2020年11月9日07:00 GMT
Calquence demonstrated superior progression-free survival 和 favourable tolerability in both previously untreated 和 relapsed or refractory patients
澳门在线赌城娱乐公司 Calquence (acalabrutinib), a next-generation selective Bruton’s tyrosine kinase (BTK) inhibitor, has been 批准 in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.
The approval by the European Commission was based on positive results from two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL 和 提升 in patients with relapsed or refractory CLL.1,2 在此之前 建议批准 by the Committee for Medicinal Products for Human Use of the European 药物 Agency in July 2020.
保罗•图灵, MD, 导演, CLL战略研究计划, Università Vita-Salute San Raffaele in Milan, 和 investigator of the 提升 Phase III trial, said: “One of our biggest hurdles in treating chronic lymphocytic leukaemia is finding tolerable treatment options that manage the disease long term, which typically impacts older patients with comorbidities. Today’s news marks great progress for patients in Europe, as the Phase III clinical trials for Calquence showed a significant improvement in comparison with current st和ard treatments.”
戴夫Fredrickson, 执行副总裁, 肿瘤事业部, said: “This approval represents a key development for patients in Europe who until now have had limited chemotherapy-free treatment options. As our first European approval in blood 癌症s, Calquence provides a new tolerable treatment option with uncompromised efficacy 和 the potential to positively impact the quality of life for thous和s of patients living with chronic lymphocytic leukaemia.”
在ELEVATE-TN III期试验中， Calquence combined with obinutuzumab 和 as monotherapy reduced the risk of disease progression or death by 90% 和 80%分别, compared with st和ard chemo-immunotherapy treatment chlorambucil plus obinutuzumab, in patients with previously untreated CLL.1 In the 提升 Phase III trial, 88% of patients with relapsed or refractory CLL taking Calquence remained alive 和 free from disease progression after 12 months compared with 68% of patients on rituximab combined with idelalisib or bendamustine.2 Data from the interim results of the trials were published in 《澳门第一赌城在线娱乐》 和 临床肿瘤学杂志分别.
Calquence is 批准 for the treatment of CLL 和 small lymphocytic lymphoma in the US 和 is 批准 for CLL in several other countries worldwide. Calquence is also 批准 for the treatment of adult patients with mantle cell lymphoma (制程) who have received at least one prior therapy in the US 和 several other countries. Calquence is not currently 批准 for the treatment of 制程 in Europe.
As part of a broad development programme, Calquence is being assessed in more than 20 澳门在线赌城娱乐-sponsored clinical trials for the treatment of patients with B-cell malignancies including CLL, 制程, 弥漫大b细胞淋巴瘤(DLBCL), Waldenström大球蛋白血症(WM), 滤泡性淋巴瘤, 以及其他血液恶性肿瘤.
慢性淋巴细胞性白血病
慢性淋巴细胞性白血病 (CLL) is the most common type of leukaemia in adults, 估计有105人,2016年全球新发病例达1万例, 和 the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.3,4,5,6 在慢性淋巴细胞白血病, too many blood stem cells in the bone marrow become abnormal lymphocytes 和 these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows t在这里 is less room for healthy white blood cells, 红细胞, 和血小板. This could result in anaemia, infection, 和 bleeding.4 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.
