First immunotherapy regimen before and after surgery to demonstrate statistically significant and clinically meaningful overall survival improvement in this setting

手术前后的第一个免疫治疗方案，以证明在这种情况下具有统计学意义和临床意义的总体生存率改善

Positive results from the NIAGARA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer (MIBC).

尼亚加拉III期临床试验的阳性结果显示，阿斯利康的Imfinzi（durvalumab）联合化疗显示，无事件生存期（EFS）的主要终点和总生存期（OS）的关键次要终点与肌肉浸润性膀胱癌（MIBC）患者的新辅助化疗相比有统计学意义和临床意义的改善。

Patients were treated with Imfinzi in combination with neoadjuvant chemotherapy before radical cystectomy (surgery to remove the bladder) followed by Imfinzi as adjuvant monotherapy..

在根治性膀胱切除术（手术切除膀胱）之前，患者接受Imfinzi联合新辅助化疗，然后接受Imfinzi作为辅助单药治疗。。

These results will be presented today during a Presidential Symposium at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain (abstract #LBA5) and simultaneously published in The New England Journal of Medicine.

这些结果将于今天在西班牙巴塞罗那举行的2024年欧洲医学肿瘤学会（ESMO）大会（摘要#LBA5）的总统研讨会上发表，并同时发表在《新英格兰医学杂志》上。

In a planned interim analysis, patients treated with the Imfinzi perioperative regimen showed a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm (based on EFS hazard ratio [HR] of 0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001).

在一项计划的中期分析中，接受Imfinzi围手术期方案治疗的患者与对照组相比，疾病进展，复发，未接受手术或死亡的风险降低了32%（基于EFS风险比[HR]为0.68；95%置信区间[CI]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 Imfinzi 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。。。

Results from the key secondary endpoint of OS showed the Imfinzi perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy (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 Imfinzi regimen were alive at two years compared to 75.2% in the comparator arm..

OS关键次要终点的结果显示，与根治性膀胱切除术的新辅助化疗相比，Imfinzi围手术期方案将死亡风险降低了25%（基于OS HR为0.75；95%CI为0.59-0.93；p=0.0106）。两组均未达到中位生存期。据估计，接受Imfinzi方案治疗的患者中有82.2%在两年内存活，而对照组为75.2%。。

Professor Thomas Powles, MD, Director of Barts Cancer Centre (QMUL), London, UK, and principal investigator in the NIAGARA trial, said: “Neoadjuvant chemotherapy with bladder removal has been the mainstay of treatment for patients with muscle-invasive bladder cancer for nearly twenty years; however, half of patients still go on to suffer a devastating recurrence.

英国伦敦巴特斯癌症中心（QMUL）主任、尼亚加拉试验首席研究员、医学博士托马斯·鲍尔斯教授说：“近二十年来，膀胱切除的新辅助化疗一直是肌肉浸润性膀胱癌患者的主要治疗方法；然而，一半的患者仍然遭受毁灭性的复发。

Adding durvalumab before and after surgery significantly reduced the chance of recurrence and extended survival, a significant advance with the potential to transform the standard of care for these patients who desperately need better outcomes.”.

手术前后添加durvalumab可显着降低复发率和延长生存期，这是一项重大进步，有可能改变这些迫切需要更好结果的患者的护理标准。”。

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The NIAGARA data showed compelling improvements in both event-free survival and overall survival, with more than 80 per cent of patients treated with the Imfinzi perioperative regimen alive at two years. This is the first immunotherapy regimen to significantly extend overall survival in muscle-invasive bladder cancer, and it further validates our strategy to move cancer treatment as early as possible to maximise benefit for patients.”.

