Odronextamab 是一种 CD20×CD3 双特异性抗体，可利用细胞毒性 T 细胞破坏恶性 B 细胞，已在复发/难治性 (R/R) B 细胞非霍奇金淋巴瘤的多种亚型中表现出令人鼓舞的活性。这项 II 期研究 (ELM- 2；NCT03888105）评估了 odronextamab 在接受 ≥2 线全身治疗后的 R/R 滤泡性淋巴瘤 (FL) 患者中的情况。患者以 21 天为一个周期接受静脉注射 odronextamab，并在第 1 周期中逐步增加剂量，以帮助减轻细胞因子释放综合征 (CRS) 的风险，直至疾病进展或出现不可接受的毒性。主要终点是独立中央审查的客观缓解率 (ORR)。在接受评估的 128 名患者中，95% 完成了第 1 周期，85% 完成了≥4 个周期。 20.1个月疗效随访时，ORR为80.0%，完全缓解率为73.4%。完全缓解的中位持续时间为 25.1 个月。中位无进展生存期为 20.7 个月，中位总生存期尚未达到。 16% 的患者因不良事件 (AE) 停药。最常见的治疗中出现的 AE 是 CRS（56%；≥3 级 1.7% [1/60]，0.7/4/20 mg 递增）、中性粒细胞减少症 (39%) 和发热 (38%)。Odronextamab 达到对于接受过多次治疗的 R/R FL 患者，完全缓解率较高且安全性总体可控。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。

Odronextamab, a CD20×CD3 bispecific antibody that engages cytotoxic T cells to destroy malignant B cells, has demonstrated encouraging activity across multiple subtypes of relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma.This phase II study (ELM-2; NCT03888105) evaluated odronextamab in patients with R/R follicular lymphoma (FL) after ≥2 lines of systemic therapy. Patients received intravenous odronextamab in 21-day cycles, with step-up dosing in Cycle 1 to help mitigate the risk of cytokine release syndrome (CRS), until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) by independent central review.Among 128 patients evaluated, 95% completed Cycle 1, and 85% completed ≥4 cycles. At 20.1 months' efficacy follow-up, ORR was 80.0% and complete response rate was 73.4%. Median duration of complete response was 25.1 months. Median progression-free survival was 20.7 months, and median overall survival was not reached. Discontinuation of odronextamab due to adverse events (AEs) occurred in 16% of patients. The most common treatment-emergent AEs were CRS (56%; grade ≥3 1.7% [1/60] with 0.7/4/20 mg step-up), neutropenia (39%), and pyrexia (38%).Odronextamab achieved high complete response rates with generally manageable safety in patients with heavily pretreated R/R FL.Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.