JELMYTO® Shows 86% Recurrence-Free Survival (RFS) at 24 Months: Real-World AUA 2024 Analysis

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company specializing in urothelial and specialty cancer treatments, presents findings from a sub-analysis of JELMYTO (mitomycin) for pyelocalyceal solution at the American Urological Association Meeting 2024. In a cohort of complete responders to induction therapy (n=53) with low-grade Ta upper tract urothelial carcinoma (UTUC), JELMYTO demonstrates an 86% recurrence-free survival (RFS) rate at 24 months, irrespective of patient characteristics or treatment usage. Among complete responders receiving maintenance therapy (30%), RFS at 24 months is 100%, compared to 61% for those not receiving maintenance therapy.

Dr. Adam Feldman, Urologic Oncologist at Massachusetts General Hospital, emphasized the favorable response to JELMYTO treatment among low-grade UTUC patients, with an 86% recurrence-free survival rate at the 24-month mark. According to Dr. Yair Lotan, Professor of Urology at UT Southwestern, maintenance therapy with JELMYTO following successful induction treatment resulted in a 100% recurrence-free survival rate, further demonstrating its efficacy.

Data from 15 centers on patients treated with JELMYTO for upper tract urothelial cancers (UTUC) showed promising results. Among patients with low-grade Ta disease at baseline who had no evidence of disease following JELMYTO induction, recurrence-free survival was calculated at 24 months. Exploratory analyses were conducted to assess the impact of tumor size, ureteral involvement, and multifocality of UTUC on recurrence-free survival.

Dr. Mark Schoenberg, Chief Medical Officer at UroGen, highlighted these findings as additional evidence of JELMYTO’s efficacy in treating low-grade upper tract urothelial cancer. However, the limitations of these sub-analyses include the sample size, retrospective design, lack of a control group, and the absence of a centralized pathology review.

To further explore JELMYTO’s potential in treating UTUC, investigators are enrolling patients in the uTRACT Registry to capture data in a standardized manner. JELMYTO is a mitomycin-containing reverse thermal gel indicated for adult patients with low-grade UTUC. UroGen is dedicated to developing innovative solutions for urothelial and specialty cancers, aiming to provide better treatment options for patients.

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