Low-grade intermediate-risk non-muscle-invasive bladder cancer (LG IR NMIBC) is a recurrent disease, thus requiring repeated transurethral resection of bladder tumors (TURBT) under general anesthesia. We evaluated the efficacy and safety of UGN-102, a mitomycin-containing reverse thermal gel, as a primary chemoablative therapeutic alternative to TURBT for patients with LG IR NMIBC.
This prospective, Phase 2b, open-label, single-arm trial recruited patients with biopsy-proven LG IR NMIBC to receive 6 once-weekly instillations of UGN-102. The primary endpoint was complete response (CR) rate, defined as the proportion of patients with negative endoscopic examination, negative cytology, and negative for-cause biopsy 3 months after treatment initiation. Patients with CR were followed quarterly up to 12 months to assess durability of treatment effect. Safety and adverse events were monitored throughout the trial.
Sixty-three patients (38 males, 25 females, 33-96 years) enrolled and received ≥1 instillation of UGN-102. Forty-one (65%) achieved CR at 3 months, of whom 39 (95%), 30 (73%), and 25 (61%) remained disease-free at 6, 9, and 12 months after treatment initiation, respectively; 13 patients had documented recurrences. The probability of durable response 9 months after CR (12 months after treatment initiation) was estimated to be 73% by Kaplan-Meier analysis. Common adverse events (incidence ≥10%) included dysuria, urinary frequency, hematuria, micturition urgency, urinary tract infection, and fatigue.
Nonsurgical primary chemoablation of LG IR NMIBC using UGN-102 resulted in significant treatment response with sustained durability. UGN-102 may provide an alternative to repetitive surgery for patients with LG IR NMIBC.
The Journal of urology. 2021 Aug 26 [Epub ahead of print]
K Kent Chevli, Neal D Shore, Andrew Trainer, Angela B Smith, Daniel Saltzstein, Yaron Ehrlich, Jay D Raman, Boris Friedman, Richard D'Anna, David Morris, Brian Hu, Mark Tyson, Alexander Sankin, Max Kates, Jennifer Linehan, Douglas Scherr, Steven Kester, Michael Verni, Karim Chamie, Lawrence Karsh, Arnold Cinman, Andrew Meads, Soumi Lahiri, Madlen Malinowski, Nimrod Gabai, Sunil Raju, Mark Schoenberg, Elyse Seltzer, William C Huang
State University of New York at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York., Atlantic Urology Clinics, Carolina Urologic Research Center, Myrtle Beach, South Carolina., Adult Pediatric Urology & Urogynecology, Omaha, Nebraska., University of North Carolina School of Medicine, Chapel Hill, North Carolina., Urology San Antonio, San Antonio, Texas., Rabin Medical Center, Petah-Tikva, Israel., Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania., Lady Davis Carmel Medical Center, Technicon - Israel Institute of Technology, Haifa, Israel., Arkansas Urology, Little Rock, Arkansas., Urology Associates, Nashville, Tennessee., Loma Linda University, Loma Linda, California., Mayo Clinic, Scottsdale, Arizona., Albert Einstein College of Medicine, Bronx, New York., Brady Urological Institute, Johns Hopkins Medicine, Baltimore, Maryland., John Wayne Cancer Institute, Santa Monica, California., Weill Medical College of Cornell University, New York, New York., Urology Center of Florida, Pompano Beach, Florida., Urology Center of Las Vegas, Las Vegas, Nevada., UCLA, Los Angeles, California., The Urology Center of Colorado, Denver, Colorado., Tower Urology, Los Angeles, California., UroGen Pharma, New York, New York., NYU Langone Urology Associates, New York, New York.