Purpose: Reported here are results from the esophageal squamous cell carcinoma (SCC) cohort of a Phase II, non-comparative, basket study, evaluating the anti-tumor activity and safety of FAP-IL2v plus atezolizumab in patients with advanced/metastatic solid tumors (NCT03386721). Experimental design: Eligible patients had an Eastern Cooperative Oncology Group performance status of 0–1; measurable metastatic, persistent, or recurrent esophageal SCC; progression on ≥1 prior therapy; and were checkpoint inhibitor naive. Patients received FAP-IL2v 10 mg plus atezolizumab 1200 mg intravenously every 3 weeks, or FAP-IL2v weekly for 4 weeks, then every 2 weeks, plus atezolizumab 840 mg intravenously every 2 weeks. Primary endpoint was investigator-assessed objective response rate (ORR). Results: In the response-evaluable population (N=34), best confirmed ORR was 20.6% (95% confidence interval [CI]: 10.4–36.8) with a complete response (CR) seen in one patient and partial responses (PR) in six patients. Disease control rate was 44.1% (CR=2.9%; PR=17.6%; stable disease [SD]=23.5%) and median duration of response was 10.1 months (95% CI: 5.6–26.7). Median progression-free survival was 1.9 months (95% CI: 1.8–3.7). Analysis of response by PD-L1 expression (Ventana SP263) resulted in an ORR of 26.7 % for patients with PD-L1-positive tumors (tumor area positivity [TAP] cut-off ≥1%; n=15) and 7.1% for patients with PD-L1-negative tumors (TAP cut-off <1%; n=14). Overall, the treatment combination was tolerable and adverse events were consistent with the known safety profiles of each drug. Conclusions: FAP-IL2v plus atezolizumab demonstrated clinical activity and was tolerable in patients with previously treated esophageal SCC.

中文翻译：

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确定 simlukafusp alfa (FAP-IL2v) 联合 atezolizumab 对食管癌的抗肿瘤活性和安全性的 II 期研究

目的：本文报告的是一项 II 期非比较性篮子研究的食管鳞状细胞癌 (SCC) 队列的结果，该研究评估了 FAP-IL2v 加阿特朱单抗对晚期/转移性实体瘤患者的抗肿瘤活性和安全性（NCT03386721）。实验设计：符合条件的患者东部肿瘤合作组表现状态为 0-1；可测量的转移性、持续性或复发性食管鳞状细胞癌； ≥1 种既往治疗进展；并且检查点抑制剂是天真的。患者每 3 周接受 FAP-IL2v 10 mg 加 atezolizumab 1200 mg 静脉注射，或每周接受 FAP-IL2v 治疗，持续 4 周，然后每 2 周接受一次，再加上每 2 周静脉注射 atezolizumab 840 mg。主要终点是研究者评估的客观缓解率（ORR）。结果：在可评估疗效的人群 (N=34) 中，最佳确认的 ORR 为 20.6%（95% 置信区间 [CI]：10.4–36.8），一名患者出现完全缓解 (CR)，一名患者出现部分缓解 (PR)在六名患者中。疾病控制率为 44.1%（CR=2.9%；PR=17.6%；疾病稳定 [SD]=23.5%），中位缓解持续时间为 10.1 个月（95% CI：5.6-26.7）。中位无进展生存期为 1.9 个月（95% CI：1.8–3.7）。根据 PD-L1 表达 (Ventana SP263) 进行的疗效分析显示，PD-L1 阳性肿瘤患者的 ORR 为 26.7%（肿瘤面积阳性 [TAP] 截止值≥1%；n=15），PD-L1 阳性肿瘤患者的 ORR 为 7.1%。 PD-L1阴性肿瘤患者（TAP截止值<1%；n=14）。总体而言，治疗组合是可以耐受的，并且不良事件与每种药物的已知安全性一致。结论：FAP-IL2v 联合 atezolizumab 在既往治疗过的食管鳞状细胞癌患者中表现出临床活性并且是可耐受的。