UroGen : Phase 3 Data Show JELMYTO Provides Effective & Durable Kidney-sparing Treatment Option

(RTTNews) - UroGen Pharma Ltd. (URGN) said new data from phase 3 OLYMPUS study showed that JELMYTO has provided an effective and durable kidney-sparing treatment option and should be considered as primary therapy for adult patients with low-grade upper tract urothelial cancer.

The results from the ongoing, non-interventional, rollover study were presented at the 23rd Annual Society of Urologic Oncology Meeting in San Diego.

The clinical benefit of JELMYTO was demonstrated in the phase 3 OLYMPUS study and data highlighted the long-term durability of that benefit.

At the time of data cut off (February 25, 2022), data were available for 16 of 23 patients who had remained in complete response at the end of the OLYMPUS study. The median durability of response among the 16 patients was 28.9 months (14.6 to 47.6 months).

Thirteen patients remained in complete response, two patients had recurrence of low-grade upper tract urothelial carcinoma (LG-UTUC) on the same side as treated in OLYMPUS, and one patient underwent radical nephroureterectomy (RNU) due to ureteral stricture without evidence of UTUC at the time of surgery. No patient had progressed to high-grade disease.

"These data are the first to show the potential for long-term recurrence free survival in patients treated with JELMYTO. We look forward to additional independent validation of this important observation," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen.