肿瘤细胞治疗研究
英文原题：Effectiveness of linvoseltamab versus real-world standard-of-care in triple-class-exposed relapsed/refractory multiple myeloma in the United States.
Effectiveness of linvoseltamab versus real-world standard-of-care in triple-class-exposed relapsed/refractory multiple myeloma in the United States.
2期linvoseltamab 200 mg队列（N = 105）与一个外部对照臂进行了比较，该对照臂包含来自两个美国电子健康记录数据库COTA和Guardian Research Network的149例接受真实世界（RW）标准治疗（SOC）的患者。
LINKER-MM1（NCT03761108）是一项关于linvoseltamab的1/2期研究，linvoseltamab是一种人源BCMA×CD3双特异性抗体，用于治疗既往接受过至少3线治疗（3L+）且三类药物暴露（TCE）或三类药物难治（TCR）的复发/难治性多发性骨髓瘤（RRMM）患者。2期linvoseltamab 200 mg队列（N = 105）与一个外部对照臂进行了比较，该外部对照臂包含来自两个美国电子健康记录数据库（COTA和Guardian Research Network）的149例接受真实世界（RW）标准治疗（SOC）的患者。关键的LINKER-MM1入选标准被应用于RW SOC队列；一个独立数据审查委员会评估了数据相关性和质量以及队列可比性。采用逆概率治疗加权来平衡队列间的基线特征。最常见的SOC方案为卡非佐米、泊马度胺和地塞米松联合方案（8.6%）以及达雷妥尤单抗、泊马度胺和地塞米松联合方案（8.2%）。没有患者接受CAR-T 细胞治疗或双特异性抗体。Linvoseltamab的客观缓解率高于RW SOC（加权比值比3.8 [95% CI：2.5-6.6]），中位无进展生存期（加权风险比[wHR] 0.29 [95% CI：0.23-0.39]）、至下一次治疗时间（wHR 0.20 [95% CI：0.15-0.26]）和总生存期（wHR 0.41 [95% CI：0.32-0.52]）均更长，表明其作为3L+及TCE/TCR RRMM有效治疗方案的潜力。
LINKER-MM1 (NCT03761108) is a Phase 1/2 study of linvoseltamab, a human BCMA×CD3 bispecific antibody for patients with relapsed/refractory multiple myeloma (RRMM) who are triple-class exposed (TCE) with ≥3 prior lines of therapy (3L+), or triple-class refractory (TCR). The Phase 2 linvoseltamab 200 mg cohort (N = 105) was compared with an external control arm comprising 149 patients from two US electronic health record databases, COTA and Guardian Research Network, treated with real-world (RW) standard-of-care (SOC). Key LINKER-MM1 eligibility criteria were applied to the RW SOC cohort; an independent data review committee assessed data relevance and quality, and cohort comparability. Inverse probability of treatment weighting was used to balance baseline characteristics between cohorts. The most common SOC regimens were combinations of carfilzomib, pomalidomide, and dexamethasone (8.6%) and daratumumab, pomalidomide, and dexamethasone (8.2%). No patients received chimeric antigen receptor T cell therapy or bispecific antibodies. Linvoseltamab had a higher objective response rate than RW SOC (weighted odds ratio 3.8 [95% CI: 2.5-6.6]), and longer median progression-free survival (weighted hazard ratio [wHR] 0.29 [95% CI: 0.23-0.39]), time to next treatment (wHR 0.20 [95% CI: 0.15-0.26]), and overall survival (wHR 0.41 [95% CI: 0.32-0.52]), demonstrating its potential as an effective treatment for 3L+ and TCE/TCR RRMM.
MEMBER ACCOUNT
登录成功会直接打开下一页。
