Marabelle Aurelien, O'Malley David M, Hendifar Andrew E, Ascierto Paolo A, Motola-Kuba Daniel, Penel Nicolas, Cassier Philippe A, Bariani Giovanni, De Jesus-Acosta Ana, Doi Toshihiko, Longo Federico, Miller Wilson H, Oh Do-Youn, Gottfried Maya, Yao Lili, Jin Fan, Gozman Alexander, Maio Michele
Gustave Roussy, Institut National de la Santé et de la Recherche Médicale U1015 & CIC1428, Universite Paris Saclay, Villejuif, France.
The Ohio State University Wexner Medical Center, Columbus, OH, USA.
Nat Cancer. 2025 Feb;6(2):253-258. doi: 10.1038/s43018-024-00894-y. Epub 2025 Feb 20.
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.
2期KEYNOTE-158试验（NCT02628067）评估了帕博利珠单抗在微卫星高度不稳定和错配修复缺陷（MSI-H/dMMR）非结直肠癌肿瘤中的疗效。该试验有373名参与者（95%有基线MSI/dMMR记录），随访4.5年，主要终点总缓解率为33.8%。次要终点缓解持续时间、总生存期和无进展生存期分别为63.2个月、19.8个月和4.0个月。50名（13%）参与者发生了≥3级治疗相关不良事件。这些结果进一步支持帕博利珠单抗在MSI-H/dMMR肿瘤中的应用。
