个体化新抗原疗法联合抗PD-1治疗晚期黑色素瘤、非小细胞肺癌或膀胱癌的Ib期试验
A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer
新抗原是癌细胞突变产生的、可被T细胞识别的重要靶点。该开放标签Ib期试验评估个体化新抗原疫苗NEO-PV-01联合PD-1阻断治疗晚期黑色素瘤、非小细胞肺癌或膀胱癌。82例患者中方案安全，未出现治疗相关严重不良事件；所有患者均产生了新的新抗原特异性CD4+和CD8+ T细胞反应。疫苗诱导的T细胞具有细胞毒性表型，能浸润肿瘤并介导杀伤，还观察到对疫苗外新抗原的表位扩展。
为什么推荐给您：个体化新抗原疫苗联合PD-1阻断的首次人体试验，显示安全性和免疫原性，属新模态早期阳性结果。
不需要生物学背景，多打比方
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摘要Abstract
Neoantigens arise from mutations in cancer cells and are important targets of T cell-mediated anti-tumor immunity. Here, we report the first open-label, phase Ib clinical trial of a personalized neoantigen-based vaccine, NEO-PV-01, in combination with PD-1 blockade in patients with advanced melanoma, non-small cell lung cancer, or bladder cancer. This analysis of 82 patients demonstrated that the regimen was safe, with no treatment-related serious adverse events observed. De novo neoantigen-specific CD4+ and CD8+ T cell responses were observed post-vaccination in all of the patients. The vaccine-induced T cells had a cytotoxic phenotype and were capable of trafficking to the tumor and mediating cell killing. In addition, epitope spread to neoantigens not included in the vaccine was detected post-vaccination. These data support the safety and immunogenicity of this regimen in patients with advanced solid tumors (Clinicaltrials.gov: NCT02897765).