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. 2022 Feb;13(1):426–437. doi: 10.21037/jgo-21-274

Table 3. Single agent immunotherapy trials in HCC.

Trial Author No. of patients Study arm ECOG Child-Pugh score Primary end point
Sangro et al. (42) 21 Tremelimumab in chronic hepatitis C 0 or 1 A or B Safety and efficacy: TTP was 6.48 months (95% CI, 3.95–9.14) and median OS was 8.2 months (95% CI, 4.64–21.34)
Wainberg et al. (45) 40 Durvalumab (phase I/II) 0 or 1 A Safety and efficacy: median OS 13.2 months (6.3–21.1); ORR 10.3% (2.9–24.2)
Keynote-240 Finn et al. (46) 413 Pembrolizumab vs. placebo (phase III, second-line setting) 0 or 1 A OS: 13.9 months (95% CI, 11.6–16.0) for pembro vs. 10.6 months (95% CI, 8.3–13.5) for placebo (HR =0.781; 95% CI, 0.611–0.998; P=0.0238); PFS: 3.0 months (95% CI, 2.8–4.1) vs. 2.8 months (95% CI, 1.6–3.0)
CheckMate-459 Yau et al. (44) 743 Nivolumab vs. sorafenib (phase III, first-line setting) OS: 16.4 months for nivolumab vs. 14.7 months for sorafenib (HR =0.85; 95% CI, 0.72–1.02; P=0.0752); ORR: 15% with nivolumab (14 patients with CR) vs. 7% with sorafenib (5 patients with CR)

HCC, hepatocellular carcinoma; ORR, objective response rate; OS, overall survival; HR, hazard ratio; CR, complete response.