The Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s Imfinzi (durvalumab) met the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC) based on the AEGEAN Phase III trial results with an overall tolerable safety profile.

美国食品和药物管理局（FDA）肿瘤药物咨询委员会（ODAC）承认，阿斯利康（AstraZeneca）的Imfinzi（durvalumab）在治疗可切除的非小细胞肺癌（NSCLC）方面达到了无事件生存（EFS）的主要终点。爱琴海III期试验结果具有总体可耐受的安全性。

In the trial, adult patients with resectable early-stage (IIA-IIIB) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements were treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.

在该试验中，成年可切除早期（IIA-IIIB）NSCLC患者，无已知表皮生长因子受体（EGFR）突变或间变性淋巴瘤激酶（ALK）重排，在手术前联合新辅助化疗和术后辅助单药治疗。

The discussion noted that while the contribution by phase of neoadjuvant and adjuvant components of the perioperative regimen could not be clearly assigned based on the trial design, this is an important potential regimen for patients..

讨论指出，虽然根据试验设计无法明确分配围手术期方案中新辅助和辅助成分的阶段贡献，但这是患者重要的潜在方案。。

John V. Heymach, MD, PhD, Professor and Chair Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center in Houston, Texas, said: “The majority of patients with resectable lung cancer face recurrence of their disease even after surgery and neoadjuvant chemotherapy. The Committee acknowledged the potential to address this urgent unmet need with durvalumab both before and after surgery, which can significantly increase the time patients live without progression and recurrence events in this curative-intent setting.”.

德克萨斯州休斯顿德克萨斯大学安德森癌症中心胸/头颈医学肿瘤学教授兼主席约翰·海马赫（John V.Heymach）博士说：“大多数可切除肺癌患者即使在手术和新辅助化疗后也会面临疾病复发。委员会承认，在手术前后使用durvalumab可以解决这一迫切未满足的需求，这可以显着增加患者在这种治愈意图下没有进展和复发事件的时间。”。

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The Committee’s discussion of the AEGEAN data highlighted the significant benefit delivered by this Imfinzi-based regimen for patients with resectable lung cancer. We are committed to working closely with the FDA to bring this novel immunotherapy option to patients that offers a flexible chemotherapy backbone.”.

阿斯利康肿瘤研发执行副总裁苏珊·加尔布雷斯（SusanGalbraith）表示：“委员会对爱琴海数据的讨论突出了这种基于Imfinzi的方案对可切除肺癌患者的显着益处。我们致力于与FDA密切合作，为提供灵活化疗骨干的患者带来这种新型免疫治疗选择。”。

Results from a planned interim analysis of EFS from the AEGEAN trial showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events or death versus chemotherapy alone in patients treated with the Imfinzi-based regimen before and after surgery (32% data maturity; EFS hazard ratio of 0.68; 95% confidence interval [CI] 0.53-0.88; p=0.003902).

来自爱琴海试验的EFS计划中期分析的结果显示，在手术前后使用基于Imfinzi的方案治疗的患者中，与单独化疗相比，复发，进展事件或死亡风险降低了32%，具有统计学意义和临床意义（32%数据成熟度；EFS风险比为0.68；95%置信区间为0.53-0.88；p=0.003902）。

In a final analysis of pathologic complete response (pCR), treatment with Imfinzi plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone (difference in pCR 13.0%; 95% CI 8.7-17.6)..

在病理完全缓解（pCR）的最终分析中，术前使用Imfinzi加新辅助化疗的患者pCR率为17.2%，而单独使用新辅助化疗的患者pCR率为4.3%（pCR差异为13.0%；95%CI为8.7-17.6）。。

Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients' ability to complete surgery versus chemotherapy alone..

Imfinzi通常耐受性良好，在新辅助和辅助环境中未观察到新的安全信号。此外，将Imfinzi添加到新辅助化疗中与该组合的已知特征一致，并且不损害患者完成手术的能力而不是单独化疗。。

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA will consider the feedback as it reviews the submission and is not bound by the Committee’s recommendation.

