CAR-T(CAR-T)细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CAR-T(CAR-T)细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Real-World Experience with Teclistamab for Relapsed/Refractory Multiple Myeloma from the US Myeloma Immunotherapy Consortium.
Real-World Experience with Teclistamab for Relapsed/Refractory Multiple Myeloma from the US Myeloma Immunotherapy Consortium.
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Teclistamab是一种抗CD3-/B细胞成熟抗原(BCMA)双特异性抗体,已获批用于复发/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开展了一项关于teclistamab获批后真实世界结局的回顾性研究。在509例患者中,89%不符合MajesTEC-1试验的入组条件,主要原因是既往接受过BCMA靶向治疗、血细胞减少或体能状态下降。细胞因子释放综合征发生于54%(1.4%为≥3级),免疫效应细胞相关神经毒性综合征发生于11%(2.2%为≥3级),无致死性事件。感染发生于42%,并导致5%的患者死亡。53%的患者达到部分缓解(PR)或更好,45%达到非常好的PR或更好。中位随访10.1个月时,估计的中位无进展生存期(PFS)为5.8个月,12个月总生存率为61%。未达到非常好的PR及较短PFS的独立预测因素包括既往9个月内接受过BCMA靶向CAR-T 细胞治疗、高疾病负荷、淋巴细胞减少和铁蛋白升高。意义:T细胞衔接双特异性抗体如teclistamab代表了多发性骨髓瘤和其他血液肿瘤的重要新治疗模式。本研究评估了teclistamab的真实世界安全性和有效性,包括其在初始I/II期研究中未纳入人群中的活性,并确定了与治疗反应相关的临床变量。参见Zweegman等人的相关评论,第542页。
UNLABELLED: 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 post-approval, 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. See related commentary by Zweegman et al. , p. 542.
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