Pooled safety profiles of bispecific antibodies targeting PD-1/CTLA-4 or PD-1/VEGF in non-small cell lung cancer: a systematic review and single-arm meta-analysis
Abstract
Objective: This study aimed to systematically synthesize and separately quantify the pooled safety profiles of bispecific antibodies (BsAbs) targeting PD-1/CTLA-4 or PD-1/VEGF in patients with non-small cell lung cancer (NSCLC), and to descriptively summarize class-specific safety patterns.
Methods: Following PRISMA guidelines, we systematically reviewed prospective clinical trials published through January 2026. A total of 17 studies, encompassing 1802 patients, were included. Single-arm proportion meta-analyses were conducted separately for each BsAb class using random-effects models. No formal between-class statistical comparison was performed. Given the clinical heterogeneity across included cohorts, including differences in study phase, treatment line, molecular subtype, and treatment regimen, pooled estimates were interpreted descriptively. Subgroup analyses by treatment regimen, treatment line, and individual BsAb agent were considered exploratory. Because of the limited number of cohorts within each phase stratum, the impact of study phase was assessed descriptively rather than through formal stratified meta-analysis.
Results: In separate pooled analyses, the incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 41.79% for PD-1/CTLA-4 BsAbs and 43.51% for PD-1/VEGF BsAbs. Exploratory subgroup analyses suggested different patterns of heterogeneity across the available cohorts. In PD-1/CTLA-4 BsAb studies, AE rates appeared to vary across…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 1,802 participants or records.
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