UroGen Pharma Ltd. announced final data from two key trials, evaluating the safety and efficacy of investigational agent UGN-102 (mitomycin) for intravesical solution in adult patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC) and Jelmyto®(mitomycin) for pyelocalyceal solution in adult patients with low-grade upper tract urothelial cancer (LG-UTUC). The results were presented at the virtual 2021 American Urological Association (AUA) Annual Meeting and published as a supplement to the September 10, 2021 issue of The Journal of Urology®. Phase 2b OPTIMA II: A podium presentation of the final OPTIMA II trial results [21-8601-Podium Presentation [1]] 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 (=10%) 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 U.S. Food and Drug Administration (FDA) for adults with LG-UTUC, demonstrated clinically meaningful response in adults with LG-UTUC. Of 71 patients who initiated treatment, trial results showed 58% (41/71) achieved CR with durability of response at 12 months estimated to be 81.8% by Kaplan-Meier analysis. In this subset of patients, 56% (23/41) remained in CR after 12 months, including 50% (6/12) who did not receive any maintenance instillations and 59% (17/29) who received =1 maintenance instillation. The most common adverse reactions (=20%) reported in the OLYMPUS trial were ureteric obstruction, urinary tract infection, hematuria, flank pain, nausea, dysuria, renal dysfunction, vomiting, fatigue, and abdominal pain. 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.