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. 2023 Sep 22;23(2):316–329. doi: 10.17998/jlc.2023.09.04

Table 1.

Results of clinical trials for immunotherapy in patients with advanced HCC

Study Drug Phase Setting Median OS HR for OS Median PFS ORR
IMbrave15042 Atezolizumab and bevacizumab vs. sorafenib III First-line 19.2 mo for atezolizumab and bevacizumab vs. 13.4 mo for sorafenib 0.66 6.9 mo for atezolizumab and bevacizumab vs. 4.3 mo for sorafenib 30% for atezolizumab and bevacizumab vs. 11% for sorafenib
HIMALAYA46 Durvalumab and tremelimumab or durvalumab vs. sorafenib III First-line 16.43 mo for STRIDE vs. 13.77 mo for sorafenib 0.78 3.78 mo for STRIDE and 3.65 mo for durvalumab vs. 4.07 for sorafenib 20.1% for STRIDE, 17% for durvalumab vs. 5.1 for sorafenib
ORIENT-3292 Sintilimab and bevacizumab biosimilar IBI305 vs. sorafenib III First-line NR for Sintilimab and IBI305 vs. 10.4 mo for sorafenib 0.57 4.6 mo for Sintilimab and IBI305 vs. 2.8 mo for sorafenib 21% for Sintilimab and IBI305 vs. 4.7% for sorafenib
COSMIC-32193 Cabozantinib and atezolizumab vs. sorafenib III First-line 15.4 mo for cabozantinib and atezolizumab vs. 15.5 mo for sorafenib 0.90 6.8 mo for cabozantinib and atezolizumab vs. 4.2 mo for sorafenib 13% for cabozantinib and atezolizumab vs. 6% for sorafenib
CheckMate 45938 Nivolumab vs. sorafenib III First-line 16.4 mo for nivolumab vs. 14.7 mo for sorafenib 0.85 3.7 mo for nivolumab vs. 3.8 mo for sorafenib 15% for nivolumab and 7% for sorafenib
LEAP-00249 Lenvatinib and pembrolizumab vs. lenvatinib III First-line 21.2 mo for lenvatinib and pembrolizumab vs. 19 mo for lenvatinib 0.83 8.2 mo for lenvatinib and pembrolizumab vs. 8.1 mo for lenvatinib 26.1% for lenvatinib and pembrolizumab vs. 17.5% for lenvatinib
Qin, et al.94 Camrelizumab and rivoceranib vs. sorafenib III First-line 22.1 mo for camrelizumab and rivoceranib vs. 15.2 mo for sorafenib 0.62 5.6 mo for camrelizumab and rivoceranib vs. 3.7 mo for sorafenib 25.4% for camrelizumab and rivoceranib vs. 5.9% for sorafenib
KEYNOTE-2408 Pembrolizumab vs. BSC III Second-line (after sorafenib) 13.9 mo for pembrolizumab vs. 10.6 mo for BSC 0.78 3.0 mo for pembrolizumab vs. 2.8 mo for BSC 18.3% for pembrolizumab vs. 4.4% for BSC
KEYNOTE-39439 Pembrolizumab vs. placebo III Second-line 14.6 mo for pembrolizumab vs. 13.0 mo for placebo 0.79 2.6 mo for pembrolizumab vs. 2.3 mo for placebo 12.7% for pembrolizumab vs. 1.3% for placebo

HCC, hepatocellular carcinoma; OS, overall survival; HR, hazard ratio; PFS, progression-free survival; ORR, objective response rate; mo, months; NR, not reached; BSC, best supportive care.