2020年11月12日07:00 GMT
CALAVI did not meet the primary endpoint of increasing the proportion of patients who remained alive and free of respiratory failure
CALAVI II期临床试验 Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. 的加入 Calquence to best supportive care (BSC) did not increase the proportion of patients who remained alive and free of respiratory failure. 没有新的安全信号 Calquence 在试验中观察到了什么.
José Baselga, Executive Vice President, 肿瘤学 R&D, said: “Since the beginning of the year, 澳门在线赌城娱乐 has been committed to doing everything we can to respond to COVID-19, including investigating existing medicines as potential treatments. The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 While the CALAVI results are disappointing, we remain committed to advancing science that helps patients during this unprecedented global pandemic, including clinical trials for the 澳门在线赌城娱乐 Oxford coronavirus vaccine and our long-acting antibody combination.”
The CALAVI programme comprised two Phase II trials investigating acalabrutinib plus BSC versus BSC alone in hospitalised patients with COVID-19 disease.
The safety and tolerability profiles for Calquence in the CALAVI Phase II trials were consistent with previous trials. The data will be presented in due course.
Results from the CALAVI Phase II trials do not impact approved indications or pending approvals for Calquence 在血癌患者中.
CALAVI
The CALAVI Phase II programme comprised two randomised, 非盲, multicentre trials evaluating the efficacy and safety of Calquence with BSC versus BSC alone in patients hospitalised with respiratory complications of COVID-19. The trials were randomised (1:1) and evaluated the addition of Calquence to current BSC in patients who were hospitalised but not on mechanical ventilation and not in the intensive care unit. The primary endpoint measured respiratory failure or death. The trials were conducted in the US (CALAVI澳门第一赌城在线娱乐) and in multiple other countries across the world (CALAVI).2,3
Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Calquence binds covalently to BTK, t在这里by inhibiting its activity.4,5 在b细胞, BTK signalling results in activation of pathways necessary for B-cell proliferation, 人口贩卖, 趋化性, 和附着力.4
As part of an extensive clinical development programme, 澳门在线赌城娱乐 and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including chronic lymphocytic leukaemia, 套细胞淋巴瘤, 弥漫大b细胞淋巴瘤, Waldenstrom的macroglobulinaemia, 滤泡淋巴瘤, 以及其他血液恶性肿瘤.
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, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - 肿瘤学, 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 operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. 请访问 澳门在线赌城娱乐.com 并在推特 @上关注公司澳门在线赌城娱乐.
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参考文献
1. Roschewski M等. Inhibition of Bruton tyrosine kinase in patients with severe COVID-19. Sci Immunol. 2020;5(28). DOI: 10.1126 / sciimmunol.abd0110.
2. 临床试验.政府. Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. (CALAVI澳门第一赌城在线娱乐). NCT标识符:NCT04380688. 网上. 2020年10月.
3. 临床试验.政府. Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. (CALAVI). NCT标识符:NCT04346199. 网上. 2020年10月.
4. Calquence® (acalabrutinib) [prescribing information]. Wilmington, DE; 澳门在线赌城娱乐 Pharmaceuticals LP; 2019.
5. 吴杰，张敏 & 刘D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. [J]血液学. 2016;9(21).
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