与对照组相比，Imfinzi围手术期方案使复发风险降低32%，死亡风险降低25%. NIAGARA III期临床试验中单独新辅助化疗治疗肌肉浸润性膀胱癌

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

NIAGARA III期临床试验的积极结果显示，澳门葡京网赌游戏的治疗效果良好 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). 患者接受了 Imfinzi in combination with neoadjuvant chemotherapy before radical cystectomy (surgery to remove the bladder) followed by Imfinzi 作为辅助单一疗法.

These results will be presented today during a Presidential Symposium at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, 西班牙(摘要#LBA5)，同时发表于 新英格兰医学杂志.

在一项计划中的中期分析中，接受治疗的患者 Imfinzi 围手术期方案显示疾病进展风险降低32%, recurrence, 未接受手术, 与对照组相比(基于EFS风险比[HR]为0.68; 95% confidence interval [CI] 0.56-0.82; p<0.0001). 估计中位EFS尚未达到 Imfinzi arm versus 46.比较臂1个月. 估计有67人.8%的患者接受了治疗 Imfinzi 与59组相比，两组无事件发生.比较组为8%.

OS的主要次要终点结果显示 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). 两组的中位生存期均未达到. 估计有82人.2%的患者接受了治疗 Imfinzi 前者存活两年，后者存活75年.在比较组中是2%.

托马斯·鲍尔斯教授, MD, 巴茨癌症中心主任, London, UK, 也是尼亚加拉试验的首席研究员, said: “新辅助化疗 with bladder removal has been the mainstay of treatment for patients with muscle-invasive bladder cancer for nearly twenty years; however, 一半的病人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.”

Susan Galbraith，肿瘤学研究中心执行副总裁&D, AstraZeneca, 他说:“NIAGARA的数据显示，无事件生存率和总生存率都有显著提高, 超过80%的病人接受了治疗 Imfinzi 围手术期存活2年. 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.”

结果总结:尼亚加拉

Imfinzi was generally well tolerated and no new safety signals were observed in the neoadjuvant and adjuvant settings. 此外,添加 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. 任何原因导致的3级和4级不良事件发生率为69% Imfinzi 68%的患者接受了新辅助化疗.

除了尼亚加拉， Imfinzi 是否也在早期和晚期膀胱癌的各种治疗组合中进行测试, 包括非肌肉侵袭性疾病(POTOMAC), patients with MIBC who are cisplatin-ineligible or refusing cisplatin (VOLGA) and locally advanced or metastatic disease (NILE).

Notes

肌肉浸润性膀胱癌 
膀胱癌是世界上第九大常见癌症, 有超过614个,每年诊断出的病人有000人.¹ 最常见的膀胱癌是尿路上皮癌, 哪个是从泌尿道的尿路上皮细胞开始的.²

MIBC, 因其生长于膀胱肌壁而得名, 约占所有膀胱癌病例的四分之一.^3,4 在MIBC环境中，大约有11.7万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，患者也会经历高复发率和不良预后.⁶ 大约50%接受膀胱切除手术的患者会经历疾病复发.⁶ 预防手术后疾病复发的治疗方案是迫切需要的.   

NIAGARA  
NIAGARA是一项随机、开放标签、多中心、全球III期临床试验 Imfinzi 作为根治性膀胱切除术前后MIBC患者的治疗方法. 在试验中，1063名患者被随机分配接受治疗 Imfinzi 在膀胱切除术前加化疗或单独化疗，然后是 Imfinzi 或者手术后没有进一步治疗.  

该试验正在包括美国在内的22个国家的192个中心进行, Canada, Europe, 澳大利亚和亚洲. 它的两个主要终点是EFS, defined as the time from treatment randomisation to an event like tumour recurrence or progression and pathologic complete response. 关键的次要终点是操作系统和安全性.   

​Imfinzi
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, 对抗肿瘤的免疫逃避策略，释放对免疫反应的抑制.

​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 是否被批准作为可切除的非小细胞肺癌的围手术期治疗联合新辅助化疗, 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)和化疗治疗转移性NSCLC.  ​

除了对肺癌的适应症， Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo 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HCC的单药治疗. Imfinzi 是否也被批准与化疗(卡铂和紫杉醇)联合使用 Imfinzi monotherapy in primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) in the US. In the EU, Imfinzi 加上化疗之后 Lynparza (olaparib) and Imfinzi 是否被批准用于错配修复熟练疾病晚期或复发子宫内膜癌患者, and Imfinzi 加上化疗之后 Imfinzi 该药物被批准用于dMMR疾病患者.

自2017年5月首次获批以来，已有超过22万名患者接受了治疗 Imfinzi. 作为广泛发展计划的一部分， 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, 几种胃肠道和妇科癌症, 以及其他实体肿瘤.

澳门葡京网赌游戏在免疫肿瘤学(IO)中的应用
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.

澳门葡京网赌游戏致力于重新定义癌症治疗，并帮助改变癌症患者的治疗结果 Imfinzi 作为一种单一疗法或与 Imjudo 以及其他新的免疫疗法和模式. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, 包括细胞疗法和T细胞接合剂.

​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. 有广泛的临床项目, 该公司还支持在早期疾病阶段使用IO治疗, 哪里有最大的治愈潜力. 

澳门葡京网赌游戏在肿瘤学
澳门葡京网赌游戏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, 跟随科学去了解癌症及其所有的复杂性, 开发并向患者提供改变生活的药物. 

该公司专注于一些最具挑战性的癌症. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, 有可能催化医学实践的变化，改变病人的体验.

澳门葡京网赌游戏的愿景是重新定义癌症治疗和, one day, 消除癌症作为死亡原因.

AstraZeneca
澳门葡京网赌游戏(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门葡京赌博游戏公司，专注于发现, development, 以及肿瘤学处方药的商业化, Rare Diseases, 和澳门葡京赌博游戏, 包括心血管, Renal & 新陈代谢和呼吸 & Immunology. 总部设在剑桥, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit lunchpenny.com 并在社交媒体上关注公司 @AstraZeneca. 

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