2020年11月20日07:00 GMT
Four-week dosing now approved in all Imfinzi indications, reducing medical visits and improving patient convenience
澳门在线赌城娱乐公司 Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,每4周固定剂量500mg, 在化疗(CRT)后不可切除的III期非小细胞肺癌(NSCLC)和先前治疗过的晚期膀胱癌的批准适应症中. This new option is consistent with the approved Imfinzi 该药物将用于广泛期小细胞肺癌(ES-SCLC)，体重超过30kg的患者可作为每两周10mg/kg基于体重的剂量的替代方案.
The approval by the Food and Drug Administration (FDA) was based on data from several Imfinzi 临床试验, 包括 the PACIFIC Phase III trial which supported the two-week, weight-based dosing in unresectable III期非小细胞肺癌, and the CASPIAN Phase III trial which used four-week, fixed-dosing during maintenance treatment in ES-SCLC. 该决定是在 优先审核 FDA于2020年8月批准的.
维多利亚米. Villaflor, MD, 希望之城癌症中心肿瘤内科和治疗研究部临床教授, 洛杉矶, 加州, 他说:“这种新的为期四周的剂量选择使医生可以选择将关键癌症治疗的就诊次数减少一半，并为患者提供更方便的治疗方案。. 另外, 它限制了特别容易受到COVID-19并发症影响的人群在医疗保健环境中受到感染的潜在风险.”
戴夫Fredrickson, 执行副总裁, 肿瘤事业部, 他说:“这种跨适应症的新剂量选择的批准反映了澳门第一赌城在线娱乐对改善患者体验和确保护理连续性的持续承诺，这是任何时候的优先事项, 尤其是在大流行期间. 巨蟹座不会等待, 澳门第一赌城在线娱乐的工作是为患者提供治疗方案，承认这一流行病对癌症护理构成的挑战, 使他们能够在真正需要的时候去看医生，避免可预防的与医疗保健相关的感染.”
4周1500毫克固定剂量的选择 Imfinzi is also under regulatory review in several other countries, 包括 在欧盟 where the new dosing option was granted accelerated assessment.
Imfinzi is approved in the curative-intent setting of unresectable, 在美国，CRT后的III期NSCLC, 在欧盟, in Japan, 在中国和许多其他国家, 基于太平洋III期试验. Imfinzi 在美国和其他几个国家也被批准用于治疗晚期膀胱癌患者. 另外, 它在美国是被批准的, the EU, 日本和世界上其他几个国家在CASPIAN III期试验的基础上治疗ES-SCLC.
III期非小细胞肺癌
III期非小细胞肺癌 (locally advanced) is commonly divided into three sub-categories (IIIA, iib及IIIC), defined by how much the cancer has spread locally and the possibility of surgery.1 Stage III disease is different from Stage IV disease, 癌症扩散(转移)的部位, as the majority of Stage III patients are currently treated with curative intent.1,2
III期NSCLC约占NSCLC发病率的三分之一，2015年估计影响近200例,000 patients in the following eight large countries: China, France, Germany, Italy, Japan, Spain, UK, 和美国, 大约有43个,仅在美国就有5000个病例.3,4 The majority of III期非小细胞肺癌 patients are diagnosed with unresectable tumours.5 在批准之前 Imfinzi in this setting, no new treatments beyond CRT had been available to patients for decades.6-8
小细胞肺癌
SCLC是一个非常激进的组织, fast-growing form of lung cancer that typically recurs and progresses rapidly, 尽管最初对化疗有反应.9,10 About two thirds of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body.11 预后特别差, as only 6% of all SCLC patients will be alive five years after diagnosis.11
膀胱癌
In 2018, 大约有550,000 people were diagnosed with 膀胱癌 around the world and 200,000人死于这种疾病.12 局部晚期和转移性膀胱癌仍然是一个医疗需求未得到满足的领域，通常只有七分之一的患者在诊断后五年存活.13 Urothelial cancer (UC) is the most common form of 膀胱癌.14 UC is the 10th most common cancer worldwide and the 13th most common cause of cancer death.12,15 PD-L1在膀胱癌患者的肿瘤和免疫细胞中广泛表达，并帮助肿瘤逃避免疫系统的检测.16
Imfinzi
Imfinzi (durvalumab)是一种人单克隆抗体，结合PD-L1并阻断PD-L1与PD-1和CD80的相互作用, 对抗肿瘤的免疫逃避策略，释放对免疫反应的抑制.
作为广泛发展计划的一部分， Imfinzi is also being tested as a monotherapy and in combinations 包括 with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, 作为非小细胞肺癌的一种治疗方法, SCLC, 膀胱癌, 头颈癌, 肝癌, 胆道癌, 食道癌, 胃癌, 子宫颈癌, 卵巢癌, 子宫内膜癌及其他实体瘤.
澳门在线赌城娱乐治疗肺癌
澳门在线赌城娱乐拥有全面的已批准和潜在的晚期开发新药组合，用于治疗跨越不同组织学的不同形式的肺癌, 疾病的几个阶段, 治疗路线和作用方式.
一项广泛的免疫肿瘤学(IO)开发计划侧重于没有靶向基因突变的肺癌患者, which represent up to three-quarters of all patients with lung cancer.17 Imfinzi, 抗pdl1抗体, 是否正在开发用于晚期疾病患者(POSEIDON和PEARL III期试验)和早期疾病患者的药物, 包括 potentially-curative settings (MERMAID-1, AEGEAN, 辅助BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, 和ADRIATIC III期试验)，既可作为单药治疗，也可与tremelimumab和/或化疗联合使用.
