RE-MIND2：基于真实世界数据在复发/难治性弥漫性大 B 细胞淋巴瘤患者中，比较 tafasitamab 联合来那度胺与 polatuzumab vedotin/苯达莫司汀/利妥昔单抗（pola-BR）、嵌合抗原受体 T 细胞疗法以及来那度胺/利妥昔单抗（R2）的疗效。
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.
机构信息
Division of Hematology, Mayo Clinic, Rochester, MN, USA.
Department of Oncology, Asan Medical Center, Songpa-gu, Seoul, South Korea.
出版信息
Ann Hematol. 2023 Jul;102(7):1773-1787. doi: 10.1007/s00277-023-05196-4. Epub 2023 May 12.
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).
RE-MIND2（NCT04697160）比较了 tafasitamab+来那度胺治疗与其他疗法治疗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）患者的患者结局。我们报告了主要分析中未评估的三种预先指定治疗的结果数据。数据是从北美、欧洲和亚太地区的多个研究点回顾性收集的。患者年龄≥18 岁，组织学证实为 DLBCL，并接受≥2 种 DLBCL 系统治疗（包括≥1 种抗 CD20 治疗）。采用倾向评分基于的 1:1 最近邻匹配，对观察队列和 L-MIND 队列中的患者进行匹配，平衡了六个协变量。tafasilamab+lenalidomide 与 polatuzumab vedotin+bendamustine+rituximab（pola-BR）、rituximab+lenalidomide（R2）和 CD19 嵌合抗原受体 T 细胞（CAR-T）疗法进行了比较。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 个研究点入组了 3454 名患者进入观察队列。tafasilamab+lenalidomide 与 pola-BR（n=24 对）、R2（n=33 对）和 CAR-T 治疗（n=37 对）严格匹配的患者对，比较了治疗反应和无进展生存期。与 pola-BR（HR：0.441；p=0.034）和 R2（HR：0.435；p=0.012）相比，tafasilamab+lenalidomide 观察到 OS 显著获益。在 tafasilamab+lenalidomide 和 CAR-T 队列中观察到相似的 OS（HR：0.953，p=0.892）。与 pola-BR 和 R2 相比，tafasilamab+lenalidomide 似乎改善了生存结果，与 CAR-T 相比观察到相似的结果。尽管基于有限的患者数量，但这些数据可能有助于为 R/R DLBCL 的新兴疗法提供背景信息。临床试验注册：NCT04697160（2021 年 1 月 6 日）。
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