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Background <p>Pembrolizumab monotherapy is the standard first-line treatment for advanced non-small-cell lung cancer (NSCLC) with programmed cell death ligand-1 (PD-L1) expression ≥&#xa0;50%. However, long-term effectiveness and safety in real-world populations remain underexplored.</p> Methods <p>We systematically searched PubMed, Embase, and the Cochrane Library through February 2025 for real-world studies reporting outcomes of first-line pembrolizumab monotherapy in patients with advanced NSCLC and PD-L1 ≥&#xa0;50%, excluding those with EGFR/ALK alterations. Primary outcomes were pooled mean overall survival (OS), timepoint-specific OS rates, and progression-free survival. Secondary outcomes included adverse event rates and hazard ratios (HRs) for OS based on age, Eastern Cooperative Oncology Group performance status, PD-L1 intensity, and brain metastases. Kaplan–Meier curves were digitally reconstructed using R.</p> Results <p>In total, 12 studies encompassing 17,506 patients were included. The pooled mean OS was 21.0 months (95% confidence interval [CI] 16.9–25.1), and the 60-month OS rate was 29.0%. Mean progression-free survival was 8.7 months (95% CI 6.3–11.0). Any-grade and grade ≥3 adverse events occurred in 52% and 12% of patients, respectively. Age ≥70 years was associated with worse OS (HR 1.26; 95% CI 1.23–1.29). Eastern Cooperative Oncology Group status ≥2 was also linked to poorer outcomes (HR 2.05; 95% CI 1.04–4.05). No significant OS difference was observed for PD-L1 or brain metastases.</p> Conclusions <p>Real-world evidence confirms the long-term effectiveness and safety of pembrolizumab monotherapy for advanced NSCLC with PD-L1 ≥50%. Survival outcomes closely mirrored those from previous trials, supporting the generalizability of pembrolizumab’s benefit across routine practice.</p>

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Real-World Long-Term Outcomes of First-Line Pembrolizumab in Advanced PD-L1 ≥ 50% NSCLC: A Systematic Review and Meta-analysis

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月5日

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  • Guilherme Franceschini Machado,
  • Iago T. C. Grillo,
  • Paula Duarte D’ambrosio,
  • Victoria Trasatti Romao,
  • Lorena Escalante Romero,
  • Tulio Caldonazo,
  • Felipe S. Passos

摘要

Background

Pembrolizumab monotherapy is the standard first-line treatment for advanced non-small-cell lung cancer (NSCLC) with programmed cell death ligand-1 (PD-L1) expression ≥ 50%. However, long-term effectiveness and safety in real-world populations remain underexplored.

Methods

We systematically searched PubMed, Embase, and the Cochrane Library through February 2025 for real-world studies reporting outcomes of first-line pembrolizumab monotherapy in patients with advanced NSCLC and PD-L1 ≥ 50%, excluding those with EGFR/ALK alterations. Primary outcomes were pooled mean overall survival (OS), timepoint-specific OS rates, and progression-free survival. Secondary outcomes included adverse event rates and hazard ratios (HRs) for OS based on age, Eastern Cooperative Oncology Group performance status, PD-L1 intensity, and brain metastases. Kaplan–Meier curves were digitally reconstructed using R.

Results

In total, 12 studies encompassing 17,506 patients were included. The pooled mean OS was 21.0 months (95% confidence interval [CI] 16.9–25.1), and the 60-month OS rate was 29.0%. Mean progression-free survival was 8.7 months (95% CI 6.3–11.0). Any-grade and grade ≥3 adverse events occurred in 52% and 12% of patients, respectively. Age ≥70 years was associated with worse OS (HR 1.26; 95% CI 1.23–1.29). Eastern Cooperative Oncology Group status ≥2 was also linked to poorer outcomes (HR 2.05; 95% CI 1.04–4.05). No significant OS difference was observed for PD-L1 or brain metastases.

Conclusions

Real-world evidence confirms the long-term effectiveness and safety of pembrolizumab monotherapy for advanced NSCLC with PD-L1 ≥50%. Survival outcomes closely mirrored those from previous trials, supporting the generalizability of pembrolizumab’s benefit across routine practice.