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.