文章目录

ELM-2期临床试验的主要疗效和安全性分析

原文发布日期：2025-03-17

英文摘要：

摘要翻译：

这项第二阶段、多 cohort、持续进行的ELM-2研究评估了针对难治性（难疗性，R/R）B细胞非霍奇金淋巴瘤患者使用奥尼克西塔单抗（odronextamab，一种CD20×CD3双特异性抗体），在经历≥2线治疗后。当前报告的主要分析是DLBCL cohort的分析。受试者在达到疾病进展或不耐受毒性时接受静脉注射奥尼克西塔单抗，在第1剂次剂量递增以减少细胞释放综合征（CRS）风险，给药周期为21天。主要终点为客观应答率（ORR）。次要终点包括完全应答率（CR）、应答持续时间、无进展生存期（PFS）和总生存期（OS）。共招募了127名受试者。在29.9个月的疗效随访时，ORR为52.0%，CR率为31.5%。ORR和CR的中位持续时间为10.2和17.9个月。4-cycle day 15处不可及的极低残留病灶与PFS获益相关联。在剂量递增为0.7至4至20 mg（n=60）时，CRS是治疗过程中最常见的不良事件（占53.3%，≥3级1.7%）。没有报告免疫效果细胞相关的神经毒副作用综合征。在82/127（64.6%）受试者中感染被报告（≥3级38.6%；其中新冠病毒2019（COVID-19），18.1%，≥3级，12.6%）。结论：奥尼克西塔单抗在经重治疗的难治性DLBCL患者中的疗效有前途，并且与支持治疗一起使用的安全性能良好。临床试验注册号：NCT03888105。

原文链接：

文章：

ELM-2期临床试验的主要疗效和安全性分析

primary efficacy and safety analysis in phase 2 ELM-2 trial

原文发布日期：2025-03-17

英文摘要：

The phase 2, multicohort, ongoing ELM-2 study evaluates odronextamab, a CD20×CD3 bispecific antibody, in patients with relapsed/refractory (R/R) B cell non-Hodgkin lymphoma after ≥2 lines of therapy. Here primary analysis of the diffuse large B cell lymphoma (DLBCL) cohort is reported. Patients received intravenous odronextamab in 21-day cycles until progression or unacceptable toxicity, with cycle 1 step-up dosing to mitigate cytokine release syndrome (CRS) risk. The primary endpoint was objective response rate (ORR). Secondary endpoints included complete response (CR) rate, duration of response, progression-free survival (PFS) and overall survival. A total of 127 patients were enrolled. At the 29.9-month efficacy follow-up, the ORR was 52.0% and CR rate was 31.5%. Median durations of response and CR were 10.2 and 17.9 months, respectively. Undetectable minimal residual disease at cycle 4 day 15 was associated with PFS benefit. With a step-up of 0.7 to 4 to 20 mg (n = 60), CRS was the most common treatment-emergent adverse event (53.3% (grade ≥3, 1.7%)). No immune effector cell-associated neurotoxicity syndrome was reported. Infections were reported in 82/127 (64.6%) patients (grade ≥3, 38.6%; coronavirus disease 2019, 18.1% (grade ≥3, 12.6%)). In conclusion, odronextamab showed encouraging efficacy in heavily pretreated R/R DLBCL and generally manageable safety with supportive care. Clinical trial registration: NCT03888105.