20 November 2020 07:00 GMT
四周剂量现已批准用于所有Imfinzi适应症, 减少就医次数，提高患者便利性
AstraZeneca’s Imfinzi (durvalumab)已在美国获得批准，作为一种额外的剂量选择, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer. 这个新选项与已批准的选项一致 Imfinzi dosing in extensive-stage small cell lung cancer (ES-SCLC) and will be available to patients weighing more than 30kg as an alternative to the approved weight-based dosing of 10mg/kg every two weeks.
美国食品和药物管理局(FDA)的批准是基于来自几个国家的数据 Imfinzi clinical trials, 包括支持为期两周的PACIFIC III期试验, 不可切除的III期NSCLC中基于体重的剂量, 以及使用4周的CASPIAN III期试验, ES-SCLC维持治疗期间固定给药. The decision follows the Priority Review granted by the FDA in August 2020.
Victoria M. Villaflor, MD, Clinical Professor in the Department of Medical Oncology and Therapeutics Research at City of Hope Cancer Center, Los Angeles, California, said: “This new four-week dosing option gives doctors the choice to cut the number of visits for critical cancer treatment in half and offers a regimen that is more convenient for patients. Additionally, it limits potential exposure to infection in the healthcare environment for a population that is especially vulnerable to complications from COVID-19.”
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “The approval of this new dosing option across indications reflects our ongoing commitment to improve the patient experience and ensure continuity of care - a priority at all times, but especially during the pandemic. Cancer won’t wait, and it is our job to provide patients with treatment options that acknowledge the challenges the pandemic poses to cancer care, enabling them to visit their physician when truly needed and avoid preventable exposure to healthcare-associated infections.”
The four-week 1,500mg fixed-dosing option for Imfinzi 是否也在其他几个国家接受监管审查, 包括在欧盟，新的剂量选择被授予加速评估.
Imfinzi 在不可切除的治疗目的下被批准吗, 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 is also approved for previously treated patients with advanced bladder cancer in the US and several other countries. Additionally, it is approved in the US, the EU, Japan and several other countries around the world for the treatment of ES-SCLC based on the CASPIAN Phase III trial.
Stage III NSCLC
III期NSCLC(局部晚期)通常分为三个亚类(IIIA), IIIB and IIIC), 根据癌症局部扩散的程度和手术的可能性来确定.1 III期疾病不同于IV期疾病, where the cancer has spread (metastasised), 因为目前大多数III期患者的治疗目的是治愈.1,2
Stage III NSCLC represents approximately one third of NSCLC incidence and in 2015 was estimated to affect nearly 200,在以下8个大国，000名患者:中国, France, Germany, Italy, Japan, Spain, UK, and the US, with approximately 43,000 cases in the US alone.3,4 大多数III期非小细胞肺癌患者被诊断为不可切除的肿瘤.5 Prior to approval of Imfinzi 在这种情况下，几十年来，除了CRT之外，没有新的治疗方法可供患者使用.6-8
Small cell lung cancer
SCLC is a highly aggressive, 一种生长迅速的肺癌，通常复发和进展迅速, despite initial response to chemotherapy.9,10 大约三分之二的SCLC患者被诊断为广泛期疾病, 在这种情况下，癌症已经通过肺部或身体其他部位广泛扩散.11 Prognosis is particularly poor, 因为只有6%的SCLC患者在诊断后的5年内存活.11
Bladder cancer
In 2018, approximately 550,全世界有000人被诊断患有膀胱癌，200人被诊断患有膀胱癌,000 died from the disease.12 Locally advanced and metastatic bladder cancer remains an area of unmet medical need and typically only one in seven patients is alive five years after diagnosis.13 尿路上皮癌(UC)是膀胱癌最常见的形式.14 UC是全球第10大常见癌症，也是第13大常见癌症死亡原因.12,15 PD-L1 is widely expressed in tumour and immune cells in patients with bladder cancer and helps tumours evade detection from the immune system.16
Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses.
As part of a broad development programme, Imfinzi 是否正在进行单药治疗和包括tremelimumab在内的联合治疗试验, 抗ctla4单克隆抗体及潜在新药, 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
AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action.
An extensive Immuno-Oncology (IO) development programme focuses on lung cancer patients without a targetable genetic mutation, 占肺癌患者总数的四分之三.17 Imfinzi, an anti-PDL1 antibody, is in development for patients with advanced disease (POSEIDON and PEARL Phase III trials) and for patients in earlier stages of disease, 包括潜在的治疗设置(美人鱼-1), AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC Phase III trials) both as monotherapy and in combination with tremelimumab and/or chemotherapy.
Imfinzi NeoCOAST的II期临床试验也在进行中, COAST和HUDSON与早期研发的潜在新药联合使用, including Enhertu (trastuzumab deruxtecan).
AstraZeneca’s approach to IO
IO is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. The Company’s IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumour types.
该公司正在进行一个全面的临床试验项目，包括 Imfinzi 作为单一疗法或与tremelimumab联合治疗多种肿瘤类型, stages of disease, and lines of therapy, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, 将IO组合与辐射相结合的能力, chemotherapy, 来自澳门葡京网赌游戏肿瘤产品线的小靶向分子, and from research partners, 可能为广泛的肿瘤提供新的治疗选择.
AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. 2014年至2020年间有7种新药上市, 还有大量正在开发的小分子和生物制剂, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.
通过利用六个科学平台的力量-免疫肿瘤学, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, 和细胞疗法——并通过支持个性化组合的发展, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, 以科学为主导的澳门葡京赌博游戏公司，专注于发现, 处方药的开发和商业化, 主要用于治疗肿瘤等三个治疗领域的疾病, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit jc200.net and follow the Company on Twitter @AstraZeneca.
Contacts
References
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12. 世界卫生组织国际癌症研究机构. Cancer Fact Sheets – Bladder. Available at http://gco.iarc.fr/today/data/factsheets/cancers/30-Bladder-fact-sheet.pdf. Accessed September 2020.
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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.
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Adrian Kemp
Company Secretary
AstraZeneca PLC