Chapter 4 130 Translational relevance PD-(L)1 blockade therapies have significantly improved the survival of a subset of patients with advanced stage non-small cell lung cancer. However, most patients don’t benefit, but still are at risk of adverse effects associated. This asks for biomarkers to better predict benefit. PD-1T TILs, a tumor- reactive T-cell population, constitute such a biomarker, and can be accurately quantified by digital image analysis in FFPE tumor tissue. Yet, this method is complex, limiting its application in routine patient care. As an alternative, a PD-1T mRNA expression signature measured in FFPE tissue samples with industry standard technology is more suitable for implementation in routine diagnostics. The PD-1T signature reached equally high sensitivity and negative predictive value as the digital image analysis-based IHC quantification of PD-1T TILs, making it particularly suited for reliably identifying advanced stage non-small cell lung cancer patients who have a low chance of benefitting from PD- (L)1 blockade therapy.
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