Skip to main content

Table 1 PD-L1 assay characteristics and performance in NSCLC

From: The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of non-small cell lung cancer (NSCLC)

Assay Antibody FDA-approved Indication in NSCLC Cutoff Value Performancea
22C3 IHC pharmDx Monoclonal mouse anti-PD-L1, Clone 223 Approved as a companion diagnostic to select patients with advanced NSCLC for treatment with pembrolizumab first-line (TPS ≥ 50%) or after progression on a platinum containing chemotherapy regimen (TPS ≥ 1%) • TPS < 1% PD-L1 negative
• TPS 1–49% PD-L1 positive
• TPS ≥ 50% High PD-L1 expression
Found to be closely aligned with 28–8 and SP263 IHC assays
28–8 IHC pharmDx Monoclonal Rabbit anti-PD-L1, Clone 28–8 Approved as a complementary diagnostic to aid in non-squamous NSCLC patient selection for treatment with nivolumab Qualitative test reported as a percentage of tumor cells exhibiting positive membrane staining Found to be closely aligned with 22C3 and SP263 IHC assays
PD-L1 (SP142) Assay Monoclonal Rabbit anti-PD-L1, Clone SP142 Approved as a complementary diagnostic to aid in NSCLC patient selection for treatment with atezolizumab PD-L1 expression in ≥ 50% tumor cells or ≥ 10% immune-infiltrating cells is associated with enhanced survival Consistently stained fewer PD-L1 tumor cells
PD-L1 (SP263) Assay Monoclonal Rabbit anti-PD-L1, Clone SP263 CE mark only, not approved by the FDA for patients with NSCLC The CE mark was granted and expanded based on demonstrated equivalency to the 28–8 and the 22C3 IHC assays Found to be closely aligned with 22C3 and 28–8 IHC assays
  1. Abbreviations IHC immunohistochemistry, NSCLC non-small cell lung cancer, PD-L1 programmed cell death ligand 1, TPS tumor proportion score
  2. aAs assessed in Phase I of the Blueprint PD-L1 IHC assay Comparison Project [56]