AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union (EU) for the treatment of adult patients with resectable muscle-invasive bladder cancer (MIBC) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder)..

阿斯利康的英飞凡（度伐利尤单抗）已在欧盟获批，用于治疗可切除的肌层浸润性膀胱癌（MIBC）成年患者，与吉西他滨和顺铂联合作为新辅助治疗，随后在根治性膀胱切除术（切除膀胱的手术）后使用英飞凡单药作为辅助治疗。

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the NIAGARA Phase III trial, which were published in The New England Journal of Medicine.

欧盟委员会的批准遵循了人用药品委员会的积极意见，并基于 NIAGARA III 期试验的结果，该结果已发表在《新英格兰医学杂志》上。

In a planned interim analysis, the Imfinzi-based perioperative regimen demonstrated a statistically significant 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus neoadjuvant chemotherapy with radical cystectomy alone (based on event-free survival [EFS] hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001).

在计划的中期分析中，基于Imfinzi的围手术期方案显示，与单独使用新辅助化疗和根治性膀胱切除术相比，疾病进展、复发、未接受手术或死亡的风险显著降低了32%（基于无事件生存期[EFS]风险比[HR]为0.68；95%置信区间[CI]为0.56-0.82；p<0.0001）。

Estimated median EFS was not yet reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event free at two years compared to 59.8% in the comparator arm..

Imfinzi组的估计中位EFS尚未达到，而对照组为46.1个月。接受该方案治疗的患者中，约67.8%在两年时无事件，而对照组为59.8%。

Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus the comparator arm (based on OS HR of 0.75; 95% CI 0.59-0.93; p=0.0106). Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm..

关键次要终点总生存期（OS）的结果显示，与对照组相比，基于Imfinzi的围手术期方案将死亡风险降低了25%（基于OS HR为0.75；95% CI 0.59-0.93；p=0.0106）。两组均未达到中位生存期。据估计，接受该方案治疗的患者中有82.2%在两年时仍然存活，而对照组为75.2%。

In 2024, over 35,000 people in the five major European countries were treated for MIBC.1 Despite this representing a curative-intent setting, many patients experience disease recurrence after surgery with current standard-of-care neoadjuvant chemotherapy.2

2024年，欧洲五大国家中超过35,000人接受了MIBC治疗。尽管这代表着治愈意图的设定，但许多患者在手术后使用当前标准的新辅助化疗后仍会出现疾病复发。

Dr Michiel Van der Heijden, medical oncologist and Group Leader at the Netherlands Cancer Institute, and investigator in the NIAGARA trial, said: “The durvalumab-based perioperative regimen is an important new treatment option for patients in Europe with muscle-invasive bladder cancer, as currently nearly half experience disease recurrence despite treatment with neoadjuvant chemotherapy and surgery to remove the bladder.

荷兰癌症研究所的医学肿瘤学家、小组负责人 Michiel Van der Heijden 博士以及 NIAGARA 试验的研究者表示：“基于度伐利尤单抗的围手术期方案对于欧洲患有肌层浸润性膀胱癌的患者来说是一个重要的新治疗选择，因为目前尽管接受了新辅助化疗和膀胱切除手术，仍有近一半的患者出现疾病复发。”

The NIAGARA results showed how this regimen reduced the risk of recurrence by nearly a third and significantly extended survival, underscoring its potential to transform clinical practice in this curative-intent setting.'.

NIAGARA 研究结果表明，该方案将复发风险降低了近三分之一，并显著延长了生存期，突显了其在治愈意图背景下转变临床实践的潜力。

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Imfinzi is poised to transform the standard of care for muscle-invasive bladder cancer in Europe as the first and only perioperative immunotherapy for these patients. In the NIAGARA Phase III trial, more than 80 per cent of patients were still alive two years after treatment with the Imfinzi regimen, setting a new survival benchmark for a disease that has seen few treatment advances in decades.”.

阿斯利康肿瘤血液事业部执行副总裁戴夫·弗雷德里克森表示：“Imfinzi 将作为欧洲首个也是唯一一个针对这些患者的围手术期免疫疗法，有望改变肌层浸润性膀胱癌的治疗标准。在 NIAGARA III 期试验中，超过 80% 的患者在接受 Imfinzi 方案治疗两年后仍然存活，为这种数十年来鲜有治疗进展的疾病树立了新的生存基准。”

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 compared to neoadjuvant chemotherapy alone.

Imfinzi通常具有良好的耐受性，在新辅助和辅助治疗环境中未观察到新的安全信号。此外，将Imfinzi加入新辅助化疗与其已知的特性一致，并且与单独使用新辅助化疗相比，未影响患者完成手术的能力。

Immune-mediated adverse events were consistent with the known profile of Imfinzi, manageable and mostly low-grade..

