在全球 3 期研究 309/KEYNOTE-775 (NCT03517449) 的第一次中期分析中，与医生选择的治疗相比，仑伐替尼派姆单抗显着改善无进展生存期 (PFS)、总生存期 (OS) 和客观缓解率 (ORR)既往接受过治疗的晚期/复发性子宫内膜癌（EC）患者的化疗（TPC）。这项探索性分析评估了在预先指定的最终分析时在东亚入组的患者的结果。≥18 岁的女性，经组织学证实患有晚期、复发或转移性 EC，在 1 次铂类化疗后疾病进展（2 次，如果 1 次给予新辅助/辅助设置）被登记。患者按 1:1 的比例随机分配至乐伐替尼 20 mg 每日口服一次，加派姆单抗 200 mg 每 3 周静脉注射一次（≤ 35 个周期）或 TPC（阿霉素或紫杉醇）。主要终点是根据 RECIST v1.1 通过盲法独立中央审查得出的 PFS 和 OS。该亚组分析未分配 alpha。 在 155 名东亚患者中（lenvatinib pembrolizumab，n=77；TPC，n=78），中位随访时间（数据截止日期：2022 年 3 月 1 日）为 34.3（范围，25.1- 43.0) 个月。在错配修复熟练 (pMMR) 人群和所有人群中，PFS（乐伐替尼派姆单抗与 TPC）的风险比 (HR) 和 95% 置信区间 (CI) 分别为 0.74 (0.49-1.10) 和 0.64 (0.44-0.94) 。 OS 的 HR (95% CI) 分别为 0.68 (0.45-1.02) 和 0.61 (0.41-0.90)。 lenvatinib pembrolizumab 的 ORR 为 36%，TPC (pMMR) 的 ORR 为 22%，分别为 39% 和 21%（所有参与者）。与治疗相关的不良事件发生率分别为 97% 和 96%（3-5 级、74% 和 72%）。与 TPC 相比，Lenvatinib pembrolizumab 提供了具有临床意义的益处和可控的安全性，支持其在既往接受过治疗的东亚患者中的使用高级/复发 EC.ClinicalTrials.gov 标识符：NCT03517449.© 2024。亚洲妇科肿瘤学会、韩国妇科肿瘤学会和日本妇科肿瘤学会。

In the global phase 3 Study 309/KEYNOTE-775 (NCT03517449) at the first interim analysis, lenvatinib+pembrolizumab significantly improved progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) versus treatment of physician's choice chemotherapy (TPC) in patients with previously treated advanced/recurrent endometrial cancer (EC). This exploratory analysis evaluated outcomes in patients enrolled in East Asia at the time of prespecified final analysis.Women ≥18 years with histologically confirmed advanced, recurrent, or metastatic EC with progressive disease after 1 platinum-based chemotherapy (2 if 1 given in neoadjuvant/adjuvant setting) were enrolled. Patients were randomized 1:1 to lenvatinib 20 mg orally once daily plus pembrolizumab 200mg intravenously every 3 weeks (≤35 cycles) or TPC (doxorubicin or paclitaxel). Primary endpoints were PFS per RECIST v1.1 by blinded independent central review and OS. No alpha was assigned for this subgroup analysis.Among 155 East Asian patients (lenvatinib+pembrolizumab, n=77; TPC, n=78), median follow-up time (data cutoff: March 1, 2022) was 34.3 (range, 25.1-43.0) months. Hazard ratios (HRs) with 95% confidence intervals (CIs) for PFS (lenvatinib+pembrolizumab versus TPC) were 0.74 (0.49-1.10) and 0.64 (0.44-0.94) in the mismatch repair proficient (pMMR) and all-comer populations, respectively. HRs (95% CI) for OS were 0.68 (0.45-1.02) and 0.61 (0.41-0.90), respectively. ORRs were 36% with lenvatinib+pembrolizumab and 22% with TPC (pMMR) and 39% and 21%, respectively (all-comers). Treatment-related adverse events occurred in 97% and 96% (grade 3-5, 74% and 72%), respectively.Lenvatinib+pembrolizumab provided clinically meaningful benefit with manageable safety compared with TPC, supporting its use in East Asian patients with previously treated advanced/recurrent EC.ClinicalTrials.gov Identifier: NCT03517449.© 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.