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CAR-T 细胞与双特异性抗体作为多发性骨髓瘤三线或后线治疗的比较：一项荟萃分析

英文原题：Comparison of CAR T-cell and bispecific antibody as third-line or later-line treatments for multiple myeloma: a meta-analysis.

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Comparison of CAR T-cell and bispecific antibody as third-line or later-line treatments for multiple myeloma: a meta-analysis.

PubMed 2024/11/17（内容时间） J Immunother Cancer Q1 · IF 11.7（JCR 2025）

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靶点：BCMA技术：CAR-T技术：双特异性抗体多发性骨髓瘤地区：中国
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研究概要

与双特异性抗体相比，CAR-T 细胞治疗显示出更高的 CR 率，但严重不良事件增加。

中文摘要

背景

CAR-T 细胞疗法和双特异性抗体彻底改变了多发性骨髓瘤治疗格局。然而，目前缺乏比较这两种方法疗效和安全性的研究。本荟萃分析评估靶向B细胞成熟抗原（BCMA）的CAR-T 细胞疗法和BCMA/CD3双特异性抗体作为复发/难治性多发性骨髓瘤（RRMM）三线及后续治疗的疗效和安全性。

方法

我们检索PubMed、Embase、Web of Science和Cochrane数据库截至2024年5月31日的文献，确定11项符合条件的研究，共涉及1,269名参与者。采用随机效应模型评估主要结局（完全缓解〔CR〕率）和次要结局（总缓解率〔ORR〕），并使用荟萃回归分析校正相关协变量。

结果

CAR-T 细胞疗法的合并CR率（0.54，95% CI：0.42–0.69）显著高于双特异性抗体（0.35，0.30–0.41；p<0.01），合并ORR也更高（0.83，0.76–0.90，对比0.65，0.59–0.71；p<0.01）。然而，CAR-T 治疗不良事件发生率更高，特别是细胞因子释放综合征（CRS：0.83，0.70–0.97；双特异性抗体为0.59，0.43–0.74；p<0.05）。CAR-T 组重度CRS（3级）发生率为0.07（0.03–0.14），而双特异性抗体组几乎未发生（0.01，0.00–0.02；p<0.01）。血液学不良事件也在CAR-T 组更常见，包括中性粒细胞减少（3级：0.88，0.81–0.95，对比0.48，0.30–0.67；p<0.01）和贫血（3级：0.55，0.47–0.62，对比0.34，0.28–0.40；p<0.01）。此外，不同CAR-T 产品间疗效也有差异；与伊德卡布他仑赛相比，西达基奥仑赛的CR率更高（0.77，0.71–0.84，对比0.37，0.32–0.41；p<0.01），ORR也更高（0.91，0.83–0.99，对比0.73，0.68–0.77；p<0.01）。

结论

与双特异性抗体相比，CAR-T 细胞疗法的CR率更高，但严重不良事件也更多。

展开英文摘要原文
BACKGROUND

CAR-T-cell therapy and bispecific antibody have revolutionized the treatment landscape for multiple myeloma. However, there is currently a lack of studies comparing the efficacy and safety of these two approaches. This meta-analysis assesses the efficacy and safety of B-cell maturation antigen (BCMA)-directed CAR-T-cell therapies and BCMA CD3 bispecific antibodies as third-line or later interventions for relapsed/refractory multiple myeloma (RRMM).

METHODS

We searched PubMed, Embase, Web of Science, and Cochrane databases up to May 31, 2024, identifying 11 eligible studies encompassing 1269 participants. Random-effects models evaluated the primary (complete response (CR) rate) and secondary (overall response rate (ORR)) outcomes, while meta-regression analyses adjusted for relevant covariates.

RESULTS

CAR-T-cell therapy achieved significantly higher pooled CR rate (0.54 (95% CI 0.42-0.69) vs bispecific antibodies 0.35 (0.30-0.41), p<0.01) and pooled ORR (0.83 (0.76-0.90) vs 0.65 (0.59-0.71), p<0.01). However, CAR-T therapy had a higher incidence of adverse events, particularly cytokine release syndrome (CRS 0.83 (0.70-0.97) vs bispecific antibodies 0.59 (0.43-0.74), p<0.05). Severe CRS (grade 3) occurred at a rate of 0.07 (0.03-0.14) in the CAR-T cell group, contrasting with a negligible rate of 0.01 (0.00-0.02) in the bispecific antibody group (p<0.01). Hematologic adverse events, including neutropenia (grade 3; 0.88 (0.81-0.95) vs 0.48 (0.30-0.67), p<0.01) and anemia (grade 3; 0.55 (0.47-0.62) vs 0.34 (0.28 to 0.40), p<0.01), were also more frequent in the CAR-T-cell group. Furthermore, differences in efficacy were observed among various CAR-T products, with ciltacabtagene autoleucel showing greater efficacy in CR rate (0.77 (0.71-0.84) vs 0.37 (0.32-0.41), p<0.01) and ORR (0.91 (0.83-0.99) vs 0.73 (0.68-0.77), p<0.01) compared with idecabtagene vicleucel.

CONCLUSION

CAR-T-cell therapy demonstrated superior CR rates compared with bispecific antibodies, although with an increase in severe adverse events.

论文信息

作者
Liang X、Wang Y、Luo B、Lin B、Lu W、Tian S、Liu D、Wang L
第一作者单位
Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing, China.China
通讯作者单位
Department of Hematology, Beijing Tongren Hospital, Capital Medical University, Beijing, China wangliangtrhos@126.com.China
文献类型
荟萃分析 · 对照研究
期刊
Journal for immunotherapy of cancer2024 Nov 17
原文标识
PubMed 39551604　·　DOI 10.1136/jitc-2024-010064

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