Chapter 2 26 Translational relevance Despite the clinical success of anti-PD-1 treatment, robust predictive biomarkers are still lacking. As PD-1 blockade can reinvigorate dysfunctional T cells, we hypothesized that new biomarkers could be developed by assessing such direct effectors of the anti-tumor immune response. We previously identified a tumor-reactive T cell population, termed PD-1T TILs, with predictive potential in a small cohort of nonsmall cell lung cancer (NSCLC) patients. In this study, PD-1T TILs were assessed as a predictive biomarker for durable clinical benefit in two NSCLC cohorts treated with PD-1 blockade, reaching high sensitivity and high negative predictive value. The predictive performance was superior compared to PD-L1 and TLS. Therefore, this biomarker may positively impact treatment decision making in clinical practice, as it improves patient stratification. Importantly, it specifically identifies a patient group that is unlikely to benefit from PD-1 blockade, thereby providing a tool to reduce overtreatment.
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