药物总部位于英国剑桥，在125多个国家销售，全球数百万患者使用。