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替雷利珠单抗治疗复发/难治性多发性骨髓瘤的真实世界安全性和有效性:一项多中心回顾性研究及描述性荟萃分析的结果

Real-world safety and efficacy of teclistamab in relapsed/refractory multiple myeloma: results from a multicenter, retrospective study and descriptive meta-analysis.

作者信息

Varma Gaurav, Fogel Lindsay, Gordon Beth, Saldarriaga Mateo Mejia, Ahn Jaeil, Aleman Adolfo, Caro Jessica, Rosenberg Maya C, Monge Jorge, Parmar Harsh, Kaminetzky David, Moskovits Tibor, Siegel David S, Morgan Gareth J, Niesvizky Ruben, Davies Faith E, Biran Noa

机构信息

Center for Blood Cancers, Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA.

Multiple Myeloma Division, The John Theurer Cancer Center, Hackensack Meridian Health, Hackensack, NJ, USA.

出版信息

Leuk Lymphoma. 2025 May;66(5):942-951. doi: 10.1080/10428194.2024.2446617. Epub 2025 Jan 5.

Abstract

Patients participating in clinical trials are highly selected and may not represent the general population. The pivotal study of teclistamab (MajesTEC-1), a B-cell maturation antigen (BCMA)xCD3 bispecific antibody, demonstrated impressive response rates and progression free survival in relapsed/refractory multiple myeloma (RRMM) with acceptable toxicity. We performed a retrospective study of 58 patients treated as standard of care at four US academic centers to determine how these results translated to the real-world. Most patients (87.9%) would not have been eligible for the MajesTEC-1 study due to either disease related factors, patient related comorbidities or socio-economic/geographical factors. Despite these 'less-favorable' characteristics we observed similar efficacy and toxicity to MajesTEC-1. A meta-analysis with six other published real-world series (n = 546) confirmed these results. These data support the significant clinical activity of teclistamab in RRMM and highlights the importance of real-world data to accompany the pivotal trial data to further inform daily clinical practice.

摘要

参与临床试验的患者经过了严格筛选,可能无法代表普通人群。B细胞成熟抗原(BCMA)×CD3双特异性抗体teclistamab(MajesTEC-1)的关键研究表明,复发/难治性多发性骨髓瘤(RRMM)患者使用该药物后缓解率和无进展生存期令人印象深刻,且毒性可接受。我们对美国四个学术中心接受标准治疗的58例患者进行了一项回顾性研究,以确定这些结果在现实世界中的情况。由于疾病相关因素、患者相关合并症或社会经济/地理因素,大多数患者(87.9%)不符合MajesTEC-1研究的入选标准。尽管存在这些“不太有利”的特征,但我们观察到其疗效和毒性与MajesTEC-1相似。一项对其他六个已发表的真实世界系列研究(n = 546)的荟萃分析证实了这些结果。这些数据支持teclistamab在RRMM中的显著临床活性,并强调了真实世界数据与关键试验数据相结合以进一步指导日常临床实践的重要性。

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