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首个BTK抑制剂显示出有利的总体生存趋势
vs. 在这种情况下的标准治疗化学免疫疗法
Positive high-level results from an interim analysis of the 回声 Phase III trial showed 澳门在线赌城娱乐’s Calquence (acalabrutinib)与标准化疗免疫疗法联合使用, 苯达莫司汀和利妥昔单抗, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus standard of care in previously untreated adult patients with mantle cell lymphoma (制程).
观察到一种有利于…的趋势 Calquence 总生存期(OS)的次要终点为化疗免疫治疗. The OS data were not mature at the time of this analysis and the trial will continue to assess OS.
制程是一种罕见的侵袭性非霍奇金淋巴瘤(NHL)。, 通常被诊断为晚期疾病, resulting when B-lymphocytes mutate into malignant cells within a region of the lymph node known as the mantle zone.1,2 据估计，全世界有超过27,500名患者被诊断为制程.3,4
迈克尔•王, MD, 普丁·克拉克教授, 套细胞淋巴瘤卓越项目主任, 休斯顿MD安德森癌症中心临床试验联合主任, 他是这项试验的首席研究员, said: “These positive progression-free survival results from the 回声 Phase III trial could provide a new standard of care for patients with mantle cell lymphoma. 合并 Calquence into the first-line mantle cell lymphoma setting would give many more patients the opportunity to benefit from the robust efficacy and strong safety profile we’ve seen with this medicine.”
Susan Galbraith，肿瘤学研究中心执行副总裁&D, 澳门在线赌城娱乐, said: “These impactful results in mantle cell lymphoma show that bringing Calquence 在一线环境中显著延缓了疾病的进展, 第一次, 显示出延长寿命的潜力. The improvement in progression-free survival together with the differentiated safety profile of Calquence are both important as we strive to transform outcomes earlier in the course of disease treatment.”
的安全性和耐受性 Calquence was consistent with its known safety profile, and no new safety signals were identified.
The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
As part of an extensive clinical 发展 programme, 澳门在线赌城娱乐 is currently evaluating Calquence 单独或联合治疗多种b细胞血癌, 包括慢性淋巴细胞性白血病, 制程, 弥漫性大b细胞淋巴瘤.
Calquence 已经被用来治疗80多个,000 patients worldwide and is approved for the treatment of CLL and small lymphocytic lymphoma (SLL) in the US and Japan, approved for CLL in the EU and many other countries worldwide and approved in China for relapsed or refractory CLL and SLL. Calquence 在美国也被批准了吗, China and several other countries for the treatment of adult patients with 制程 谁 have received at least one prior therapy. Calquence 目前尚未在日本或欧盟批准用于治疗制程.
笔记
套细胞淋巴瘤
制程是一种罕见的b细胞非霍奇金淋巴瘤亚型.5 制程约占非霍奇金淋巴瘤的3-6%，年发病率为0.每100人5人,000 population in Western countries; in the US, 据估计，大约有4,每年诊断出的制程新病例有000例.5,6 虽然制程患者最初对治疗有反应，但患者确实容易复发.5
回声
回声是随机的, 双盲, 安慰剂对照, 多中心III期临床试验评估的有效性和安全性 Calquence plus 苯达莫司汀和利妥昔单抗 compared to standard of care chemoimmunotherapy (苯达莫司汀和利妥昔单抗) in adult patients at or over 65 years of age (n=598) with previously untreated 制程.7 在实验组中，患者以1:1的比例随机分配接受任何一种治疗 Calquence 或者每天口服两次安慰剂, 治疗周期为28天, 加苯达莫司汀第1天和第2天利妥昔单抗第1天. 经过六个周期 Calquence 或安慰剂联合苯达莫司汀和利妥昔单抗，患者接受 Calquence or placebo plus maintenance rituximab for two years and then either Calquence or placebo only until disease progression.7
主要终点是PFS，次要终点包括OS, 总反应率(ORR), 反应持续时间(DoR)和反应时间(TTR).7 The trial includes 27 countries across North and South America, Europe, Asia and Oceania.7
回声试验于2017年至2023年进行，持续到2019冠状病毒病大流行期间. Patients with blood cancer remain at a disproportionately high risk of severe outcomes from COVID-19, 包括与一般人群相比的住院率和死亡率.8
Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Calquence 与BTK共价结合，从而抑制其活性.9 在B细胞中, BTK信号导致b细胞增殖所需通路的激活, 人口贩卖, 趋化性和粘附性.
