Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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%).
CONCLUSIONS: Odronextamab achieved high complete response rates with generally manageable safety in patients with heavily pretreated R/R FL.
METHODS: 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.
RESULTS: 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%).
CONCLUSIONS: Odronextamab achieved high complete response rates with generally manageable safety in patients with heavily pretreated R/R FL.
摘要：
背景：Odronextamab，一种CD20×CD3双特异性抗体，可结合细胞毒性T细胞破坏恶性B细胞，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。
方法：这项II期研究（ELM-2;NCT03888105）评估了≥2行全身治疗后R/R滤泡性淋巴瘤（FL）患者的odronextamab。患者在21天周期内接受静脉注射odronextamab，在第1周期中增加剂量以帮助减轻细胞因子释放综合征（CRS）的风险，直到疾病进展或不可接受的毒性。主要终点是独立中央评估的客观缓解率（ORR）。
结果：在评估的128名患者中，95%完成1个周期，85%完成≥4个周期。在20.1个月的疗效随访时，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，未达到中位总生存期.16％的患者因不良事件（AE）而停用odronextamab。最常见的治疗引起的不良事件是CRS（56％；等级≥31.7％[1/60]，增加0.7/4/20mg），中性粒细胞减少症（39%），和发热（38%）。
结论：Odronextamab在接受严重预处理的R/RFL患者中获得了较高的完全缓解率，安全性通常可控。
方法：这项II期研究（ELM-2;NCT03888105）评估了≥2行全身治疗后R/R滤泡性淋巴瘤（FL）患者的odronextamab。患者在21天周期内接受静脉注射odronextamab，在第1周期中增加剂量以帮助减轻细胞因子释放综合征（CRS）的风险，直到疾病进展或不可接受的毒性。主要终点是独立中央评估的客观缓解率（ORR）。
结果：在评估的128名患者中，95%完成1个周期，85%完成≥4个周期。在20.1个月的疗效随访时，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，未达到中位总生存期.16％的患者因不良事件（AE）而停用odronextamab。最常见的治疗引起的不良事件是CRS（56％；等级≥31.7％[1/60]，增加0.7/4/20mg），中性粒细胞减少症（39%），和发热（38%）。
结论：Odronextamab在接受严重预处理的R/RFL患者中获得了较高的完全缓解率，安全性通常可控。
