PD-1/PD-L1 inhibitors plus anti-angiogenic TKIs improve PFS but not OS in advanced NSCLC
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Key Takeaway
Consider PFS benefit of PD-1/PD-L1 plus anti-angiogenic TKIs in advanced NSCLC, but note no OS improvement and lack of safety data.
This systematic review and meta-analysis evaluated the efficacy of combining PD-1/PD-L1 inhibitors with multi-targeted anti-angiogenic tyrosine kinase inhibitors (TKIs) in 2,787 patients with advanced or metastatic non-small cell lung cancer (NSCLC). The analysis compared this combination regimen against a control group, with progression-free survival (PFS) and overall survival (OS) as primary outcomes.
The main results showed a statistically significant improvement in PFS for the combination therapy group, with a hazard ratio (HR) of 0.82 (95% confidence interval: 0.69-0.97, p=0.021). However, there was no statistically significant difference in OS between the groups, with an HR of 0.97 (95% CI: 0.88-1.07, p=0.554). Absolute numbers for these outcomes were not reported.
No safety, tolerability, or adverse event data were reported in the analysis. Key limitations include the absence of safety information, which is critical for assessing the risk-benefit profile of this combination. The study setting and follow-up duration were also not reported. The efficacy of this combination regimen in advanced NSCLC remains controversial, as the PFS benefit did not translate into an OS advantage. These findings should be interpreted cautiously until more comprehensive data, particularly on safety, are available.
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View Original Abstract ↓
BackgroundThe efficacy of combining programmed cell death protein-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors with multi-targeted anti-angiogenic tyrosine kinase inhibitors (TKIs) in advanced or metastatic non-small cell lung cancer (NSCLC) remains controversial. This study therefore aimed to systematically evaluate the efficacy of this combination regimen in patients with advanced or metastatic NSCLC.MethodsWe systematically searched PubMed, EMBASE, Web of Science, ClinicalTrials.gov, and the Cochrane Library databases for relevant randomized controlled trials (RCTs) up to July 2025. The primary outcomes were progression-free survival (PFS) and overall survival (OS), analyzed using the hazard ratio (HR) and 95% confidence interval (95%CI).ResultsA total of six RCTs were included, involving 2,787 participants. Results demonstrated that the intervention group receiving PD-1/PD-L1 inhibitors combined with anti-angiogenic TKIs showed improved PFS compared with the control group (HR = 0.82, 95%CI: 0.69-0.97, p=0.021). However, no statistically significant difference was observed between the two groups in OS (HR = 0.97, 95%CI: 0.88-1.07, p=0.554). Subgroup analyses indicated that the PFS benefit was more pronounced in patients aged0.05).ConclusionThe combination of PD-1/PD-L1 inhibitors and anti-angiogenic TKIs significantly improved PFS in patients with advanced or metastatic NSCLC but did not translate into an OS benefit.Systematic Review Registrationhttps://www.crd.york.ac.uk/PROSPERO/, identifier CRD420251126527.
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