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德国 123 例 RRMM 患者中 teclistamab 的真实世界分析

英文原题:Real-world analysis of teclistamab in 123 RRMM patients from Germany.

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Real-world analysis of teclistamab in 123 RRMM patients from Germany.

PubMed 2024/01/20(内容时间) Leukemia Q1 · IF 8.8(JCR 2025)

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中文摘要

Teclistamab是一种靶向B细胞成熟抗原(BCMA)和CD3的双特异性抗体,在MAJESTEC-1试验中治疗复发/难治性多发性骨髓瘤(RRMM)患者显示较高缓解率和持久缓解。

我们回顾性评估了德国18家中心123例患者的疗效和耐受性,以判断真实世界结局是否与试验相当。多数患者对三类药物(93%)或五种药物(60%)耐药;37%的患者曾接受靶向BCMA的治疗,包括idecabtagene vicleucel(ide-cel)CAR-T(21/123,17.1%)。中位随访5.5个月时,总缓解率(ORR)为59.3%,中位无进展生存期(PFS)为8.7个月。亚组分析发现,伴髓外病变(ORR 37%,中位PFS 2.1个月)、ISS分期为III期(37%,1.3个月)和既往接受ide-cel治疗(33%,1.8个月)的患者,其ORR和中位PFS显著较低。尽管如此,既往接受ide-cel患者的缓解持续时间与未接受抗BCMA治疗者相当。感染和3级血细胞减少是最常见的不良事件。

总之,真实世界中teclistamab的疗效和安全性特征与关键试验相当。

展开英文摘要原文

Teclistamab, a B-cell maturation antigen (BCMA) CD3 directed bispecific antibody, has shown high response rates and durable remissions in the MAJESTEC-1 trial in patients with relapsed and refractory multiple myeloma (RRMM).

We retrospectively assessed efficacy and tolerability in 123 patients treated at 18 different German centers to determine whether outcome is comparable in the real-world setting. Most patients had triple-class (93%) or penta-drug (60%) refractory disease, 37% of patients had received BCMA-directed pretreatment including idecabtagene vicleucel (ide-cel) CAR-T cell therapy (21/123, 17. 1%). With a follow-up of 5. 5 months, we observed an overall response rate (ORR) of 59. 3% and a median progression-free survival (PFS) of 8. 7 months.

In subgroup analyses, we found significantly lower ORR and median PFS in patients with extramedullary disease (37%/2. 1 months), and/or an ISS of 3 (37%/1. 3 months), and ide-cel pretreated patients (33%/1. 8 months). Nonetheless, the duration of response in ide-cel pretreated patients was comparable to that of anti-BCMA naive patients. Infections and grade 3 cytopenias were the most frequent adverse events. In summary, we found that teclistamab exhibited a comparable efficacy and safety profile in the real-world setting as in the pivotal trial.

论文信息

作者
Riedhammer C、Bassermann F、Besemer B、Bewarder M、Brunner F、Carpinteiro A、Einsele H、Faltin J
第一作者单位
Department of Internal Medicine II, University Hospital of Würzburg, Würzburg, Germany.Germany
通讯作者单位
Department of Internal Medicine II, University Hospital of Würzburg, Würzburg, Germany. Rasche_L@ukw.de.Germany
文献类型
非美国政府资助研究
期刊
Leukemia2024 Feb
原文标识
PubMed 38245601 · DOI 10.1038/s41375-024-02154-5