PD-1T TILs as precision biomarker in NSCLC 43 2 Figure 3. Impact of lesion-specific response and tissue sample properties on the predictive accuracy of PD-1T TILs. (A) Percentage of responsive versus progressive lesions during treatment in the PD-1T high (≥90 per mm2) (n=11) and PD-1T low (<90 per mm2) (n=14) group of patients with PD within 12 months. A lesion was defined progressive when ≥20% growth was seen compared to the smallest diameter during treatment. (B) Example of a PD-1T high IHC staining with 10 individually annotated tumor areas of 1 mm2. (C) Quantification of PD-1T TILs per each mm2 area in five resection specimens. Each dot indicates an individual measurement. Two tumors are PD-1T low (grey shades), three tumors are PD-1T high (red shades). The cross indicates PD-1T TILs per mm2 normalized per total tumor area. (D-E) The predictive value of PD-1T TILs in the total cohort and different subgroups. Each comparison is marked in a grey square. Shown is the area under the curve (AUC) for DC 6m (D) and 12m (E) with 95% CI interval. P-value was determined by one-sided permutation test. Comparison with PD-L1 as established biomarker Pretreatment patient selection based on ≥50% or ≥1% tumor PD-L1 expression has been extensively studied, with contradictory results1–3,5,6. However, improved outcomes in the KEYNOTE-024 study for patients with ≥50% PD-L1 expression have led to the implementation of PD-L1 testing in routine diagnostics2. Therefore, we compared the predictive value of PD-1T TILs to the PD-L1 tumor proportion score (TPS) in the validation set (Fig. 4A). The fraction of disease control and PD for patients with tumors expressing ≥50%, 1-50% or no PD-L1 are shown in Fig. S3A (DC 6m) and
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