UroGen Pharma has reported the outcomes from a long-term follow-up study of JELMYTO (mitomycin) for pyelocalyceal solution for treating low-grade, upper tract urothelial cancer (LG-UTUC) in adult population.
Among the 71 subjects enrolled in the trial, 41 achieved a complete response after treatment with JELMYTO. The median duration of response was 47.8 months, with a median follow-up of 28.1 months.
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The analysis had some limitations such as its post-hoc nature and the selection bias of the 20 subjects who entered the long-term follow-up, according to the company.
The JELMYTO uTRACT Registry is currently enrolling subjects to collect longitudinal real-world usage data and further understand the treatment’s potential.
As of 10 July, 191 patients have been enrolled across 19 activated sites.
UroGen Pharma chief medical officer Mark Schoenberg said: “Previous research indicates that managing relapse and preserving organ function should be the primary treatment goal for LG-UTUC due to the low risk of disease progression.
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By GlobalData“We are encouraged by the study’s findings, which provide compelling evidence for favourable long-term durability of JELMYTO as a primary treatment for LG-UTUC, with increasing evidence showing extended response times in some patients.”
JELMYTO (mitomycin) for pyelocalyceal solution is a reverse thermal gel that contains 4mg of mitomycin per mL.
It is administered via a ureteral catheter or nephrostomy tube. The solution transitions from a viscous liquid when cooled to a semi-solid gel at body temperature. It allows for sustained release and removal through normal urinary flow.
The unique delivery system of JELMYTO allows it to conform to the upper urinary tract anatomy.
The eventual semisolid gel enables chemoablative therapy to stay in the collecting system for four to six hours, preventing it from being quickly diluted or flushed away by urine flow.
Last month, UroGen Pharma dosed the first patient for the Phase III UTOPIA clinical trial for UGN-103 (mitomycin) for an intravesical solution to treat low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
