KEYNOTE-158试验的最新结果
原文发布日期:2025-02-20
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updated results of the KEYNOTE-158 trial
The phase 2 trial KEYNOTE-158 (NCT02628067) evaluated pembrolizumab in microsatellite-instability-high and mismatch-repair-deficient (MSI-H/dMMR) noncolorectal tumors. With 373 participants (95% with baseline MSI/dMMR documentation) and 4.5 years of follow-up, the primary endpoint of overall response rate was 33.8%. Secondary endpoints of duration of response, overall survival and progression-free survival were 63.2, 19.8 and 4.0 months, respectively. Grade ≥3 treatment-related adverse events occurred in 50 (13%) participants. These results further support pembrolizumab use in MSI-H/dMMR tumors.
第二阶段临床试验KEYNOTE-158(NCT02628067)评估了pembrolizumab在微卫星不稳定性高且 mismatch-repair-deficient(MSI-H/dMMR)非结直肠肿瘤中的应用。该研究招募了373名受试者(其中95%为基线阶段具有MSI/dMMR文档支持的参与者),随访时间达4.5年,主要终点“总体应答率”为33.8%。次要终点包括反应持续时间和无进展生存期,分别为63.2个月、19.8个月和4.0个月。至少有3级治疗相关不良事件的受试者占50人(13%),这些结果进一步支持pembrolizumab在MSI-H/dMMR肿瘤中的应用。
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