Five-year outcomes following primary chemoablation with UGN-101 in low-grade upper tract urothelial carcinoma: Evidence of durable complete response from an observational long-term follow-up of the phase 3 Olympus trial
Phillip M. Pierorazio, Brian Hu, Jay D. Raman, Hristos Kaimakliotis, Alexander Sankin, Nirmish Singla, Andrew Meads, Brent Burger, Michael J. Louie, Karim Chamie, Alon Weizer, Nikky Ugwuoke, Hetal Pandya, Mark SchoenbergBackground
UGN-101 is indicated for patients with low-grade upper tract urothelial carcinoma (LG-UTUC).
Objective
Evaluate long-term duration of response (DoR) in patients with complete response (CR) following UGN-101 treatment in the Phase 3 Olympus trial.
Design
Non-interventional, observational, long-term follow-up study (BL007).
Methods
Patients who remained event-free 12 months after achieving CR at 3 months in Olympus were eligible. Patients were monitored for up to 5 years or until recurrence, progression, or death. DoR was assessed using Kaplan–Meier methods.
Results
In Olympus, estimated median DoR among all 41 patients who achieved a CR at 3 months was 47.8 months; median follow-up: 28.1 months (95% confidence interval [CI], 13.1, 60.1). As of March 21, 2025, 75% (15/20) of patients in BL007 were event-free. The median follow-up for the 20 patients in BL007 was 53.3 months (95% CI: 27.9, 72.8), with median DoR not estimable (NE) (95% CI: 43.5, NE). There was no progression to high-grade disease.
Conclusion
UGN-101 demonstrated durable responses in patients with LG-UTUC, with sustained disease control over extended follow-up, supporting its role as a kidney-sparing treatment option.