阿斯利康肿瘤研发执行副总裁苏珊·加尔布雷斯（SusanGalbraith）表示：“尼亚加拉的数据显示，无事件生存率和总生存率都有令人信服的改善，超过80%接受Imfinzi围手术期方案治疗的患者在两年内存活。这是第一个显着延长肌肉浸润性膀胱癌总生存期的免疫治疗方案，它进一步验证了我们尽早进行癌症治疗以最大限度地提高患者益处的策略。”。

Summary of results: NIAGARA

结果摘要：尼亚加拉

Imfinzi-based regimen

基于无限的养生法

(n=533)

（n=533）

Neoadjuvant chemotherapy

新辅助化疗

(n=530)

（n=530）

EFS

EFS

Number of patients with event (%)

事件患者人数（%）

187 (35.1)

187 (35.1)

246 (46.4)

246 (46.4)

Median EFS (95% CI) (in months)

EFS中位数（95%置信区间）（以月为单位）

NR (NR-NR)

NR（NR-NR）

46.1 (32.2-NR)

46.1（32.2-NR）

HR (95% CI)

人力资源（95%置信区间）

0.68

0.68

(0.56-0.82)

(0.56-0.82)

p-value

p值

<0.0001

<0.0001

EFS rate at 12 months (%)

12个月时的EFS率（%）

76.0

76.0

69.9

69.9

EFS rate at 24 months (%)

24个月时的EFS率（%）

67.8

67.8

59.8

59.8

OS

操作系统

Number of deaths, n (%)

死亡人数，n（%）

136 (25.5)

136 (25.5)

169 (31.9)

169 (31.9)

HR (95% CI)

人力资源（95%置信区间）

0.75

0.75

(0.59-0.93)

(0.59-0.93)

Stratified log-rank p-value

分层对数秩p值

0.0106

0.0106

OS rate at 12 months (%)

12个月时的OS率（%）

89.5

89.5

86.5

86.5

OS rate at 24 months (%)

24个月时的OS率（%）

82.2

82.2

75.2

75.2

​iWith the observed number of events, the boundary for declaring statistical significance was 0.04123 for a 4.9% overall 2-sided alpha

​I根据观察到的事件数量，对于4.9%的总体双侧α，宣布统计显着性的边界为0.04123

iiWith the observed number of events, the boundary for declaring statistical significance was 0.01543 for a 4.9% overall 2-sided alpha. Data cutoff 24 Apr 2024.

ii根据观察到的事件数量，对于4.9%的总体双侧α，宣布统计显着性的边界为0.01543。2024年4月24日数据截止。

iiiUnplanned pCR re-analysis (DCO Apr 24), including 59 samples omitted from formal pCR analysis.

IIIUN计划pCR重新分析（DCO Apr 24），包括正式pCR分析中省略的59个样品。

NR, not reached

NR，未达到

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，并且与单独的新辅助化疗相比，不会损害患者完成手术的能力。

Grade 3 and 4 adverse events due to any cause occurred in 69% of patients treated with Imfinzi and 68% of patients treated with neoadjuvant chemotherapy..

69%接受Imfinzi治疗的患者和68%接受新辅助化疗的患者发生了任何原因引起的3级和4级不良事件。。

In addition to NIAGARA, Imfinzi is also being tested across early- and late-stage bladder cancer in various treatment combinations, including in non-muscle invasive disease (POTOMAC), patients with MIBC who are cisplatin-ineligible or refusing cisplatin (VOLGA) and locally advanced or metastatic disease (NILE)..

除了尼亚加拉，Imfinzi还在各种治疗组合中对早期和晚期膀胱癌进行测试，包括非肌肉浸润性疾病（POTOMAC），顺铂不合格或拒绝顺铂的MIBC患者（伏尔加）和局部晚期或转移性疾病（NILE）。。

Notes

注意事项

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.1 The most common type of bladder cancer is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.2

膀胱癌是世界上第九大最常见的癌症，每年诊断出614000多名患者。1最常见的膀胱癌类型是尿路上皮癌，始于泌尿道的尿路上皮细胞。2

MIBC, named for its growth into the muscle wall of the bladder, accounts for about a quarter of all bladder cancer cases.3,4 In the MIBC setting, approximately 117,000 patients are treated with current standard of care.5 Standard treatment includes neoadjuvant chemotherapy and radical cystectomy.6 However, even after cystectomy, patients experience high rates of recurrence and a poor prognosis.6 Approximately 50% of patients who undergo bladder removal surgery experience disease recurrence.6 Treatment options that prevent disease recurrence after surgery are critically needed.   .

