— Multi-Center Retrospective Study was Presented at the 2022 American Urological Association Annual Meeting in New Orleans —
NEW ORLEANS–(BUSINESS WIRE)–
UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, today highlights new data on real-world experience utilizing the antegrade approach via nephrostomy tube for administration of JELMYTO® (mitomycin) for pyelocalyceal solution. This data adds to a growing body of evidence on the safety and efficacy profile of the antegrade method of administration for JELMYTO. These data were presented during a podium presentation at the 2022 American Urological Association (AUA) annual meeting in New Orleans, Louisiana.
“JELMYTO is efficacious as a chemoablative agent in adult patients with low grade upper tract urothelial cancer, and while it’s FDA approved for both antegrade and retrograde administration, prior reports are limited to the retrograde experience,” said Kyle Rose, MD, Urologic Oncology Fellow at Moffitt Cancer Center in Tampa, Fla., and study investigator. “These data provide additional evidence that instillation via a nephrostomy tube is an effective instillation method with a safety profile that offers an encouraging option to appropriate patients.”
Dr. Rose presented the abstract Antegrade Administration of Reverse Thermal Mytomycin Gel for Primary Chemoablation of Upper Tract Carcinoma via Percutaneous Nephrostomy Tube: A Multi-Institutional Real-World Experience (Abstract PD58-06) during a podium presentation at the AUA annual meeting on Monday, May 16.
“All 71 patients in the Phase 3 OLYMPUS trial utilized the retrograde approach to administer JELMYTO, therefore we are pleased to see real-world evidence that supports the utilization of the antegrade approach giving physicians and patients more options to administer JELMYTO based on their preference and experience,” said Mark Schoenberg, MD, Chief Medical Officer, UroGen.
About This Study
The real-world data from this retrospective analysis was pooled from Moffitt Cancer Center, Tampa, FL; University of Missouri School of Medicine, Columbia, MO; The University of Texas MD Anderson Cancer Center, Houston, TX; and Mayo Clinic, Rochester, MN.
Twenty-six patients received nephrostomy tube administration of JELMYTO, six patients (23%) had solitary kidneys. Nine patients (35%) went on to receive at least one dose of maintenance therapy. Ureteral stenosis occurred in four patients (15%). Other adverse events included fatigue (27%), flank pain (19%), urinary tract infection (12%), sepsis (8%) and hematuria (8%). No patients had impaired renal function during follow-up and no deaths occurred.
Thirteen patients (50%) exhibited a complete response at post-induction ureteroscopy while 12 patients (46%) had a partial response. One patient experienced progression to invasive disease and required a nephroureterectomy. At a median follow-up of seven months (IQR 3-9) post-induction, no patients who experienced a complete response recurred.
The limitations of this study include the retrospective nature, small sample size, and pooled reporting of results. There is a need for larger studies with longer follow-up to study more conclusively any potential advantages of antegrade JELMYTO administration when compared to retrograde instillation.
About the Pivotal OLYMPUS Study
OLYMPUS (Optimized DeLiverY of Mitomycin for Primary UTUC Study) was an open-label, single-arm Phase 3 clinical study of UGN-101 JELMYTO (mitomycin) for pyelocalyceal solution, to evaluate the safety, tolerability and tumor ablative effect of JELMYTO in patients with low-grade Upper Tract Urothelial Cancer UTUC (LG UTUC). Seventy-one patients were treated at clinical sites across the United States and Israel. Study participants were treated with six weekly instillations of JELMYTO administered via a standard catheter. Four to six weeks following the last instillation, patients underwent a Primary Disease Evaluation (PDE) to determine Complete Response (CR), the primary endpoint of the study. PDE involved a ureteroscopy and wash cytology, a standard microscopic test of cells obtained from the urine to detect cancer and for cause biopsy. Patients who achieved a CR at the PDE timepoint were eligible for the maintenance phase of the trial, during which they could receive monthly maintenance instillations for up to 12 months and were assessed to determine the durability of response with JELMYTO.
In the OLYMPUS study, data was generated for the retrograde administration of JELMYTO. In that study population ureteric obstruction was reported in 58% (n=41) of patients receiving JELMYTO, including 17% (n=12) of patients who experienced Grade 3 obstruction.
