在尼亚加拉 III期临床试验中，Imfinzi对肌肉侵袭性膀胱癌的无事件生存期和总生存期有统计学意义和临床意义的改善

First immunotherapy regimen before and after
surgery to extend survival in bladder 癌症
 

Positive high-level results from the 尼亚加拉 Phase III trial showed 澳门在线赌城娱乐’s Imfinzi (durvalumab)联合化疗与肌肉浸润性膀胱癌(MIBC)患者的新辅助化疗相比，在无事件生存期(EFS)的主要终点和总生存期(OS)的关键次要终点方面显示出具有统计学意义和临床意义的改善。. 患者接受了 Imfinzi in combination with neoadjuvant chemotherapy before cystectomy (surgery to remove the bladder) followed by Imfinzi 作为辅助单一疗法.

大约四分之一的膀胱癌患者有肿瘤侵入膀胱肌壁的迹象(无远处转移)。, 称为MIBC.^1,2 In the MIBC setting, approximately 117,000 patients are treated with current standard of care.³ Standard treatment includes neoadjuvant chemotherapy and radical cystectomy.⁴ However, even after cystectomy, patients experience high rates of recurrence and a poor prognosis.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, 他说:“接受标准治疗的肌肉浸润性膀胱癌患者中，近一半仍会出现疾病复发或进展. 这些尼亚加拉数据首次表明，在手术前化疗中加入durvalumab，随后使用durvalumab可延长患者的生命.”

Susan Galbraith, Executive Vice President, 肿瘤学 R&D, 澳门在线赌城娱乐, 他说:“尼亚加拉的研究结果支持澳门第一赌城在线娱乐将免疫疗法引入癌症早期治疗的策略. 围手术期治疗方案 Imfinzi improved survival and reduced the rate at which patients experience disease recurrence or progression. 澳门第一赌城在线娱乐渴望尽快将这种有可能改变患者护理标准的方案带来.”

Imfinzi 在新辅助治疗或辅助治疗中是否普遍耐受良好，没有观察到新的安全性问题. 的安全概况 Imfinzi and neoadjuvant chemotherapy was consistent with the known profile of the individual medicines. 的加入 Imfinzi 与单独的新辅助化疗相比，是否会增加不良事件导致的停药率，是否会影响患者完成手术的能力. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

笔记

肌肉浸润性膀胱癌
Bladder 癌症 is the 9th most common 癌症 in the world, 有超过614个,每年诊断出的病人有000人.⁵ The most common type of bladder 癌症 is urothelial carcinoma, which begins in the urothelial cells of the urinary tract.⁶

肌肉浸润性膀胱癌, named for its growth into the muscle wall of the bladder, accounts for about a quarter of all bladder 癌症 cases.^1,2 Approximately 50% of patients 谁 undergo bladder removal surgery experience disease recurrence.⁴ Treatment options that prevent disease recurrence after surgery are critically needed.  

尼亚加拉
尼亚加拉 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, 1063 patients were randomised to receive Imfinzi plus chemotherapy or chemotherapy alone prior to cystectomy, followed by Imfinzi 或者手术后没有进一步治疗. 

The trial is being conducted at 192 centres across 22 countries and regions including in North America, 南美, 欧洲, 澳大利亚和亚洲. 它的两个主要终点是EFS, 定义为从治疗随机化到肿瘤复发或进展和病理完全缓解等事件的时间. Key secondary endpoints are OS and safety.  

Imfinzi 
Imfinzi (durvalumab)是一种人单克隆抗体，结合PD-L1蛋白并阻断PD-L1与PD-1和CD80蛋白的相互作用, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi 在治疗目的为不可切除的情况下，唯一批准的免疫疗法和全球护理标准是不可切除的吗, III期非小细胞肺癌(非小细胞肺癌)患者的疾病在放化疗后没有进展. Imfinzi 也被批准用于治疗广泛期小细胞肺癌(SCLC)，并与短疗程的 Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic 非小细胞肺癌.

Imfinzi 瑞士已批准在术前联合新辅助含铂化疗，并在术后作为辅助单药治疗，用于治疗可切除的、无已知表皮生长因子受体(EGFR)突变或间变性淋巴瘤激酶(ALK)重排的成年非小细胞肺癌患者.

In addition to its indications in lung 癌症s, Imfinzi 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道癌，并与 Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi 在日本和欧盟也被批准作为不可切除HCC的单药治疗，并与化疗(卡铂+紫杉醇)联合使用 Imfinzi monotherapy in primary advanced or recurrent endometrial 癌症 that is mismatch repair deficient in the US.

Since the first approval in May 2017, more than 220,000 patients have been treated with Imfinzi. As part of a broad 发展 programme, Imfinzi 是否在SCLC患者的单独治疗和联合其他抗癌治疗中进行了测试, 非小细胞肺癌, 乳腺癌, several gastrointestinal and gynaecologic 癌症s, 以及其他实体肿瘤.

Imfinzi is being tested across early- and late-stage bladder 癌症 in various treatment combinations, including in non-muscle invasive disease (POTOMAC), 不适合顺铂治疗或拒绝顺铂治疗(VOLGA)和局部晚期或转移性疾病(NILE)的MIBC患者.

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. 该公司拥有全面和多样化的IO产品组合和管道，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.

澳门在线赌城娱乐 strives to redefine 癌症 care and help transform outcomes for patients with Imfinzi 作为一种单一疗法或与 Imjudo as well as other novel immunotherapies and modalities. 该公司还在研究下一代免疫疗法，如双特异性抗体，以及利用免疫的不同方面来靶向癌症的疗法, including cell therapy and T cell engagers.

澳门在线赌城娱乐正在寻求一种创新的临床策略，将基于io的治疗方法引入到各种癌症类型的新环境中，以实现长期生存. 该公司专注于探索新的联合方法，以帮助预防治疗耐药性和驱动更长时间的免疫反应. 有广泛的临床项目, the Company also champions the use of IO treatment in earlier disease stages, w在这里 t在这里 is the greatest potential for cure.

澳门在线赌城娱乐在肿瘤学  
澳门在线赌城娱乐 is leading a revolution in oncology with the ambition to provide cures for 癌症 in every form, following the science to understand 癌症 and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company's focus is on some of the most challenging 癌症s. 正是通过持续的创新，澳门在线赌城娱乐建立了行业中最多样化的产品组合和管道之一, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

澳门在线赌城娱乐 has the vision to redefine 癌症 care and, 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) is a global, science-led biopharmaceutical company that focuses on the discovery, 发展, and commercialisation of prescription medicines in 肿瘤学, 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, 澳门在线赌城娱乐的创新药物在超过125个国家销售，并被全球数百万患者使用. 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