Abstract
Abstract Background Since its approval in December 2015, nivolumab has been widely used as a second-line treatment for non-small cell lung cancer (NSCLC) patients regardless of tumor PD-L1 expression or histology. However, the relationship between nivolumab effectiveness and PD-L1 expression using 22C3 PharmDx in the real-world setting is unclear. Methods Data from patient who initiated nivolumab treatment from April 1, 2016 to December 31, 2016 were collected at 23 regional medical institutions across Japan. Tumor PD-L1 expression was determined using PD-L1 IHC 22C3 PharmDx or 28-8 PharmDx assays. Here, we report the relationship between nivolumab effectiveness/safety and PD-L1 expression using 22C3 PharmDx, from a multicenter, observational study; CA209-9CR (NCT03273790). Results PD-L1 expression in 348 cases of NSCLC was determined using the 22C3 PharmDx assay. The propotion of cases with PD-L1 negative ( Conclusion These real-world data show relationship of nivolumab effectiveness and PD-L1 expression using 22C3 PharmDx.
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