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2期LYSA研究

原文发布日期：2025-04-03

英文摘要：

摘要翻译：

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2期LYSA研究

a phase 2 LYSA study

原文发布日期：2025-04-03

英文摘要：

Persons with diffuse large B cell lymphoma (DLBCL) refractory or in first progression/relapsed (R/R) after chimeric antigen receptor T (CAR-T) cell therapy exhibit dramatic outcomes. We enrolled such persons in a phase 2 single-arm, nonblinded trial (NCT04703686) to evaluate the efficacy and safety of glofitamab, a CD20–CD3 T cell-engaging bispecific antibody, using a short ramp-up regimen to reach full dose within 1 week. A total of 46 participants received at least one glofitamab infusion following obinutuzumab (anti-CD20 monoclonal antibody) pretreatment. The primary endpoint was overall survival (OS). Secondary endpoints included independent-assessed best overall metabolic response rate (OMRR) and complete metabolic response rate (CMRR), progression-free survival (PFS), duration of response, safety and tolerability and health-related quality of life. After a median follow-up of 15.3 months (95% confidence interval (CI), 10.1–17.7), the primary endpoint was met, achieving a median OS of 14.7 months (90% CI, 8.8–not reached). The best OMRR was 76.1%. The best CMRR was 45.7%. The median PFS was 3.8 months (95% CI, 2.4–19.6). Despite the shortened setup dosing, no excess cytokine release syndrome or neurotoxicity events were observed (grade ≥ 3, 0% for both). In conclusion, glofitamab improved OS in participants with R/R DLBCL after CAR-T cell therapy, with a favorable safety profile.

摘要翻译：

接受单抗治疗（anti-CD20单克隆抗体）后复发或初次进展（R/R）的扩散型大B细胞淋巴瘤（DLBCL）患者展现出戏剧性的临床效果。我们招募了此类患者参加一项II期、单臂、非盲试验（NCT04703686），旨在评估CD20-CD3 T细胞结合型双特异性抗体glofitamab的疗效及安全性，采用缩短至一周即可达到完全给药剂量的“快步推进”给药方案。共46名受试者在瑞波坦（obinutuzumab）抗CD20单克隆抗体治疗后至少接受过一次glofitamab输注。主要终点为总生存期（OS）。次要终点包括独立评估的最佳总体代谢反应率（OMRR）、完全代谢反应率（CMRR）、无进展生存期（PFS）、反应持续时间、安全性和耐受性以及与健康相关的Quality of Life（QOL）。在15.3个月的中位随访期间（95%置信区间，10.1-17.7），主要终点已达到预期，总生存期的中位值为14.7个月（90% CI，8.8-未达到）。最佳OMRR达76.1%，CMRR为45.7%。无进展生存期的中位值为3.8个月（95% CI，2.4-19.6）。尽管缩短了给药剂量，但未观察到过量放血症或神经毒性的相关事件（≥3级事件率均为0%）。研究结论表明，在CAR-T细胞治疗后接受glofitamab治疗的R/R DLBCL患者中，总生存期得到了改善，且其安全性和耐受性表现良好。