On December 1, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, reported new data from the OLYMPUS registration trial designed to obtain long-term follow-up data on JELMYTO (mitomycin) for pyelocalyceal solution that shows median durability of response (DOR) of 28.9 months (Press release, UroGen Pharma, DEC 2, 2022, View Source [SID1234624705]). The study (Abstract #158) was presented at SUO on December 1.
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"The clinical benefit of JELMYTO was demonstrated in the Phase 3 OLYMPUS study and data presented today highlighted the long-term durability of that benefit," said Dr. Phillip Pierorazio, M.D., Chief, Section of Urology at Penn Presbyterian Medical Center, Philadelphia, PA. "JELMYTO provides an effective and durable kidney-sparing treatment option and should be considered as primary therapy for adult patients with LG-UTUC."
Patients who completed OLYMPUS were eligible to participate in this rollover study. Outcomes of interest include DOR in patients who remain in complete response (CR) at the end of OLYMPUS, events of disease recurrence and progression, post-study treatments and death.
At the time of data cut off (February 25, 2022), data were available for 16 of 23 patients who had remained in CR at the end of the OLYMPUS study. The median DOR among the 16 patients was 28.9 months (14.6 to 47.6 months). Thirteen patients remained in CR, 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.
"JELMYTO is an important addition to the urologist’s tool kit for treating LG-UTUC," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. "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."
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 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 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 quarterly 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 stenosis was reported in 58% (n=41) of patients receiving JELMYTO, with only 17% (n=12) of patients experiencing a Grade 3 event.
About LG-UTUC
LG-UTUC is a rare disease managed by endoscopic methods and radical nephroureterectomy. Endoscopic resection and laser ablation attempt to preserve the kidney, though there is a high risk of recurrence that may eventually necessitate removal of the kidney. Although kidney removal is the current standard for treatment of high-grade UTUC, it may be over-treatment in LG-UTUC, as kidney removal offers similar five-year survival as kidney-sparing procedures but is associated with significant morbidity.