Chapter 5 172 Translational Relevance Predictive biomarkers for the efficacy of PD-(L)1 inhibition in non-small cell lung cancer (NSCLC) beyond PD-L1 are lacking. We retrospectively developed a pretreatment proteomic signature derived from peripheral blood that was able to stratify patients for benefit of nivolumab in treatment of relapsed NSCLC. A signature consisting of 274 mass spectral features derived from a development set of 116 patients was associated with progression free survival (PFS) and overall survival (OS) across 2 validation cohorts (n=98 and n=75). In pooled analysis, a significantly better OS was demonstrated for “sensitive” relative to “not sensitive” patients, hazard ratio (HR) 0.58 (95% CI: 0.38-0-87, P=0.009). There was no significant association with clinical factors including PD-L1 immunohistochemistry. Further prospective exploration of the predictive capabilities of this assay is underway.
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