New Real-World Retrospective Analysis Presented at AUA 2024 Reports 86% Recurrence-Free Survival (RFS) at 24 Months with JELMYTO Across All Studied Patient and Disease Characteristics in Cohort of Responders to Induction Therapy - Seite 2

“These findings provide additional evidence reinforcing JELMYTO's position as a valuable therapeutic option for patients with low-grade upper tract urothelial cancer and add to the growing body of real-world evidence in extending the long-term positive outcomes for patients,” said Mark Schoenberg, MD, Chief Medical Officer at UroGen. “This real-world evidence reaffirms JELMYTO's role as a valuable tool in our fight against this disease.”

There were 136 cases of UTUC treated with JELMYTO with a cumulative median (IQR) follow-up of 22 (12-27) months including 107 cases of LGTa UTUC. After initial treatment, 74% of post-endoscopic ablation and 39% of chemoablative patients were disease-free totaling 53 cases with LGTa UTUC without evidence of disease following JELMYTO induction. The limitations of these sub-analyses include the sample size, retrospective design, lack of a control group, and the lack of a centralized pathology review and standardized clinicopathologic assessment.

To further explore the full potential of JELMYTO for the treatment of patients with UTUC, investigators are in the process of enrolling the prospective and retrospective uTRACT Registry to capture data in a large-scale, standardized manner to report further on patient outcomes following JELMYTO treatment including long-term longitudinal follow-up.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with low-grade-UTUC (LG-UTUC). It is approved for adult patients with LG-UTUC. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.