Consistency of tumor and immune cell programmed cell death ligand-1 expression within and between tumor blocks using the VENTANA SP263 assay

Table 1 Comparison of approved PD-L1 diagnostic assays and PD-L1 cut-offs in NSCLC, HNSCC and UC

	VENTANA SP263 [19, 30]	Dako 22C3 [21]	Dako 28–8 [20]	VENTANA SP142 [22]
Developed as companion diagnostic assay for:	Durvalumab (AstraZeneca/ MedImmune)^a	Pembrolizumab (Merck Sharp & Dohme)	Nivolumab (Bristol-Myers Squibb)	Atezolizumab (Genentech/Roche)
Compartment	TC; TC or IC	TC; TC & IC	TC	TC or IC; IC
PD-L1 cut-off NSCLC	≥25% TC [30]	≥50% TC - 1 L [21, 31] ≥1% TC - 2 L [31]	≥1%, ≥5%, ≥10% TC [8]	≥50% TC or ≥ 10% IC [13, 22]
PD-L1 cut-off HNSCC	≥25% TC [30]	≥1, ≥50 CPS^b [17]	≥1%, ≥5%, ≥10% TC [10]	–
PD-L1 cut-off UC	≥25% TC or IC [4]	≥10 CPS^b [32]	≥1%, ≥5% TC [11]	≥5% IC [12, 22]
FDA regulatory status	Approved complementary diagnostic in UC	Approved companion diagnostic in NSCLC	Approved complementary diagnostic in NSCLC	Approved complementary diagnostic in NSCLC and UC

^aVENTANA SP263 is also approved for use with nivolumab and pembrolizumab in NSCLC patients (CE mark only; not FDA approved) [19]
^bPreviously reported as, and equivalent to ≥1%, ≥10% or ≥ 50% CPS [33]
CPS combined positive score evaluating both TC and IC, HNSCC head and neck squamous cell carcinoma, IC tumor-infiltrating immune cell, NSCLC non-small cell lung cancer, PD-L1 programmed cell death ligand-1, TC tumor cell, UC urothelial carcinoma

ISSN: 1746-1596