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Obinutuzumab-atezolizumab-lenalidomide for the treatment of patients with relapsed/refractory follicular lymphoma: final analysis of a Phase Ib/II trial
Blood Cancer Journal ( IF 12.9 ) Pub Date : 2021-08-20 , DOI: 10.1038/s41408-021-00539-8
Franck Morschhauser 1 , Nilanjan Ghosh 2 , Izidore S Lossos 3 , M Lia Palomba 4 , Amitkumar Mehta 5 , Olivier Casasnovas 6 , Don Stevens 7 , Sudhakar Katakam 8 , Andrea Knapp 8 , Tina Nielsen 8 , Ron McCord 9 , Gilles Salles 10
Affiliation  

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.



中文翻译:

Obinutuzumab-atezolizumab-lenalidomide 用于治疗复发/难治性滤泡性淋巴瘤患者:Ib/II 期试验的最终分析

我们在一项开放标签、多中心 Ib/II 期研究 (BO29562; NCT02631577) 中评估了三联方案 obinutuzumab-atezolizumab-lenalidomide (G-atezo-len) 对复发/难治性 (R/R) 滤泡性淋巴瘤 (FL) 患者的疗效. 最初的 3 + 3 剂量递增阶段以确定推荐的 II 期来那度胺剂量,然后是 G-atezo-len 诱导和维持的扩展阶段。在最终分析中,38 名患者(来那度胺 15 mg,n  = 4;20 mg,n  = 34)完成了试验。在诱导结束时,疗效人群(来那度胺 20 mg,n  = 32)的完全缓解率为 71.9%(双难治患者 [利妥昔单抗和烷化剂难治] [ n ] 为 66.7% = 12]; 50.0% 在一线治疗后 24 个月内出现疾病进展的患者 [ n  = 12])。36个月无进展生存率为68.4%。所有接受治疗的患者都有 ≥1 次不良事件(AE;3-5 级 AE,32 名患者 [84%];严重 AE,18 名患者 [47%];导致停用任何研究药物的 AE,11 名患者 [29%]) . 有 2 例致命 AE(1 例 merkel 癌、1 例肉瘤样癌;均与任何研究药物无关)。G-atezo-len 方案对 R/R FL 患者有效且可耐受。AE 与单个药物的已知安全性特征一致。

更新日期:2021-08-20
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