鲁昔单抗(Lumiliximab) - 药物靶点：CD23_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-CD23 monoclonal antibody、Gomiliximab、Gomiliximab (USAN)

+ [5]

靶点

CD23

作用机制

CD23拮抗剂(免疫球蛋白ε-Fc受体拮抗剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [3]

在研适应症-

非在研适应症

过敏性哮喘哮喘慢性淋巴细胞白血病+ [2]

原研机构

Biogen, Inc.

在研机构-

非在研机构

Biogen Idec Ltd.

Biogen, Inc.Biogen (Denmark) A/S

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 616719387H

来源: *****

Sequence Code 174989L

来源: *****

关联

14

项与鲁昔单抗相关的临床试验

EUCTR2006-002987-24-CZ / Not yet recruitingN/A

A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia - Lumiliximab in combination with FCR in the treatment of relapsed CLL

开始日期2008-08-21

申办/合作机构

Biogen Idec Ltd.

EUCTR2006-002987-24-PT / Not yet recruitingN/A

A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia - Lumiliximab in combination with FCR in the treatment of relapsed CLL

开始日期2008-08-08

申办/合作机构

Biogen Idec Ltd.

EUCTR2006-002987-24-LT / Not yet recruitingN/A

A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia - Lumiliximab in combination with FCR in the treatment of relapsed CLL

开始日期2008-07-04

申办/合作机构

Biogen Idec Ltd.

100 项与鲁昔单抗相关的临床结果

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100 项与鲁昔单抗相关的转化医学

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100 项与鲁昔单抗相关的专利（医药）

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41

项与鲁昔单抗相关的文献（医药）

2024-02-01·Journal of Allergy and Clinical Immunology

IgE directly affects eosinophil migration in chronic rhinosinusitis with nasal polyps through CCR3 and predicts the efficacy of omalizumab

Article

作者: Sun, Ying ; Zhang, Luo ; Cao, Feifei ; Li, Ying ; Yu, Jiaqi ; Piao, Yingshi ; Shen, Shen ; Xiong, Wei ; Wang, Chengshuo ; Wang, Yang ; Hu, Chen ; Yan, Bing

BACKGROUNDWhether IgE affects eosinophil migration in chronic rhinosinusitis with nasal polyps (CRSwNP) remains largely unclear. Moreover, our understanding of local IgE, eosinophils, and omalizumab efficacy in CRSwNP remains limited.OBJECTIVEWe investigated whether IgE acts directly on eosinophils and determined its role in omalizumab therapy.METHODSEosinophils and their surface receptors were detected by hematoxylin and eosin staining and flow cytometry. IgE and its receptors, eosinophil peroxidase (EPX), eosinophilic cationic protein, and CCR3 were detected by immunohistochemistry and immunofluorescence. Functional analyses were performed on blood eosinophils and polyp tissues. Logistic regression was performed to screen for risk factors. Receiver operating characteristic curve was generated to evaluate the accuracy.RESULTSBoth FcεRI and CD23 were expressed on eosinophils. The expression of FcεRI and CD23 on eosinophil in nasal polyp tissue was higher than in peripheral blood (both P < .001). IgE and EPX colocalized in CRSwNP. IgE directly promoted eosinophil migration by upregulating CCR3 in CRSwNP but not in healthy controls. Omalizumab and lumiliximab were found to be effective in restraining this migration, indicating CD23 was involved in IgE-induced eosinophil migration. Both IgE⁺ and EPX⁺ cells were significantly reduced after omalizumab treatment in those who experienced response (IgE⁺ cells, P = .001; EPX⁺ cells, P = .016) but not in those with no response (IgE⁺ cells, P = .060; EPX⁺ cells, P = .151). Baseline IgE⁺ cell levels were higher in those with response compared to those without response (P = .024). The baseline local IgE⁺ cell count predicted omalizumab efficacy with an accuracy of 0.811.CONCLUSIONSIgE directly promotes eosinophil migration, and baseline local IgE⁺ cell counts are predictive of omalizumab efficacy in CRSwNP.

2014-11-01·British Journal of Haematology2区 · 医学

A randomized, open‐label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia

2区 · 医学

Article

作者: Flinn, Ian W. ; Byrd, John C. ; N/A ; Hughes, Steven G. ; Robak, Tadeusz ; Trone, Denise ; Hellmann, Andrzej ; Shannon, Megan ; Hillmen, Peter ; Awan, Farrukh T.

SummaryLumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B‐cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open‐label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty‐seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression‐free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.

