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PD-1/PD-L1 pathway status in patients with non-small cell lung cancer Yoon Kyung Jeon Department of Pathology, Seoul National University College of Medicine Immune checkpoint pathway generally refers to a variety of inhibitory interactions between T cells and antigen presenting cells or host cells, as represented by the CD80 or CD86/CTLA4 pathway and the programmed cell death 1 ligand-1 (PD-L1) or PD-L2/PD-1 pathway. Physiologically, this pathway contributes to the maintenance of self-tolerance and control of immune responses, thereby preventing autoimmunity and harmful tissue damage. Cancer also utilizes immune checkpoints to evade the immune surveillance by host. Blockade of these immune checkpoints reactivate and enhance anti-tumor immune responses, and has emerged as a highly promising therapeutic strategy for cancer. However, CTLA4 and PD-1/PD-L1 blockade have shown clinical efficacy in a subset of cancer patients, thus demanding identification of predictive biomarkers. PD-1/PD-L1 blockade has achieved favorable clinical benefit in patients with several types of cancer including malignant melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, bladder cancer, and Hodgkin lymphoma. In NSCLC, responsiveness to PD-1/PD-L1 blockade was related with the PD-L1 expression level in tumor cells and/or tumor-infiltrating immune cells, preexisting adaptive immune responses, and the mutational load of tumor. Among these, PDL1 expression in tumor cells has been approved for companion diagnostics for PD-1 blockade therapy in NSCLC. In this talk, expression pattern and clinicopathological feature of PD-1/PD-L1 pathway in NSCLC and the mechanism of PD-L1 induction by EML4-ALK will be briefly reviewed.