The efficacy and safety of disitamab vedotin plus immunotherapy in locally advanced or metastatic solid tumors: a systematic review and meta-analysis

Background The combination of disitamab vedotin (DV), a novel human epidermal growth factor receptor 2 (HER2)-targeting antibody-drug conjugate, with immunotherapy represents a promising strategy for locally advanced or metastatic solid tumors. However, comprehensive evidence regarding its efficacy and safety is lacking. This systematic review and meta-analysis aimed to synthesize available data on this combination regimen. Methods We systematically searched PubMed, Scopus, Embase, and the Cochrane Library for studies published up to December 31, 2025. The primary outcomes were objective response rate (ORR) and treatment-related adverse events (TRAEs). Secondary outcomes included disease control rate (DCR) and median progression-free survival (mPFS). Pooled analyses were performed using a random-effects model. Results 21 studies involving 1183 patients were included. The pooled ORR was 53% (95% CI: 46%–60%), and the DCR was 82% (95% CI: 77%–86%). The pooled mPFS was 7.8 months (95% CI: 6.6–8.9). Subgroup analyses indicated superior efficacy in urothelial carcinoma, HER2-positive tumors, and first-line treatment settings. Any-grade and grade ≥3 TRAEs occurred in 91.1% and 36.8% of patients, respectively, with a toxicity profile dominated by DV-related adverse events such as fatigue, peripheral neuropathy, and hematological toxicities. Conclusion The combination of DV and immunotherapy demonstrates encouraging antitumor activity and a manageable safety profile in patients with locally advanced or metastatic solid tumors, particularly in HER2-expressing populations and when used in the first-line setting. These findings support further investigation of this combination in randomized controlled trials. Systematic Review Registration https://www.crd.york.ac.uk/prospero/ , identifier CRD420251154446.