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Efficacy and safety of bispecific antibodies versus other antitumor therapies in solid tumors: a systematic review and meta-analysis

Yan Y, Gao W, Zhu Z, Zheng L, Lu Y, Sun L, Jiang G

Frontiers in immunology, 2026

3,505 participants

Abstract

Background: Bispecific antibodies (BsAbs) have emerged as a promising strategy for solid tumor treatment, yet their comparative efficacy and safety versus other antitumor therapies remain unclear.

Materials and methods: Literature was systematically searched in PubMed, Embase, Cochrane Library, and Scopus from inception up to August 2026. American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO) and clinicaltrials.gov were also checked. Progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and adverse events (AEs) were used to assess efficacy and safety. Publication bias was assessed using funnel plots. Heterogeneity was evaluated using subgroup, meta-regression and sensitivity analyses. The protocol was preregistered in the International Prospective Register of Systematic Reviews (CRD420261359397).

Results: A total of 9 eligible studies involving 3,505 patients were included. Compared with other antitumor therapies, BsAbs demonstrated significant improvements in PFS (hazard ratio [HR]: 0.76, 95% confidence interval [CI]: 0.61-0.94, p=0.011) and OS (HR: 0.78, 95% CI: 0.63-0.95, p=0.016). ORR showed a borderline effect (Risk Ratio [RR]: 1.20, 95% CI: 1.00-1.44, p=0.046). Subgroup analyses suggested potential benefits in selected populations, particularly among patients treated with T-cell engaging BsAbs or tumor microenvironment/angiogenesis-modulating BsAbs, patients aged <65 years, and patients with non-small…

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: 3,505 participants or records.

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