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

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. 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). 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 cell lung cancer (NSCLC). Regarding safety, renal and vascular toxicities, including proteinuria, peripheral edema, and hypertension, as well as immune-related toxicities such as cytokine release syndrome and rash, were more frequently observed in the BsAb group. Other increased adverse events included anemia, pain in extremity, decreased appetite, and vomiting. BsAb-based regimens significantly improve PFS and OS compared with non-BsAb antitumor therapies in patients with solid tumors. Although the overall AE profile appeared manageable, renal and vascular toxicities and immune-related/inflammatory toxicities warrant particular attention. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD420261359397.