Epcoritamab 是一种皮下注射的 CD3xCD20 双特异性抗体，在全球多中心关键 II 期试验 EPCORE NHL- 中，对复发或难治性 (R/R) 弥漫性大 B 细胞淋巴瘤 (DLBCL) 患者显示出深度、持久的反应，且安全性可控。 1.在这里，我们介绍了类似的 EPCORE NHL-3 I/II 期试验的结果，该试验评估了先前接受过两种或多种疗法治疗的 R/R CD20 B 细胞非霍奇金淋巴瘤日本患者的 epcoritamab 单药疗法。 Epcoritamab 以 28 天为一个周期皮下注射；在第 1-3 个周期中每周一次，在第 4-9 个周期中每 2 周一次，从第 10 个周期每 4 周一次，直到疾病进展或出现不可接受的毒性。在第 1 个治疗周期中，采用了逐步给药和细胞因子释放综合征 (CRS) 预防措施。截至 2022 年 1 月 31 日，36 名患者接受了 48 mg epcoritamab 单药治疗。中位随访时间为 8.4 个月，独立审查委员会的总体缓解率和完全缓解率分别为 55.6% 和 44.4%。在数据截止时尚未达到中位缓解持续时间、完全缓解持续时间和总生存期。最常见的任何级别的治疗中出现的不良事件是 CRS（83.3%）、注射部位反应（69.4%）、感染（44.4%）、中性粒细胞减少（38.9%）、低钾血症（27.8%）和淋巴细胞计数减少（ 25.0%）。细胞因子释放综合征的发生是可以预测的；事件主要是低级别（1-2 级），全部得到解决，并且没有导致治疗停止。这些令人鼓舞的结果与之前的发现一致，并支持正在进行的 epcoritamab 治疗 R/R DLBCL 的临床评估，包括早期治疗线。© 2023 作者。约翰·威利出版的《癌症科学》

Epcoritamab is a subcutaneously administered CD3xCD20 bispecific Ab that showed deep, durable responses with a manageable safety profile in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in the global multicenter pivotal phase II trial EPCORE NHL-1. Here, we present results from the similar EPCORE NHL-3 phase I/II trial evaluating epcoritamab monotherapy in Japanese patients with R/R CD20+ B-cell non-Hodgkin's lymphoma previously treated with two or more lines of therapy. Epcoritamab was dosed subcutaneously in 28-day cycles; once weekly during cycles 1-3, every 2 weeks during cycles 4-9, and every 4 weeks from cycle 10 until disease progression or unacceptable toxicity. Step-up dosing and cytokine release syndrome (CRS) prophylaxis were used during treatment cycle 1. As of January 31, 2022, 36 patients received treatment with 48 mg epcoritamab monotherapy. At a median follow-up of 8.4 months, overall response and complete response rates by independent review committee were 55.6% and 44.4%, respectively. The median duration of response, duration of complete response, and overall survival were not reached at the time of data cut-off. The most common treatment-emergent adverse events of any grade were CRS (83.3%), injection-site reactions (69.4%), infections (44.4%), neutropenia (38.9%), hypokalemia (27.8%), and decreased lymphocyte count (25.0%). Cytokine release syndrome occurrence was predictable; events were primarily low grade (grade 1-2), all resolved, and none led to treatment discontinuation. These encouraging results are consistent with previous findings and support the ongoing clinical evaluation of epcoritamab for the treatment of R/R DLBCL, including in earlier treatment lines.© 2023 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.