免疫介导的不良事件与Imfinzi的已知特征一致，可管理且大多为低级别。

The European Society for Medical Oncology (ESMO) has published its assessment of the NIAGARA regimen against the Magnitude of Clinical Benefit Scale (MCBS), awarding it the highest possible grade of “A” in the curative setting.3 The ESMO-MCBS facilitates improved decision-making regarding the value of anti-cancer therapies and is used in several ways, including in clinical guidelines and in health technology assessments in a growing number of countries.4.

欧洲医学肿瘤学会 (ESMO) 根据临床获益幅度量表 (MCBS) 对 NIAGARA 方案进行了评估，并在治愈性治疗环境中给予了其最高的“A”级评分。ESMO-MCBS 有助于改进关于抗癌疗法价值的决策，并以多种方式使用，包括在临床指南和越来越多国家的卫生技术评估中。

Imfinzi is approved in the US and other countries in this setting based on the NIAGARA results. Regulatory applications for this indication are currently under review in Japan and several other countries. Imfinzi is also approved in other curative-intent settings based on the PACIFIC and AEGEAN Phase III trials in non-small cell lung cancer (NSCLC), and in limited-stage small cell lung cancer (SCLC) based on the ADRIATIC Phase III trial..

基于NIAGARA试验结果，Imfinzi在美国和其他国家的这一适应症中已获批。针对这一适应症的监管申请目前正在日本及其他多个国家接受审查。Imfinzi还基于PACIFIC和AEGEAN III期试验在非小细胞肺癌（NSCLC）中的其他治愈意图设置中获得批准，并基于ADRIATIC III期试验在局限期小细胞肺癌（SCLC）中获批。

Notes

笔记

Muscle-invasive bladder cancer

肌肉浸润性膀胱癌

Bladder cancer is the 9th most common cancer in the world, with more than 614,000 patients diagnosed each year.5 The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.6 Bladder cancer is considered muscle-invasive when there is evidence of the tumour invading the muscle wall of the bladder but no distant metastases.6 In MIBC, approximately 50% of patients who undergo bladder removal surgery experience disease recurrence.2 Treatment options that prevent disease recurrence after surgery are critically needed in this curative-intent setting..

膀胱癌是全球第九大常见癌症，每年有超过614,000名患者被诊断出患有此病。最常见的膀胱癌类型是尿路上皮癌，它起源于尿路的尿路上皮细胞。当有证据显示肿瘤侵犯膀胱的肌壁但没有远处转移时，膀胱癌被认为是肌层浸润性的。在肌层浸润性膀胱癌中，大约50%接受膀胱切除手术的患者会出现疾病复发。在此以治愈为目的的情况下，迫切需要能防止术后疾病复发的治疗选择。

NIAGARA

尼亚加拉

NIAGARA is a randomised, open-label, multi-centre, global Phase III trial evaluating perioperative Imfinzi as treatment for patients with MIBC before and after radical cystectomy. In the trial, 1,063 patients were randomised to receive four cycles of Imfinzi plus neoadjuvant chemotherapy prior to cystectomy followed by eight cycles of Imfinzi monotherapy, or neoadjuvant chemotherapy alone prior to cystectomy with no further treatment after surgery.

NIAGARA 是一项随机、开放标签、多中心、全球 III 期试验，评估围手术期使用 Imfinzi 治疗肌层浸润性膀胱癌（MIBC）患者在根治性膀胱切除术前后的疗效。试验中，1,063 名患者被随机分配接受膀胱切除术前四个周期的 Imfinzi 联合新辅助化疗，随后接受八个周期的 Imfinzi 单药治疗，或仅接受膀胱切除术前的新辅助化疗且术后不进行进一步治疗。

NIAGARA is the largest global Phase III trial in this setting..

NIAGARA 是这一领域中全球规模最大的 III 期临床试验。

The trial is being conducted at 192 centres in 22 countries across North America, South America, Europe, Australia and Asia. Its dual primary endpoints are EFS and pathologic complete response at the time of cystectomy. Key secondary endpoints are OS and safety.

该试验正在北美、南美、欧洲、澳大利亚和亚洲的22个国家的192个中心进行。其双重主要终点是膀胱切除术时的无事件生存期（EFS）和病理完全缓解。关键的次要终点是总生存期（OS）和安全性。

Imfinzi

英飞凡

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）是一种人源性单克隆抗体，能够与PD-L1蛋白结合，阻断PD-L1与PD-1和CD80蛋白的相互作用，从而对抗肿瘤的免疫逃逸策略，并解除对免疫反应的抑制。

In May 2025, Imfinzi plus standard-of-care Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial.