ELEVATE-TN
ELEVATE-TN (ACE-CL-007)是一项随机试验, 多中心, open-label Phase III trial evaluating the safety 和 efficacy of Calquence in combination with obinutuzumab, CD20单克隆抗体, or Calquence 单独使用与氯霉素比较, 一个化疗, in combination with obinutuzumab in previously untreated patients with CLL. 65岁以上患者, or between 18 和 65 years of age with a total Cumulative Illness Rating Scale >6 or creatinine clearance of 30 to 69mL/min, 被录取. In the trial, 535 patients were 随机 (1:1:1) into three arms. 第一组患者接受 chlorambucil in combination with obinutuzumab. 第二组患者接受 Calquence (100mg approximately every 12 hours until disease progression or unacceptable toxicity) in combination with obinutuzumab. 第三组患者接受 Calquence monotherapy (100mg approximately every 12 hours until disease progression or unacceptable toxicity).1
The primary endpoint was progression-free survival (PFS) in the Calquence 和 obinutuzumab arm compared to the chlorambucil 和 obinutuzumab arm, assessed by an independent review committee (IRC), 和 a key secondary endpoint was IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil 和 obinutuzumab arm. Other secondary endpoints included objective response rate, time to next treatment 和 overall survival (OS).1
提升
提升 (ACE-CL-309)是全球性的, 随机, 多中心, open-label Phase III trial evaluating the efficacy of Calquence in patients with relapsed or refractory CLL. In the trial, 310 patients were 随机 (1:1) into two arms. 第一组患者接受 Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity). 第二组患者接受 investigator’s choice of either rituximab, CD20单克隆抗体, 与理想相结合, PI3K抑制剂, or rituximab in combination with bendamustine, 一个化疗.2
The primary endpoint was PFS assessed by an IRC, 和 key secondary endpoints included physician-assessed PFS, IRC- 和 physician-assessed overall response rate 和 duration of response, 以及操作系统, patient-reported outcomes 和 time to next treatment.2
Calquence
Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. Calquence binds covalently to BTK, t在这里by inhibiting its activity.7,8 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.7
As part of an extensive clinical development programme, 澳门在线赌城娱乐 和 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 癌症s including CLL, 制程, DLBCL, WM, FL, 以及其他血液恶性肿瘤.
澳门在线赌城娱乐在血液学
利用其在肿瘤学领域的优势, 澳门在线赌城娱乐 has established haematology as one of four key oncology disease areas of focus. The Company’s haematology franchise includes two medicines 批准 by the US Food 和 Drug Administration 和 a robust global development programme for a broad portfolio of potential blood 癌症 treatments. Acerta Pharma serves as 澳门在线赌城娱乐公司 haematology research 和 development arm. 澳门在线赌城娱乐 partners with like-minded science-led companies to advance the discovery 和 development of therapies to address unmet need.
澳门在线赌城娱乐在肿瘤学
澳门在线赌城娱乐 has a deep-rooted heritage in oncology 和 offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives 和 the Company’s future. With seven new medicines launched between 2014 和 2020, 和 a broad pipeline of small molecules 和 biologics in development, the Company is committed to advance oncology as a key growth driver for 澳门在线赌城娱乐 focused on lung, 卵巢, 乳腺和血液学.
By harnessing the power of six scientific platforms - Immuno-肿瘤学, 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, 和 Cell Therapies - 和 by championing the development of personalised combinations, 澳门在线赌城娱乐 has the vision to redefine 癌症 treatment 和 one day eliminate 癌症 as a cause of death.
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 和 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 和 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. Sharman JP，等. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). 血. 2019; 134 (Supplement_1): 31. doi: 10.1182 /血液- 2019 - 128404.
2. Ghia P，等. 提升:第三期, R和omized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia [published online ahead of print, 2020年5月27日]. J .临床肿瘤学. 2020; JCO1903355. doi: 10.1200 / JCO.19.03355.
3. 美国癌症协会. 什么是慢性淋巴细胞白血病? 可以在 http://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html. 2020年8月.
4. 国家癌症研究所. Chronic Lymphocytic Leukemia Treatment (PDQ®)–Patient Version. 可在http://www下载.癌症.gov/types/leukemia/patient/cll-treatment-pdq. 2020年8月.
5. 全球 Burden of Disease Cancer Collaboration. 全球, 区域, 和全国癌症发病率, 死亡率, 逝去的生命岁月, 残疾生活年数, 和 Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016. JAMA杂志. 2018;4(11):1553-1568.
6. Jain N，等. Prevalence 和 Economic Burden of Chronic Lymphocytic Leukemia (CLL) in the Era of Oral Targeted Therapies. 血. 2015;126:871.
7. Calquence® (acalabrutinib) [prescribing information]. Wilmington, DE; 澳门在线赌城娱乐 Pharmaceuticals LP; 2019.
8. 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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