Pharma Focus America

Comparative Retrospective Study Finds Lower Stricture Rate and Comparable Oncological Outcomes with Antegrade Administration of JELMYTO® over Retrograde Administration

Wednesday, June 21, 2023

UroGen Pharma Ltd., a biotech company specializing in the development and commercialization of solutions for urothelial and specialty cancers, has announced the results of a sub-analysis conducted during the initial post-commercial utilization review of JELMYTO® (mitomycin) for pyelocalyceal solution. This study is the first of its kind to compare the different modes of administration for JELMYTO, an approved treatment for low-grade upper tract urothelial cancer (LG-UTUC) in adult patients. The findings from this study, titled "Route of Administration for UGN-101 and Impact on Oncological and Safety Outcomes," have been published online in European Urology Focus.

UroGen Pharma Ltd., a biotech company specializing in urothelial and specialty cancers, has released the results of a sub-analysis conducted during the initial post-commercial utilization review of JELMYTO® (mitomycin) for pyelocalyceal solution. The analysis compared the antegrade and retrograde modes of administration for JELMYTO in the treatment of low-grade upper tract urothelial cancer (LG-UTUC).

The sub-analysis included 132 patients and 136 renal units treated with JELMYTO. Among them, 43% received antegrade administration, while 57% received retrograde administration. The study found that the antegrade approach had a lower occurrence of strictures (12%) compared to the retrograde group (32%). Although there was no significant difference in overall response rates, the antegrade group showed a higher complete response (CR) rate of 60% compared to 48% in the retrograde group (p=0.1). The partial response (PR) rates were also favorable, with 60% CR and 32% PR for antegrade administration, and 48% CR and 28% PR for retrograde administration.

In the OLYMPUS clinical study, which focused on retrograde administration of JELMYTO, ureteric obstruction was reported in 58% (n=41) of patients, including 17% (n=12) who experienced Grade 3 obstruction.

Dr. Jennifer Linehan, Associate Professor of Urology and Urologic Oncology, expressed optimism about the study's findings, stating that they provide evidence supporting the potential advantages of antegrade administration of JELMYTO. She emphasized the importance of considering the pros and cons of each treatment approach when choosing between retrograde and antegrade administration.

Dr. Mark Schoenberg, Chief Medical Officer of UroGen, also highlighted the value of having options and the growing body of evidence that can assist physicians and patients in making informed decisions about the mode of JELMYTO administration.

The researchers acknowledged the study's limitations, including its retrospective design and potential treatment bias. They emphasized the need for further investigation into patient-reported tolerability, quality of life, cost analysis, long-term safety, and treatment durability. To address these areas, patients are being enrolled in the uTRACT Registry, a comprehensive study aiming to gather standardized data and provide insights into patient outcomes following JELMYTO treatment, including long-term follow-up.

Thermo Fisher Scientific - mRNA ServicesFuture Labs Live USA 2024World Vaccine Congress Europe 2024World Orphan Drug Congress 2024Advanced Therapies USA 2024World Orphan Drug Congress Europe 2024