Real-World Comparative Effectiveness of Nivolumab versus Pembrolizumab in Patients with Unresectable Hepatocellular Carcinoma

Hsin Yu Kuo, Meng Zhi Han, Chih Hsiang Liao, Yih Jyh Lin, Chung Teng Wang, Shang Hung Chen, Ting Tsung Chang, Po Jun Chen, Sheng Hsiang Lin, Chiung Yu Chen, Chiao Hsiung Chuang, I. Chin Wu, Juei Seng Wu, Tzu Chun Hong, Ming Tsung Hsieh, Yang Cheng Lee, Hung Tsung Wu, Hong Ming Tsai

Research output: Contribution to journalArticlepeer-review


Purpose: Immune checkpoint inhibitors are effective therapies for advanced hepatocellular carcinoma (HCC); however, comparisons of the clinical efficacy and safety profile for these drugs are still scarce. Thus, the aims of this study were to investigate the differences in efficacy and safety between nivolumab and pembrolizumab in unresectable HCC patients in a real-world setting. Patients and methods: A total of 115 patients who received treatment with nivolumab (n = 73) or pembrolizumab (n = 42) in combination with or without tyrosine kinase inhibitors was enrolled. Therapeutic response, survival outcomes, and safety profiles were compared among these groups. Multivariate analysis of survival response was performed using Cox proportional hazards regression. Results: Patients treated with pembrolizumab demonstrated a significantly higher objective response rate than those with nivolumab (38.1% vs. 15.1%; odds ratio 4.18, p = 0.005) regardless of the combination strategies. In addition, pembrolizumab performed a better overall survival (OS) than nivolumab, (34.9 vs. 9.5 months; hazard ratio (HR) = 0.39, p = 0.004). In subgroup analysis, pembrolizumab exhibited favorable OS than nivolumab for monotherapy (HR = 0.16, p = 0.001) or combination therapy (HR = 0.33, p = 0.006) as second-line or later-line (HR = 0.19, p = 0.001) therapy and those with (HR = 0.31, p = 0.006) or without (HR = 0.15, p = 0.004) well-compensated liver disease. The incidence of adverse events was comparable for both treatments. Conclusion: Both pembrolizumab and nivolumab had significant effects for HCC therapy, and pembrolizumab had a significant survival benefit as compared with nivolumab.

Original languageEnglish
Article number2263
Issue number11
Publication statusPublished - 2022 Nov

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science


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