Table 4 PD-L1 immunohistochemistry companion diagnostics.

From: Novel uses of immunohistochemistry in breast pathology: interpretation and pitfalls

 

PD-L1 IHC 22C3 Pharm Dx

PD-L1 IHC 28-8 Pharm Dx

Ventana PD-L1 (SP142) assay

Ventana PD-L1 (SP263) assay

Clone

22C3

28-8

SP142

SP263

Platform

Dako

Dako

Ventana

Ventana

Drug

Pembrolizumab (anti-PD-1, Merck)

Nivolumab (anti-PD-1, BMS)

Atezolizumab (anti-PD-L1, Roche)

Durvalumab (anti-PD-L1, AstraZeneca)

Tumor type approval with associated positive PD-L1 score threshold

 

 Cervical SqCC ≥ 1 (CPS)

NSCLC ≥1% (TC)

NSCLC ≥50% (TC), ≥10% (IC)

None

 

 Esophageal SqCC ≥10 (CPS)

 

TNBC ≥1% (IC)

 
 

 Gastric/GEJ ≥1 (CPS)

 

Urothelial Ca ≥5% (IC)

 
 

 HNSCC ≥1 (CPS)

 

 NSCLC ≥1% (TPS)

 

 Urothelial Ca ≥10 (CPS)

  1. BMS Bristol-Myers Squibb, Ca carcinoma, CPS combined positive score, which incorporates tumor cell and immune cells PD-L1 labeling, GEJ gastroesophageal junction, HNSCC head and neck squamous cell carcinoma, IC immune cell labeling, defined by the tumor area occupied by PD-L1+ immune cells, NSCLC non-small cell lung carcinoma, SqCC squamous cell carcinoma, TC tumor cell labeling, TNBC triple negative breast carcinoma, TPS tumor proportion score, which incorporates tumor cell labeling.
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