POD1UM-203, an open-label, multicenter, phase II study, evaluated retifanlimab, a humanized monoclonal antibody targeting programmed cell death protein-1 (PD-1) in patients with selected solid tumors where immune checkpoint inhibitor therapies have previously shown efficacy. Eligible patients (≥18 years) had measurable disease and included unresectable or metastatic melanoma, treatment-naive metastatic non-small-cell lung cancer (NSCLC) with high programmed death-ligand 1 (PD-L1) expression (tumor proportion score ≥50%), cisplatin-ineligible locally advanced/metastatic urothelial carcinoma (UC) with PD-L1 expression (combined positive score ≥10%), or treatment-naive locally advanced/metastatic clear-cell renal cell carcinoma (RCC). Retifanlimab 500 mg was administered intravenously every 4 weeks as a 30-min infusion. The primary endpoint was investigator-assessed overall response rate. Overall, 121 patients (35 melanoma, 23 NSCLC, 29 UC, 34 RCC) were enrolled and treated. The overall response rate [95% confidence interval (CI)] was 40.0% (23.9-57.9) in the melanoma cohort, 34.8% (16.4-57.3) in the NSCLC cohort, 37.9% (20.7-57.7) in the UC cohort, and 23.5% (10.7-41.2) in the RCC cohort. Median duration of response was 11.5 months (95% CI 2.2-not reached) in the UC cohort, and was not reached in the other cohorts. Retifanlimab safety was consistent with previous experience for PD-(L)1 inhibitors. Retifanlimab demonstrated durable antitumor activity in patients with melanoma, NSCLC, UC, or RCC. The efficacy and safety of retifanlimab were as expected for a PD-(L)1 inhibitor. These data support further study of retifanlimab in solid tumors.

中文翻译：

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Retifanlimab（一种人源化抗 PD-1 单克隆抗体）在实体瘤患者中的 II 期研究 (POD1UM-203)

POD1UM-203 是一项开放标签、多中心、II 期研究，评估了 retifanlimab，这是一种靶向程序性细胞死亡蛋白-1 (PD-1) 的人源化单克隆抗体，用于免疫检查点抑制剂疗法先前已显示疗效的选定实体瘤患者。符合条件的患者（≥18岁）患有可测量的疾病，包括不可切除或转移性黑色素瘤、未经治疗的具有高程序性死亡配体1（PD-L1）表达的转移性非小细胞肺癌（NSCLC）（肿瘤比例评分≥50） %)、不适合顺铂治疗且具有 PD-L1 表达的局部晚期/转移性尿路上皮癌 (UC)（组合阳性评分≥10%）或未经治疗的局部晚期/转移性透明细胞肾细胞癌 (RCC)。 Retifanlimab 500 mg 每 4 周静脉注射一次，输注时间为 30 分钟。主要终点是研究者评估的总体缓解率。总体而言，共有 121 名患者（35 名黑色素瘤患者、23 名非小细胞肺癌患者、29 名 UC 患者、34 名肾细胞癌患者）入组并接受治疗。黑色素瘤队列的总体缓解率 [95% 置信区间 (CI)] 为 40.0% (23.9-57.9)，NSCLC 队列为 34.8% (16.4-57.3)，UC 队列为 37.9% (20.7-57.7)。 RCC 队列中为 23.5% (10.7-41.2)。 UC 队列中的中位缓解持续时间为 11.5 个月（95% CI 2.2 - 未达到），而其他队列中未达到。 Retifanlimab 的安全性与 PD-(L)1 抑制剂的先前经验一致。 Retifanlimab 在黑色素瘤、NSCLC、UC 或 RCC 患者中表现出持久的抗肿瘤活性。 Retifanlimab 的疗效和安全性符合 PD-(L)1 抑制剂的预期。这些数据支持retifanlimab在实体瘤中的进一步研究。