ODAC为FDA提供有关用于治疗癌症的市售和研究药物的独立专家建议和建议。FDA将在审查提交文件时考虑反馈，不受委员会建议的约束。

Imfinzi is approved in Switzerland and the UK for the treatment of adults with resectable NSCLC in Stage II and III without known EGFR mutations or ALK rearrangements, based on the AEGEAN results. Regulatory applications for Imfinzi in this setting are also currently under review in the EU, China and several other countries..

根据爱琴海的研究结果，Imfinzi在瑞士和英国被批准用于治疗II期和III期可切除的非小细胞肺癌，而不存在已知的EGFR突变或ALK重排。在这种情况下，Imfinzi的监管申请目前也正在欧盟、中国和其他几个国家进行审查。。

Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy based on the PACIFIC Phase III trial.

Imfinzi是唯一获得批准的免疫疗法，也是基于太平洋III期试验的放化疗后疾病未进展的患者不可切除的III期非小细胞肺癌治疗意图设定的全球护理标准。

Notes

注意事项

Lung cancer

肺癌

Each year, there are an estimated 2.4 million people diagnosed with lung cancer globally.1 Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.1-2 Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% of patients diagnosed with NSCLC.3-4.

每年，全球估计有240万人被诊断患有肺癌。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（SCLC），其中80-85%的患者被诊断为非小细胞肺癌。

The majority of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.5-6 Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition.7-8

大多数非小细胞肺癌患者被诊断出患有晚期疾病，而大约25-30%的患者在诊断时患有可切除的疾病。5-6早期肺癌的诊断通常只有在影像学上发现不相关的癌症时才能进行。7-8

The majority of patients with resectable disease eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy.9 Only 36-46% of patients with Stage II disease will survive for five years.10 This decreases to 24% for patients with Stage IIIA disease and 9% for patients with Stage IIIB disease, reflecting a high unmet medical need.10.

尽管完成了肿瘤切除和辅助化疗，但大多数可切除疾病患者最终会复发[9]。II期患者中只有36-46%会存活5年[10]。IIIA期患者的存活率降至24%，IIIB期患者为9%，反映出高度未满足的医疗需求。

AEGEAN

爱琴海

AEGEAN is a randomised, double-blind, multi-centre, placebo-controlled global Phase III trial evaluating Imfinzi as perioperative treatment for patients with resectable Stage IIA-IIIB (Eighth Edition AJCC Cancer Staging Manual) NSCLC, irrespective of PD-L1 expression. Perioperative therapy includes treatment before and after surgery, also known as neoadjuvant/adjuvant therapy.

爱琴海是一项随机，双盲，多中心，安慰剂对照的全球III期临床试验，评估Imfinzi作为可切除IIA-IIIB期（第八版AJCC癌症分期手册）NSCLC患者的围手术期治疗，无论PD-L1表达如何。围手术期治疗包括手术前后的治疗，也称为新辅助/辅助治疗。

In the trial, 802 patients were randomised to receive a 1500mg fixed dose of Imfinzi plus chemotherapy or placebo plus chemotherapy every three weeks for four cycles prior to surgery, followed by Imfinzi or placebo every four weeks (for up to 12 cycles) after surgery. Patients with known EGFR or ALK genomic tumour aberrations were excluded from the primary efficacy analyses..

在该试验中，802名患者被随机分配在手术前每三周接受1500mg固定剂量的Imfinzi加化疗或安慰剂加化疗，持续四个周期，然后在手术后每四周（最多12个周期）接受Imfinzi或安慰剂。具有已知EGFR或ALK基因组肿瘤畸变的患者被排除在主要疗效分析之外。。

In the AEGEAN trial, the primary endpoints were pCR, defined as no viable tumour in the resection specimen (including lymph nodes) following neoadjuvant therapy, and EFS, defined as the time from randomisation to an event like tumour recurrence, progression precluding definitive surgery, or death. Key secondary endpoints were major pathologic response, defined as residual viable tumour of less than or equal to 10% in the resected primary tumour following neoadjuvant therapy, disease-free survival, overall survival (OS), safety and quality of life.

在爱琴海试验中，主要终点是pCR，定义为新辅助治疗后切除标本（包括淋巴结）中没有可行的肿瘤，EFS定义为从随机化到肿瘤复发等事件的时间，排除确定性手术的进展，或死亡。关键的次要终点是主要的病理反应，定义为新辅助治疗后切除的原发肿瘤中残留存活肿瘤小于或等于10%，无病生存率，总生存率（OS），安全性和生活质量。

The final pathologic response analyses were performed after all patients had the opportunity for surgery and pathology assessment per the trial protocol. The trial enrolled participants from 264 centres in more than 25 countries and regions including in the US, Canada, Europe, South America and Asia..

