20 November 2020 07:00 GMT
Four-week dosing now approved in all Imfinzi indications, reducing medical visits and improving patient convenience
AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, 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 clinical trials, including the PACIFIC Phase III trial which supported the two-week, weight-based dosing in unresectable Stage III NSCLC, and the CASPIAN Phase III trial which used four-week, fixed-dosing during maintenance treatment in ES-SCLC. The decision follows the Priority Review granted by the FDA in August 2020.
Victoria M. Villaflor, MD, 希望之城癌症中心肿瘤内科和治疗研究部临床教授, Los Angeles, California, 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。. Additionally, 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.”
Dave Fredrickson, Executive Vice President, Oncology Business Unit, 他说:“这种跨适应症的新剂量选择的批准反映了澳门葡京赌博游戏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, but especially during the pandemic. Cancer won’t wait, 澳门葡京赌博游戏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.”
The four-week 1,500mg fixed-dosing option for Imfinzi is also under regulatory review in several other countries, including in the EU where the new dosing option was granted accelerated assessment.
Imfinzi is approved in the curative-intent setting of unresectable, Stage III NSCLC after CRT in the US, in the EU, in Japan, in China and in many other countries, based on the PACIFIC Phase III trial. 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. Additionally, it is approved in the US, 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.
Stage III NSCLC
Stage III NSCLC (locally advanced) is commonly divided into three sub-categories (IIIA, IIIB and 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, where the cancer has spread (metastasised), 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, and the US, with approximately 43,000 cases in the US alone.3,4 The majority of Stage III NSCLC patients are diagnosed with unresectable tumours.5 Prior to approval of Imfinzi in this setting, no new treatments beyond CRT had been available to patients for decades.6-8
Small cell lung cancer
SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly, despite initial response to chemotherapy.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 Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.11
Bladder cancer
In 2018, approximately 550,000 people were diagnosed with bladder cancer around the world and 200,000 died from the disease.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 bladder cancer.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.
As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combinations including with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, biliary tract cancer, oesophageal cancer, gastric cancer, cervical cancer, ovarian cancer, endometrial cancer and other solid tumours.
AstraZeneca in lung cancer
澳门葡京网赌游戏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, several stages of disease, lines of therapy and modes of action.
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, an anti-PDL1 antibody, 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, including potentially-curative settings (MERMAID-1, AEGEAN, ADJUVANT 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, including Enhertu (trastuzumab deruxtecan).
AstraZeneca’s approach to IO
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. 澳门葡京网赌游戏投资于使用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, stages of disease, and lines of therapy, 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. In addition, the ability to combine the IO portfolio with radiation, chemotherapy, small targeted molecules from across AstraZeneca’s Oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumours.
AstraZeneca in oncology
澳门葡京网赌游戏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葡京网赌游戏专注于肺部的关键增长动力, ovarian, breast and blood cancers.
By harnessing the power of six scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies – and by championing the development of personalised combinations, 澳门葡京网赌游戏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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, 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, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, 澳门葡京网赌游戏在100多个国家开展业务，其创新药物被全球数百万患者使用. Please visit siglerbertea.com and follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.
References
1. ASCO. Cancer.net. Lung Cancer – Non-Small Cell. Available at: http://www.cancer.net/cancer-types/lung-cancer/view-all. Accessed September 2020.
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. Curr Oncol. 2019;26(1):37-42.
3. Antonia SJ, et al. PACIFIC Investigators. Durvalumab After Chemoradiotherapy In Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 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 Thorac Dis. 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. J Natl Cancer Inst. 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. Accessed September 2020.
8. Hanna 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? Am Soc Clin Oncol Educ Book. 2015:e442-447.
9. Kalemkerian GP, et al. Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? J Oncol Pract. 2018;14(6):369-370.
10. National Cancer Institute. NCI Dictionary – Small Cell Lung Cancer. Available at http://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer. Accessed November 2020.
11. Cancer.Net. Lung Cancer - Small Cell. Available at http://www.cancer.net/cancer-types/lung-cancer-small-cell. Accessed November 2020.
12. World Health Organization International Agency for Research on Cancer. Cancer Fact Sheets – Bladder. Available at http://gco.iarc.fr/today/data/factsheets/cancers/30-Bladder-fact-sheet.pdf. Accessed September 2020.
13. Von der Maase H, et al. Long-Term Survival Results of a Randomized Trial Comparing Gemcitabine Plus Cisplatin, with Methotrexate, Vinblastine, Doxorubicin, Plus Cisplatin in Patients with Bladder Cancer. J Clin Oncol. 2005;23:4602-4608.
14. American Society of Clinical Oncology. Bladder Cancer: Introduction. Available at http://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed September 2020.
15. World Cancer Research Fund. Bladder Cancer Statistics. Available at http://www.wcrf.org/dietandcancer/cancer-trends/bladder-cancer-statistics. Accessed September 2020.
16. Magdalene J, et al. Immune Responses in Bladder Cancer-Role of Immune Cell Populations, Prognostic Factors and Therapeutic Implications. Front Oncol. 2019;9:1270.
17. Pakkala, S, et al. Personalized Therapy for Lung Cancer: Striking a Moving Target. JCI Insight. 2018;3(15):e120858.
Adrian Kemp
Company Secretary
AstraZeneca PLC