The combination of the anti-PD-1 antibody nivolumab plus the anti-CTLA4 antibody ipilimumab showed promising efficacy outcomes as first-line therapy in 45 patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) as part of the single-arm, phase II CheckMate 142 trial. Now, data from the phase III CheckMate 8HW trial confirm the efficacy of this combination in this setting.

A total of 303 patients who had not received systemic therapy for unresectable or metastatic dMMR/MSI-H CRC were randomly assigned (2:1) to receive either ipilimumab plus nivolumab or investigator’s choice of chemotherapy, with or without targeted therapy. Patients were also randomly assigned to a nivolumab monotherapy arm, although data from this arm were not reported at this cutoff. Progression-free survival (PFS) in those with centrally confirmed dMMR/MSI-H status (255 patients) was the primary end point.

作为单臂 II 期 CheckMate 142 试验的一部分，抗 PD-1 抗体纳武利尤单抗联合抗 CTLA4 抗体 ipilimumab 作为 45 例错配修复缺陷 （dMMR） 或微卫星不稳定性高 （MSI-H） 结直肠癌 （CRC） 患者的一线治疗显示出有希望的疗效结果。现在，来自 III 期 CheckMate 8HW 试验的数据证实了这种组合在这种情况下的疗效。

共有 303 例未接受不可切除或转移性 dMMR/MSI-H CRC 全身治疗的患者被随机分配 （2：1） 接受 ipilimumab 联合纳武利尤单抗或研究者选择的化疗，联合或不联合靶向治疗。患者也被随机分配到纳武利尤单抗单药治疗组，尽管在此临界值时未报告该组的数据。集中确诊 dMMR/MSI-H 状态的患者 （255 例患者） 的无进展生存期 （PFS） 是主要终点。