2012-01-01·Cancer Control4区 · 医学

Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia

4区 · 医学

ReviewOA

作者: Pinilla-Ibarz, Javier ; Veliz, Marays

Background Recent advances in the treatment of chronic lymphocytic leukemia (CLL) have moved beyond the traditional use of alkylating agents and purine analogs into regimens combining these two chemotherapy classes with monoclonal antibodies. Methods This article reviews treatments options for patients with relapsed or refractory CLL. Results Several studies have investigated novel agents in treating patients with 17p deletion, TP53 mutation, and fludarabine-refractory CLL, as well as patients with suboptimal response to intense treatment. These investigational agents include rituximab, alemtuzumab, ofatumumab, bendamustine, high-dose methylprednisolone, lenalidomide, lumiliximab, cyclin-dependent kinase inhibitors, small modular immunopharmaceuticals, Bcl-2 inhibitors, and histone deacetylase inhibitors. While these newer drugs and combination therapies have shown promise as treatment options for CLL, additional studies are needed to determine the immunosuppression, toxicities, and infections associated with their use. Conclusions Despite improvement in initial overall response rates, most patients relapse and require further treatment. CLL remains incurable with standard therapies due to development of disease refractoriness. As such, novel approaches such as those noted above warrant continued research to improve outcomes for patients with CLL.

1

项与鲁昔单抗相关的新闻（医药）

2023-09-12

·米内网

【重磅】科伦发威，抢20亿注射剂国产首家

精彩内容近日，四川科伦博泰生物提交了西妥昔单抗注射液3.3类新药上市申请，该产品是公司首款报产的生物类似药。原研的西妥昔单抗注射液于2013年进入中国市场，2022年在中国三大终端六大市场（统计范围见文末）合计销售额超过20亿元。图1：四川科伦博泰生物最新申报的产品情况来源：CDE官网图2：西妥昔单抗注射液的销售情况（单位：万元）来源：米内网格局数据默克的西妥昔单抗注射液于2013年获批进口，在2017版-2020版国家医保谈判目录中限制使用范围为“限RAS基因野生型的转移性结直肠癌”，2021版-2022版国家医保谈判目录中限制使用范围增加至“限RAS基因野生型的转移性结直肠癌以及头颈部鳞状细胞癌”。在医保加持下，默克的西妥昔单抗注射液在公立医院终端（城市公立医院+县级公立医院）的销售额持续高涨，2022年已突破20亿元关口，此外，该产品在零售药店终端（城市实体药店+网上药店）的销售额也在2022年超过了1.5亿元，潜力不容小觑。科伦药业在9月11日发布的公告中提到的，A140注射液（西妥昔单抗注射液）是国内首家以原研西妥昔单抗为参照药，按照《西妥昔单抗注射液生物类似药临床试验设计指导原则（试行）》研发和申报生产的产品，与参照药西妥昔单抗有一致的氨基酸序列和相同的作用机制，拟申报的适应症与参照药一致。图3：科伦药业（及子公司）申报上市的生物药来源：米内网中国申报进度（MED）数据库米内网数据显示，目前科伦药业及子公司申报上市的生物药有三款，涉及两款1类新药泰特利单抗注射液（PD-L1）和注射用A166（HER2-ADC）正在审评审批中，而西妥昔单抗注射液是公司首款报产的生物类似药。资料来源：米内网数据库、CDE官网、公司公告注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至9月12日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

抗体药物偶联物生物类似药

100 项与鲁昔单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06463	鲁昔单抗	-	DB06162

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性慢性淋巴细胞白血病	临床3期	希腊	Biogen, Inc.	2006-11-01
过敏性哮喘	临床3期	美国	Biogen Idec Ltd.	-
哮喘	临床3期	-	Biogen (Denmark) A/S	-
慢性淋巴细胞白血病	临床3期	-	Biogen (Denmark) A/S	-
慢性淋巴细胞白血病	临床3期	美国	Biogen Idec Ltd.	-
慢性淋巴细胞白血病	临床3期	加拿大	Biogen Idec Ltd.	-
慢性淋巴细胞白血病	临床3期	澳大利亚	Biogen Idec Ltd.	-
慢性淋巴细胞白血病	临床3期	欧盟	Biogen Idec Ltd.	-
过敏性鼻炎	临床3期	美国	Biogen Idec Ltd.	-
过敏性鼻炎	临床3期	-	Biogen (Denmark) A/S	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00391066 (152CL201, Pubmed \| Int J Radiat Oncol Biol Phys)	临床2/3期	复发性慢性淋巴细胞白血病	627	Lumiliximab with fludarabine, cyclophosphamideLumiliximab with fludarabine, cyclophosphamideLumiliximab with fludarabine, cyclophosphamide and rituximab	(觸網醖範艱齋壓鬱窪鏇) = 襯製選壓壓觸鹽憲選築壓遞憲齋製獵繭夢繭鏇 (餘壓鹹築餘壓觸製獵襯 ) 更多	不佳	2014-11-01
	临床2/3期	复发性慢性淋巴细胞白血病	627	Fludarabine, cyclophosphamideFludarabine, cyclophosphamide and rituximab	(觸網醖範艱齋壓鬱窪鏇) = 範襯襯構鹹遞積鬱壓範壓遞憲齋製獵繭夢繭鏇 (餘壓鹹築餘壓觸製獵襯 ) 更多	不佳	2014-11-01
ASCO2008	临床1/2期	复发性慢性淋巴细胞白血病	-	Lumiliximab	(範簾衊觸鏇廠構艱鏇衊) = 餘築鹽選觸獵窪網齋蓋製簾廠鹽繭鹽廠蓋鹹鬱 (襯憲鑰窪齋範鏇壓鏇衊 ) 更多	-	2008-05-20