Use of programmed cell death protein ligand 1 assay to predict the outcomes of non-small cell lung cancer patients treated with immune checkpoint inhibitors

Table 1 Correlation between nivolumab activity and outcome and programmed cell death protein ligand 1 immunohistochemestry score

Author/study	Marker antibody	Tumor type	Treatment line	PD-L1 cutoff	N pts	Response (%)	mPFS mo (95%CI)	mOS mo (95%CI)
Nivolumab
Gettinger et al[8] Phase I	Dako 28-8	NSCLC	> 2	≥ 5 %	33	15	3.3 (1.8-7.5)	7.8 (5.6-21.7)
				< 5%	35	14	1.8 (1.7-2.3)	10.5 (5.2-14.8)
Rizvi et al[9] CM 063 Phase II	Dako 28-8	Squamous	≥ 2	≥ 5%	25	24	NR	NR
		NSCLC		< 5%	51	14	NR	NR
Brahmer et al[10] CM 017 Phase III	Dako 28-8	Squamous	> 1	≥ 10%	36	19	3.7 (NR)	11 (NR)
		NSCLC		< 10%	81	16	2.3 (NR)	8.2 (NR)
				≥ 5%	42	21	4.8 (NR)	10 (NR)
				< 5%	75	15	2.2 (NR)	8.5 (NR)
				≥ 1%	63	17	3.3 (NR)	9.3 (NR)
				< 1%	54	17	3.1 (NR)	8.7 (NR)
Borgheai et al[11] CM 057 Phase III	Dako 28-8	Non squamous	> 1	≥ 10%	86	37	5.0 (NR)	19.9 (NR)
		NSCLC		< 10%	145	11	2.1 (NR)	9.9 (NR)
				≥ 5%	95	34	5.0 (NR)	19.4 (NR)
				< 5%	136	14	2.1 (NR)	9.8 (NR)
				≥ 1%	123	31	4.2 (NR)	17.7 (NR)
				< 1%	108	9	2.1 (NR)	10.5 (NR)
Gettinger et al[12] CM 012 Phase I	Dako 28-8	NSCLC	1	≥ 50%	12	50	NR	NR
				< 50%	34	15	NR	NR
				≥ 25%	18	44	NR	NR
				< 25%	28	11	NR	NR
				≥ 10%	20	40	NR	NR
				< 10%	26	12	NR	NR
				≥ 5%	26	31	NR	NR
				< 5%	20	15	NR	NR
				≥ 1%	32	28	NR	NR
				< 1%	14	14	NR	NR
Rizvi et al[13] CM012 Phase I	Dako 28-8	NSCLC	1	≥ 1%	23	48	6.0 (< 0.1+-21.8)	20.2 (6.2-28.8+)
				< 1%	21	43	5.2 (0.9+-28.7+)	19.2 (4.5-29.7+)
Socinski et al[14] CM 026 Phase III	Dako 28-8	NSCLC	1	≥ 5%	NR	76.80	NR	NR
				< 5%	NR	NR	NR	NR
				≥ 25%	NR	48.70	NR	NR
				< 25%	NR	NR	NR	NR
				≥ 50%	NR	32.50	NR	NR
				< 50%	NR	NR	NR	NR
				≥ 75%	NR	20.70	NR	NR
				< 75%	NR	NR	NR	NR

CM: CheckMate; NR: Not reported; pts: Patients; NSCLC: Non-small cell lung cancer; PD-L1: Programmed cell death protein ligand 1; mPFS: Median progression free survival; mOS: Median overall survival.