Nivolumab plus ipilimumab improves survival over lenvatinib or sorafenib in liver cancer

1. Median overall survival was 3.1 months greater in the nivolumab plus ipilimumab group.

2. Grade 3-4 treatment-related adverse events were similar between both groups.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Patients with unresectable hepatocellular carcinoma (HCC) face a poor prognosis, and current treatments offer limited long-term benefits. There is a need for more effective first-line therapies in this population. This randomized controlled trial aimed to compare the efficacy and safety of nivolumab plus ipilimumab versus lenvatinib or sorafenib in treatment-naive patients with unresectable HCC. The primary outcome of this study was overall survival, while a key secondary outcome was the safety profile of treatments. According to study results, nivolumab plus ipilimumab significantly improved overall survival at 24 and 36 months compared to lenvatinib or sorafenib. Although this study was well done, it was limited by increased rates of treatment-related hepatic failure with the immunotherapy combination.

Click to read the study in The Lancet

Relevant Reading: Tremelimumab plus Durvalumab in Unresectable Hepatocellular Carcinoma

In-depth [randomized controlled trial]: Between Jan 6, 2020, and Nov 8, 2021, 1148 patients were assessed for eligibility across 163 hospitals in 25 countries. Included were patients ≥ 18 with unresectable HCC, ≥ 1 untreated lesion, a Child–Pugh score of 5-6, and an ECOG performance status of 0-1. Altogether, 668 patients (335 in nivolumab plus ipilimumab and 333 in lenvatinib or sorafenib) were included in the final analysis. The primary outcome of overall survival was significantly improved in the nivolumab plus ipilimumab group compared to the control group (median survival 23.7 months vs. 20.6 months, hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.65-0.96). The secondary outcome of safety showed comparable rates of grade 3–4 treatment-related adverse events between groups (41% vs. 42%). Overall, findings from this study suggest that nivolumab plus ipilimumab offers a survival benefit and manageable safety profile, supporting its use as a first-line treatment for unresectable hepatocellular carcinoma.

Image: PD

©2025 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.