Introduction Lenvatinib (dosing for patients who weigh ≥60 kg was 12 mg/day; for patients who weigh <60 kg, the dose was 8 mg/day) plus pembrolizumab 200 mg once every 3 weeks demonstrated antitumor activity and a manageable safety profile in patients with first-line unresectable hepatocellular carcinoma (uHCC) in the open-label phase 1b Study 116/KEYNOTE-524 (primary analysis data cutoff date: October 31, 2019; median follow-up: 10.6 months). This analysis (updated data cutoff date: March 31, 2021) reports efficacy results from 17 months of additional follow-up time. Methods 100 patients with uHCC were included in the primary analysis (median follow-up: 27.6 months). Endpoints included overall survival (OS), investigator-assessed progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR) per modified RECIST. Landmark analyses of OS by the best response at 3 and 9 months were performed. Pembrolizumab antidrug antibodies (ADAs) and concentrations were also measured (cutoff date: August 7, 2020). Results ORR was 43.0% (95% CI 33.1-53.3%) and median DOR was 17.1 months (95% CI 6.9-19.3 months). Median PFS and OS were 9.3 months (95% CI 7.4-9.8 months) and 20.4 months (95% CI 14.4-25.9 months), respectively. No treatment-emergent ADAs were detected. Conclusion Results show a sustained treatment effect with lenvatinib plus pembrolizumab in patients with uHCC in the first-line setting.

中文翻译：

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乐伐替尼加派姆单抗治疗不可切除肝细胞癌患者的 1b 期研究：研究 116 的扩展分析。


乐伐替尼（对于体重≥60公斤的患者，剂量为12毫克/天；对于体重<60公斤的患者，剂量为8毫克/天）加派姆单抗200毫克，每3周一次，显示出抗肿瘤活性和可控的安全性。开放标签 1b 期研究 116/KEYNOTE-524 中的一线不可切除肝细胞癌 (uHCC) 患者（主要分析数据截止日期：2019 年 10 月 31 日；中位随访时间：10.6 个月）。该分析（更新数据截止日期：2021 年 3 月 31 日）报告了 17 个月额外随访时间的疗效结果。方法 主要分析纳入 100 名 uHCC 患者（中位随访时间：27.6 个月）。终点包括总生存期 (OS)、研究者评估的无进展生存期 (PFS)、客观缓解率 (ORR) 和根据修改后的 RECIST 的缓解持续时间 (DOR)。根据 3 个月和 9 个月时的最佳反应对 OS 进行了标志性分析。还测量了 Pembrolizumab 抗药抗体 (ADA) 和浓度（截止日期：2020 年 8 月 7 日）。结果 ORR 为 43.0%（95% CI 33.1-53.3%），中位 DOR 为 17.1 个月（95% CI 6.9-19.3 个月）。中位 PFS 和 OS 分别为 9.3 个月（95% CI 7.4-9.8 个月）和 20.4 个月（95% CI 14.4-25.9 个月）。未检测到治疗引起的 ADA。结论 结果显示乐伐替尼联合派姆单抗对一线治疗 uHCC 患者具有持续治疗效果。