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

Biomarker Research

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

Bioassay	Drug	Disease Target	Cut Off^b	ORR+^c	ORR-^d	SENS^e	SPEC^f
Roche Ventana SP263	Durvalumab	NSCLC^a	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 22C3^g	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%

^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

ISSN: 2050-7771