Primary results (median follow-up, 10.7 months) from the pivotal EPCORE^® NHL-1 study in relapsed or refractory (R/R) large B-cell lymphoma (LBCL) demonstrated deep, durable responses with epcoritamab, a CD3xCD20 bispecific antibody, when used as monotherapy. We report long-term efficacy and safety results in patients with LBCL (N = 157; 25.1-month median follow-up). As of April 21, 2023, overall response rate was 63.1% and complete response (CR) rate was 40.1%. Estimated 24-month progression-free survival (PFS) and overall survival (OS) rates were 27.8% and 44.6%, respectively. An estimated 64.2% of complete responders remained in CR at 24 months. Estimated 24-month PFS and OS rates among complete responders were 65.1% and 78.2%, respectively. Of 119 minimal residual disease (MRD)-evaluable patients, 45.4% had MRD negativity, which correlated with longer PFS and OS. CR rates were generally consistent across predefined subgroups: 36% prior chimeric antigen receptor (CAR) T-cell therapy, 32% primary refractory disease, and 37% International Prognostic Index ≥3. The most common treatment-emergent adverse events were cytokine release syndrome (51.0%), pyrexia (24.8%), fatigue (24.2%), and neutropenia (23.6%). These results underscore the long-term benefit of epcoritamab for treating R/R LBCL with deep responses across subgroups, including patients with hard-to-treat disease and expected poor prognosis (ClinicalTrials.gov Registration: NCT03625037).

针对复发或难治性 (R/R) 大 B 细胞淋巴瘤 (LBCL) 的关键 EPCORE ^® NHL-1 研究的主要结果（中位随访时间为 10.7 个月）表明，epcoritab（一种 CD3xCD20 双特异性抗体）可产生深度、持久的反应，当用作单一疗法时。我们报告了 LBCL 患者的长期疗效和安全性结果（ N = 157；中位随访时间为 25.1 个月）。截至2023年4月21日，总体缓解率为63.1%，完全缓解（CR）率为40.1%。预计 24 个月无进展生存率 (PFS) 和总生存率 (OS) 分别为 27.8% 和 44.6%。估计 64.2% 的完全缓解者在 24 个月时仍处于 CR 状态。完全缓解者的估计 24 个月 PFS 和 OS 率分别为 65.1% 和 78.2%。在 119 名可评估微小残留病 (MRD) 的患者中，45.4% 的 MRD 呈阴性，这与更长的 PFS 和 OS 相关。 CR 率在预定义的亚组中基本一致：既往嵌合抗原受体 (CAR) T 细胞治疗率为 36%，原发性难治性疾病率为 32%，国际预后指数≥3 为 37%。最常见的治疗引起的不良事件是细胞因子释放综合征（51.0%）、发热（24.8%）、疲劳（24.2%）和中性粒细胞减少症（23.6%）。这些结果强调了 epcoritamab 治疗 R/R LBCL 的长期益处，并在各个亚组中产生深度反应，包括患有难以治疗的疾病和预期不良预后的患者（ClinicalTrials.gov 注册号：NCT03625037）。