PDF(Pubmed)
Abstract：
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).
摘要：
RE-MIND2（NCT04697160）比较了L-MIND（NCT02399085）他法他单抗来那度胺试验的患者结果与接受其他疗法治疗的复发/难治性（R/R）弥漫性大B细胞淋巴瘤（DLBCL）患者的患者结果。自体干细胞移植不合格。我们提供了在主要分析中未评估的三种预先指定的治疗方法的结果数据。数据是回顾性地从北美的网站收集的，欧洲,和亚太地区。患者年龄≥18岁，经组织学证实为DLBCL，并接受了≥2种DLBCL全身治疗（包括≥1种抗CD20治疗）。纳入观察性和L-MIND队列的患者使用基于倾向评分的1:1最近邻匹配进行匹配，对六个协变量保持平衡。比较了Tafasitamab+来那度胺与polatuzumabvedotin+苯达莫司汀+利妥昔单抗(pola-BR),利妥昔单抗+来那度胺（R2），和CD19嵌合抗原受体T细胞（CAR-T）疗法。主要终点是总生存期（OS）。次要终点包括治疗反应和无进展生存期。从200个网站，3,454例患者被纳入观察队列。严格匹配的患者对包括塔法他他单抗+来那度胺与波拉-BR（n=24对），对R2（n=33对），和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，他他他单抗+来那度胺观察到显着的OS益处。在tafasitamab+来那度胺和CAR-T队列中观察到相当的OS(HR:0.953,p=0.892)。与pola-BR和R2相比，Tafasitamab+来那度胺似乎改善了生存结果，与CAR-T相比，观察到了相当的结果。尽管基于有限的患者人数，这些数据可能有助于将R/RDLBCL的新兴治疗方法纳入情境.临床试验注册：NCT04697160（2021年1月6日）。
