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World J Gastroenterol. Apr 21, 2023; 29(15): 2261-2271
Published online Apr 21, 2023. doi: 10.3748/wjg.v29.i15.2261
Table 2 Current Food and Drug Administration-approved immunotherapy agents in second-line use post-progression on sorafenib in advanced hepatocellular carcinoma
Immunotherapy agent
Checkmate 040 (NCT01658878)
Keynote 224 (NCT02702414)
DrugsIpilimumab, nivolumabPembrolizumab
Drug class combinationCTLA-4 inhibitor, PD-1 inhibitorPD-1 inhibitor
Study populationChild-Pugh A, ECOG score 0/1, prior systemic therapy with sorafenib or intolerance to sorafenibChild-Pugh A, ECOG score 0/1, prior systemic therapy with sorafenib or intolerance to sorafenib
Overall survival22.8mo (95%CI: 9.4-not reached)12.9 mo (95%CI: 9.7-15.5)
Median progression free survival3.9 mo (95%CI: 2.6-8.3)4.9 mo (95%CI: 3.4-7.2)
Overall response rate32%18%
Most common treatment related AERash, hepatitis, hypothyroidismHypothyroidism, hepatitis, adrenal insufficiency
Child-Pugh score B group studiedNo data availableRetrospective data available
FDA approvalYesYes