
浏览全部资源
扫码关注微信
1.中国航天科工集团七三一医院药学部,北京 100074
2.中国航天科工集团 七三一医院胸外科,北京 100074
3.北京医院药学部,北京 100730
主管药师,博士。研究方向:循证医学与医学信息学、指南和共识的制作与评价、抗肿瘤药物管理。E-mail:zhenglis1270755@163.com
副主任药师,博士。研究方向:老年慢病管理、药物警戒与合理用药、指南和共识的制作与评价。E-mail:sxl1220@163.com
收稿日期:2023-07-21,
修回日期:2023-11-01,
录用日期:2023-11-07,
纸质出版日期:2023-12-30
移动端阅览
郑丽,张凯华,孙雪林.弥漫大B细胞淋巴瘤治疗新药格菲妥单抗 [J].中国药房,2023,34(24):3064-3067.
ZHENG Li,ZHANG Kaihua,SUN Xuelin.Glofitamab for diffuse large B cell lymphoma[J].ZHONGGUO YAOFANG,2023,34(24):3064-3067.
郑丽,张凯华,孙雪林.弥漫大B细胞淋巴瘤治疗新药格菲妥单抗 [J].中国药房,2023,34(24):3064-3067. DOI: 10.6039/j.issn.1001-0408.2023.24.20.
ZHENG Li,ZHANG Kaihua,SUN Xuelin.Glofitamab for diffuse large B cell lymphoma[J].ZHONGGUO YAOFANG,2023,34(24):3064-3067. DOI: 10.6039/j.issn.1001-0408.2023.24.20.
弥漫大B细胞淋巴瘤(DLBCL)是一种来源于成熟B细胞的恶性肿瘤,目前其临床治疗以化学治疗为主,但仍有部分患者会在治疗后复发或进展为难治性DLBCL。2023年6月15日,美国FDA批准抗CD3/CD20双特异性单克隆抗体格菲妥单抗上市,为既往接受过二线或二线以上系统治疗后复发或进展为难治性DLBCL的患者提供了新的治疗方案。本文对格菲妥单抗的药理作用、临床研究、安全性及用法用量等进行了简要概述。格菲妥单抗主要通过促进T细胞的活化和增殖,激活T细胞释放肿瘤细胞杀伤蛋白,进而介导B细胞的裂解而发挥治疗DLBCL的作用。临床研究显示,格菲妥单抗对复发或难治性DLBCL具有较好的完全缓解率和客观缓解率,其常见不良反应包括轻/中度细胞因子释放综合征、肌肉骨骼疼痛、皮疹和疲劳,未见明显的药物相互作用。
Diffuse large B cell lymphoma (DLBCL) is a malignant tumor derived from mature B cells. Currently, chemotherapy is still the main clinical treatment. However, some patients experience recurrence or refractory conditions after treatment. On June 15, 2023, the FDA approved the marketing of glofitamab, a CD3/CD20 bispecific monoclonal antibody, to provide the new treatment plan for patients with recurrent or refractory DLBCL after receiving 2-line or above systemic treatment. This article reviews pharmacological effects, clinical studies, safety, usage and dosage of glofitamab. Glofitamab mainly plays a therapeutic role in DLBCL by promoting the activation and proliferation of T cells,activating T cells to release tumor cell-killing proteins, and mediating the lysis of B cells. Clinical studies have shown that glofitamab has a better complete and objective response rate for recurrent or refractory DLBCL. Common adverse reactions caused by glofitamab include mild/moderate cytokine release syndrome, musculoskeletal pain, rash, fatigue, and so on,without significant drug interactions.
DUNLEAVY K , ERDMANN T , LENZ G . Targeting the B-cell receptor pathway in diffuse large B-cell lymphoma [J ] . Cancer Treat Rev , 2018 , 65 : 41 - 46 .
佟丹江 . 弥漫大B细胞淋巴瘤的流行病学分析 [J ] . 中国现代药物应用 , 2016 , 10 ( 8 ): 46 - 47 .
