Dou Zixuan, Wang Li, Rui Meng, Yang Yulong, Zhou Yunzhi, Zhang JieLi, Zhao Qiuhong, Wang Mengzhao, Wang Hanping, Zhang Xiaotong, Cui Xiaoxia, Si Xiaoyan, Zhang Li
School of Medicine, Tsinghua Medicine, Tsinghua University, Beijing, China.
Department of Respiratory and Critical Care Medicine, Hebei Yanda Hospital, Langfang, China.
Thorac Cancer. 2025 Jun;16(12):e70101. doi: 10.1111/1759-7714.70101.
Envafolimab is a novel immune checkpoint inhibitor (ICI) with several advantages due to its subcutaneous administration. Phases I and II randomized controlled trials have demonstrated promising efficacy in treating colorectal and gastric cancer. However, the safety and efficacy of Envafolimab in patients with advanced lung cancer remain to be investigated.
This retrospective, multicenter, open-label, single-arm cohort study examined real-world medical data from patients treated at four medical centers to assess the safety and efficacy of Envafolimab in treating patients with advanced lung cancer. The primary safety outcome was Envafolimab-related treatment-emergent adverse events (TEAEs) and immune-related adverse events (irAEs). The primary efficacy outcomes included overall survival (OS) and progression-free survival (PFS). Then, the relationship between clinical parameters and prognosis was investigated using univariate and multivariate regression analyses. Furthermore, the impact of tumor EGFR driver mutation status and PD-L1 expression on prognosis was explicitly explored in patients with nonsmall-cell lung cancer (NSCLC).
The cohort comprised 58 patients with a median follow-up time of 8.3 months (from March 1, 2022, to March 7, 2024). Envafolimab-related TEAEs and irAEs were observed in 53.4% and 27.6% of patients, respectively. No specific clinical factors were identified as being associated with irAEs. The median OS was 8.5 months (95% confidence interval [CI] 6.2-10.8), and the median PFS was 6.1 months (95% CI 3.8-8.3). For 47 patients with NSCLC, factors including ECOG PS > 2 (HR: 2.91, p = 0.015), Stage IV tumor (HR: 3.43, p = 0.043), and nonfirst-line Envafolimab treatment (HR: 3.27, p = 0.026) were associated with poor prognosis.
Envafolimab demonstrates a tolerable safety profile and favorable efficacy. With its subcutaneous formulation, Envafolimab shows promising potential for treating advanced lung cancer.
恩沃利单抗是一种新型免疫检查点抑制剂（ICI），因其皮下给药具有多种优势。I期和II期随机对照试验已证明其在治疗结直肠癌和胃癌方面具有良好疗效。然而，恩沃利单抗在晚期肺癌患者中的安全性和疗效仍有待研究。
这项回顾性、多中心、开放标签、单臂队列研究检查了四个医疗中心接受治疗患者的真实世界医学数据，以评估恩沃利单抗治疗晚期肺癌患者的安全性和疗效。主要安全结局为与恩沃利单抗相关的治疗中出现的不良事件（TEAE）和免疫相关不良事件（irAE）。主要疗效结局包括总生存期（OS）和无进展生存期（PFS）。然后，使用单变量和多变量回归分析研究临床参数与预后之间的关系。此外，在非小细胞肺癌（NSCLC）患者中明确探讨了肿瘤表皮生长因子受体（EGFR）驱动基因突变状态和程序性死亡受体配体1（PD-L1）表达对预后的影响。
该队列包括58例患者，中位随访时间为8.3个月（从2022年3月1日至2024年3月7日）。分别在53.4%和27.6%的患者中观察到与恩沃利单抗相关的TEAE和irAE。未发现与irAE相关的特定临床因素。中位OS为8.5个月（95%置信区间[CI]6.2 - 10.8），中位PFS为6.1个月（95%CI 3.8 - 8.3）。对于47例NSCLC患者，包括东部肿瘤协作组（ECOG）体能状态（PS）>2（风险比[HR]：2.91，p = 0.015）、IV期肿瘤（HR：3.43，p = 0.043）和非一线恩沃利单抗治疗（HR：3.27，p = 0.026）等因素与预后不良相关。
恩沃利单抗显示出可耐受的安全性和良好的疗效。凭借其皮下制剂，恩沃利单抗在治疗晚期肺癌方面显示出有前景的潜力。
