Abstract：
We report efficacy, safety and biomarker data from a phase-II study evaluating atezolizumab (eight 21-day cycle as induction therapy) in combination with obinutuzumab in patients with relapsed/refractory mantle cell lymphoma (MCL, n = 30) or Waldenström\'s macroglobulinemia (WM, n = 4), and in combination with rituximab in patients with marginal zone lymphoma (MZL, n = 21). All patients received atezolizumab monotherapy as maintenance for ≤10 cycles. Objective response rates at end of induction were 16.7% (MCL) and 42.9% (MZL), with no responses in WM. Median duration of response was 6.8 months (range 5.7-not estimable) for MCL and not reached for MZL. Treatment-emergent adverse events (TEAEs) occurred in 93.3%, 95.2% and 100% of MCL, MZL and WM patients, respectively. One fatal TEAE (pneumonia) occurred in each of the MCL and MZL groups. Biomarker analysis highlighted the importance of characterizing the immune environment to optimize efficacy of immunotherapy regimens.Trial registration details: EudraCT: 2016-003579-22.
摘要：
我们报告疗效，来自II期研究的安全性和生物标志物数据，该研究评估了阿特珠单抗（八个21天周期作为诱导治疗）与奥比努珠单抗联合治疗复发性/难治性套细胞淋巴瘤（MCL，n=30)或Waldenström巨球蛋白血症(WM，n=4),并联合利妥昔单抗治疗边缘区淋巴瘤患者（MZL，n=21)。所有患者均接受阿特珠单抗单药治疗，维持治疗≤10个周期。诱导结束时的客观应答率分别为16.7%(MCL)和42.9%(MZL),在WM中没有回应。MCL的中位反应持续时间为6.8个月(范围5.7-不可估计)，MZL未达到。治疗引起的不良事件（TEAE）发生率为93.3％，MCL的95.2％和100％，MZL和WM患者，分别。在MCL和MZL组中的每一个中发生了一个致命的TEAE(肺炎)。生物标志物分析强调了表征免疫环境对优化免疫疗法疗效的重要性。试用注册详细信息：EudraCT：2016-003579-22。
