Toripalimab plus disitamab vedotin versus tislelizumab-based combination in advanced urothelial carcinoma: a real-world comparative study.

BACKGROUND

The optimal PD-1 inhibitor to combine with disitamab vedotin in advanced urothelial carcinoma remains unclear. This study aimed to compare the real-world efficacy and safety of toripalimab plus disitamab vedotin versus tislelizumab plus disitamab vedotin in patients with locally advanced or metastatic urothelial carcinoma.

METHODS

In this retrospective study, clinical data were collected from patients with locally advanced or metastatic urothelial carcinoma treated with a PD-1 inhibitor combined with disitamab vedotin between August 2021 and July 2025. Patients received either toripalimab-based (Group A) or tislelizumab-based therapy (Group B). Overall survival (OS) and progression-free survival (PFS) were evaluated using the Kaplan-Meier method. Tumor response was assessed according to RECIST criteria, including complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD), as well as objective response rate (ORR) and disease control rate (DCR). Treatment-related adverse events (TRAEs) were graded according to standard criteria.

RESULTS

No significant differences were observed between the two groups in OS or PFS. The ORR and overall tumor response profiles were comparable between Group A and Group B. However, Group A demonstrated a lower rate of disease progression (9.30% vs. 28.95%) and a higher DCR (90.70% vs. 71.05%) compared with Group B. In terms of safety, the tislelizumab-based regimen was associated with significantly higher incidences of dermatitis, hypokalemia, anemia, and hypocalcemia.

CONCLUSIONS

In this real-world study, toripalimab plus disitamab vedotin and tislelizumab plus disitamab vedotin demonstrated comparable efficacy in patients with locally advanced or metastatic urothelial carcinoma. Although no significant differences in survival outcomes were observed, the toripalimab-based regimen was associated with a lower rate of disease progression, a higher disease control rate, and a more favorable safety profile. Prospective multicenter studies are needed to further validate these findings.