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Long-term outcomes of treatment of low-grade upper tract urothelial carcinoma with UGN-101, a mitomycin reverse thermal gel
Joseph Brito, MD1, Brian Hu, MD
2, Nir Kleinmann, MD
3, Jay D. Raman, MD
4, Hristos Kaimakliotis, MD
5, Alexander Sankin, MD
6, Nirmish Singla, MD
7, Andrew Meads, BS
8, Brent Burger, MSc, MBA
8, Sunil Raju, MBBS
8, Michael J. Louie, MD, MPH, MSc
8, Karim Chamie, MD
9, Alon Weizer, MD
10, Mark Schoenberg, MD, FACS
8.
1Yale School of Medicine, New London, CT, USA,
2Loma Linda University, Loma Linda, CA, USA,
3Sheba Medical Center, Ramat Gan, Israel,
4Penn State Health Milton S. Hershey Medical Center, Hershey, MD, USA,
5Indiana University School of Medicine, Indianapolis, IN, USA,
6Albert Einstein College of Medicine, Bronx, NY, USA,
7The Brady Urological Institute, Johns Hopkins University, Baltimore, MD, USA,
8UroGen Pharma, Princeton, NJ, USA,
9University of California Los Angeles (UCLA), Los Angeles, CA, USA,
10Division of Columbia University at Mount Sinai Medical Center, Miami Beach, FL, USA.
BACKGROUND: Endoscopically guided ablation is commonly used to treat low-grade upper tract urothelial carcinoma (LG-UTUC). Long-term endoscopic surveillance is needed due to the recurrent nature of UTUC. We report data from a noninterventional 5-year long-term follow-up (LTFU) study of patients who achieved complete response (CR) following treatment with UGN-101, a reverse thermal gel containing 4mg mitomycin per mL, in the phase 3 OLYMPUS trial (NCT02793128).
METHODS: Patients who participated in OLYMPUS and achieved a CR after 6 once-weekly doses of UGN-101 were followed for up to 12 months after initial CR. Those still in response at 12 months could enroll in the LTFU study. Outcomes included Kaplan-Meier estimate of duration of response (DoR) and disease recurrence/progression. Supervising physicians provided semiannual updates on patients’ disease status.
RESULTS: 71 patients enrolled in OLYMPUS (68% male, 87% White, median age 71 years), and 42 achieved CR ~3 months after study initiation. Among 41 patients followed after initial CR (1 withdrew consent), including 20 who entered the 5-year LTFU, median follow-up was 28.1 months (95% CI 13.1-60.1); and median estimate of DoR was 47.8 months (95% CI 13.0-not estimable [NE]). Among the 20 patients with LTFU, median follow-up was 53.3 months (95% CI 27.9-72.8); and median DoR was NE (95% CI 43.5-NE) due to a low event rate. During LTFU, 2 patients experienced LG-UTUC tumor recurrence; 3 died (unrelated to study treatment); and 7 discontinued. 5 patients were in ongoing CR at the end of the 5-year LTFU study with the longest reported DoR of 82.6 months.
CONCLUSIONS: Patients with LG-UTUC who achieved CR after receiving treatment with UGN-101 experienced clinically meaningful long-term response. The ongoing uTRACT registry (NCT05874921) is collecting real-world data in a larger patient population (n=400), to further inform the use of UGN-101 in UTUC patients.
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