Division of Hematology/Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.
Division of Hematology/Oncology, Weill Cornell Medicine, New York, NY, USA.
Blood Cancer J. 2024 Mar 5;14(1):35. doi: 10.1038/s41408-024-01003-z.
The objective of our study was to report real-world data on the safety and efficacy of standard-of-care teclistamab in patients with relapsed/refractory multiple myeloma (MM). This is a multi-institutional retrospective cohort study and included all consecutive patients that received at least one dose of teclistamab up until August 2023. One hundred and ten patients were included, of whom, 86% had triple-class refractory disease, 76% penta-refractory disease, and 35% had prior exposure to B-cell maturation antigen (BCMA)-targeting therapies. The overall response rate (ORR) in our cohort was 62%, with a ≥ very good partial remission (VGPR) rate of 51%. The ORR in patients with and without prior BCMA-targeted therapies was 54% vs 67%, respectively (p = 0.23). At a median follow-up of 3.5 months (range, 0.39-10.92), the estimated 3 month and 6 month progression free survival (PFS) was 57% (95% CI, 48%, 68%) and 52% (95% CI, 42%, 64%) respectively. The incidence of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) was 56% and 11% respectively, with grade ≥3 CRS and ICANS noted in 3.5% and 4.6% of patients respectively. 78 unique infections were diagnosed in 44 patients, with the incidence of all-grade and grade ≥3 infections being 40% vs 26% respectively. Primary prophylaxis with intravenous immunoglobulin (IVIG) was associated with a significantly lower infection risk on multivariate analysis (Hazard ratio [HR] 0.33; 95% CI 0.17, 0.64; p = 0.001).
我们的研究目的是报告在复发/难治性多发性骨髓瘤（MM）患者中标准护理替西卡巴单抗的安全性和疗效的真实世界数据。这是一项多机构回顾性队列研究，纳入了截至 2023 年 8 月至少接受过一次替西卡巴单抗治疗的所有连续患者。共纳入 110 例患者，其中 86%有三药难治性疾病，76%有五药难治性疾病，35%有既往接受 B 细胞成熟抗原（BCMA）靶向治疗的经历。我们队列的总缓解率（ORR）为 62%，≥非常好的部分缓解（VGPR）率为 51%。有和没有既往 BCMA 靶向治疗的患者的 ORR 分别为 54%和 67%（p=0.23）。在中位随访 3.5 个月（范围，0.39-10.92）时，估计的 3 个月和 6 个月无进展生存（PFS）率分别为 57%（95%CI，48%，68%）和 52%（95%CI，42%，64%）。细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）的发生率分别为 56%和 11%，分别有 3.5%和 4.6%的患者出现≥3 级 CRS 和 ICANS。在 44 例患者中诊断出 78 种独特的感染，所有级别和≥3 级感染的发生率分别为 40%和 26%。静脉注射免疫球蛋白（IVIG）的预防性治疗与多变量分析中的感染风险显著降低相关（风险比 [HR] 0.33；95%CI 0.17，0.64；p=0.001）。
