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Single-agent immune checkpoint inhibitors
Source: Primary Liver Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 17, 2025 · Captured 2026-09-09.
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Evidence (single-agent immune checkpoint inhibitors):
The HIMALAYA trial discussed above analyzed end points for patients randomly assigned to the durvalumab monotherapy arm (n = 389) or the sorafenib monotherapy arm (n = 389).[12]
The HIMALAYA trial discussed above analyzed end points for patients randomly assigned to the durvalumab monotherapy arm (n = 389) or the sorafenib monotherapy arm (n = 389).[12]
The median OS for patients who received durvalumab monotherapy (16.56 months; 95% CI, 14.06–19.12) was noninferior to the median OS for patients who received sorafenib monotherapy (13.77 months; 95% CI, 12.25–16.13) (HR, 0.86; 95.67% CI, 0.73–1.03; noninferiority margin, 1.08).[12][Level of evidence B3]
Source links and citations
The HIMALAYA trial discussed above analyzed end points for patients randomly assigned to the durvalumab monotherapy arm (n = 389) or the sorafenib monotherapy arm (n = 389).[12]
The objective response rate was 8.2% in the durvalumab arm and 4.9% in the sorafenib arm.
The HIMALAYA trial discussed above analyzed end points for patients randomly assigned to the durvalumab monotherapy arm (n = 389) or the sorafenib monotherapy arm (n = 389).[12]
Grade 3 or higher treatment-related adverse events occurred in 37.1% of patients who received durvalumab.
The randomized, open-label, phase III CheckMate 459 trial (NCT02576509) included 743 patients with Child-Pugh class A liver disease and unresectable HCC who were naïve to systemic treatment. Patients were randomly assigned in a 1:1 ratio to receive either nivolumab (n = 371) or sorafenib (n = 372).[13]
Source links and citations
The randomized, open-label, phase III CheckMate 459 trial (NCT02576509) included 743 patients with Child-Pugh class A liver disease and unresectable HCC who were naïve to systemic treatment. Patients were randomly assigned in a 1:1 ratio to receive either nivolumab (n = 371) or sorafenib (n = 372).[13]
The median OS was 16.4 months (95% CI, 13.9–18.4) in the nivolumab arm and 14.7 months (95% CI, 11.9–17.2) in the sorafenib arm (HR, 0.85; 95% CI, 0.72–1.02; P = .075).[13][Level of evidence B3]
Source links and citations
The randomized, open-label, phase III CheckMate 459 trial (NCT02576509) included 743 patients with Child-Pugh class A liver disease and unresectable HCC who were naïve to systemic treatment. Patients were randomly assigned in a 1:1 ratio to receive either nivolumab (n = 371) or sorafenib (n = 372).[13]
The objective response rate was 15% (95% CI, 12%–19%) in the nivolumab arm and 7% (95% CI, 5%–10%) in the sorafenib arm.
The randomized, open-label, phase III CheckMate 459 trial (NCT02576509) included 743 patients with Child-Pugh class A liver disease and unresectable HCC who were naïve to systemic treatment. Patients were randomly assigned in a 1:1 ratio to receive either nivolumab (n = 371) or sorafenib (n = 372).[13]
Grade 3 or higher treatment-related adverse events occurred in 23% of patients who received nivolumab and 49% of patients who received sorafenib.
Studies cited in this source section
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Preserved source evidence · Not medical advice