2

Published clinical trials utilizing first-line immune checkpoint inhibitors

Lead author, yearStudy typeSolid tumor typeInterventionBiomarkerOutcome*
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 		PembrolizumabPD-L1=1%
(22C3 IHC) 		ORR 27% OS 22.1 m
Hellmann 201725 CheckMate-012 Open-label,
phase 1 		Advanced
NSCLC 		Nivolumab+ipilimumabPD-L1 stratified
(28-8 IHC) 		ORR 38–47%
(PD-L1=1%=ORR 57%)
Balar 201711Open-label,
phase 2 		Advanced
urothelial 		AtezolizumabPD-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 201610Open-label,
phase 2 		Advanced
Merkel cell 		PembrolizumabNoneORR 56%
Reck 201634Randomized-controlled, phase 3Extensive
SCLC 		Etoposide/platinum
+/- ipilimumab 		NoneOS 11.0 m vs. 10.9 m NS
Postow 201523 CheckMate-069 Open-label, phase 1Advanced melanoma,
BRAF-WT 		Nivolumab
+ipilimumab 		NoneORR 61%
Robert 20156 CheckMate-066 Randomized-controlled, phase 3Advanced melanoma,
BRAF-WT 		Nivolumab
vs. dacarbazine 		None12 m OS 72.9% vs. 42.1%
Aglietta 201435Open-label,
phase 1b 		Advanced
pancreatic 		Tremelimumab
+gemcitabine 		NoneORR 5.9% OS 7.4 m
Reck 201333Randomized-controlled, phase 2Extensive
SCLC 		Paclitaxel/carboplatin
+/- ipilimumab (phased/concurrent) 		NoneOS 9.9 m vs. 12.9 m vs. 9.1 m

*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.