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The company reported updated findings from its UGN-101 Phase 3 OLYMPUS Trial and initial data from its UGN-102 Phase 2b OPTIMA II Trial.
UroGen Pharma (NASDAQ:URGN) has announced updated findings from its UGN-101 Phase 3 OLYMPUS Trial and initial data from its UGN-102 Phase 2b OPTIMA II Trial.
As quoted in the press release:
Results from a final analysis of the primary endpoint for pivotal Phase 3 OLYMPUS showed that investigational UGN-101 (mitomycin gel) for instillation demonstrated a 59 percent CR rate in patients with LG UTUC. Findings were consistent with previously presented results.
The final analysis of the primary endpoint showed that in the OLYMPUS intent-to-treat population, 42 of the 71 patients (59 percent) achieved a CR. Forty-one patients entered follow-up, which is still ongoing. Durability of response was determined by Kaplan-Meier to be 89 percent at 6 months and 84 percent at 12 months after primary disease evaluation (PDE). The estimated median time-to-recurrence was 13.0 months. Thirty four of the 71 patients treated in the study were initially characterized by the treating physician as having endoscopically unresectable tumor at baseline. Twenty of 34 patients (59 percent) achieved a CR at the PDE assessment and 12-month durability was identical for this subgroup.
In OLYMPUS, the most common treatment emergent adverse events (TEAE) included ureteral stenosis, urinary tract infection, hematuria, flank pain, dysuria, renal impairment, hydronephrosis and frequency. Most TEAEs were characterized as mild to moderate and transient. Sixty-seven percent (48/71) of patients in the trial experienced an adverse event involving the renal/urinary tract. Of these, 23 percent (11/48) did not require surgical intervention, 50 percent (24/48) required temporary ureteral stent placement, 23 percent (11/48) required a long-term ureteral stent and 4 percent (2/48) required nephroureterectomy. At the time of database lock, the most common Grade 3 TEAE’s included ureteral stenosis (8.5 percent), hematuria, flank pain, and urinary tract infection (3 percent each). There was one Grade 4 TEAE of subdural hematoma (1.4 percent).