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Intravesical Disitamab Vedotin (RC48) for HER2-Expressing High-Risk Non-Muscle-Invasive Bladder Cancer: A Single-Arm,

Xu Chen1,2,3, Ming Huang1,2, Zehua Chen1,2

  • 1Department of Urology Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou China.

Medcomm
|July 15, 2025
PubMed

Insights

Intravesical Disitamab vedotin (RC48) shows promise for high-risk non-muscle-invasive bladder cancer (HR-NMIBC) expressing HER2. This novel treatment was well-tolerated and demonstrated preliminary efficacy, offering hope for improved outcomes.

Area of Science:

  • Oncology
  • Urology
  • Clinical Trials

Background:

  • HER2 expression in high-risk non-muscle-invasive bladder cancer (HR-NMIBC) is linked to poor response to Bacillus Calmette-Guérin (BCG) therapy.
  • There is an urgent need for novel intravesical treatments for HER2-expressing HR-NMIBC.

Purpose of the Study:

  • To evaluate the safety and tolerability of intravesical Disitamab vedotin (RC48) in patients with HER2-expressing HR-NMIBC.
  • To assess the preliminary oncological outcomes, including recurrence-free survival (RFS) and progression-free survival (PFS).

Main Methods:

  • A single-arm, phase I clinical trial (ChiCTR2300073975) involving nine patients with HER2-expressing HR-NMIBC.
  • Patients received intravesical RC48 weekly for 6 weeks (60, 120, or 180 mg doses), followed by optional monthly maintenance doses.
  • Safety was assessed by monitoring dose-limiting toxicities (DLTs) and drug-related adverse events (AEs).

Main Results:

  • All nine patients completed the induction course without DLTs or grade ≥3 drug-related AEs.
  • The most common drug-related AEs were urinary tract infection (55.6%), urinary frequency (11.1%), and hematuria (11.1%).
  • At 12 months, RFS was 87.5% and PFS was 100%, indicating promising oncological outcomes.

Conclusions:

  • Intravesical RC48 is safe and well-tolerated in HER2-expressing HR-NMIBC patients.
  • RC48 demonstrates preliminary efficacy in terms of recurrence and progression.
  • Further dose exploration is ongoing to determine the maximum tolerated dose and optimize treatment regimens.
Keywords:
Disitamab vedotin (RC48)antibody‒drug conjugates (ADC)efficacyintravesicalnon‐muscle‐invasive bladder cancersafety

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