替雷利珠单抗治疗复发或难治性多发性骨髓瘤的有效性和安全性：一项系统评价和荟萃分析。

Effectiveness and safety of teclistamab for relapsed or refractory multiple myeloma: a systematic review and meta-analysis.

作者信息

Li Wenze, Zhao Defeng, Jiao Yu, Dong Weilin, Wang Ziyi, Yan Xiaojing

机构信息

Department of Hematology, The First Affiliated Hospital of China Medical University, Shenyang, China.

Department of Thoracic Surgery, The First Affiliated Hospital of China Medical University, Shenyang, China.

出版信息

Front Immunol. 2025 Apr 25;16:1565407. doi: 10.3389/fimmu.2025.1565407. eCollection 2025.

DOI:10.3389/fimmu.2025.1565407

PMID:40352937

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12061972/

Abstract

BACKGROUND

Multiple myeloma (MM) is a hematological malignancy with limited treatment options for patients with relapsed/refractory MM (RRMM). Teclistamab, a B-cell maturation antigen (BCMA) × CD3 bispecific antibody, has shown promising results in clinical trials and real-world studies.

METHODS

PubMed/MEDLINE, Web of Science, EMBASE, Cochrane Library, ClinicalTrials.gov, and meeting libraries were searched from inception to 14 November 2024. The assessed outcomes included overall survival (OS), progression-free survival, time to next treatment, duration of response, overall response rate (ORR), ≥complete response (≥CR), ≥very good partial response (≥VGPR), VGPR, partial response, and adverse events.

RESULTS

In total, 34 studies involving 4,064 patients were included. In pairwise meta-analysis, teclistamab demonstrated superior OS [hazard ratio (HR) = 0.69, 95% confidence interval (CI): 0.54-0.89; p = 0.037] compared to existing RRMM treatments. Real-world studies showed comparable ORR (62%, 95% CI: 58%-66%) but slightly lower survival outcomes, possibly because of shorter follow-up times and higher-risk populations. Subgroup analyses revealed enhanced efficacy with combination therapies (ORR: 85% vs 62%, p < 0.0001) and notable clinical benefits in the China cohort (≥VGPR: 77%, ≥CR: 58%). Safety profiles indicated manageable cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, though infection risks required vigilant management.

CONCLUSIONS

Teclistamab continues to be a promising and effective treatment option for RRMM patients, including those previously exposed to BCMA-targeted therapies, and offers new hope for overcoming resistance and achieving better early disease control. Further research is needed to optimize its application in diverse populations, particularly in Asian cohorts.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/prospero/#myprospero, identifier CRD42025633838.

摘要

背景

多发性骨髓瘤（MM）是一种血液系统恶性肿瘤，复发/难治性MM（RRMM）患者的治疗选择有限。替雷利珠单抗是一种B细胞成熟抗原（BCMA）×CD3双特异性抗体，在临床试验和真实世界研究中均显示出有前景的结果。

方法

检索了PubMed/MEDLINE、Web of Science、EMBASE、Cochrane图书馆、ClinicalTrials.gov以及会议文献库，检索时间从创建至2024年11月14日。评估的结局包括总生存期（OS）、无进展生存期、下次治疗时间、缓解持续时间、总缓解率（ORR）、≥完全缓解（≥CR）、≥非常好的部分缓解（≥VGPR）、VGPR、部分缓解以及不良事件。

结果

共纳入34项研究，涉及4064例患者。在成对荟萃分析中，与现有的RRMM治疗方法相比，替雷利珠单抗显示出更优的总生存期[风险比（HR）=0.69，95%置信区间（CI）：0.54 - 0.89；p = 0.037]。真实世界研究显示ORR相当（62%，95%CI：58% - 66%），但生存结局略低，这可能是由于随访时间较短和人群风险较高。亚组分析显示联合治疗疗效增强（ORR：85%对62%，p < 0.0001），在中国队列中具有显著的临床益处（≥VGPR：77%，≥CR：58%）。安全性方面表明细胞因子释放综合征和免疫效应细胞相关神经毒性综合征可控，不过感染风险需要谨慎管理。