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RE-MIND2:基于真实世界数据的 tafasitamab 联合来那度胺对比 polatuzumab vedotin/苯达莫司汀/利妥昔单抗 (pola-BR)、CAR-T 疗法及来那度胺/利妥昔单抗 (R2) 在复发/难治性弥漫大 B 细胞淋巴瘤患者中的比较疗效

英文原题:RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma.

PubMed 2023/05/12(内容时间) Ann Hematol Q3 · IF 2.3(JCR 2025)

研究概要

患者年龄为18岁,经组织学确诊为DLBCL,并接受过2种DLBCL全身治疗(包括1种抗CD20治疗)。

中文摘要

RE-MIND2 (NCT04697160) 将 L-MIND (NCT02399085) 试验中 tafasitamab+lenalidomide 治疗的患者结局与不适合自体干细胞移植的复发/难治性 (R/R) 弥漫性大 B 细胞淋巴瘤 (DLBCL) 患者接受其他治疗的结局进行了比较。我们展示了主要分析中未评估的三种预先指定治疗方案的结局数据。数据从北美、欧洲和亚太地区的中心进行回顾性收集。患者年龄≥18 岁,经组织学确诊为 DLBCL,并接受过 2 种全身性治疗用于 DLBCL(包括 1 种抗 CD20 治疗)。观察队列和 L-MIND 队列中的入组患者使用基于倾向评分的 1:1 最近邻匹配进行匹配,并对六个协变量进行平衡。将 tafasitamab+lenalidomide 与 polatuzumab vedotin+bendamustine+rituximab (pola-BR)、rituximab+lenalidomide (R2) 和 CD19-CAR-T 细胞 疗法进行比较。主要终点为总生存期 (OS)。次要终点包括治疗缓解和无进展生存期。来自 200 个中心,3,454 名患者入组观察队列。严格匹配的患者配对包括 tafasitamab+lenalidomide 对比 pola-BR(n = 24 对)、对比 R2(n = 33 对)以及对比 CAR-T 疗法(n = 37 对)。与 pola-BR(HR:0.441;p = 0.034)和 R2(HR:0.435;p = 0.012)相比,tafasitamab+lenalidomide 观察到显著的 OS 获益。在 tafasitamab+lenalidomide 和 CAR-T 队列中观察到可比的 OS(HR:0.953,p = 0.892)。与 pola-BR 和 R2 相比,tafasitamab+lenalidomide 似乎改善了生存结局,而与 CAR-T 相比观察到可比的结局。尽管基于有限的患者数量,这些数据可能有助于为R/R DLBCL的新兴疗法提供背景参考。临床试验注册:NCT04697160(2021年1月6日)。

展开英文摘要原文

RE-MIND2 (NCT04697160) compared patient outcomes from the L-MIND (NCT02399085) trial of tafasitamab+lenalidomide with those of patients treated with other therapies for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are autologous stem cell transplant ineligible. We present outcomes data for three pre-specified treatments not assessed in the primary analysis. Data were retrospectively collected from sites in North America, Europe, and the Asia Pacific region. Patients were aged 18 years with histologically confirmed DLBCL and received 2 systemic therapies for DLBCL (including 1 anti-CD20 therapy). Patients enrolled in the observational and L-MIND cohorts were matched using propensity score-based 1:1 nearest-neighbor matching, balanced for six covariates. Tafasitamab+lenalidomide was compared with polatuzumab vedotin+bendamustine+rituximab (pola-BR), rituximab+lenalidomide (R2), and CD19-chimeric antigen receptor T-cell (CAR-T) therapies. The primary endpoint was overall survival (OS). Secondary endpoints included treatment response and progression-free survival. From 200 sites, 3,454 patients were enrolled in the observational cohort. Strictly matched patient pairs consisted of tafasitamab+lenalidomide versus pola-BR (n = 24 pairs), versus R2 (n = 33 pairs), and versus CAR-T therapies (n = 37 pairs). A significant OS benefit was observed with tafasitamab+lenalidomide versus pola-BR (HR: 0.441; p = 0.034) and R2 (HR: 0.435; p = 0.012). Comparable OS was observed in tafasitamab+lenalidomide and CAR-T cohorts (HR: 0.953, p = 0.892). Tafasitamab+lenalidomide appeared to improve survival outcomes versus pola-BR and R2, and comparable outcomes were observed versus CAR-T. Although based on limited patient numbers, these data may help to contextualize emerging therapies for R/R DLBCL. CLINICAL TRIAL REGISTRATION: NCT04697160 (January 6, 2021).

论文信息

作者
Nowakowski GS、Yoon DH、Mondello P、Joffe E、Peters A、Fleury I、Greil R、Ku M
单位
Division of Hematology, Mayo Clinic, Rochester, MN, USA. Nowakowski.Grzegorz@mayo.edu.United States
期刊
Annals of hematology2023 Jul
原文标识
PubMed 37171597 · DOI 10.1007/s00277-023-05196-4