尽管尼伐肿单抗具有较高的疗效，但需要可靠的生物标志物来预测其疗效。我们根据GI-SCREEN项目中参与的晚期胃癌患者的TP53突变评估了尼伐肿单抗的疗效。从2015年4月至2017年3月期间，我们从GI-SCREEN数据库获取了913名晚期胃癌患者的肿瘤标本测序数据和临床病理信息。同时，还提供了266名接受尼伐肿单抗治疗的患者的随访信息。在接受尼伐肿单抗治疗的266名患者中，TP53野生型（wt）患者的客观缓解率（ORR）（24.6%）高于TP53突变型患者（14.8%）。在TP53突变型患者中，移码型的ORR值相对较高，而过渡型和转换型的ORR值较低（分别为23.1%、13.6%和13.0%）。中位进展无病生存期（PFS）在TP53野生型患者中显著较长，而在突变型患者中较短（3.3个月 vs 2.1个月，HR 1.4，95% CI 1.1-1.9）。在TP53突变型患者中，移码型的PFS显著长于转换型。尼伐肿单抗在TP53野生型患者中显示出更好的疗效。在TP53突变型患者中，移码型可能因尼伐肿单抗治疗而具有疗效。© 2023. 作者（们）独家向Springer Nature Limited授予许可。

Although nivolumab has a high efficacy, reliable biomarkers are needed to predict the efficacy. We evaluated the nivolumab efficacy according to the TP53 mutation in advanced gastric cancer patients enrolled in the GI-SCREEN project.Sequence data of tumour specimens and clinicopathological information of 913 patients with advanced gastric cancer who were enrolled between April 2015 and March 2017 were obtained from the GI-SCREEN database. The follow-up information of 266 patients treated with nivolumab was also provided.Among 266 patients treated with nivolumab, the objective response rate (ORR) of TP53 wild type (wt) patients (24.6%) was higher than that of TP53 mutant patients (14.8%). Among TP53 mutant patients, the ORR of the frameshift type tended to be higher than the transition and transversion type (23.1%, 13.6%, and 13.0%, respectively). The median progression-free survival (PFS) was statistically longer in TP53 wt patients than in mutant patients (3.3 vs 2.1 months, HR 1.4, 95% CI 1.1-1.9). Among TP53 mutant patients, PFS was statistically longer in the frameshift type than in the transversion type.Nivolumab showed better efficacy in TP53 wt patients than in mutant patients. Among TP53 mutant patients, the frameshift type may have efficacy from nivolumab treatment.© 2023. The Author(s), under exclusive licence to Springer Nature Limited.