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Background <p>A substantial number of patients with metastatic melanoma (MM) treated with anti-PD-1 monotherapy have initial stable disease (SD), yet the real-world prognosis of these patients remains unclear.</p> Methods <p>In this nationwide cohort study, we analysed real-world outcomes of patients with MM treated with pembrolizumab in Denmark. Focusing on patients with initial SD, we assessed best overall response (BOR), progression-free survival (PFS), and overall survival (OS) and identified predictors of survival in multivariable analyses.</p> Results <p>Out of 1048 included patients, 233 (22.2%) had initial SD with a median PFS and OS of 14.7 and 50.1 months. Subsequent partial response (PR) or complete response (CR) was developed by 44 (18.9%) and 52 (22.3%) patients showing significantly improved PFS compared to patients with continued SD (PR: HR 0.52, 95% CI 0.34–0.81, <i>p</i> = 0.003; CR: HR 0.15, 95% CI 0.07–0.32, <i>p</i> &lt; 0.001) and survival rates comparable to patients with initial PR and CR, respectively. Furthermore, 49 (21.0%) patients showed continued disease control (median follow-up of 82.3 months). For 51.0% of these patients, the last dose of pembrolizumab was administered during SD with a median treatment duration of 12.4 months.</p> Conclusions <p>Of patients with initial SD, 40% developed a subsequent objective response with improved long-term prognosis comparable to patients with initial response. More than 20% exhibited continued disease control.</p>

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Long-term clinical outcome of patients with metastatic melanoma and initial stable disease during anti-PD-1 checkpoint inhibitor immunotherapy with pembrolizumab

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月26日

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  • Inge Mansfield Noringriis,
  • Marco Donia,
  • Kasper Madsen,
  • Henrik Schmidt,
  • Charlotte Aaquist Haslund,
  • Lars Bastholt,
  • Inge Marie Svane,
  • Eva Ellebaek

摘要

Background

A substantial number of patients with metastatic melanoma (MM) treated with anti-PD-1 monotherapy have initial stable disease (SD), yet the real-world prognosis of these patients remains unclear.

Methods

In this nationwide cohort study, we analysed real-world outcomes of patients with MM treated with pembrolizumab in Denmark. Focusing on patients with initial SD, we assessed best overall response (BOR), progression-free survival (PFS), and overall survival (OS) and identified predictors of survival in multivariable analyses.

Results

Out of 1048 included patients, 233 (22.2%) had initial SD with a median PFS and OS of 14.7 and 50.1 months. Subsequent partial response (PR) or complete response (CR) was developed by 44 (18.9%) and 52 (22.3%) patients showing significantly improved PFS compared to patients with continued SD (PR: HR 0.52, 95% CI 0.34–0.81, p = 0.003; CR: HR 0.15, 95% CI 0.07–0.32, p < 0.001) and survival rates comparable to patients with initial PR and CR, respectively. Furthermore, 49 (21.0%) patients showed continued disease control (median follow-up of 82.3 months). For 51.0% of these patients, the last dose of pembrolizumab was administered during SD with a median treatment duration of 12.4 months.

Conclusions

Of patients with initial SD, 40% developed a subsequent objective response with improved long-term prognosis comparable to patients with initial response. More than 20% exhibited continued disease control.