Imfinzi is also in development in the Phase II trials NeoCOAST, COAST and HUDSON in combination with potential new medicines from the early-stage pipeline, 包括 Enhertu (曲妥珠单抗deruxtecan).
澳门在线赌城娱乐的IO方法
IO是一种旨在刺激人体免疫系统攻击肿瘤的治疗方法. 该公司的IO产品组合以免疫疗法为基础，旨在克服抗肿瘤免疫抑制. 澳门在线赌城娱乐投资于使用IO方法，为各种肿瘤类型的新患者群体提供长期生存.
The Company is pursuing a comprehensive clinical-trial programme that includes Imfinzi as a monotherapy and in combination with tremelimumab in multiple tumour types, 疾病的阶段, 以及治疗方法, 在相关的情况下，使用PD-L1生物标志物作为决策工具，为患者确定最佳的潜在治疗途径. 除了, the ability to combine the IO portfolio with radiation, 化疗, small targeted molecules from across 澳门在线赌城娱乐公司 Oncology pipeline, 从研究伙伴那里, may provide new treatment options across a broad range of tumours.
澳门在线赌城娱乐在肿瘤学
澳门在线赌城娱乐在肿瘤学领域有着深厚的传统，并提供快速增长的新药组合，这些新药有可能改变患者的生活和公司的未来. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, 公司致力于将肿瘤作为澳门在线赌城娱乐专注于肺部的关键增长动力, ovarian, 乳腺癌和血癌.
By harnessing the power of six scientific platforms – Immuno-Oncology, 肿瘤驱动因素和耐药性, DNA损伤反应, 抗体药物偶联物, 表观遗传学, and Cell Therapies – and by championing the development of personalised combinations, 澳门在线赌城娱乐的愿景是重新定义癌症治疗，并有一天消除癌症这一死亡原因.
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, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, 心血管, Renal & 新陈代谢和呼吸 & 免疫学. 总部设在剑桥, UK, 澳门在线赌城娱乐在100多个国家开展业务，其创新药物被全球数百万患者使用. 请访问 澳门在线赌城娱乐.com 并在Twitter上关注公司 @澳门在线赌城娱乐.
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参考文献
1. ASCO. Cancer.net. 肺癌-非小细胞. 可以在: http://www.cancer.net/cancer-types/lung-cancer/view-all. 2020年9月访问.
2. Cheema PK, et al. III期局部晚期不可切除非小细胞肺癌的治疗进展展望. 咕咕叫杂志. 2019;26(1):37-42.
3. 安东尼娅SJ, et al. 太平洋调查人员. Durvalumab After Chemoradiotherapy In Stage III Non-Small-Cell Lung Cancer. [英]医学. 2017;377(20):1919-1929.
4. EpiCast Report: NSCLC Epidemiology Forecast to 2025. GlobalData. 2016.
5. Provencio M, et al. Inoperable Stage III Non-Small Cell Lung Cancer: Current Treatment And Role Of Vinorelbine. J胸腺病. 2011;3:197-204.
6. Curran WJ, et al. 序贯放化疗与同步放化疗治疗III期非小细胞肺癌:随机III期试验RTOG 9410. 美国国立癌症研究所. 2011;103(19):1452-1460.
7. NCCN. NCCN肿瘤学临床实践指南(NCCN指南)-非小细胞肺癌. Version 8. 2017. http://www.nccn.org/professionals/physician_gls/pdf/nscl_blocks.pdf. 2020年9月访问.
8. 汉娜N, et al. III期肺癌全身治疗的现行标准和临床试验:什么是新的? 我是社会学家吗. 2015:e442-447.
9. Kalemkerian GP等. Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? J肿瘤学实践. 2018;14(6):369-370.
10. 国家癌症研究所. NCI词典-小细胞肺癌. 可以在 http://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer. 2020年11月访问.
11. Cancer.Net. 肺癌-小细胞. 可以在 http://www.cancer.net/cancer-types/lung-cancer-small-cell. 2020年11月访问.
12. World Health Organization International Agency for Research on Cancer. 癌症概况-膀胱. 可以在 http://gco.iarc.fr/today/data/factsheets/cancers/30-Bladder-fact-sheet.pdf. 2020年9月访问.
13. 冯·德·马斯， et al. Long-Term Survival Results of a Randomized Trial Comparing Gemcitabine Plus Cisplatin, 与甲氨蝶呤, 长春花碱, 阿霉素, 联合顺铂治疗膀胱癌. J .临床肿瘤学. 2005;23:4602-4608.
14. 美国临床肿瘤学会. 膀胱癌:介绍. 可以在 http://www.cancer.net/cancer-types/bladder-cancer/introduction. 2020年9月访问.
15. 世界癌症研究基金. 膀胱癌统计数字. 可以在 http://www.wcrf.org/dietandcancer/cancer-trends/bladder-cancer-statistics. 2020年9月访问.
16. 抹大拉, et al. Immune Responses in Bladder Cancer-Role of Immune Cell Populations, 预后因素和治疗意义. 前肿瘤防治杂志. 2019;9:1270.
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