Treatment options are limited for patients with non–clear cell renal cell carcinoma (nccRCC). Patients with nccRCC experienced a favorable objective response rate (ORR) in a phase 2 trial of cabozantinib plus nivolumab. We now report updated efficacy and safety results at median follow-up of 34 mo for patients with papillary, unclassified, or translocation-associated RCC. Cabozantinib and nivolumab were administered at standard doses to patients with metastatic nccRCC that had progressed on zero or one line of systemic therapy. The primary endpoint was the ORR according to Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and adverse events. Forty patients were treated. At median follow-up of 34 mo for survivors, the ORR was 48% (95% confidence interval [CI] 31.5–63.9%). Median PFS was 13 mo (95% CI 7–16); the 12-mo and 24-mo PFS rates were 51% (95% CI 34–65%) and 23% (95% CI 11–37%), respectively. Median OS was 28 mo (95% CI 23–43); the 18-mo and 36-mo OS rates were 70% (95% CI 53–82%) and 44% (95% CI 28–60%), respectively. No new safety signals were seen with cabozantinib and nivolumab. This extended follow-up analysis demonstrates promising efficacy, and highlights the potential for sustained responses with cabozantinib plus nivolumab in patients with metastatic nccRCC.

中文翻译：

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卡博替尼联合纳武利尤单抗治疗非透明细胞肾细胞癌患者：2 期试验的最新结果


非透明细胞肾细胞癌 （nccRCC） 患者的治疗选择有限。在 cabozantinib 联合纳武利尤单抗的 2 期试验中，nccRCC 患者获得了良好的客观缓解率 （ORR）。我们现在报告了中位随访 34 个月时对状、未分类或易位相关 RCC 患者的最新疗效和安全性结果。卡博替尼和纳武利尤单抗以标准剂量给药于接受 0 线或 1 线全身治疗后进展的转移性 nccRCC 患者。主要终点是根据实体瘤反应评估标准 v1.1 的 ORR。次要终点包括无进展生存期 （PFS） 、总生存期 （OS） 和不良事件。40 名患者接受了治疗。在幸存者的中位随访 34 个月时，ORR 为 48% （95% 置信区间 [CI] 31.5-63.9%）。中位 PFS 为 13 个月 （95% CI 7-16）;12 个月和 24 个月 PFS 率分别为 51% （95% CI 34-65%） 和 23% （95% CI 11-37%）。中位 OS 为 28 个月 （95% CI 23-43）;18 个月和 36 个月 OS 率分别为 70% （95% CI 53-82%） 和 44% （95% CI 28-60%）。卡博替尼和纳武利尤单抗未见新的安全性信号。这项扩展的随访分析证明了有希望的疗效，并强调了卡博替尼联合纳武利尤单抗对转移性 nccRCC 患者持续反应的可能性。