MIBC因其生长到膀胱肌壁而得名，约占所有膀胱癌病例的四分之一[3,4]。在MIBC环境中，约有117000名患者接受了目前的标准治疗[5]。标准治疗包括新辅助化疗和根治性膀胱切除术[6]。然而，即使在膀胱切除术后，患者的复发率也很高，预后不良[6]。大约50%接受膀胱切除术的患者会出现疾病复发[6]。迫切需要预防手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 Imfinzi as treatment for patients with MIBC before and after radical cystectomy. In the trial, 1,063 patients were randomised to receive Imfinzi plus chemotherapy or chemotherapy alone prior to cystectomy, followed by Imfinzi or no further treatment after surgery.  .

尼亚加拉是一项随机，开放标签，多中心，全球III期临床试验，评估Imfinzi在根治性膀胱切除术前后治疗MIBC患者。在该试验中，1063名患者被随机分配在膀胱切除术前接受Imfinzi加化疗或单独化疗，然后接受Imfinzi或手术后不进行进一步治疗。。

The trial is being conducted at 192 centres across 22 countries including in the US, Canada, Europe, Australia and Asia. Its dual primary endpoints are EFS, defined as the time from treatment randomisation to an event like tumour recurrence or progression and pathologic complete response. Key secondary endpoints are OS and safety.   .

该试验正在美国、加拿大、欧洲、澳大利亚和亚洲等22个国家的192个中心进行。其双重主要终点是EFS，定义为从治疗随机化到肿瘤复发或进展以及病理完全缓解等事件的时间。关键的次要终点是操作系统和安全性。。

​Imfinzi

配置

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蛋白结合并阻断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并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 non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy. Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, in combination with chemotherapy for the treatment of extensive-stage small cell lung cancer (SCLC) and in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC.  ​.

​Imfinzi是唯一获得批准的免疫疗法，也是放化疗后疾病未进展的患者无法切除的III期非小细胞肺癌（NSCLC）治疗意图设定的全球护理标准。此外，Imfinzi被批准为围手术期治疗，与可切除NSCLC的新辅助化疗联合，与化疗联合治疗广泛期小细胞肺癌（SCLC），并与短期Imjudo（tremelimumab）和化疗联合治疗转移性NSCLC。。

​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.

​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）。Imfinzi在日本和欧盟也被批准作为不可切除的HCC的单一疗法。

Imfinzi is also approved in combination with chemotherapy (carboplatin and paclitaxel) followed by Imfinzi monotherapy in primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) in the US. In the EU, Imfinzi plus chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient disease advanced or recurrent endometrial cancer, and Imfinzi plus chemotherapy followed by Imfinzi alone is approved for patients with dMMR disease..

Imfinzi还被批准与化疗（卡铂和紫杉醇）联合使用，然后在美国使用Imfinzi单药治疗错配修复缺陷型（dMMR）的原发性晚期或复发性子宫内膜癌。在欧盟，Imfinzi加化疗，然后是Lynparza（olaparib）和Imfinzi被批准用于错配修复熟练的疾病晚期或复发性子宫内膜癌患者，Imfinzi加化疗，然后单独使用Imfinzi被批准用于dMMR疾病患者。。

​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。。。

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..

。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..

​阿斯利康努力重新定义癌症护理，并帮助将“Imfinzi”作为单一疗法以及与“Imjudo”以及其他新型免疫疗法和方式相结合的患者改变预后。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.

。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。。

Contacts

联系人

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References

参考文献

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Cerner CancerMPact数据库。2024年9月访问。反映了G8国家（美国，欧盟，日本，中国）的流行病学估计。

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