Table 2 PD-L1 assay interpretation guidelines and scoring

From: Immunohistochemical detection of PD-L1 among diverse human neoplasms in a reference laboratory: observations based upon 62,896 cases

Antibody

Site/tumor type

Interpretation guidelines [positive]a

22C3

Gastroesophageal

Combined positive score (CPS); [Tumor + immune cells = > 1%]

 

Other sites

Tumor proportion score (TPS); [Tumor = > 1% expression; tumor = > 50% high expression]

28-8

 

[Tumor cells > 1%]

 

NSCLC

PD-L1 expression [tumor = > 1%; tumor = > 5%; tumor = > 10%b]

 

HNSCC

PD-L1 expression [Tumor cells > 1%]

 

Urothelial

PD-L1 expression [Tumor cells > 1%]

 

Melanoma

PD-L1 expression [Tumor cells > 1%]

SP142

Urothelial

PD-L1 expression [ = > 5% in tumor-infiltrating immune cells]

 

NSCLC

PD-L1 expression [Tumor cell = > 50% or Immune cell = > 10%]

SP263

Urothelial

PD-L1 status [Tumor cells = > 25% OR Immune cells present > 1% and tumor associated immune cell staining = > 25% OR Immune cells present = 1% and tumor associated immune cell staining 100%: PD-L1 status – high]

 

NSCLC

PD-L1 IHC score [Tumor cells = > 1%]

  1. aAdditional indications and interpretation methods have been approved since the time of data collection. These interpretations were not included in the evaluation of this data
  2. bDifferent expression cutoffs are associated with different levels of survival with nivolumab therapy