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

IF 2.2 4区 医学 Q3 HEMATOLOGY Leukemia & Lymphoma Pub Date : 2025-01-05 DOI:10.1080/10428194.2024.2446617
Gaurav Varma, Lindsay Fogel, Beth Gordon, Mateo Mejia Saldarriaga, Jaeil Ahn, Adolfo Aleman, Jessica Caro, Maya C Rosenberg, Jorge Monge, Harsh Parmar, David Kaminetzky, Tibor Moskovits, David S Siegel, Gareth J Morgan, Ruben Niesvizky, Faith E Davies, Noa Biran
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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.

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teclistamab治疗复发/难治性多发性骨髓瘤的安全性和有效性:来自多中心、回顾性研究和描述性荟萃分析的结果
参与临床试验的患者是经过高度筛选的,可能不能代表一般人群。teclistamab (MajesTEC-1)是一种b细胞成熟抗原(BCMA)xCD3双特异性抗体,其关键研究显示,在毒性可接受的复发/难治性多发性骨髓瘤(RRMM)中,teclistamab (MajesTEC-1)的反应率和无进展生存期令人印象深刻。我们对美国四个学术中心的58名患者进行了回顾性研究,以确定这些结果如何转化为现实世界。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研究的条件。尽管有这些“不太有利”的特征,我们观察到MajesTEC-1的疗效和毒性相似。对其他六个已发表的真实世界系列(n = 546)的荟萃分析证实了这些结果。这些数据支持了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的重要性,以进一步为日常临床实践提供信息。
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来源期刊
Leukemia & Lymphoma
Leukemia & Lymphoma 医学-血液学
CiteScore
4.10
自引率
3.80%
发文量
384
审稿时长
1.8 months
期刊介绍: Leukemia & Lymphoma in its fourth decade continues to provide an international forum for publication of high quality clinical, translational, and basic science research, and original observations relating to all aspects of hematological malignancies. The scope ranges from clinical and clinico-pathological investigations to fundamental research in disease biology, mechanisms of action of novel agents, development of combination chemotherapy, pharmacology and pharmacogenomics as well as ethics and epidemiology. Submissions of unique clinical observations or confirmatory studies are considered and published as Letters to the Editor
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