(UroToday.com) The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, IL between May 30th and June 3rd, 2025, was host to a kidney and bladder cancers poster session. Dr. Zongren Wang presented the ongoing PUNCH03 study, a phase II trial of disitamab vedotin combined with tislelizumab and bacillus Calmette-Guerin (BCG) in HER2-positive high-risk non-muscle-invasive bladder cancer (NMIBC).
The KEYNOTE-057 study demonstrated the efficacy and safety of IV pembrolizumab monotherapy for patients with BCG-unresponsive NIMBC,1 and is now FDA approved in this setting. Disitamab vedotin (RC48) is a novel antibody-drug conjugate that targets the HER2 protein. The objective of the phase II PUNCH03 trial was to evaluate the efficacy and safety of the combination of disitamab vedotin plus tislelizumab and BCG for HER2-positive, high-risk NMIBC patients.
PUNCH-03 is an ongoing, open-label, phase II trial enrolling BCG-naïve, high-risk, HER-2 positive (IHC 2+/3+) NMIBC patients with multiple papillary tumors (high-grade Ta or T1). The study schema is summarized below:
All eligible participants will 1st undergo a complete TURBT to remove all visible papillary lesions. Next, patients receive disitamab vedotin (2 mg/kg IVx1 cycle) + tislelizumab (200 mg IV x1 cycle), followed by a 2nd TURBT. Patients are then planned for ≥1 year of tislelizumab (200 mg IV every 3 weeks) + 3–5 cycles of disitamab vedotin (2 mg/kg IV every 2 weeks) + 18 instillations of BCG (induction x 6, maintenance: 3 instillations every 2 weeks, 9 instillations every 4 weeks thereafter). The primary end point is the recurrence-free survival (RFS) rate at 12 months. The secondary endpoints are:
- Bladder preservation rate
- Overall survival
- Safety
Presented by: Zongren Wang, Department of Urology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
Written by: Rashid K. Sayyid, MD, MSc – Robotic Urologic Oncology Fellow at The University of Southern California, @rksayyid on Twitter during the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting, Chicago, IL, Fri, May 30 – Tues, Jun 3, 2025.
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