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Background <p>Urothelial carcinoma (UC) is an aggressive malignancy with limited options for patients unresponsive to chemotherapy or immunotherapy. Disitamab vedotin (RC48), a HER2-targeted antibody-drug conjugate(ADC), has shown promising results in clinical trials, but real-world data are lacking.</p> Methods <p>We conducted a single-center retrospective study of patients with histologically confirmed UC who received RC48 alone or in combination with PD-1 inhibitors between August 2022 and June 2024. Key inclusion criteria were at least one measurable lesion and adequate organ function; patients with incomplete records, concurrent active malignancies, or severe organ dysfunction precluding systemic therapy were excluded.</p> Results <p>A total of 71 patients were included. The ORR was 69.0%, including 15 complete and 34 partial responses. The median PFS was 24 months, and OS data were immature at cutoff. In subgroup analyses, patients receiving RC48 + PD-1 inhibitors achieved an ORR of 70.0% versus 63.6% with RC48 monotherapy. Grade ≥ 3 treatment-related adverse events occurred in 21.1% of patients, most commonly anemia and decreased appetite; events were generally manageable with supportive care and dose modification.</p> Conclusions <p>RC48 showed encouraging activity and manageable safety in a real-world UC cohort. Prospective multicenter studies with longer follow-up are needed to validate these findings, compare monotherapy versus combination strategies, and define the optimal role of RC48 across UC disease stages.</p>

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Real-world evaluation of the efficacy and safety of disitamab vedotin (RC48) in urothelial carcinoma

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月5日

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  • Tianxiang Zhou,
  • Haojie Liu,
  • Yuefan Shen,
  • Sihai Shao

摘要

Background

Urothelial carcinoma (UC) is an aggressive malignancy with limited options for patients unresponsive to chemotherapy or immunotherapy. Disitamab vedotin (RC48), a HER2-targeted antibody-drug conjugate(ADC), has shown promising results in clinical trials, but real-world data are lacking.

Methods

We conducted a single-center retrospective study of patients with histologically confirmed UC who received RC48 alone or in combination with PD-1 inhibitors between August 2022 and June 2024. Key inclusion criteria were at least one measurable lesion and adequate organ function; patients with incomplete records, concurrent active malignancies, or severe organ dysfunction precluding systemic therapy were excluded.

Results

A total of 71 patients were included. The ORR was 69.0%, including 15 complete and 34 partial responses. The median PFS was 24 months, and OS data were immature at cutoff. In subgroup analyses, patients receiving RC48 + PD-1 inhibitors achieved an ORR of 70.0% versus 63.6% with RC48 monotherapy. Grade ≥ 3 treatment-related adverse events occurred in 21.1% of patients, most commonly anemia and decreased appetite; events were generally manageable with supportive care and dose modification.

Conclusions

RC48 showed encouraging activity and manageable safety in a real-world UC cohort. Prospective multicenter studies with longer follow-up are needed to validate these findings, compare monotherapy versus combination strategies, and define the optimal role of RC48 across UC disease stages.