2.

Published clinical trials utilizing first-line immune checkpoint inhibitors

Lead author, year	Study type	Solid tumor type	Intervention	Biomarker	Outcome*
*All results are significant unless otherwise noted. IHC: immunohistochemistry. m: month, NS: not significant. ORR: overall response rate. OS: overall survival. PD-L1: programmed death ligand-1. PFS: progression-free survival. SCLC: small cell lung cancer. WT: wild-type.
Carbone 201718 CheckMate-026	Open-label, phase 3	Advanced NSCLC	Nivolumab vs. chemotherapy	PD-L1≥1% (28-8 IHC)	PFS 4.2 m vs. 5.9 m
Hui 201739 KEYNOTE-001	Open-label, phase 1b	Advanced NSCLC	Pembrolizumab	PD-L1≥1% (22C3 IHC)	ORR 27% OS 22.1 m
Hellmann 201725 CheckMate-012	Open-label, phase 1	Advanced NSCLC	Nivolumab+ipilimumab	PD-L1 stratified (28-8 IHC)	ORR 38–47% (PD-L1≥1%=ORR 57%)
Balar 201711	Open-label, phase 2	Advanced urothelial	Atezolizumab	PD-L1 stratified (SP142)	ORR 23% (No PD-L1 association)
Langer 201636 KEYNOTE-021	Open-label, phase 2	Advanced NSCLC	Platinum doublet +/- pembrolizumab	PD-L1 stratified (22C3 IHC)	ORR 55% vs. 29%
Reck 201617 KEYNOTE-024	Open-label, phase 3	Advanced NSCLC	Pembrolizumab vs. chemotherapy	PD-L1≥50% (22C3 IHC)	PFS 10.3 m vs. 6.0 m
Nghiem 201610	Open-label, phase 2	Advanced Merkel cell	Pembrolizumab	None	ORR 56%
Reck 201634	Randomized-controlled, phase 3	Extensive SCLC	Etoposide/platinum +/- ipilimumab	None	OS 11.0 m vs. 10.9 m NS
Postow 201523 CheckMate-069	Open-label, phase 1	Advanced melanoma, BRAF-WT	Nivolumab +ipilimumab	None	ORR 61%
Robert 20156 CheckMate-066	Randomized-controlled, phase 3	Advanced melanoma, BRAF-WT	Nivolumab vs. dacarbazine	None	12 m OS 72.9% vs. 42.1%
Aglietta 201435	Open-label, phase 1b	Advanced pancreatic	Tremelimumab +gemcitabine	None	ORR 5.9% OS 7.4 m
Reck 201333	Randomized-controlled, phase 2	Extensive SCLC	Paclitaxel/carboplatin +/- ipilimumab (phased/concurrent)	None	OS 9.9 m vs. 12.9 m vs. 9.1 m