Anti-cancer agents in medicinal chemistry · 2026
Efficacy and Safety of Pembrolizumab as Monotherapy and in Combination with Chemotherapy versus Chemotherapy Alone for Advanced Gastric or Gastroesophageal Junction Cancer: A Systematic Review and Meta-Analysis.
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Bai Zhiqiang, Ding Zujun, Yang Shu, Du Kaixin, Deng Lei, Qian Yechao, Li Hang
Аннотация
INTRODUCTION: This study aimed to assess the effectiveness and safety of pembrolizumab, used either as a monotherapy or in combination with chemotherapy, compared to chemotherapy alone in patients with advanced Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) cancer.
METHODS: A comprehensive literature search was conducted in Web of Science, PubMed, and Embase up to October 13, 2025. Included were Randomized Controlled Trials (RCTs) involving adults with pathologically confirmed advanced GC/GEJ cancer that compared pembrolizumab-based regimens to chemotherapy alone. Data were pooled using random-effects models, and study quality was assessed with the Cochrane Risk of Bias Tool.
RESULTS: The analysis included 10 RCTs with 6,030 patients. Pembrolizumab combined with chemotherapy demonstrated a significant improvement in overall survival (OS: HR 0.80, 95% CI 0.65-0.97, P=0.02, I 2 =72.2%) and progression-free survival (PFS: HR 0.73, 95% CI 0.56-0.95, P=0.01, I2 =81.3%) compared to chemotherapy alone. Benefits in OS and PFS were also observed in subgroups with PD-L1 CPS ≥1 and CPS ≥10. In contrast, pembrolizumab monotherapy did not significantly improve OS (HR 0.99, 95% CI 0.88-1.12, P=0.89, I2 =0%) and was associated with shorter PFS (HR 1.51, 95% CI 1.34-1.71, P<0.001, I2 =0%). The combination therapy also resulted in higher complete and objective response rates.
DISCUSSION: This systematic review and meta-analysis provide comprehensive evidence regarding the efficacy and safety of pembrolizumab as monotherapy and in combination with chemotherapy for advanced GC/GEJC. Pooled analysis indicates that combination therapy yields significant survival benefits, particularly in patients with elevated PD-L1 expression. Conversely, monotherapy demonstrated no overall survival advantage and was associated with inferior progression-free survival compared to chemotherapy alone.
CONCLUSION: Pembrolizumab combined with chemotherapy is an effective therapeutic strategy for advanced GC/GEJC, whereas monotherapy lacks superior efficacy in the general population and should be interpreted with caution due to observed heterogeneity.
METHODS: A comprehensive literature search was conducted in Web of Science, PubMed, and Embase up to October 13, 2025. Included were Randomized Controlled Trials (RCTs) involving adults with pathologically confirmed advanced GC/GEJ cancer that compared pembrolizumab-based regimens to chemotherapy alone. Data were pooled using random-effects models, and study quality was assessed with the Cochrane Risk of Bias Tool.
RESULTS: The analysis included 10 RCTs with 6,030 patients. Pembrolizumab combined with chemotherapy demonstrated a significant improvement in overall survival (OS: HR 0.80, 95% CI 0.65-0.97, P=0.02, I 2 =72.2%) and progression-free survival (PFS: HR 0.73, 95% CI 0.56-0.95, P=0.01, I2 =81.3%) compared to chemotherapy alone. Benefits in OS and PFS were also observed in subgroups with PD-L1 CPS ≥1 and CPS ≥10. In contrast, pembrolizumab monotherapy did not significantly improve OS (HR 0.99, 95% CI 0.88-1.12, P=0.89, I2 =0%) and was associated with shorter PFS (HR 1.51, 95% CI 1.34-1.71, P<0.001, I2 =0%). The combination therapy also resulted in higher complete and objective response rates.
DISCUSSION: This systematic review and meta-analysis provide comprehensive evidence regarding the efficacy and safety of pembrolizumab as monotherapy and in combination with chemotherapy for advanced GC/GEJC. Pooled analysis indicates that combination therapy yields significant survival benefits, particularly in patients with elevated PD-L1 expression. Conversely, monotherapy demonstrated no overall survival advantage and was associated with inferior progression-free survival compared to chemotherapy alone.
CONCLUSION: Pembrolizumab combined with chemotherapy is an effective therapeutic strategy for advanced GC/GEJC, whereas monotherapy lacks superior efficacy in the general population and should be interpreted with caution due to observed heterogeneity.