澳门在线赌城娱乐在血液学
澳门在线赌城娱乐正在推动科学的界限，重新定义血液学护理. 澳门第一赌城在线娱乐已经扩大了对血液病患者的承诺, 通过收购Alexion，不仅在肿瘤学领域，而且在罕见疾病领域, 让澳门第一赌城在线娱乐能够接触到更多需求未被满足的病人. 通过运用澳门第一赌城在线娱乐对血癌的深刻理解, leveraging our strength in solid tumour oncology and delivering on Alexion’s pioneering legacy in complement science to provide innovative medicines for rare diseases, we are pursuing the end-to-end 发展 of novel therapies designed to target underlying drivers of disease. 继澳门在线赌城娱乐最近收购Gracell生物技术公司., we have broadened our pipeline of innovative cell therapies with a differentiated manufacturing process to potentially further address haematologic malignancies.
通过针对血液病高未满足的医疗需求, 澳门第一赌城在线娱乐的目标是提供创新的药物和方法来改善患者的治疗效果. 澳门第一赌城在线娱乐的目标是帮助改变恶性肿瘤患者的生活, 罕见病和其他相关血液病, 由患者的见解塑造, 对护理人员和医生产生最有意义的影响.
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 cancer in every form, 跟随科学去了解癌症及其所有的复杂性, 开发并向患者提供改变生活的药物.
该公司专注于一些最具挑战性的癌症. It is through persistent innovation that 澳门在线赌城娱乐 has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.
澳门在线赌城娱乐的愿景是重新定义癌症治疗和, 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)是一家全球性制药公司, 以科学为主导的澳门第一赌城在线娱乐公司，专注于发现, 发展, 以及肿瘤学处方药的商业化, 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 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 并在社交媒体上关注公司 @澳门在线赌城娱乐.
参考文献
1. 淋巴瘤研究基金会. 套细胞淋巴瘤. 可在:http://lymphoma.org/aboutlymphoma/nhl/mcl/. 2024年4月发布.
2. 国家罕见疾病组织. 套细胞淋巴瘤. 可在:http://rarediseases.org/rare-diseases/mantle-cell-lymphoma/. 2024年4月发布.
3. GLOBOCAN. 非霍奇金淋巴瘤. 可以在: http://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf. 2024年4月发布.
4. 林志刚，高志强，李志强，等. 套细胞淋巴瘤. 可以在: http://www.ncbi.nlm.国家卫生iarc院.gov/books/NBK536985/. 2024年4月发布.
5. 谢志强，王立民，王立民. 套细胞淋巴瘤. J .临床肿瘤学. 2016;34(11):1256-1269. doi: 10.1200 / JCO.2015.63.5904.
6. MD安德森癌症中心. 关于套细胞淋巴瘤要知道些什么. 可以在: http://www.mdanderson.org/cancerwise/what-to-know-about-mantle-cell-lymphoma-symptoms-diagnosis-and-treatment.h00-159385101.html. 2024年4月发布.
7. 临床试验.政府. A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated 制程. 可以在: http://clinicaltrials.政府 /研究/ NCT02972840. 2024年4月发布.
8. Dube S等. 继续d Increased Risk of COVID-19 Hospitalisation and Death in Immunocompromised Individuals Despite Receipt of ≥4 Vaccine Doses: Updated 2023 Results from INFORM, 英国回顾性健康数据库研究. ecmid 2024海报P0409
9. 吴军，张敏，刘东. Acalabrutinib (ACP-196):选择性第二代BTK抑制剂. [J]血液学. 2016;9(21).
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