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.