Table 1.

Summary of the design of phase II/III studies leading to IO registrations in NSCLC

Study	Phase	Agent	Control arm	Line of therapy	PD-L1 selection	Primary endpoint
CM026	III	Nivo.	Plat. Cx	1st	PD-L1 ≥ 1%	≥ 5% PD-L1+PFS (m): Nivo vs. Chemo: 4.2 vs. 5.9
KN024	III	Pembro.	Plat. Cx	1st	PD-L1 ≥ 50%	≥ 50% PD-L1+PFS (m): Pembro. vs. Chemo: 10.3 vs. 6.0
KN021G	II	Pembro./Cx	Plat. Cx	1st	None	ORR: Pembro./Cx vs. Chemo: 56.7% vs. 30.2%
BIRCH	II	Atezo.	None	1st	PD-L1 positive	Arm A ORR: ITT: 25%
KN001	Ib	Pembro.	None	1st & ≥ 2nd	None	ORR:	1st	≥ 2nd
						PD-L1 < 1%	10%	9.9%
						PD-L1 ≥ 1%	17.4%	12.9%
						PD-L1 ≥ 50%	58.3%	38.3%
KN010	I/II	Pembro.2 mg/10 mg	Docetaxel	2nd	PD-L1 ≥ 1%	ORR: 30%/29% vs. 8%
CM017	III	Nivo.	Docetaxel	2nd	None	mOS (m): 9.2 vs. 6.0
CM057	III	Nivo.	Docetaxel	2nd	None	mOS (m): 12.2 vs. 9.5
POPLAR	II	Atezo	Docetaxel	2nd	None	mOS (m): ITT group 12.6 vs. 9.7
OAK	III	Atezo	Docetaxel	2nd	None	mOS (m): ITT group 13.8 vs. 9.6

Note: NSCLC, non-small cell lung cancer; PD-L1, programmed death ligand 1.