In the randomized, open-label, phase 3 CheckMate 214 trial, nivolumab plus ipilimumab (nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 wk for four doses, then nivolumab 3 mg/kg every 2 wk) had superior efficacy over sunitinib (50 mg once daily, 4 wk on, 2 wk off) in patients with untreated International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate- or poor-risk advanced renal cell carcinoma; the benefits were sustained through extended follow-up. To better characterize the association between outcomes and IMDC risk in CheckMate 214, we completed a post hoc analysis (n = 1051) of efficacy by the number of IMDC risk factors. The investigator-assessed objective response rate (ORR), overall survival (OS), and investigator-assessed progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors v1.1 were evaluated. ORR with nivolumab plus ipilimumab was consistent across zero to six IMDC risk factors, whereas with sunitinib it decreased with increasing number of risk factors. Benefits of nivolumab plus ipilimumab over sunitinib in terms of ORR (40–44% vs 16–38%), OS (hazard ratio [HR] 0.50–0.72), and PFS (HR 0.44–0.86) were consistently observed in subgroups with one, two, three, or four to six IMDC risk factors (p < 0.05 for treatment × no. of risk factors interaction). These results demonstrate the benefit of first-line nivolumab plus ipilimumab over sunitinib across all intermediate-risk and poor-risk groups, regardless of the number of IMDC risk factors.

Patient summary

This report from the CheckMate 214 study describes a consistent efficacy benefit with first-line nivolumab plus ipilimumab over first-line sunitinib in all groups of patients with intermediate-risk or poor-risk advanced renal cell carcinoma, regardless of the number of risk factors they had before starting treatment. We conclude that there is a benefit of first-line treatment with nivolumab plus ipilimumab for all intermediate-risk patients, including those with one or two risk factors, and for all poor-risk patients, independent of the number of risk factors.

中文翻译：

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根据CheckMate 214中IMDC危险因素的数量，Nivolumab和Ipilimumab的疗效。

在随机的，开放标签的3期CheckMate 214试验中，尼古鲁单抗加依普利单抗（尼沃单抗3 mg / kg加伊美单抗1 mg / kg每3周每4周一次，然后尼古鲁单抗3 mg / kg每2周一次）优于未治疗的国际转移性肾细胞癌数据库联合会（IMDC）中危或低危晚期肾细胞癌患者中的舒尼替尼（50 mg每天一次，每周4 w​​k，每周2 wk）；这些好处是通过延长随访来维持的。为了更好地表征CheckMate 214中结局与IMDC风险之间的关联，我们完成了事后分析（n IMDC危险因素的数量= 1051）。根据实体瘤反应评估标准v1.1对研究者评估的客观缓解率（ORR），总生存期（OS）和研究者评估的无进展生存期（PFS）进行了评估。在零到六个IMDC危险因素中，与nivolumab联合ipilimumab的ORR一致，而舒尼替尼的ORR随着危险因素数目的增加而降低。在具有一组的亚组中，一致观察到尼古鲁单抗联合依匹莫单抗相对舒尼替尼的ORR（40–44％vs 16–38％），OS（危险比[HR] 0.50–0.72）和PFS（HR 0.44–0.86）的益处。 ，2、3或4到6个IMDC危险因素（p <0.05治疗×否 风险因素的相互作用）。这些结果证明，在所有中等风险和低风险组中，一线尼古拉单抗联合依匹莫单抗相对于舒尼替尼的益处，无论IMDC危险因素的数量如何。

病人总结

CheckMate 214研究的这份报告描述了在所有中危或低危晚期肾细胞癌患者中，与一线舒尼替尼相比，一线nivolumab联合ipilimumab的疗效始终如一在开始治疗之前。我们得出结论，对于所有中等风险患者（包括具有一个或两个危险因素的患者）以及所有低风险患者，使用尼古鲁单抗联合依匹莫单抗进行一线治疗是有益的，而与危险因素的数量无关。