2025年5月，Imfinzi联合标准护理的卡介苗诱导和维持治疗，在POTOMAC III期试验中达到了高风险非肌层浸润性膀胱癌患者的无病生存主要终点。

In lung cancer, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC.

在肺癌方面，Imfinzi 是基于总生存期（OS）的全球标准治疗方案，适用于在接受化放疗（CRT）后疾病未进展的不可切除的III期非小细胞肺癌（NSCLC）患者。此外，Imfinzi 还被批准作为可切除非小细胞肺癌的围手术期治疗，与新辅助化疗联合使用；并与短疗程的Imjudo（tremelimumab）和化疗联合用于治疗转移性非小细胞肺癌。

Imfinzi is also approved for limited-stage SCLC in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC..

Imfinzi 还被批准用于有限期小细胞肺癌（SCLC），适用于在接受同步铂类放化疗后疾病未进展的患者；以及联合化疗用于广泛期小细胞肺癌（SCLC）的治疗。

Imfinzi is also approved in combination with chemotherapy 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.

Imfinzi 还被批准与化疗联合用于局部晚期或转移性胆道癌，并与 Imjudo 联合用于不可切除的肝细胞癌 (HCC)。Imfinzi 还在日本和欧盟被批准作为单药治疗不可切除的肝细胞癌 (HCC)。

In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met the primary endpoint of EFS in the MATTERHORN Phase III trial in resectable gastric and gastroesophageal junction cancers.

2025年3月，在可切除的胃癌和胃食管交界处癌的MATTERHORN III期试验中，围手术期Imfinzi联合标准护理化疗达到了EFS的主要终点。

Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan..

Imfinzi联合化疗后使用Imfinzi单药疗法已被批准作为主要晚期或复发性子宫内膜癌（仅限美国和欧盟的错配修复缺陷型疾病）的一线治疗。Imfinzi联合化疗后使用Lynparza（奥拉帕尼）和Imfinzi已被批准用于欧盟和日本的错配修复完整型晚期或复发性子宫内膜癌患者。

Since the first approval in May 2017, more than 414,000 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 NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers..

自2017年5月首次获批以来，已有超过414,000名患者接受了Imfinzi治疗。作为一项广泛开发计划的一部分，Imfinzi正在作为单一疗法以及与其它抗癌疗法联合用于治疗非小细胞肺癌、膀胱癌、乳腺癌、卵巢癌和多种胃肠道癌症的患者中进行测试。

AstraZeneca in immuno-oncology (IO)

阿斯利康在免疫肿瘤学（IO）领域

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概念引入高未满足医疗需求的专用临床领域的先驱。该公司拥有一个全面且多样化的IO产品组合和研发管线，专注于设计能够克服抗肿瘤免疫反应逃避并刺激人体免疫系统攻击肿瘤的免疫疗法。

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..

阿斯利康致力于通过英飞凡单药治疗以及与英达珠联合使用，以及其他新型免疫疗法和治疗模式，重新定义癌症护理并帮助改善患者的治疗结果。公司还在研究下一代免疫疗法，例如双特异性抗体和利用免疫不同方面来靶向癌症的治疗方法，包括细胞疗法和T细胞接合器。

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.

阿斯利康正在推进一项创新的临床策略，旨在将基于免疫肿瘤（IO）的疗法引入到广泛的癌症类型的新治疗场景中，以实现长期生存。公司专注于探索新型组合方法，以帮助防止治疗耐药性并推动更持久的免疫反应。

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..

通过广泛的临床项目，该公司还倡导在疾病早期阶段使用IO治疗，因为在这些阶段治愈的潜力最大。

AstraZeneca in oncology

阿斯利康在肿瘤学领域

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.

阿斯利康正引领一场肿瘤学革命，致力于为各种形式的癌症提供治愈方案。通过科学研究深入了解癌症及其复杂性，发现、开发并交付改变生命的药物给患者。

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.

公司的重点是一些最具挑战性的癌症。正是通过不懈的创新，阿斯利康建立了业内最多样化的产品组合和研发管线之一，有望催化医学实践的变革，并彻底改变患者的治疗体验。

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

阿斯利康有重新定义癌症护理并有朝一日消除癌症作为死亡原因的愿景。

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）是一家全球领先的、以科学为导向的生物制药公司，专注于肿瘤学、罕见疾病以及包括心血管、肾脏与代谢、呼吸与免疫学在内的生物制药领域的处方药的研发、生产和商业化。

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..

总部位于英国剑桥的阿斯利康公司的创新药物在全球125多个国家销售，被全球数百万患者使用。请访问astrazeneca.com，并在社交媒体上关注该公司@AstraZeneca。