PURPOSE Patients with advanced endometrial carcinoma have limited treatment options. We report final primary efficacy analysis results for a patient cohort with advanced endometrial carcinoma receiving lenvatinib plus pembrolizumab in an ongoing phase Ib/II study of selected solid tumors. METHODS Patients took lenvatinib 20 mg once daily orally plus pembrolizumab 200 mg intravenously once every 3 weeks, in 3-week cycles. The primary end point was objective response rate (ORR) at 24 weeks (ORRWk24); secondary efficacy end points included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Tumor assessments were evaluated by investigators per immune-related RECIST. RESULTS At data cutoff, 108 patients with previously treated endometrial carcinoma were enrolled, with a median follow-up of 18.7 months. The ORRWk24 was 38.0% (95% CI, 28.8% to 47.8%). Among subgroups, the ORRWk24 (95% CI) was 63.6% (30.8% to 89.1%) in patients with microsatellite instability (MSI)–high tumors (n = 11) and 36.2% (26.5% to 46.7%) in patients with microsatellite-stable tumors (n = 94). For previously treated patients, regardless of tumor MSI status, the median DOR was 21.2 months (95% CI, 7.6 months to not estimable), median PFS was 7.4 months (95% CI, 5.3 to 8.7 months), and median OS was 16.7 months (15.0 months to not estimable). Grade 3 or 4 treatment-related adverse events occurred in 83/124 (66.9%) patients. CONCLUSION Lenvatinib plus pembrolizumab showed promising antitumor activity in patients with advanced endometrial carcinoma who have experienced disease progression after prior systemic therapy, regardless of tumor MSI status. The combination therapy had a manageable toxicity profile.

中文翻译：

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乐伐替尼加派姆单抗治疗晚期子宫内膜癌患者

目的晚期子宫内膜癌患者的治疗选择有限。我们报告了接受乐伐替尼联合帕博利珠单抗的晚期子宫内膜癌患者队列的最终主要疗效分析结果，该队列正在进行对选定实体瘤的 Ib/II 期研究。方法 患者服用乐伐替尼 20 毫克，每天一次口服加派姆单抗 200 毫克静脉注射，每 3 周一次，以 3 周为周期。主要终点是 24 周时的客观缓解率 (ORR) (ORRWk24)；次要疗效终点包括缓解持续时间（DOR）、无进展生存期（PFS）和总生存期（OS）。肿瘤评估由研究人员根据免疫相关 RECIST 进行评估。结果 在数据截止时，纳入了 108 名既往接受过治疗的子宫内膜癌患者，中位随访时间为 18.7 个月。ORRWk24 为 38.0%（95% CI，28.8% 至 47.8%）。在亚组中，微卫星不稳定性 (MSI) 高肿瘤患者 (n = 11) 的 ORRWk24 (95% CI) 为 63.6%（30.8% 至 89.1%），而微卫星不稳定性（MSI）患者为 36.2%（26.5% 至 46.7%） -稳定的肿瘤（n = 94）。对于既往接受过治疗的患者，无论肿瘤 MSI 状态如何，中位 DOR 为 21.2 个月（95% CI，7.6 个月至不可估计），中位 PFS 为 7.4 个月（95% CI，5.3 至 8.7 个月），中位 OS 为 16.7月（15.0 个月到不可估量）。83/124 (66.9%) 患者发生了 3 级或 4 级治疗相关不良事件。结论 Lenvatinib 加 pembrolizumab 在既往全身治疗后疾病进展的晚期子宫内膜癌患者中显示出有希望的抗肿瘤活性，无论肿瘤 MSI 状态如何。