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Although the blockade of programmed cell death 1 (PD-1)/PD-ligand (L) 1 has demonstrated promising and durable clinical responses for non-small-cell lung cancers (NSCLCs), NSCLC patients with epidermal growth factor receptor ( EGFR ) mutations responded poorly to PD-1/PD-L1 inhibitors. Previous studies have identified several predictive biomarkers, including the expression of PD-L1 on tumor cells, for PD-1/PD-L1 blockade therapies in NSCLC patients; however, the usefulness of these biomarkers in NSCLCs with  EGFR  mutations has not been elucidated. The present study was conducted to evaluate the predictive biomarkers for PD-1/PD-L1 inhibitors in  EGFR -mutated NSCLCs. We retrospectively analyzed 9 patients treated with nivolumab for  EGFR -mutated NSCLCs. All but one patient received EGFR-tyrosine kinase inhibitors before nivolumab treatment. The overall response rate and median progression-free survival were 11% and 33 days (95% confidence interval (CI); 7 to 51), respectively. Univariate analysis revealed that patients with a good performance status ( P  = 0.11; hazard ratio (HR) 0.183, 95% CI 0.0217 to 1.549), a high density of CD4 +  T cells ( P  = 0.136; HR 0.313, 95% CI 0.045 to 1.417) and a high density of Foxp3 +  cells ( P  = 0.09; HR 0.264, 95% CI 0.0372 to 1.222) in the tumor microenvironment tended to have longer progression-free survival with nivolumab. Multivariate analysis revealed that a high density of CD4 +  T cells ( P  = 0.005; HR<0.001, 95% CI <0.001 to 0.28) and a high density of Foxp3 +  cells ( P  = 0.003; HR<0.001, 95% CI NA) in tumor tissues were strongly correlated with better progression-free survival. In contrast to previous studies in wild type  EGFR  NSCLCs, PD-L1 expression was not associated with the clinical benefit of anti-PD-1 treatment in  EGFR -mutated NSCLCs. The current study indicated that immune status in the tumor microenvironment may be important for the effectiveness of nivolumab in NSCLC patients with  EGFR  mutations.

Retrospective analysis of antitumor effects and biomarkers for nivolumab in NSCLC patients with EGFR mutations