Tafasitamab+来那度胺(LEN),复发/难治性(R/R)弥漫性大B细胞淋巴瘤(DLBCL)的无化学免疫治疗,在单臂L-MIND研究(NCT02399085)中证明了在自体干细胞移植不合格患者中的疗效。RE-MIND2(NCT04697160),一个观察,回顾性队列研究,比较L-MIND患者与接受其他全身治疗的匹配患者队列的结局.与一组合并的全身治疗(PST)相比,使用他他他单抗+LEN的总生存期(OS)延长,苯达莫司汀+利妥昔单抗(BR),利妥昔单抗+吉西他滨+奥沙利铂,polatuzumabvedotin+BR(pola-BR),和利妥昔单抗+LEN(R2)。与CD19嵌合抗原受体T细胞疗法(CAR-T)相比,检测到相当的OS。然而,关于tafasitamab+LEN在特定亚群中的相对有效性的信息有限。这项研究旨在确定在没有头对头试验的情况下,在临床相关患者亚组中,tafasitamab+LEN与其他治疗对R/RDLBCL的相对有效性。L-MIND队列与RE-MIND2患者使用基于估计倾向评分的1:1最近邻匹配平衡至少6个协变量进行匹配。进行了敏感性分析。这项研究是在学术界进行的,public,和欧洲的私立医院,北美,和亚太地区。患者年龄≥18岁,经组织学证实为DLBCL,既往接受DLBCL全身治疗≥2次,包括≥1种抗CD20治疗。提供了塔法他单抗+LEN与PST的数据,对抗pola-BR,对R2和对CAR-T。对结外位点(ENS)数量的患者亚组进行了假设生成分析(0-1vs.≥2)和乳酸脱氢酶(LDH)升高(是与no).主要终点是OS。在3,454名患者中,961、106、106和149用PST治疗,pola-BR,R2和CAR-T,导致76,24,33,和37匹配的对患者接受tafasitamab+LEN,分别。对于Tafasitamab+LEN与PST的比较,ENS≥2的患者的OS危险比分别为0.803、0.524、0.478和1.459,LDH升高的患者的OS危险比分别为0.627、0.585、0.420和1.663。pola-BR,R2和CAR-T,分别。在大多数患者亚组中,有倾向于倾向于tafasitamab+LEN。对于某些具有高风险疾病的患者,相对于选择的全身疗法,该组合可以与改善的OS相关。这些分析不能用于统计比较,应谨慎解释。资金:MorphoSysAG。
Tafasitamab+lenalidomide (LEN), a chemo-free immunotherapy for relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), demonstrated efficacy in autologous stem cell transplant-ineligible patients in the single-arm L-MIND study (NCT02399085). RE-MIND2 (NCT04697160), an observational, retrospective cohort study, compared patient outcomes from L-MIND with matched patient cohorts treated with other systemic therapies. Prolonged overall survival (OS) with
tafasitamab+LEN was detected compared to a cohort of pooled systemic therapies (PST), bendamustine+rituximab (BR), rituximab+gemcitabine+oxaliplatin, polatuzumab vedotin+BR (pola-BR), and rituximab+LEN (R2). Comparable OS was detected versus CD19 chimeric antigen receptor T-cell therapies (CAR-T). However, limited information is available on the comparative effectiveness of tafasitamab+LEN in specific subpopulations. This study aimed to determine the relative effectiveness of
tafasitamab+LEN versus other treatments for R/R DLBCL in clinically relevant patient subgroups in the absence of head-to-head trials. The L-MIND cohort was matched with RE-MIND2 patients using estimated propensity score-based 1:1 nearest neighbor matching balanced for a minimum of six covariates. Sensitivity analyses were conducted. The study was conducted at academic, public, and private hospitals in Europe, North America, and the Asia-Pacific region. Patients were ≥18 years old with histologically confirmed DLBCL and ≥2 prior systemic therapies for DLBCL, including ≥1 anti-CD20 therapy. Data are presented for
tafasitamab+LEN versus PST, versus pola-BR, versus R2, and versus CAR-T. Hypothesis-generating analyses were conducted for patient subgroups of number of extranodal sites (ENS) (0-1 vs. ≥2) and elevated lactate dehydrogenase (LDH) (yes vs. no). The primary endpoint was OS. Of 3,454 patients enrolled, 961, 106, 106, and 149 were treated with PST, pola-BR, R2, and CAR-T, resulting in 76, 24, 33, and 37 matched pairs for patients receiving tafasitamab+LEN, respectively. Hazard ratios for OS for patients with ≥2 ENS were 0.803, 0.524, 0.478, and 1.459, and for patients with elevated LDH were 0.627, 0.585, 0.420, and 1.663, for comparisons of tafasitamab+LEN versus PST, pola-BR, R2, and CAR-T, respectively. There was a trend towards favoring
tafasitamab+LEN in most patient subgroups. The combination may be associated with improved OS versus selected systemic therapies for certain patients with high-risk disease. These analyses are not powered for statistical comparison and should be interpreted with caution. Funding: MorphoSys AG.