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Background <p>Adjuvant anti-PD-1 therapy improves outcomes in resected stage IIB/IIC melanoma at high risk of recurrence; however, no randomized head-to-head trial has directly compared pembrolizumab with nivolumab.</p> Objective <p>The objective was to compare the efficacy of pembrolizumab and nivolumab as adjuvant therapies in resected stage IIB/IIC melanoma using an indirect treatment comparison (ITC).</p> Patients and Methods <p>An anchored Bucher ITC was performed linking the results of KEYNOTE-716 and the CheckMate-76K trials. Primary analyses used the most recent follow-up hazard ratios (HRs), with secondary analyses based on the original trial publications.</p> Results <p>The ITC showed no statistically significant differences between pembrolizumab and nivolumab for recurrence-free survival (RFS; HR 0.97, 95% confidence intervals (CI) 0.69–1.35) or distant metastasis-free survival (DMFS; HR 0.81, 95% CI 0.54–1.21). Subgroup analyses for RFS were also nonsignificant: stage IIB HR 0.97, 95% CI 0.62–1.50; stage IIC HR 1.00, 95% CI 0.61–1.65; age &lt; 65 years HR 1.20, 95% CI 0.76–1.89; and age ≥ 65 years HR 0.77, 95% CI 0.47–1.25. Secondary analyses based on the original trial publications yielded nonsignificant estimates that numerically favored nivolumab, with RFS HR 1.48 (95% CI 0.98–2.23) and DMFS HR 1.26 (95% CI 0.74–2.13).</p> Conclusions <p>This ITC demonstrated no statistically significant differences between pembrolizumab and nivolumab for RFS or DMFS in resected stage IIB/IIC melanoma, with consistently null findings across subgroup analyses. Longer follow-up attenuated earlier numerical trends, with effect estimates converging toward unity.</p>

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Indirect Comparison of the Efficacy of Pembrolizumab Versus Nivolumab as Adjuvant Options for Stage IIB/IIC Melanoma

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月8日

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  • Dimitrios A. Andreikos,
  • Iro Argyropoulou,
  • Charalampos Theocharopoulos,
  • Amalia Anastasopoulou,
  • Dimitra Stefanou,
  • Giorgos Lyrarakis,
  • Dirk Schadendorf,
  • Helen Gogas,
  • Dimitrios C. Ziogas

摘要

Background

Adjuvant anti-PD-1 therapy improves outcomes in resected stage IIB/IIC melanoma at high risk of recurrence; however, no randomized head-to-head trial has directly compared pembrolizumab with nivolumab.

Objective

The objective was to compare the efficacy of pembrolizumab and nivolumab as adjuvant therapies in resected stage IIB/IIC melanoma using an indirect treatment comparison (ITC).

Patients and Methods

An anchored Bucher ITC was performed linking the results of KEYNOTE-716 and the CheckMate-76K trials. Primary analyses used the most recent follow-up hazard ratios (HRs), with secondary analyses based on the original trial publications.

Results

The ITC showed no statistically significant differences between pembrolizumab and nivolumab for recurrence-free survival (RFS; HR 0.97, 95% confidence intervals (CI) 0.69–1.35) or distant metastasis-free survival (DMFS; HR 0.81, 95% CI 0.54–1.21). Subgroup analyses for RFS were also nonsignificant: stage IIB HR 0.97, 95% CI 0.62–1.50; stage IIC HR 1.00, 95% CI 0.61–1.65; age < 65 years HR 1.20, 95% CI 0.76–1.89; and age ≥ 65 years HR 0.77, 95% CI 0.47–1.25. Secondary analyses based on the original trial publications yielded nonsignificant estimates that numerically favored nivolumab, with RFS HR 1.48 (95% CI 0.98–2.23) and DMFS HR 1.26 (95% CI 0.74–2.13).

Conclusions

This ITC demonstrated no statistically significant differences between pembrolizumab and nivolumab for RFS or DMFS in resected stage IIB/IIC melanoma, with consistently null findings across subgroup analyses. Longer follow-up attenuated earlier numerical trends, with effect estimates converging toward unity.