Fig. 5

Representative survival curves illustrating the different clinical scenarios involved in the FDA approval of pembrolizumab using the PD-L1 22C3 PharmDx assay (a) vs. nivolumab using the PD-L1 28–8 PharmDx assay (b). For pembrolizumab administered in second-line NSCLC, panel a shows Kaplan–Meier estimates of progression-free survival according to the proportion score of the percentage of neoplastic cells with membranous PD-L1 staining. In this context, the biomarker was used as inclusion criteria to select the patient population in which the clinical activity of pembrolizumab was assessed. For nivolumab, PD-L1 expression was assessed retrospectively in prospectively collected tissue samples. Panel b illustrates Kaplan-Meier estimates of progress-free survival in patients receiving nivolumab or docetaxel by PD-L1 expression level. In this study, the test was not used for patient selection but to evaluate the interaction between PD-L1 expression and clinical benefit. Panel a from The New England Journal of Medicine, 2015, 372, 2018-2028 Edward B. Garon et al., Pembrolizumab for the Treatment of Non–Small-Cell Lung Cancer. Copyright © 2015 Massachusetts Medical Society. Panel b from The New England Journal of Medicine, 2015, 373, 1627-1639 Hossein Borghaei et al., Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer, 373, 1627-1639. Copyright © 2015 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society