Tafasitamab 联合来那度胺对比系统性疗法治疗复发/难治弥漫性大 B 细胞淋巴瘤的疗效改善：RE-MIND2，一项观察性回顾性匹配队列研究。

Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study.

机构信息

Division of Hematology, Mayo Clinic, Rochester, Minnesota.

Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.

出版信息

Clin Cancer Res. 2022 Sep 15;28(18):4003-4017. doi: 10.1158/1078-0432.CCR-21-3648.

DOI:10.1158/1078-0432.CCR-21-3648

PMID:35674661

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9475241/

Abstract

PURPOSE

In RE-MIND2 (NCT04697160), patient-level outcomes from the L-MIND study (NCT02399085) of tafasitamab plus lenalidomide were retrospectively compared with patient-level matched observational cohorts treated with National Cancer Care Network (NCCN)/European Society for Medical Oncology (ESMO)-listed systemic therapies for relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

PATIENTS AND METHODS

Data were collected from health records of eligible patients aged ≥18 years with histologically confirmed DLBCL who had received ≥2 systemic therapies for DLBCL (including ≥1 anti-CD20 therapy). Patients from L-MIND were matched with patients from the RE-MIND2 observational cohort using estimated propensity score-based 1:1 nearest-neighbor matching, balanced for nine covariates. The primary analysis compared tafasitamab plus lenalidomide with patients who received any systemic therapy for R/R DLBCL (pooled in one cohort) or bendamustine plus rituximab (BR) or rituximab plus gemcitabine and oxaliplatin (R-GemOx; as two distinct cohorts). The primary endpoint was overall survival (OS). Secondary endpoints included treatment response and time-to-event outcomes.

RESULTS

In RE-MIND2, 3,454 patients were enrolled from 200 sites in North America, Europe, and Asia-Pacific. Strictly matched pairs of patients consisted of tafasitamab plus lenalidomide versus systemic therapies pooled (n = 76 pairs), versus BR (n = 75 pairs), and versus R-GemOx (n = 74 pairs). Significantly prolonged OS was reported with tafasitamab plus lenalidomide versus systemic pooled therapies [hazard ratios (HR): 0.55; P = 0.0068], BR (HR: 0.42; P < 0.0001), and R-GemOx (HR: 0.47; P = 0.0003).

CONCLUSIONS

RE-MIND2, a retrospective observational study, met its primary endpoint, demonstrating prolonged OS with tafasitamab plus lenalidomide versus BR and R-GemOx. See related commentary by Cherng and Westin, p. 3908.

摘要

目的

在 RE-MIND2（NCT04697160）中，回顾性比较了 L-MIND 研究（NCT02399085）中 tafasitamab 联合来那度胺的患者水平结局与接受国家癌症护理网络（NCCN）/欧洲肿瘤内科学会（ESMO）列出的用于治疗复发性/难治性弥漫性大 B 细胞淋巴瘤（DLBCL）的系统治疗的患者水平匹配观察队列。

方法

从年龄≥18 岁且组织学确诊为 DLBCL 的符合条件的患者的健康记录中收集数据，这些患者接受了≥2 种用于 DLBCL 的系统治疗（包括≥1 种抗 CD20 治疗）。使用基于估计倾向评分的 1:1 最近邻匹配，对 L-MIND 中的患者与来自 RE-MIND2 观察队列的患者进行匹配，平衡了 9 个协变量。主要分析比较了 tafasitamab 联合来那度胺与接受任何用于 R/R DLBCL 的系统治疗的患者（汇集在一个队列中）或苯达莫司汀联合利妥昔单抗（BR）或利妥昔单抗联合吉西他滨和奥沙利铂（R-GemOx；作为两个不同的队列）。主要终点是总生存期（OS）。次要终点包括治疗反应和时间事件结局。

结果

在 RE-MIND2 中，来自北美、欧洲和亚太地区 200 个地点的 3454 名患者入组。严格匹配的患者对包括 tafasitamab 联合来那度胺与系统治疗（n=76 对）、BR（n=75 对）和 R-GemOx（n=74 对）。与系统治疗相比，tafasitamab 联合来那度胺显著延长了 OS [风险比（HR）：0.55；P=0.0068]、BR（HR：0.42；P<0.0001）和 R-GemOx（HR：0.47；P=0.0003）。