TONG D J . Epidemiological analysis of diffuse large B-cell lymphoma [J ] . Chin J Mod Drug Appl , 2016 , 10 ( 8 ): 46 - 47 .
SEHN L H , GASCOYNE R D . Diffuse large B-cell lymphoma:optimizing outcome in the context of clinical and biologic heterogeneity [J ] . Blood , 2015 , 125 ( 1 ): 22 - 32 .
GOLDFINGER M , COOPER D L . lenalidomide in DLBCL:are we past the cell of origin? [J ] . Clin Adv Hematol Oncol , 2021 , 19 ( 5 ): 320 - 325 .
MINSON A , DICKINSON M . Glofitamab CD20-TCB bispecific antibody [J ] . Leuk Lymphoma , 2021 , 62 ( 13 ): 3098 - 3108 .
SUROWKA M , SCHAEFER W , KLEIN C . Ten years in the making:application of CrossMab technology for the development of therapeutic bispecific antibodies and antibody fusion proteins [J ] . mAbs , 2021 , 13 ( 1 ): 1967714 .
CREMASCO F , MENIETTI E , SPEZIALE D , et al . Cross-linking of T cell to B cell lymphoma by the T cell bispecific antibody CD20-TCB induces IFNγ/CXCL10-dependent peripheral T cell recruitment in humanized murine model [J ] . PLoS One , 2021 , 16 ( 1 ): e0241091 .
FDA . Glofitamab-gxbm(Columvi) prescribing information [EB/OL ] .( 2023-06-15 )[ 2023-07-21 ] . https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761309s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761309s000lbl.pdf .
DICKINSON M J , CARLO-STELLA C , MORSCHHAUSER F , et al . Glofitamab for relapsed or refractory diffuse large B-cell lymphoma [J ] . N Engl J Med , 2022 , 387 ( 24 ): 2220 - 2231 .
SONG Y Q , ZHANG H L , HUANG H Q , et al . Glo-fitamab monotherapy demonstrates high complete response rates and manageable safety in Chinese patients with relapsed or refractory diffuse large B-cell lymphoma and ≥2 prior therapies [J ] . Blood , 2022 , 140 (supplement 1 ): 12050 - 12051 .
HUTCHINGS M , SUREDA A , TEROL M J , et al . Glofi-tamab(glofit)in combination with polatuzumab vedotin(pola):phase Ⅰb/Ⅱ preliminary data support manageable safety and encouraging efficacy in relapsed/refractory(R/R)diffuse large B-cell lymphoma(DLBCL) [J ] . Blood , 2021 , 138 ( Supplement 1 ): 525 .
TOPP M S , TANI M , DICKINSON M , et al . Glofitamab plus R-CHOP induces high response rates and a favorable safety profile in patients with previously untreated diffuse large B-cell lymphoma(DLBCL):results from a phase Ⅰb study [J ] . Blood , 2022 , 140 ( Supplement 1 ): 1775 - 1777 .
GUST J , HAY K A , HANAFI L A , et al . Endothelial activation and blood-brain barrier disruption in neurotoxicity after adoptive immunotherapy with CD19 CAR-T cells [J ] . Cancer Discov , 2017 , 7 ( 12 ): 1404 - 1419 .
MAUDE S L , FREY N , SHAW P A , et al . Chimeric antigen receptor T cells for sustained remissions in leukemia [J ] . N Engl J Med , 2014 , 371 ( 16 ): 1507 - 1517 .
BACAC M , COLOMBETTI S , HERTER S , et al . CD20-TCB with obinutuzumab pretreatment as next-generation treatment of hematologic malignancies [J ] . Clin Cancer Res , 2018 , 24 ( 19 ): 4785 - 4797 .
SANCHEZ-PAULETE A R , LABIANO S , RODRIGUEZ-RUIZ M E , et al . Deciphering CD137(4-1BB)signaling in T-cell costimulation for translation into successful cancer immunotherapy [J ] . Eur J Immunol , 2016 , 46 ( 3 ): 513 - 522 .
0
浏览量
185
下载量
0
CSCD
关联资源
相关文章
相关作者
相关机构
京公网安备11010802024621