Nivolumab did not improve overall survival in patients with advanced hepatocellular carcinoma

1. The median overall survival for nivolumab was 16.4 months and for sorafenib was 14.7 months

2. Patients receiving nivolumab experienced adverse events such as fatigue, pruritus, rash, aspartate aminotransferase increase

Evidence Rating Level: 1 (Excellent)

Study Rundown: There has been further investigation on the use of immuno-oncology monotherapy to address the inflammation and immunosuppression commonly seen in hepatocellular carcinoma. In 2015, sorafenib was the only approved drug to treat hepatocellular carcinoma. This study aimed to evaluate the effectiveness and safety of nivolumab monotherapy compared with sorafenib monotherapy as first line therapy for patients with advanced hepatocellular carcinoma. The primary end point (overall survival (OS)) was longer in the nivolumab group (16.4 months) compared to the sorafenib group (14.7) at the 22.8 months but not statistically significant different (p=0.075). Commonly reported side effects included fatigue, pruritus, rash, aspartate aminotransferase increase. Overall, this study demonstrated that nivolumab as first line therapy for advanced hepatocellular carcinoma did not improve patients’ overall survival. Further investigations may be needed to better understand long-term effects of nivolumab.

Click to read the study in The Lancet Oncology

Click to read an accompanying invited commentary in The Lancet Oncology

Relevant Reading: Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma

In-Depth [randomized controlled trial]: Patients were eligible if they had advanced hepatocellular carcinoma not eligible for, or whose disease progressed after, surgery or local treatment; with no previous systemic therapy received for hepatocellular carcinoma. The primary endpoint was the overall survival calculated based on the intention-to-treat population. In total, 743 were randomly, equally assigned to each treatment group (371 to nivolumab, 372 to sorafenib). The median follow-up for each group were the following: nivolumab (15.2 months, interquartile range [IQR]: 5.7 – 28.0) and sorafenib (13.4 months, IQR: 5.7 – 25.9).  At a minimum follow-up period for the study of 22.8 months, the median overall survival (OS) for nivolumab was 16.4 months (95% confidence interval [CI]:  13.9-18.4) and sorafenib was 14.7 months (95% CI: 11.9 -17.2). The hazard ratio [HR] was 0.85 (95% CI 0.72-1.02), p=0.075. 242 (66%) patients have died in the nivolumab group compared to the 270 (74%) in the sorafenib group with the main cause being disease progression. 4 deaths in the nivolumab group have been assessed as related to the drug: liver failure (n=2), hepatoxicity (n=1), subarachnoid hemorrhage (n=1).

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