Table 1.

Past clinical trials on systemic immunotherapy in HCC that resulted in regulatory approval.

Trial Name	Treatment arms	Line of Therapy	Primary Endpoint	ORR	PFS	OS
CHECKMATE 040	Nivolumab* single arm	Second	ORR	15%	N/A	N/A
CHECKMATE 040	Nivolumab + ipilimumab** single arm	Second	ORR	32%	N/A	N/A
IMbrave150	Atezolizumab+bevacizumab vs. sorafenib	First	OS and PFS	29.8 vs. 11.3%	6.8 vs. 4.3 months	19.2 vs. 13.4 months (HR 0.66)
KEYNOTE 224	Pembrolizumab** single arm	Second	ORR	17%	N/A	N/A

^*Initial regulatory approval by the U.S. Food and Drug Administration has been withdrawn by the manufacturer. No approval by the European Medicines Agency.

^**Regulatory approval by the U.S. Food and Drug Administration but not the European Medicines Agency.

HR, hazard ratio; N/A, not available; ORR, overall response rate; OS, overall survival; PFS, progression-free survival.