UGN-101 appeared to be well tolerated, with most treatment-emergent adverse events characterized as mild or moderate and transient. The adverse events included urinary tract infection, flank pain, ureteral narrowing and hydronephrosis, and time-limited creatinine elevation. Mark Schoenberg, MD, chief medical officer of UroGen, said these findings are promising and demonstrate the potential of UGN-101 to become the first drug ever approved for low-grade UTUC.
“It could be approved in the next 6 to 9 months,” Dr. Schoenberg said in an interview with Urology Times.
OLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study) is an open-label, single-arm phase III clinical trial of UGN-101 and is anticipated to enroll approximately 74 patients at clinical sites across the United States and Israel.
UGN-101 is an investigational drug formulation of mitomycin that utilizes the RTGel technology platform, UroGen’s proprietary sustained-release, hydrogel-based formulation. This is designed to allow longer exposure of mitomycin C to the urinary tract tissue, thereby potentially enabling the treatment of tumors via non-surgical means. The FDA has granted both Orphan Drug and Fast Track designations to UGN-101 for the treatment of low-grade UTUC.
“Despite advances in endoscopic management of low-grade UTUC, nephrectomy is often required to manage recurrent, large-volume, or inaccessible tumors in the renal pelvis. The high complete response rate observed in this interim analysis are encouraging and, if borne out through the rest of the trial and consistently durable, these data suggest that this novel chemoablation treatment approach may help patients avoid or delay the need for nephrectomy,” Dr. Lerner told Urology Times.
Dr. Lerner has received compensation for serving on a UroGen advisory board, and his institution receives funds for his role as principal investigator of the OLYMPUS trial.
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