SYSTEMATIC REVIEW article
Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
This article is part of the Research TopicCommunity Series in Immune Cell Therapy Approaches Targeting Tumor Microenvironment: Volume IIView all 5 articles
The efficacy and safety of disitamab vedotin plus immunotherapy in locally advanced or metastatic solid tumors: a systematic review and meta-analysis
Provisionally accepted
Jianjun Ye
Zeyu Chen
Jie Feng
Xinyang LiaoShiyu ZhangQihao Wang
Lei ZhengTiancheng Liu
Qiang Wei
Yige Bao*- West China Hospital, Sichuan University, Chengdu, China
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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.
Keywords: Disitamab vedotin, HER2, Immunotherapy, Meta-analysis, solid tumors
Received: 09 Dec 2025; Accepted: 09 Feb 2026.
Copyright: © 2026 Ye, Chen, Feng, Liao, Zhang, Wang, Zheng, Liu, Wei and Bao. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yige Bao
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