在所有患者都有机会根据试验方案进行手术和病理评估后，进行最终的病理反应分析。该试验招募了来自美国、加拿大、欧洲、南美和亚洲等25个国家和地区264个中心的参与者。。

Imfinzi

鱼

Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi（durvalumab）是一种人类单克隆抗体，与PD-L1蛋白结合，阻断PD-L1与PD-1和CD80蛋白的相互作用，对抗肿瘤的免疫逃避策略，释放对免疫反应的抑制作用。

Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy. Imfinzi is also approved for the treatment of extensive-stage SCLC and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. .

Imfinzi是放化疗后疾病未进展的不可切除III期非小细胞肺癌患者治疗意图设定中唯一获得批准的免疫疗法和全球护理标准。Imfinzi也被批准用于治疗广泛期SCLC，并与短期Imjudo（tremelimumab）和化疗联合用于治疗转移性NSCLC。。

In limited-stage SCLC, Imfinzi demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of OS and progression-free survival compared to placebo in patients who had not progressed following standard-of-care concurrent chemoradiotherapy in the ADRIATIC Phase III trial..

在有限期SCLC中，与安慰剂相比，在亚得里亚海III期试验中，在标准治疗同步放化疗后未进展的患者中，Imfinzi在OS和无进展生存的双重主要终点方面表现出统计学上显着且临床上有意义的改善。。

In addition to its indications in lung cancers, Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU and in combination with chemotherapy (carboplatin plus paclitaxel) followed by Imfinzi monotherapy in primary advanced or recurrent endometrial cancer that is mismatch repair deficient in the US.  .

除了肺癌的适应症外，Imfinzi还被批准与化疗（吉西他滨加顺铂）联合治疗局部晚期或转移性胆管癌，并与Imjudo联合治疗不可切除的肝细胞癌（HCC）。。

Since the first approval in May 2017, more than 220,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, breast cancer, bladder cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours.  .

自2017年5月首次批准以来，已有超过220000名患者接受了Imfinzi治疗。作为广泛发展计划的一部分，Imfinzi正在作为单一疗法进行测试，并与其他抗癌疗法联合用于小细胞肺癌，非小细胞肺癌，乳腺癌，膀胱癌，几种胃肠道和妇科癌症以及其他实体瘤患者。

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 (osimertinib) and Iressa (gefitinib); Imfinzi and Imjudo; Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo; Orpathys (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（osimertinib）和Iressa（吉非替尼）；Imfinzi和Imjudo；Enhertu（曲妥珠单抗deruxtecan）和达托帕单抗deruxtecan与Daiichi Sankyo合作；Orpathys（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 immuno-oncology (IO)

阿斯利康免疫肿瘤学（IO）

AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours..

阿斯利康是将免疫疗法的概念引入高度未满足医疗需求的专用临床领域的先驱。该公司拥有全面多样的IO投资组合和渠道，以免疫疗法为基础，旨在克服抗肿瘤免疫反应的逃避，并刺激人体免疫系统攻击肿瘤。。

AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T cell engagers..

阿斯利康致力于重新定义癌症护理，并帮助将Imfinzi患者的结果转化为单一疗法，并与Imjudo以及其他新型免疫疗法和方式相结合。该公司还正在研究下一代免疫疗法，如双特异性抗体和疗法，这些疗法利用免疫的不同方面来靶向癌症，包括细胞疗法和T细胞参与者。。

AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses.

阿斯利康正在寻求一种创新的临床策略，将基于IO的疗法引入各种癌症类型的新环境中，以提供长期生存。该公司专注于探索新的组合方法，以帮助预防治疗耐药性并驱动更长的免疫反应。

With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure..

凭借广泛的临床计划，该公司还倡导在疾病早期阶段使用IO治疗，因为早期疾病具有最大的治愈潜力。。

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. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. .

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。请访问astrazeneca.com并在社交媒体@astrazeneca上关注该公司。