On November 13, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, reported that it will highlight data from two key Phase 3 trials evaluating UGN-102, an investigational treatment in development for LG-IR-NMIBC at the 2023 Society of Urologic Oncology (SUO) annual meeting, November 28-December 1 in Washington D.C (Press release, UroGen Pharma, NOV 13, 2023, View Source [SID1234637565]). These data presentations further UroGen’s mission of developing and commercializing innovative treatments for urothelial and specialty cancers that provide patients with novel non-surgical options to fulfill the unmet needs that exist with current standards of care.
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"The ATLAS and ENVISION Phase 3 clinical trials broaden our understanding of potentially using a new approach to treat LG-IR-NMIBC," says Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "We’re particularly excited that the SUO selected the ENVISION study as one of only two late-breaking trials designated for oral presentations, which we believe further reinforces its potential in advancing bladder cancer treatment. We are optimistic for what the future may hold for LG-IR-NMIBC patients who suffer from this highly prevalent and recurrent disease."
Key highlights of UGN-102 data accepted by SUO:
Abstract Title
Presentation Details
Primary chemoablation for recurrent low-grade intermediate risk (LG IR) NMIBC: The ENVISION trial
Podium Oral Presentation: Urothelial Cancer Session I
Thursday, Nov 30th,
12:04 p.m. – 12:09 p.m. EST
*Abstract available day of presentation
Presenter:
Sandip Prasad, M.D.
Morristown Medical Center/Atlantic Health System and Garden State Urology, Morristown, NJ
Treatment of low-grade intermediate risk non-muscle invasive bladder cancer with UGN-102 + transurethral resection of bladder tumor (TURBT) compared to TURBT monotherapy: the Phase 3 ATLAS trial
Poster #132
Poster Available:
Thursday, Nov 30th,
2:15 p.m. – 3:15 p.m. EST
Presenter:
Sandip Prasad, M.D.
Morristown Medical Center/Atlantic Health System and Garden State Urology, Morristown, NJ
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates submitting an NDA for UGN-102 in 2024.