JELMYTO® Shows 86% Recurrence-Free Survival at 24 Months in AUA 2024 Real-World Study

UroGen Pharma Ltd. recently shared encouraging results from a sub-analysis of the first extensive real-world patient cohort review of JELMYTO (mitomycin) for pyelocalyceal solution, unveiled at the American Urological Association Meeting 2024 in San Antonio, Texas. Focusing on patients with low-grade Ta upper tract urothelial carcinoma (UTUC) who responded completely to induction therapy (n=53), the data revealed an 86% recurrence-free survival (RFS) rate at 24 months, regardless of the initial disease characteristics or whether the therapy was used for chemoablation or post-endoscopic ablation. Remarkably, for those who received maintenance therapy, the RFS was 100%, compared to 61% for those who did not.

Dr. Adam Feldman, Urologic Oncologist at Massachusetts General Hospital, highlighted these findings, underscoring that there was no significant difference in disease recurrence based on tumor characteristics or timing of administration. This supports the clinical utility of JELMYTO and offers hope for improved long-term outcomes for patients.

A separate analysis by Dr. Yair Lotan from UT Southwestern and Parkland Health and Hospital System corroborated these findings. Dr. Lotan reported that maintenance therapy post-successful induction treatment (n=16) also resulted in a 100% RFS rate, adding further evidence of JELMYTO’s significant role in managing low-grade UTUC.

The data was gathered from 15 centers involving patients treated with JELMYTO for upper tract urothelial cancers. Among 53 patients with low-grade Ta disease and no evident disease post-JELMYTO induction, RFS calculations showed positive outcomes. Chemoablative use of JELMYTO was defined as treatment amidst known residual UTUC, while post-chemoablation use was after complete endoscopic ablation. Exploratory analyses examined the impact of factors like tumor size, ureteral involvement, and multifocality on RFS at 24 months.

Dr. Mark Schoenberg, Chief Medical Officer at UroGen, emphasized that these findings reinforce JELMYTO's value as a therapeutic option, contributing to the growing body of real-world evidence supporting its long-term efficacy.

The study reviewed 136 UTUC cases treated with JELMYTO, with a median follow-up of 22 months. Out of 107 LGTa UTUC cases, 74% of post-endoscopic ablation and 39% of chemoablative patients were disease-free, leading to 53 cases showing no disease evidence post-JELMYTO induction. However, the sub-analyses had limitations, including sample size, retrospective design, lack of a control group, and inconsistent pathology reviews.

Investigators are now enrolling patients in the uTRACT Registry to capture comprehensive data and report on patient outcomes following JELMYTO treatment, including long-term follow-up.

JELMYTO, containing mitomycin, is approved for treating adult patients with low-grade upper tract urothelial cancer. The drug transforms from a liquid to a semi-solid gel at body temperature, allowing it to remain in the urinary tract for several hours, facilitating chemoablative therapy.

Upper tract urothelial cancer, a subset of urothelial cancers, originates in the ureter or renal pelvis. It predominantly affects older patients who often have other comorbidities. Currently, treatment options are limited, with high recurrence rates following endoscopic surgery or nephroureterectomy.

UroGen Pharma Ltd., based in Princeton, NJ, and with operations in Israel, focuses on developing innovative treatments for urothelial and specialty cancers. Their RTGel technology allows for longer exposure of urinary tract tissues to medications, potentially improving treatment efficacy.

This real-world evidence highlights the significant potential of JELMYTO in treating low-grade UTUC and underscores the need for further research to explore its full benefits in diverse patient populations.