PD-L1 was regarded as a predictive biomarker in a first-in-human study of nivolumab, and a subsequent larger-scale phase I study of NSCLC further confirmed this finding; at a cut-off of 5% PD-L1-positive tumor cells, the overall response rate (ORR) of PD-L1-positive patients was 36%, whereas the ORR of PD-L1-negative patients was 0% [34]. This evidence concerns the gene CD274 and neoplasm.