Avelumab can kill cancer cells through immune checkpoint inhibition and antibody-dependent cell-mediated cytotoxicity (ADCC). Here, we analyzed the clinical efficacy and adverse events (AEs) in 3935 cancer patients from 21 trials. Compared with conventional treatment, avelumab monotherapy was associated with more tumor responses and less AEs. The pooled objective response rate was 14.18 % (95 % CI, 10.68 %–18.08 %). More PD-L1 positive patients responded to avelumab monotherapy compared to PD-L1 negative patients. The overall incidence was 73.78 % for all-grade treatment-related AE (TRAE), 14.44 % for high-grade TRAE, 6.07 % for serious adverse event, 0.44 % for fatal adverse event, 17.86 % for all-grade immune-related AE (irAE), and 3.22 % for high-grade irAE. In summary, avelumab monotherapy presents an active anti-tumor activity, shows no sign of increased toxicity due to the ADCC. These characteristics provide rational for further application of avelumab in cancer treatment.

Avelumab 可以通过免疫检查点抑制和抗体依赖性细胞介导的细胞毒性 (ADCC) 杀死癌细胞。在这里，我们分析了来自 21 项试验的 3935 名癌症患者的临床疗效和不良事件 (AE)。与常规治疗相比，avelumab 单药治疗与更多的肿瘤反应和更少的 AE 相关。汇总的客观缓解率为 14.18 %（95 % CI，10.68 %–18.08 %）。与 PD-L1 阴性患者相比，更多 PD-L1 阳性患者对 avelumab 单药治疗有反应。全级别治疗相关 AE (TRAE) 的总发生率为 73.78 %，高级别 TRAE 为 14.44 %，严重不良事件为 6.07 %，致命不良事件为 0.44 %，所有级别免疫相关 AE 为 17.86 % (irAE)，高等级 irAE 为 3.22%。综上所述，avelumab 单药治疗具有积极的抗肿瘤活性，由于 ADCC，没有显示出毒性增加的迹象。这些特点为 avelumab 在癌症治疗中的进一步应用提供了合理性。