文章：

奥比妥珠单抗-阿替利珠单抗-来那度胺治疗复发/难治性滤泡性淋巴瘤患者：一项Ib/II期试验的最终分析

Obinutuzumab-atezolizumab-lenalidomide for the treatment of patients with relapsed/refractory follicular lymphoma: final analysis of a Phase Ib/II trial

原文发布日期：2021-08-20

DOI: 10.1038/s41408-021-00539-8

类型: Article

开放获取: 是

英文摘要：

We evaluated the triplet regimen obinutuzumab-atezolizumab-lenalidomide (G-atezo-len) for patients with relapsed/refractory (R/R) follicular lymphoma (FL) in an open-label, multicenter phase Ib/II study (BO29562; NCT02631577). An initial 3 + 3 dose‐escalation phase to define the recommended phase II dose of lenalidomide was followed by an expansion phase with G-atezo-len induction and maintenance. At final analysis, 38 patients (lenalidomide 15 mg, n = 4; 20 mg, n = 34) had completed the trial. Complete response rate for the efficacy population (lenalidomide 20 mg, n = 32) at end-of-induction was 71.9% (66.7% in double‐refractory patients [refractory to rituximab and alkylator] [n = 12]; 50.0% in patients with progressive disease within 24 months of first-line therapy [n = 12]). The 36-month progression-free survival rate was 68.4%. All treated patients had ≥1 adverse event (AE; grade 3–5 AE, 32 patients [84%]; serious AE, 18 patients [47%]; AEs leading to discontinuation of any study drug, 11 patients [29%]). There were 2 fatal AEs (1 merkel carcinoma, 1 sarcomatoid carcinoma; both unrelated to any study drug). The G‐atezo-len regimen is effective and tolerable in patients with R/R FL. AEs were consistent with the known safety profile of the individual drugs.
 

摘要翻译： 

我们在一项开放标签、多中心Ib/II期研究（BO29562；NCT02631577）中评估了三联疗法奥滨尤妥珠单抗-阿特珠单抗-来那度胺（G-atezo-len）治疗复发/难治性滤泡性淋巴瘤患者的效果。研究首先通过3+3剂量递增阶段确定来那度胺的II期推荐剂量，随后进入G-atezo-len诱导及维持治疗的扩展阶段。最终分析时，38例患者（来那度胺15 mg组，n=4；20 mg组，n=34）已完成试验。诱导结束时疗效人群（来那度胺20 mg组，n=32）的完全缓解率为71.9%（其中双重难治患者[对利妥昔单抗和烷化剂耐药]为66.7% [n=12]；一线治疗后24个月内疾病进展患者为50.0% [n=12]）。36个月无进展生存率为68.4%。所有接受治疗的患者均出现≥1次不良事件（3-5级不良事件32例[84%]；严重不良事件18例[47%]；导致任何研究药物停用的不良事件11例[29%]）。发生2例致命不良事件（1例默克尔细胞癌，1例肉瘤样癌；均与任何研究药物无关）。G-atezo-len方案在R/R滤泡性淋巴瘤患者中有效且可耐受，其不良事件与各药物的已知安全性特征一致。

原文链接：

Obinutuzumab-atezolizumab-lenalidomide for the treatment of patients with relapsed/refractory follicular lymphoma: final analysis of a Phase Ib/II trial