Clinical trials assessing PD-1 or PD-L1 immune checkpoint inhibitors as monotherapy in NSCLC.

Table 1: Clinical trials assessing PD-1 or PD-L1 immune checkpoint inhibitors as monotherapy in NSCLC.

Clinical Trials	Lines of Treatment	Phase	Sample Size	ORR (%)	PFS (Months)	OS (Months)	AEs ≥ 3 (%)
KEYNOTE 10: Pembrolizumab vs. Docetaxel	≥ 2	Two	1034
^*Total Population				18 vs. 18 vs. 9	3.9 vs. 4.0 vs. 4.0	10.4 vs. 12.7 vs. 8.5	13 vs. 16 vs. 35
PD-L1 ≥ 50%				30 vs. 29 vs. 8	5.0 vs. 5.2 vs. 4.1	14.9 vs. 17.3 vs. 8.2
KEYNOTE 024: Pembrolizumab vs. Chemotherapy	1	Three	305	45.5 vs. 29.8	10.3 vs. 6.0	24 mths OS - 51.5% vs. 34.5%	21.4 vs. 20.7
PD-L1 ≥ 50%
Checkmate 017 (sq-NSCLC): Nivolumab vs. Docetaxel	≥ 2	Three	260	20 vs. 9	3.5 vs. 2.8	9.2 vs. 6.0	7 vs. 54
						1 yr OS - 80.2% vs. 72.4%
Checkmate 057 (nonsq-NSCLC): Nivolumab vs. Docetaxel	≥ 2	Three	582	19 vs. 12	2.3 vs. 4.2	12.2 vs. 9.4	10 vs. 54
					18 mths OS: 39% vs. 23%
Checkmate 026: Nivolumab vs. Platinum-doublet	1	Three	541	26 vs. 34	4.2 vs. 5.9	14.2 vs. 13.2	18 vs. 51
OAK: Atezolizumab vs. Docetaxel	≥ 2	Three	850
Total Population				14 vs. 13	2.8 vs. 4.0	13.8 vs. 9.6	15 vs. 43
PD-L1 ≥ 1%						15.7 vs. 10.3
Undetectable PD-L1						12.6 vs. 8.9
ATLANTIC: Single-arm Durvalumab	≥ 2	Two					10.2
Cohort 2 - PD-L1 ≥ 25%			149	16.4	3.3	10.9
PD-L1 ≤ 25%			94	7.5	1.9	9.3
Cohort 3 - PD-L1 ≥ 90%			67	30.9	2.4	NR

ORR: Overall Response Rate; PFS: Progression Free Survival; OS: Overall Survival; AEs: Adverse Effects; NR: Not reached.

^*Pembrolizumab 2 mg/kg vs. Pembrolizumab 10 mg/kg vs. Docetaxel 75 mg/m².