UroGen Pharma Ltd. highlighted the results of a sub-analysis from the first and largest post-commercial utilization review of JELMYTO(R) (mitomycin) for pyelocalyceal solution presented at the American Urological Association Meeting 2023 in Chicago, IL. The study titled, First Analysis of the Safety and Efficacy of UGN-101 in the Treatment of Ureteral Tumors (Abstract PD24-07) is the first to assess JELMYTO in treating ureteral tumors. The investigators reported no difference in outcomes at first endoscopic evaluation based on UTUC tumor location (ureter vs.

renal pelvis) (p=0.644). JELMYTO is approved for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients. In this analysis, 47 patients had UTUC tumors involving the ureter, with 12 cases of ureteral tumor only (8.8%) and 35 cases of ureteral plus renal pelvic tumors (25.7%).

In addition to similar efficacy and safety results at first endoscopic evaluation, there was also no difference in recurrence rate or progression based on tumor location. Fourteen patients (37.8%) with ureteral tumor had significant ureteral stenosis at first post-treatment evaluation, however, only 5.4% of patients developed new clinically significant stenosis when excluding patients with pre-existing hydronephrosis (excess fluid in a kidney due to a backup of urine) or ureteral stenosis. The limitations of this study include the retrospective design, lack of a control group, the lack of a centralized pathology review, and lack of 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 longitudinal follow-up.