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Introduction <p>Esophageal squamous cell carcinoma (ESCC) accounts for approximately 90% of all esophageal cancer cases and is associated with poor prognosis. However, recent advancements have transformed the treatment landscape. Tislelizumab, a humanized immunoglobulin&#xa0;G4 (IgG4) anti-programmed cell death protein&#xa0;1 (PD-1) monoclonal antibody, was developed to overcome resistance mechanisms by minimizing binding to FcγR on macrophages. The RATIONALE-302 clinical trial showed statistically significant survival benefits of tislelizumab over chemotherapy in second-line ESCC highlighting the necessity of evaluating comparative efficacy with existing treatments. This study aimed to identify trials evaluating anti-PD-1 therapies for second-line ESCC and indirectly estimate the relative efficacy of tislelizumab versus existing anti-PD-1 therapies.</p> Methods <p>A systematic literature review (SLR) was originally conducted in 2021 then updated in 2022 and 2023. A feasibility assessment (FA) was undertaken to evaluate required assumptions for indirect treatment comparisons (ITCs) and determined that anchored simulated treatment comparisons (STCs) were the most appropriate methodology. Assessed outcomes included overall survival (OS), progression-free survival (PFS), and grade ≥ 3 treatment-related adverse events (TRAEs). Analyses were conducted in the hazard ratio scale for OS and PFS and in the odds ratio scale for TRAEs, whilst uncertainty was expressed in 95% confidence intervals.</p> Results <p>The SLR identified 13 studies, six of which evaluated immunotherapies and were included in the FA. All studies were deemed similar and considered in the ITC, except for RAMONA, which differed substantially in study design, inclusion criteria, and patient characteristics. Indirect estimates obtained from the STCs were not statistically significant, except for the comparison of TRAEs with tislelizumab versus camrelizumab, where tislelizumab was more favorable.</p> Conclusions <p>Tislelizumab appears comparable to existing anti-PD-1 therapies (nivolumab, pembrolizumab, camrelizumab, and sintilimab) in OS, PFS, and TRAEs of grade ≥ 3 for patients receiving second-line treatment for ESCC with a potentially more favorable TRAE grade ≥ 3 profile than camrelizumab that requires confirmation.</p> Trial Registration <p>NCT03430843.</p>

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Comparative Efficacy and Safety of Tislelizumab in Second-Line Esophageal Squamous Cell Carcinoma: Systematic Literature Review and Simulated Treatment Comparisons

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月3日

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  • Jaffer A. Ajani,
  • Kaijun Wang,
  • Georgios F. Nikolaidis,
  • JeanPierre Coaquira Castro,
  • Maximiliano Augusto Novis de Figueiredo,
  • Jong-Mu Sun,
  • Konstantinos Soulanis,
  • Anastasios Tasoulas,
  • Lin Zhan

摘要

Introduction

Esophageal squamous cell carcinoma (ESCC) accounts for approximately 90% of all esophageal cancer cases and is associated with poor prognosis. However, recent advancements have transformed the treatment landscape. Tislelizumab, a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody, was developed to overcome resistance mechanisms by minimizing binding to FcγR on macrophages. The RATIONALE-302 clinical trial showed statistically significant survival benefits of tislelizumab over chemotherapy in second-line ESCC highlighting the necessity of evaluating comparative efficacy with existing treatments. This study aimed to identify trials evaluating anti-PD-1 therapies for second-line ESCC and indirectly estimate the relative efficacy of tislelizumab versus existing anti-PD-1 therapies.

Methods

A systematic literature review (SLR) was originally conducted in 2021 then updated in 2022 and 2023. A feasibility assessment (FA) was undertaken to evaluate required assumptions for indirect treatment comparisons (ITCs) and determined that anchored simulated treatment comparisons (STCs) were the most appropriate methodology. Assessed outcomes included overall survival (OS), progression-free survival (PFS), and grade ≥ 3 treatment-related adverse events (TRAEs). Analyses were conducted in the hazard ratio scale for OS and PFS and in the odds ratio scale for TRAEs, whilst uncertainty was expressed in 95% confidence intervals.

Results

The SLR identified 13 studies, six of which evaluated immunotherapies and were included in the FA. All studies were deemed similar and considered in the ITC, except for RAMONA, which differed substantially in study design, inclusion criteria, and patient characteristics. Indirect estimates obtained from the STCs were not statistically significant, except for the comparison of TRAEs with tislelizumab versus camrelizumab, where tislelizumab was more favorable.

Conclusions

Tislelizumab appears comparable to existing anti-PD-1 therapies (nivolumab, pembrolizumab, camrelizumab, and sintilimab) in OS, PFS, and TRAEs of grade ≥ 3 for patients receiving second-line treatment for ESCC with a potentially more favorable TRAE grade ≥ 3 profile than camrelizumab that requires confirmation.

Trial Registration

NCT03430843.