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Biomarker analysis of first-line camrelizumab plus apatinib in patients with advanced biliary tract cancers: Results from a phase II study.

e16164 Background: The prognosis of immunotherapy for patients with unresectable or metastatic biliary tract cancers (BTCs) was not very optimistic, exploring the potential biomarkers associated with tumor response in advanced BTCs may further improve the clinical benefits from immunotherapy. Methods: Fourteen advanced BTCs patients from the single-arm phase II study (ChiCTR2000034283) receiving camrelizumab (anti-PD-1 antibody) plus apatinib (VEGFR2 inhibitor) as first-line combination therapy, were included for the current biomarkers analysis. Exploratory points mainly focused on differentiated immune-related gene expression and immune pathway signatures using a 289-gene immune-related RNA panel sequencing on baseline tumor samples. Differential gene expression analysis was performed between responders (tumor regression) and non-responders (tumor extension) using Wilcoxon rank-sum test. Signature scores were calculated using the Gene Set Variation Analysis package with publicly available gene signatures. Results: Of all enrolled patients with clinical response evaluations, twelve patients had available RNA-sequencing data (6 responders vs. 6 non-responders) on baseline tumor samples. Differential gene expression analysis revealed a significantly higher BRCA2, RAD51, BRIP1 expression (p < 0.001) and decreased TGF β 1, IT GAX, ITGB2 expression (p < 0.001) in responder tumors compared with non-responder tumors. Differentiated genes were significantly enriched in receptor metabolic process pathway in responder tumors. Extensive analyses on immune cell types score were also calculated, CD8 positive T cells (p = 0.022) were significantly increased in baseline responder tumors, and Macrophages M2 cells (p = 0.008) were significantly increased in baseline non-responder tumors. Conclusions: Some differentially expressed genes and immune-related cell types were founded in defined groups, both immune- and tumor-intrinsic factors may be considered for validation in a larger study. Clinical trial information: ChiCTR2000034283.