Hepatic safety of sintilimab versus pembrolizumab in advanced non-small cell lung cancer: a retrospective observational cohort study.

Authors

Pan Ma, Yumeng Zhou, Xin Zhang, Quanfeng Zhao, Yu Peng, Hailong Jiang, Linli Xie, Yan Liao

Published in

Frontiers in immunology. Volume 17. Pages 1808972. Epub Jun 24, 2026.

Abstract

Sintilimab and Pembrolizumab are widely used in non-small cell lung cancer (NSCLC), yet direct comparisons of their safety profiles, particularly hepatotoxicity, are lacking. Given the differences in binding affinities and the complexity of patients in real-world settings, this study aims to provide a head-to-head comparison of their hepatic safety to guide clinical decision-making.
We conducted a retrospective observational cohort study to evaluate potential differences in liver function damage between Sintilimab and Pembrolizumab, administered as monotherapy or combination with chemotherapy, in patients with advanced NSCLC. Patients treated with Sintilimab or Pembrolizumab at Southwest Hospital were included. Propensity score matching (PSM) was performed using height and treatment regimen as covariates to balance between-group differences. Cox proportional hazards models and Kaplan-Meier curves were used to assess differences in hepatotoxicity. Benjamini-Hochberg correction was applied for multiple comparisons across liver function indicators.
A total of 222 patients with advanced NSCLC treated with Sintilimab or Pembrolizumab were included. The combination chemotherapy regimens did not differ significantly between the two groups. The overall incidence of hepatic-related adverse events (AEs) was 17.1% in the Sintilimab group and 18.1% in the Pembrolizumab group. No significant differences were observed in AEs related to liver function indicators, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and total bilirubin (TBIL). Kaplan-Meier analysis revealed similar risks of hepatotoxicity between the two treatment regimens. No Grade 3 or higher hepatotoxicity events were observed in either group.
In this retrospective observational cohort of Chinese patients with advanced NSCLC, Sintilimab and Pembrolizumab demonstrated comparable hepatic safety profiles, with no significant difference in the incidence, timing, or severity of hepatotoxicity. These findings suggest that Sintilimab may represent a clinically acceptable PD-1 inhibitor option without evidence of increased hepatic risk compared with Pembrolizumab in this setting. Further prospective, multi-center studies with larger and multi-ethnic cohorts are warranted to validate these findings.

PMID:
42421963
Bibliographic data and abstract were imported from PubMed on 09 Jul 2026.

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