Interim analysis of Phase III OLYMPUS trial of MitoGel shows positive results in urothelial cancer.- UroGen Pharma.
UroGen Pharma announced new findings from an interim analysis of the ongoing pivotal Phase III OLYMPUS clinical trial of UGN-101 or MitoGel (mitomycin), for the non-surgical treatment of low-grade upper tract urothelial cancer (UTUC). The interim analysis from this international, multi-center trial showed a complete response (CR) rate of 59 percent in 34 patients who were evaluated for primary disease evaluation (PDE, or the primary endpoint). PDE is conducted four to six weeks after completion of UGN-101 treatment, which was administered once weekly for six weeks.
Results showed that 20 of the interim analysis intent to treat population of 34 patients (59 percent) achieved a CR, defined as a negative ureteroscopic evaluation and a negative wash cytology. In addition, five of 34 patients (15 percent) achieved a partial response. Approximately 39 percent of tumors treated were categorized as unresectable by surgery at baseline. The CRs to date have been durable. Of the 20 patients who achieved a CR, 13 patients have reached three-month follow-up and all remain in CR. Four of these 13 patients have reached six-month follow-up and one of the 13 patients has reached nine-month follow-up. All remain in CR.
UGN-101 appeared to be well-tolerated with most treatment-emergent adverse events characterized as mild or moderate and transient. These included urinary tract infection, flank pain, ureteral narrowing and hydronephrosis and time-limited creatinine elevation. Results were presented during the plenary session at the 113th American Urological Association�s (AUA) Annual Meeting.
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