OLYMPUS Long-Term Follow-Up Demonstrates Favorable Durability of UGN-101

A recent long-term follow-up of participants in the OLYMPUS trial included analysis of the outcomes of primary chemoablation using the mitomycin reverse thermal gel UGN-101 for  patients with low-grade upper tract urothelial carcinoma (UTUC).

Patients who achieved a complete response (CR) after six doses of UGN-101, given once a week during the OLYMPUS trial, were followed up for 12 months after initial CR, and patients with a CR at study completion were eligible for long-term follow-up for up to 5 years or until disease recurrence, progression, or death.

A total of 42 patients of the 71 enrolled in the OLYMPUS trial achieved a CR four to six weeks after receiving one or more instillations of UGN-101. For the 41 patients who were followed up after initial CR, median follow-up was 28.1 months (95% CI, 13.1-57.5), and median duration of response was 47.8 months (95% CI, 13.0-not estimable [NE]).

Long-term follow-up occurred for 20 (49%) patients (median, 53.3 months; 95% CI, 27.9-65.3). No evidence of recurrence at the last follow-up was seen in 75% of patients, with an inestimable duration of response (95% CI, 43.5-NE) due to a low event rate.

Favorable long-term durability is evident among patients with low-grade UTUC who undergo primary intracavitary chemoablation with UGN-101.