UroGen Pharma presents sub-analysis of Jelmyto trial

UroGen Pharma highlights the results of a sub-analysis from the first and largest real-world patient cohort review of Jelmyto 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, or UTUC, who were complete responders to induction therapy, 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. “These findings provide additional evidence reinforcing Jelmyto’s position as a valuable therapeutic option for patients with low-grade upper tract urothelial cancer and add to the growing body of real-world evidence in extending the long-term positive outcomes for patients,” said Mark Schoenberg, MD, Chief Medical Officer at UroGen. “This real-world evidence reaffirms Jelmyto’s role as a valuable tool in our fight against this disease.” The company added: There were 136 cases of UTUC treated with Jelmyto with a cumulative median follow-up of 22 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.”