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Table 1 Biomarker assays for anti-PD-1/PD-L1 drugs and associated outcomes

From: Utility of PD-L1 immunohistochemistry assays for predicting PD-1/PD-L1 inhibitor response

Bioassay Drug Disease Target Cut Offb ORR+c ORR-d SENSe SPECf
Roche Ventana SP263 Durvalumab NSCLCa 25% 27% 5% 84% 78%
Roche Ventana SP263 Durvalumab + Tremelimumab NSCLC 25% 22.5% 29% 36% 48%
Roche Ventana SP263 Durvalumab Bladder Cancer 25% 46% 0% 100% 65%
Roche Ventana SP142 Atezolizumab Metastatic NSCLC 50% 45% 14% 76% 61%
Roche Ventana SP142 Atezolizumab Urothelial Carcinoma 1% 27% 13% NA NA
Dako 22C3 Pembrolizumab NSCLC 50% 41% 13% 76% 60%
Dako 22C3 Pembrolizumab HNSCC 1% 22% 4% 85% 55%
Dako 22C3g Pembrolizumab Melanoma 1% 39% 10% 80% 60%
Dako 28-8 Nivolumab Non-Squamous NSCLC 1% 19% 9% 68% 53%
Dako 28-8 Nivolumab Squamous NSCLC 5% 20% 20% NA NA
Dako 28-8 Nivolumab Melanoma 5% 57% 41% 58% 49%
Dako 28-8 Nivolumab + Ibilimumab Melanoma 5% 72% 55% 57% 54%
  1. aNSCLC: Non-Small-Cell Lung Cancer – bCut Off: Proportion of tumor cells expressing PD-L1 below which tumor is considered PD-L1 negative. – cORR+ Objective Response Rate in PD-L1 positive tumors. – dORR-: Objective Response Rate in PD-L1 negative tumors. – eSensitivity of bioassay for predicting response to PD-L1 blockade based on established cut off. fSpecificity of bioassay for predicting response to PD-L1 blockade based on established cut off. – gORR+ and ORR- based on weighted average of corresponding MEL scores