Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024
Efficacy and Safety of Disitamab Vedotin in Patients With Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced or Metastatic Urothelial Carcinoma: A Combined Analysis of Two Phase II Clinical Trials.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 121 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery
Vedisertib (RC48/ADC) Combined With Toripalimab in Bladder-preserving Treatment
Who cites it
121 citing papers in PubMed, 5 syntheses or guidelines pooled it, 132 citations in OpenAlex.
- Stage-specific associations of HER2 overexpression with clinical and pathological features in bladder cancer: a systematic review and meta-analysis.International urology and nephrology · 2026Pooled it
- The Local Effects of Systemic Therapies in Urological Oncology: A Systematic Review.Cancer medicine · 2026Pooled it
- Antibody-Drug Conjugates for Locally Advanced and Metastatic Urothelial Carcinoma: A Systematic Review and Meta-Analysis.JAMA network open · 2026Pooled it
- The Prognostic Value of Tumor HER2 Expression in Predicting Oncological Outcomes of Patients with Advanced Urothelial Carcinoma: A Systematic Review and Meta-Analysis.International journal of molecular sciences · 2026Pooled it
- Immunotherapy in urological cancers: new paradigms and a systematic review of clinical trials and real-world evidence.Frontiers in oncology · 2026Pooled it
- Disitamab vedotin for HER2-positive breast cancer with liver metastases: phase 3 results from the RC48-C006 phase 2/3 trial.Nature communications · 2026Trial
- Toripalimab in patients with previously treated advanced upper tract urothelial carcinoma: a subgroup analysis of the phase II POLARIS-03 trial.The oncologist · 2026Trial
- Disitamab vedotin combined with toripalimab and radiotherapy for multimodal organ-sparing treatment of muscle invasive bladder cancer: a proof-of-concept study.Neoplasia (New York, N.Y.) · 2025Trial
- Cost-effectiveness analysis of disitamab vedotin plus toripalimab versus chemotherapy as first-line treatment for HER2-expressing advanced urothelial cancer.Human vaccines & immunotherapeutics · 2026Article
- Disitamab Vedotin Plus Tislelizumab in Transurethrally Unresectable, ERBB2-Positive, Non-Muscle-Invasive Bladder Cancer: A Nonrandomized Clinical Trial.JAMA oncology · 2026Article
- Clinical toxicity of ADCs and ICI-ADC combinations: mechanisms, patterns and management.Nature reviews. Clinical oncology · 2026Review
- Article
- Post-Treatment NLR and SII Associations with Response and Progression-Free Survival After Neoadjuvant Disitamab Vedotin Plus PD-1 Blockade in Muscle-Invasive Bladder Cancer: A Real-World Cohort Study.Diagnostics (Basel, Switzerland) · 2026Article
- Integrated transcriptome analysis and machine learning to construct a homeostatic model of acetylation for bladder cancer and validate the key geneTranslational andrology and urology · 2026Article
- Overcoming barriers to bladder preservation: Emerging intravesical therapies for high-risk non-muscle-invasive bladder cancer.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2026Article
- Review
- Coordinated Expression of ADC TargetsCurrent issues in molecular biology · 2026Article
- Integrating clinically actionable biomarkers into bladder cancer care - recommendations from the International Bladder Cancer Group.Nature reviews. Urology · 2026Review
- Trastuzumab Deruxtecan in Metastatic Urothelial Carcinoma with NGS-Detected ERBB2 Amplification: A Four-Patient Real-World Case Series.Current oncology (Toronto, Ont.) · 2026Article
- Antibody-Drug Conjugates Targeting HER2 and Trop-2: A New Force in Precision Treatment for Solid Tumors.Pharmaceuticals (Basel, Switzerland) · 2026Review
61 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 16 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo evaluate the efficacy and safety of disitamab vedotin (DV, RC48-ADC), a novel humanized anti-human epidermal growth factor receptor 2 (HER2) antibody conjugated with monomethyl auristatin E, in patients with HER2-positive locally advanced or metastatic urothelial carcinoma (UC) refractory to standard or regular therapies. PATIENTS AND
methodsThe data analyzed and reported are from two phase II, open-label, multicenter, single-arm studies (RC48-C005 and RC48-C009) in patients with HER2-positive (immunohistochemistry 3+ or 2+) locally advanced or metastatic UC who have progressed on at least one previous line of systemic chemotherapy. Patients received DV treatment (2 mg/kg IV infusion, once every 2 weeks). The primary end point was objective response rate (ORR) assessed by a blinded independent review committee (BIRC). Progression-free survival (PFS), overall survival (OS), and safety were also assessed.
resultsOne hundred and seven patients were enrolled in total. The overall confirmed ORR by BIRC was 50.5% (95% CI, 40.6 to 60.3). Consistent results were observed in prespecified subgroups including patients with liver metastasis and patients previously treated with anti-PD-1/L1 therapies. By the cutoff date of May 10, 2022, the median duration of response was 7.3 months (95% CI, 5.7 to 10.8). The median PFS and OS were 5.9 months (95% CI, 4.3 to 7.2) and 14.2 months (95% CI, 9.7 to 18.8), respectively. The most common treatment-related adverse events (TRAEs) were peripheral sensory neuropathy (68.2%), leukopenia (50.5%), AST increased (42.1%), and neutropenia (42.1%). Fifty-eight (54.2%) patients experienced grade ≥3 TRAEs, including peripheral sensory neuropathy (18.7%) and neutropenia (12.1%).
conclusionDV demonstrated a promising efficacy with a manageable safety profile in patients with HER2-positive locally advanced or metastatic UC who had progressed on at least one line of systemic chemotherapy.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.