Imfinzi demonstrated statistically significant and clinically meaningful improvement in event-free survival and overall survival for muscle-invasive bladder 癌症 in 尼亚加拉 Phase III trial

前后的第一次免疫治疗方案
手术延长膀胱癌患者的生存期
 

尼亚加拉 III期临床试验的高水平阳性结果显示，澳门在线赌城娱乐的治疗效果良好 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 癌症 (MIBC). 患者接受了 Imfinzi 膀胱切除术(手术切除膀胱)前联合新辅助化疗 Imfinzi 作为辅助单一疗法.

Approximately one in four patients with bladder 癌症 has evidence of the tumour invading the muscle wall of the bladder (without distant metastases), 称为MIBC.^1,2 在MIBC环境中，大约有11.7万名患者接受了目前的标准治疗.³ 标准治疗包括新辅助化疗和根治性膀胱切除术.⁴ 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.⁴

托马斯·鲍尔斯教授, MD, 教授, 巴茨癌症中心主任, 伦敦, UK, 也是试验的调查员, said: “Nearly half of patients with muscle-invasive bladder 癌症 谁 receive standard of care still experience disease recurrence or progression. These 尼亚加拉 data show for the first time that adding durvalumab to chemotherapy before surgery followed by durvalumab extends patients’ lives.”

Susan Galbraith，肿瘤学研究中心执行副总裁&D, 澳门在线赌城娱乐, said: “The 尼亚加拉 results support our strategy to move immunotherapy to the early stages of 癌症 treatment. 围手术期治疗方案 Imfinzi 提高生存率，降低患者经历疾病复发或进展的比率. We are eager to bring this regimen with the potential to transform the standard of care to patients as soon as possible.”

Imfinzi was generally well-tolerated and no new safety concerns were observed in either the neoadjuvant or adjuvant setting. 的安全概况 Imfinzi 新辅助化疗与已知的单个药物的情况一致. 的加入 Imfinzi did not increase the discontinuation rate due to adverse events and did not compromise patients' ability to complete surgery compared to neoadjuvant chemotherapy alone. 这些数据将在即将召开的医学会议上提交，并与全球监管机构共享.

笔记

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.⁵ 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.⁶

肌肉浸润性膀胱癌, 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.^1,2 大约50%接受膀胱切除手术的患者会经历疾病复发.⁴ 预防手术后疾病复发的治疗方案是迫切需要的.  

尼亚加拉
尼亚加拉是一项随机、开放tags、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. 

该试验在包括北美在内的22个国家和地区的192个中心进行, 南美, 欧洲, 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 癌症 (非小细胞肺癌) in patients 谁se disease has not progressed after chemoradiation therapy. Imfinzi is also approved for the treatment of extensive-stage small cell lung 癌症 (SCLC) and in combination with a short course of Imjudo (tremelimumab)和化疗治疗转移性非小细胞肺癌.

Imfinzi in combination with neoadjuvant platinum-containing chemotherapy before surgery and 作为辅助单一疗法 after surgery has been approved in Switzerland for the treatment of adult patients with resectable 非小细胞肺癌 and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

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 癌症 and in combination with Imjudo 不可切除的肝细胞癌(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 单药治疗美国错配修复缺陷的原发性晚期或复发子宫内膜癌.

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-癌症 treatments for patients with SCLC, 非小细胞肺癌, 乳腺癌, 几种胃肠道和妇科癌症, 以及其他实体肿瘤.

Imfinzi 是否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 谁 are cisplatin-ineligible or refusing cisplatin (VOLGA) and locally advanced or metastatic disease (NILE).

澳门在线赌城娱乐在免疫肿瘤学(IO)中的应用
澳门在线赌城娱乐 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.

澳门在线赌城娱乐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 as well as therapeutics that harness different aspects of immunity to target 癌症, 包括细胞疗法和T细胞接合剂.

澳门在线赌城娱乐 is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of 癌症 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.

澳门在线赌城娱乐在肿瘤学  
澳门在线赌城娱乐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 澳门在线赌城娱乐 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.

澳门在线赌城娱乐的愿景是重新定义癌症治疗和, 有一天,, 消除癌症作为死亡原因.

澳门在线赌城娱乐
澳门在线赌城娱乐(LSE/STO/Nasdaq: AZN)是一家全球性制药公司, 以科学为主导的澳门第一赌城在线娱乐公司，专注于发现, 发展, 以及肿瘤学处方药的商业化, 罕见疾病, 和澳门第一赌城在线娱乐, 包括心血管, 肾 & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门在线赌城娱乐’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. 请访问 澳门在线赌城娱乐.com 并在社交媒体上关注公司 @澳门在线赌城娱乐.

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参考文献

艾德里安·坎普
公司秘书
澳门在线赌城娱乐