来自美国骨髓瘤免疫治疗联盟的Teclistamab治疗复发/难治性多发性骨髓瘤的实际经验。

IF 11.5 Q1 HEMATOLOGY
Beatrice M Razzo, Shonali Midha, Andrew J Portuguese, Ariel F Grajales-Cruz, Andre De Menezes Silva Corraes, Patrick Costello, Yuxin Liu, Adam S Sperling, Omar Nadeem, Danai Dima, Rahul Banerjee, Andrew J Cowan, Aimaz Afrough, Larry D Anderson, Alex Lieberman-Cribbin, Gurbakhash Kaur, Anmol Goyal, Shebli Atrash, Christopher J Ferreri, Peter M Voorhees, Oren Pasvolsky, Hans C Lee, Krina K Patel, Kelley L Julian, Peter A Forsberg, Megan M Herr, Saurabh Chhabra, Ricardo D Parrondo, Yi Lin, Anna Chen, Sandra P Susanibar-Adaniya, Jack Khouri, Shahzad Raza, Faiz Anwer, Mariola Vazquez-Martinez, Omar Castaneda Puglianini, Douglas W Sborov, James A Davis, Adriana Rossi, Leyla Shune, Jenny Bhurtel, Wei-Ting Hwang, Doris K Hansen, Surbhi Sidana, Alfred L Garfall, Shambavi Richard
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引用次数: 0

摘要

Teclistamab是一种抗cd3 -/ b细胞成熟抗原(BCMA)双特异性抗体,被批准用于复发/难治性多发性骨髓瘤。我们在美国多发性骨髓瘤免疫治疗联盟中对teclistamab批准后的实际结果进行了回顾性研究。在509名患者中,89%的患者不符合MajesTEC-1试验的条件,主要是由于先前的bcma定向治疗、细胞减少或表现状态下降。细胞因子释放综合征发生率为54%(1.4%分级≥3级),免疫效应细胞相关神经毒性综合征发生率为11%(2.2%分级≥3级),无致死事件。感染发生率为42%,导致死亡的发生率为5%。53%的患者达到部分缓解(PR)或更好,45%的患者达到非常好或更好。中位随访10.1个月,估计中位无进展生存期(PFS)为5.8个月,12个月总生存期为61%。PR低于非常好和PFS较短的独立预测因素包括bcma导向的嵌合抗原受体t细胞治疗,高疾病负担,淋巴细胞减少和铁蛋白升高。意义:T细胞参与双特异性抗体如teclistamab代表了多发性骨髓瘤和其他血癌的重要新治疗方式。本研究评估了teclistamab在现实世界的安全性和有效性,包括其在初始I/II期研究中未代表的人群中的活性,并确定了与治疗反应相关的临床变量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-World Experience with Teclistamab for Relapsed/Refractory Multiple Myeloma from the US Myeloma Immunotherapy Consortium.

Teclistamab is an anti-CD3-/B-cell maturation antigen (BCMA) bispecific antibody approved for use in relapsed/refractory multiple myeloma. We undertook a retrospective study of postapproval, real-world outcomes with teclistamab in the US Multiple Myeloma Immunotherapy Consortium. Among 509 patients, 89% would have been ineligible for the MajesTEC-1 trial, primarily due to prior BCMA-directed therapy, cytopenias, or diminished performance status. Cytokine release syndrome occurred in 54% (1.4% grade ≥3) and immune effector cell-associated neurotoxicity syndrome in 11% (2.2% grade ≥3), with no fatal events. Infections occurred in 42% and contributed to death in 5%. Partial response (PR) or better was achieved in 53% and very good PR or better in 45%. With 10.1 months of median follow-up, the estimated median progression-free survival (PFS) was 5.8 months and 12-month overall survival was 61%. Independent predictors of less than very good PR and shorter PFS included BCMA-directed chimeric antigen receptor T-cell therapy in the previous 9 months, high disease burden, lymphopenia, and elevated ferritin.

Significance: T cell-engaging bispecific antibodies such as teclistamab represent an important new treatment modality for multiple myeloma and other blood cancers. This study evaluates the real-world safety and efficacy of teclistamab, including its activity in populations not represented in the initial phase I/II study, and identifies clinical variables associated with treatment response.

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来源期刊
CiteScore
12.70
自引率
1.80%
发文量
139
期刊介绍: The journal Blood Cancer Discovery publishes high-quality Research Articles and Briefs that focus on major advances in basic, translational, and clinical research of leukemia, lymphoma, myeloma, and associated diseases. The topics covered include molecular and cellular features of pathogenesis, therapy response and relapse, transcriptional circuits, stem cells, differentiation, microenvironment, metabolism, immunity, mutagenesis, and clonal evolution. These subjects are investigated in both animal disease models and high-dimensional clinical data landscapes. The journal also welcomes submissions on new pharmacological, biological, and living cell therapies, as well as new diagnostic tools. They are interested in prognostic, diagnostic, and pharmacodynamic biomarkers, and computational and machine learning approaches to personalized medicine. The scope of submissions ranges from preclinical proof of concept to clinical trials and real-world evidence. Blood Cancer Discovery serves as a forum for diverse ideas that shape future research directions in hematooncology. In addition to Research Articles and Briefs, the journal also publishes Reviews, Perspectives, and Commentaries on topics of broad interest in the field.
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