Yi Jun, Yu Huangpeng, Shu Yun, Deng Yingen
Department of Oncology, The Third People's Hospital of Jiujiang, Jiujiang, Jiangxi Province, China.
Department of Pharmacy, The Third People's Hospital of Jiujiang, Jiujiang, Jiangxi Province, China.
Medicine (Baltimore). 2025 Mar 7;104(10):e41548. doi: 10.1097/MD.0000000000041548.
AK104 is a novel antibody targeting programmed cell death protein 1 (PD-1)/cytotoxic T-lymphocyte-associated protein 4. This study aimed to evaluate the safety, tolerability, and efficacy of AK104 in treating patients with advanced solid tumors who failed prior programmed cell death protein 1/programmed death-ligand 1 (PD/PD-L1) therapies. Clinical data from 135 patients with advanced solid tumors who failed PD/PD-L1 therapies were retrospectively analyzed. Patients received AK104 at a dose of 6 mg/kg every 2 weeks. Baseline demographic characteristics, clinical outcomes, adverse reactions, overall survival, progression-free survival, and quality of life assessments were analyzed. Following AK104 treatment, 17.78% of patients achieved a partial response, while 80.74% experienced stable disease, resulting in a disease control rate of 98.52%. The 1- and 2-year overall survival rates were 48.15% and 31.11%, while progression-free survival rates at 6 months and 1 year were 53.33% and 28.15%, respectively. Post-treatment, significant improvements in the quality-of-life scores, as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 and EuroQol 5 Dimensions Visual Analog Scale, were observed post-treatment. Immune-related adverse events were common, affecting 85.19% of patients, with diarrhea, enteritis, pneumonia, and thyroid dysfunction being the most frequently reported. AK104 demonstrated the ability to induce clinical responses, extend survival, and enhance quality of life in patients with advanced solid tumors who had previously failed PD-1/PD-L1 therapies, underscoring its potential as a promising therapeutic option. However, the high incidence of immune-related adverse events necessitates vigilant monitoring and management to maximize its clinical utility. Further prospective studies are warranted to validate and extend these findings in broader patient populations.
AK104是一种靶向程序性细胞死亡蛋白1（PD-1）/细胞毒性T淋巴细胞相关蛋白4的新型抗体。本研究旨在评估AK104治疗既往程序性细胞死亡蛋白1/程序性死亡配体1（PD/PD-L1）治疗失败的晚期实体瘤患者的安全性、耐受性和疗效。回顾性分析了135例既往PD/PD-L1治疗失败的晚期实体瘤患者的临床数据。患者每2周接受一次6mg/kg剂量的AK104治疗。分析了基线人口统计学特征、临床结局、不良反应、总生存期、无进展生存期和生活质量评估。接受AK104治疗后，17.78%的患者获得部分缓解，80.74%的患者病情稳定，疾病控制率为98.52%。1年和2年总生存率分别为48.15%和31.11%，6个月和1年的无进展生存率分别为53.33%和28.15%。治疗后，通过欧洲癌症研究与治疗组织生活质量问卷核心30和欧洲五维视觉模拟量表评估，生活质量得分有显著改善。免疫相关不良事件很常见，85.19%的患者受到影响，腹泻、肠炎、肺炎和甲状腺功能障碍是最常报告的。AK104显示出在既往PD-1/PD-L1治疗失败的晚期实体瘤患者中诱导临床反应、延长生存期和提高生活质量的能力，突显了其作为一种有前景的治疗选择的潜力。然而，免疫相关不良事件的高发生率需要进行密切监测和管理，以最大限度地发挥其临床效用。有必要进行进一步的前瞻性研究，以在更广泛的患者群体中验证和扩展这些发现。
