{"title":"第一次皮下ICI，恩伐利单抗治疗晚期肺癌患者的安全性和有效性：一项真实世界的研究。","authors":"Zixuan Dou, Li Wang, Meng Rui, Yulong Yang, Yunzhi Zhou, JieLi Zhang, Qiuhong Zhao, Mengzhao Wang, Hanping Wang, Xiaotong Zhang, Xiaoxia Cui, Xiaoyan Si, Li Zhang","doi":"10.1111/1759-7714.70101","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Envafolimab demonstrates a tolerable safety profile and favorable efficacy. With its subcutaneous formulation, Envafolimab shows promising potential for treating advanced lung cancer.</p>","PeriodicalId":23338,"journal":{"name":"Thoracic Cancer","volume":"16 12","pages":"e70101"},"PeriodicalIF":2.3000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12171066/pdf/","citationCount":"0","resultStr":"{\"title\":\"Safety and Efficacy of the First Subcutaneous ICI, Envafolimab, in the Treatment of Advanced Lung Cancer Patients: A Real-World Study.\",\"authors\":\"Zixuan Dou, Li Wang, Meng Rui, Yulong Yang, Yunzhi Zhou, JieLi Zhang, Qiuhong Zhao, Mengzhao Wang, Hanping Wang, Xiaotong Zhang, Xiaoxia Cui, Xiaoyan Si, Li Zhang\",\"doi\":\"10.1111/1759-7714.70101\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Envafolimab demonstrates a tolerable safety profile and favorable efficacy. 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引用次数: 0
摘要
背景：恩伐利单抗是一种新型免疫检查点抑制剂（ICI），由于其皮下给药，具有多种优势。I期和II期随机对照试验已显示出治疗结直肠癌和胃癌的良好疗效。然而，Envafolimab在晚期肺癌患者中的安全性和有效性仍有待研究。方法：这项回顾性、多中心、开放标签、单臂队列研究检查了来自4个医疗中心接受治疗的患者的真实医疗数据，以评估Envafolimab治疗晚期肺癌患者的安全性和有效性。主要的安全性指标是依伐莫来单抗相关治疗出现的不良事件（teae）和免疫相关不良事件（irAEs）。主要疗效指标包括总生存期（OS）和无进展生存期（PFS）。然后采用单因素和多因素回归分析探讨临床参数与预后的关系。此外，明确探讨非小细胞肺癌（NSCLC）患者肿瘤EGFR驱动突变状态和PD-L1表达对预后的影响。结果：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）。与依那伐利单抗相关的teae和irae分别占53.4%和27.6%。没有确定与irae相关的特定临床因素。中位OS为8.5个月（95%可信区间[CI] 6.2-10.8），中位PFS为6.1个月（95% CI 3.8-8.3）。在47例NSCLC患者中，与预后不良相关的因素包括ECOG PS >2 （HR: 2.91, p = 0.015）、IV期肿瘤（HR: 3.43, p = 0.043）和非一线恩伐莫单抗治疗（HR: 3.27, p = 0.026）。结论：恩伐利单抗具有可耐受的安全性和良好的疗效。凭借其皮下配方，恩伐利单抗显示出治疗晚期肺癌的良好潜力。
Safety and Efficacy of the First Subcutaneous ICI, Envafolimab, in the Treatment of Advanced Lung Cancer Patients: A Real-World Study.
Background: 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.
Methods: 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).
Results: 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.
Conclusion: Envafolimab demonstrates a tolerable safety profile and favorable efficacy. With its subcutaneous formulation, Envafolimab shows promising potential for treating advanced lung cancer.
期刊介绍：
Thoracic Cancer aims to facilitate international collaboration and exchange of comprehensive and cutting-edge information on basic, translational, and applied clinical research in lung cancer, esophageal cancer, mediastinal cancer, breast cancer and other thoracic malignancies. Prevention, treatment and research relevant to Asia-Pacific is a focus area, but submissions from all regions are welcomed. The editors encourage contributions relevant to prevention, general thoracic surgery, medical oncology, radiology, radiation medicine, pathology, basic cancer research, as well as epidemiological and translational studies in thoracic cancer. Thoracic Cancer is the official publication of the Chinese Society of Lung Cancer, International Chinese Society of Thoracic Surgery and is endorsed by the Korean Association for the Study of Lung Cancer and the Hong Kong Cancer Therapy Society.
The Journal publishes a range of article types including: Editorials, Invited Reviews, Mini Reviews, Original Articles, Clinical Guidelines, Technological Notes, Imaging in thoracic cancer, Meeting Reports, Case Reports, Letters to the Editor, Commentaries, and Brief Reports.
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