Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4).
Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4).
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DOI：
10.1038/s41392-021-00768-0
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发表时间：
2021-10-27
影响因子：
39.3
通讯作者：
Li J
中科院分区：
文献类型：
--
作者：
Tao R;Fan L;Song Y;Hu Y;Zhang W;Wang Y;Xu W;Li J
本研究 (ORIENT-4) 旨在评估信迪利单抗（一种人源化抗 PD-1 抗体）对复发/难治性结外 NK/T 细胞淋巴瘤 (r/r ENKTL) 患者的疗效和安全性。 ORIENT-4 是一项多中心、单臂、2 期临床试验 (NCT03228836)。至少一种基于天冬酰胺酶的治疗方案失败的 r/r ENKTL 患者被纳入每 3 周静脉注射 200mg 的信迪利单抗治疗，持续长达 24 个月。主要终点是基于卢加诺 2014 年标准的客观缓解率 (ORR)。 2017年8月31日至2018年2月7日期间入组了28名r/r ENKTL患者。21名患者（75.0%，95% CI：55.1-89.3%）获得了客观缓解。中位随访时间为 30.4 个月，但尚未达到中位总生存期 (OS)。 24 个月 OS 率为 78.6%（95% CI，58.4–89.8%）。大多数治疗相关不良事件 (TRAE) 为 1-2 级 (71.4%)，最常见的 TRAE 是淋巴细胞计数减少 (42.9%)。 7 名患者（25.0%）发生严重不良事件（SAE），无患者因不良事件死亡。信迪利单抗对 r/r ENKTL 患者有效且耐受性良好，可能成为控制患者 ENKTL 的新治疗方法。
This study (ORIENT-4) aimed to assess the efficacy and safety of sintilimab, a humanized anti-PD-1 antibody, in patients with relapsed/refractory extranodal NK/T cell lymphoma (r/r ENKTL). ORIENT-4 is a multicenter, single-arm, phase 2 clinical trial (NCT03228836). Patients with r/r ENKTL who failed to at least one asparaginase-based regimen were enrolled to receive sintilimab 200 mg intravenously every 3 weeks for up to 24 months. The primary endpoint was the objective response rate (ORR) based on Lugano 2014 criteria. Twenty-eight patients with r/r ENKTL were enrolled from August 31, 2017 to February 7, 2018. Twenty-one patients (75.0%, 95% CI: 55.1–89.3%) achieved an objective response. With a median follow-up of 30.4 months, the median overall survival (OS) was not reached. The 24-month OS rate was 78.6% (95% CI, 58.4–89.8%). Most treatment-related adverse events (TRAEs) were grade 1–2 (71.4%), and the most common TRAE was decreased lymphocyte count (42.9%). Serious adverse events (SAEs) occurred in 7 (25.0%) patients, and no patient died of adverse events. Sintilimab is effective and well tolerated in patients with r/r ENKTL and could be a novel therapeutic approach for the control of ENKTL in patients.
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