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UroGen Reports Positive Data from Two Important Studies: UGN-101 OLYMPUS Pivotal Trial in LG UTUC and UGN-102 Phase 2b OPTIMA II Trial in LG Bladder Cancer
UGN-101: Consistent Complete Response (CR) Rate of 59 Percent in Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC) Durability of Response
About this update from Urogen Pharma Ltd.
[{"type":"text","content":"\nUGN-101:\nConsistent Complete Response (CR) Rate of 59 Percent in Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC)\n\n\nDurability of Response Determined to be 89 Percent at Six Months and 84 Percent at 12 Months\n\n\nRolling NDA Submission on Track for Q4 2019 with Planned Launch in 1H 2020\n\n\nUGN-102:\nData Demonstrates CR Rate of 63 Percent in Patients with Intermediate Risk Low-Grade Non-Muscle Invasive Bladder Cancer (LG NMIBC)\n\n\nCompany Completes Enrollment Ahead of Schedule in OPTIMA II Phase 2b Trial\n\n NEW YORK--(BUSINESS WIRE)--\nUroGen Pharma Ltd. (Nasdaq: URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of uro-oncology, today announced updated findings from the UGN-101 Phase 3 OLYMPUS Trial in patients with low-grade upper tract urothelial cancer (LG UTUC), as well as initial CR data from the UGN-102 Phase 2b OPTIMA II Trial in patients with intermediate risk low-grade non-muscle invasive bladder cancer (LG NMIBC).\n\n\nResults 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.\n\n\nThe 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.\n\n\nIn 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 in...