UROGEN PHARMA LTD. Item 8.01 Other Events.
On
Phase 2b OPTIMA II
A podium presentation of the final OPTIMA II trial results showed that 65% (41/63) of patients receiving UGN-102 achieved a complete response ("CR") three months after the start of therapy. In this subset of patients, 95% (39/41) of patients, 73% (30/41) of patients and 61% (25/41) of patients who were present for evaluation at each timepoint, remained disease free at six, nine and 12 months following treatment initiation, respectively. Thirteen patients had documented recurrences. The probability of durable response nine months after CR (12 months after treatment initiation) was estimated to be 73% by Kaplan-Meier analysis.
The most common adverse events (³10%) were reported as mild to moderate and included dysuria, hematuria, urinary frequency, fatigue, urgency and urinary tract infection.
Phase 3 OLYMPUS
Results of the Phase 3 OLYMPUS trial of Jelmyto, the first and only non-surgical
kidney-sparing treatment approved by the
Results from a separate, post-hoc analysis of female patients from the OLYMPUS trial, showed similar CR and durability of CR to male patients, with 65.2% of female patients achieving CR and 71.4% maintaining durable CR at 12 months compared to 81% for the entire patient population. The most common adverse events were urinary tract infection, hematuria, ureteric stenosis, flank pain, vomiting, hydronephrosis, dysuria, and nausea. Additional research is warranted to more clearly define gender-related outcomes for female patients with LG-UTUC.
About the Phase 2b OPTIMA II Trial
OPTIMA II (OPTimized Instillation of Mitomycin for Bladder Cancer Treatment) is an open-label, single-arm, multi-center Phase 2b clinical trial of investigational agent UGN-102 (mitomycin) for intravesical solution to evaluate its safety and efficacy in patients with low-grade non-muscle invasive bladder cancer ("LG NMIBC") at intermediate risk of recurrence. Intermediate risk is defined as one or two of the following: multiple tumors, a low grade solitary tumor >3 cm, or recurrence of LG NMIBC within one year of the current diagnosis. Patients were to receive six weekly intravesical instillations of 75 mg UGN-102 in an office setting. The chemoablative effect of UGN-102 was assessed three months after initiation of study treatment with CR defined as a negative endoscopic examination, negative cytology, and when indicated, a negative for-cause biopsy. Patients achieving CR were followed quarterly to 12 months after initiation of study treatment to evaluate safety, efficacy, and durability.
About the Phase 3 OLYMPUS Trial
OLYMPUS (Optimized DeLiverY of Mitomycin for Primary UTUC Study) is an
open-label, single-arm Phase 3 clinical trial of UGN-101, Jelmyto (mitomycin)
for pyelocalyceal solution, to evaluate the safety, tolerability and tumor
ablative effect of Jelmyto in patients with low-grade UTUC. Seventy-one patients
were treated at clinical sites across
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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 to determine the durability of response with Jelmyto.
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