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

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today highlights the results of a sub-analysis from the first and largest real-world patient cohort review of JELMYTO (mitomycin) for pyelocalyceal solution presented at the American Urological Association Meeting 2024 in San Antonio, TX. Among patients with low-grade Ta upper tract urothelial carcinoma (UTUC) who were complete responders to induction therapy (n=53), JELMYTO was associated with an 86% recurrence-free survival rate at 24 months across diverse patient types regardless of initial disease characteristics or usage for chemoablation versus post-endoscopic ablation. Among the 30% of the complete responders who received maintenance therapy, RFS at 24 months was 100%, vs. 61% for those who did not receive maintenance therapy.

“The 86% recurrence-free survival rate at the 24-month mark among low-grade UTUC patients (n=53) exhibited a favorable response to the initial induction of this new treatment,” said Adam Feldman, M.D., M.P.H., Urologic Oncologist in the Department of Urology at Massachusetts General Hospital, and Director of the Combined Harvard Urologic Oncology Fellowship. “Notably, there seems to be no discernible difference in disease recurrence based on tumor characteristics or timing of administration, including primary chemoablation or post-endoscopic ablation. These results offer additional evidence for the clinical utility of JELMYTO and may also offer hope for improved long-term outcomes for our patients.”

Furthermore, a different analysis of the same patient cohort, presented by Yair Lotan, M.D., Professor of Urology and Chief of Urologic Oncology at UT Southwestern and Parkland Health and Hospital System and study investigator, reports that “maintenance therapy with JELMYTO following successful induction treatment (n = 16) yielded a RFS rate of 100%, supplying more evidence of JELMYTO’s pivotal role in treating this challenging condition,” according to Dr. Lotan.

Data was collected from 15 centers on patients treated with JELMYTO for upper tract urothelial cancers (UTUC). Recurrence-free survival was calculated in 53 patients with LGTa disease at baseline who had no evidence of disease following JELMYTO induction. Chemoablative use was defined as the administration of JELMYTO treatment in the setting of known residual UTUC, while post-chemoablation use was defined as receipt of JELMYTO following visually complete endoscopic ablation. Exploratory analyses were performed to assess impact of size of tumor, presence of ureteral involvement, and multifocality of UTUC prior to JELMYTO induction on RFS at 24 months.