UroGen Pharma Ltd. highlighted the results of a sub-analysis from the first and larger 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. 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. 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.