Study demonstrates feasibility of antegrade instillation of Jelmyto for UTUC

Antegrade instillation is a safe and effective option for administering Jelmyto (mitomycin for pyelocalyceal solution; UGN-101) for the treatment of patients with low-grade upper tract urothelial carcinoma (LG-UTUC), according to findings from a retrospective analysis published online in the Journal of Urology.1,2

In their study, corresponding author Katie Murray, DO, and coauthors both outline their approach to antegrade administration of Jelmyto and share initial safety and efficacy outcomes for the approach. Overall, the single-center retrospective study included 8 patients with LG-UTUC who received Jelmyto through antegrade instillation (once weekly for 6 instillations). At first follow-up ureteroscopy, 4 patients had a complete response and 4 patients had a partial response. The median follow-up was 7 months after last instillation (range, 6 weeks – 14 months).

Murray, a urologist in the Division of Urology, Department of Surgery, University of Missouri School of Medicine, and coauthors wrote in their manuscript that, “All patients with an initial partial response who had a follow-up ureteroscopy underwent complete endoscopic tumor ablation.” There were 2 patients with disease recurrence at 13 and 14 months, respectively. At the time of study completion, no patient had yet required radical nephroureterectomy.

Regarding safety, there was a total of 5 adverse events reported across 3 patients. One patient experienced 2 grade 1 adverse events (hematuria and fatigue). Another patient had a grade 2 rash necessitating oral medication and a delay of 1 week in treatment. And the third patient had a grade 1 palmar rash and a grade 3 ureteral stricture. The ureteral stricture was discovered in the mid-ureter during follow-up ureteroscopy and laser incision was required.

“While Jelmyto is approved for both retrograde and antegrade instillation, the instructions for administration address retrograde instillation, and this is the first time that data on antegrade instillation has been documented in a clinical setting for this chemoablative therapy,” Murray stated in a news release.

“This report showed that antegrade instillation provided a well-tolerated and effective method of Jelmyto administration. In our experience, we did not see a negative impact on patient comfort. Of note, our experience with antegrade administration in this analysis suggests that this approach, which minimizes manipulation of the ureter during instillation, may help protect against stricture formation which has been associated with repetitive instrumentation of the upper urinary tract. Given the potential benefits of antegrade versus retrograde administration of Jelmyto, we now have a replicable protocol to follow for antegrade administration using a nephrostomy tube,” added Murray.

The FDA approved Jelmyto in April 2020 for the treatment of adult patients with LG-UTUC based on results from the phase 3 OLYMPUS trial.

References

1. UroGen Announces Data that Shows In-Office Nephrostomy Tube Administration of Jelmyto® is Efficient for Doctors and Well Tolerated by Patients. Published online February 10, 2022. Accessed February 10, 2022. https://bit.ly/3685mVL

2. Rosen GH, Nallani A, Muzzey C, Murray KS. Antegrade Instillation of UGN-101 (Mitomycin for Pyelocalyceal Solution) for Low-Grade Upper Tract Urothelial Carcinoma: Initial Clinical Experience [published online ahead of print February 7, 2022]. J Urol. doi: 10.1097/JU.0000000000002454