虽然免疫检查点抑制剂 (ICIs) 通常对复发性弥漫性大 B 细胞淋巴瘤 (DLBCL) 无效，但对于未经治疗的免疫功能正常的患者可能有更大的希望。我们之前报道了派姆单抗联合利妥昔单抗、环磷酰胺、阿霉素、长春新碱和泼尼松 (PR-CHOP) 在未经治疗的 DLBCL 的 I 期试验中的安全性和早期疗效，注意到 90% 的患者有缓解（完全缓解 77%），2年无进展生存率 (PFS) 为 83%。我们在此报告了 5 年随访的长期安全性和有效性。未经治疗的 DLBCL 或 3b 级滤泡性淋巴瘤、打算接受 6 个周期的 R-CHOP 的成年患者符合资格。患者 (N = 30) 以 21 天为一个周期接受派姆单抗 200 mg IV 和 R-CHOP 治疗，共 6 个周期。中位随访时间为 4.8 年，5 年 PFS 为 71%（CI，54%-94%） 5 年总生存率为 83%（CI，71%-98%）。 7 名 (23%) 患者发生了免疫相关不良事件 (IRAE)（10% 为 3/4 级）。三种 IRAE（皮疹、甲状腺炎、类风湿性关节炎）在治疗完成 3 个月后发生。 23 名测试患者中有 19 名 (83%) 记录了 PD-L1 肿瘤表达。 19 名有任何 PD-L1 表达的患者均未复发，而 4 名无 PD-L1 表达的患者中有 2 名复发。PR-CHOP 在大多数患者中产生了持久的缓解，其中 PD-L1 治疗的效果最好。 L1表达疾病。此外，安全状况是可控的，没有一致的后期事件模式。这些数据支持将 ICI 纳入一线 DLBCL 治疗中的持续策略，以及包括肿瘤 PD-L1 表达在内的预测生物标志物的确认。版权所有 © 2023 Elsevier Inc. 保留所有权利。

While generally ineffective in relapsed diffuse large B cell lymphoma (DLBCL), immune checkpoint inhibitors (ICIs) may hold greater promise in untreated, immunocompetent patients. We previously reported safety and early efficacy of pembrolizumab plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (PR-CHOP) in a phase I trial of untreated DLBCL, noting responses in 90% of patients (complete response 77%) and a 2-year progression-free survival (PFS) of 83%. We herein report long-term safety and efficacy at 5-year follow up.Adult patients with untreated DLBCL or grade 3b follicular lymphoma, intended to receive 6 cycles of R-CHOP were eligible. Patients (N = 30) were treated with pembrolizumab 200 mg IV and R-CHOP in 21-day cycles for 6 cycles.At median follow up of 4.8 years, 5-year PFS was 71% (CI, 54%-94%) and 5-year overall survival was 83% (CI, 71%-98%). Immune-related adverse events (IRAEs) occurred in 7 (23%) patients (10% grade 3/4). Three IRAEs (rash, thyroiditis, rheumatoid arthritis) occurred beyond 3 months of treatment completion. PD-L1 tumor expression was documented in 19 of 23 (83%) tested patients. None of the 19 patients who had any PD-L1 expression have relapsed, whereas 2 out of the 4 patients with no PD-L1 expression have relapsed.PR-CHOP has led to durable responses in most patients, with the best outcomes in PD-L1-expressing disease. Furthermore, the safety profile was manageable, with no consistent pattern of late events. These data support ongoing strategies incorporating ICIs in frontline DLBCL therapy and confirmation of predictive biomarkers including tumor PD-L1 expression.Copyright © 2023 Elsevier Inc. All rights reserved.