On April 17, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that new data on investigational drug UGN-102 (mitomycin) and JELMYTO and will be presented at the American Urological Association (AUA) 2024 Annual Meeting being held in San Antonio, Texas from May 3 – 6 (Press release, UroGen Pharma, APR 17, 2024, View Source [SID1234642141]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are proud that the AUA selected the ATLAS post-hoc analysis as a podium presentation," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. "The results highlight UGN-102’s potential to help significantly advance treatment for patients with newly diagnosed and recurrent LG-IR-NMIBC, a highly prevalent and recurrent disease. Additionally, we are excited to see additional independent real-world evidence related to JELMYTO treatment of LG-UTUC patients in a diverse patient types."

Key details of UGN-102 and JELMYTO abstracts accepted by AUA:

Abstract Title

Presentation Details

Response to Primary Chemoablation with UGN-102 in Patients with New or Recurrent LG IR NMIBC: Post-hoc Analysis of the ATLAS Trial

Podium Oral Presentation:
Abstract ID 24-6641,
Saturday, May 4,
2:20-2:30 PM CDT,
Location 304A

Presenter: Dr. William Huang

Longitudinal Follow Up of Multicenter Study of UGN-101 for Upper Tract Urothelial Cancer

Podium Oral Presentation:
Abstract ID 24-7470,
Sunday, May 5,
11:10-11:20 AM CDT,
Location 301A

Presenter: Dr. Yair Lotan

Exploring Recurrence After Initial Response to UGN-101 Induction in Expanded Settings

Podium Oral Presentation:

Abstract ID 24-7534,
Sunday May 5,
11:20-11:30 AM CDT,
Location 301A

Presenter: Dr. Adam Feldman

Mitomycin-containing Reverse Thermal Gel UGN-101 for Upper Tract Urothelial Carcinoma: Retrograde Instillation in Clinic and Outcomes

Video Presentation:

Abstract ID 24-7720,
Saturday, May 4,
10:50-11:00 AM CDT,
Location Video Abstract Theater

Presenter: Dr. Golena Moncaleano

UroGen Sponsors AUA Innovation Nexus

UroGen’s President and Chief Executive Officer, Liz Barrett, will participate in a panel discussion about the state of innovation in urology and a reverse pitch on key areas of discovery and collaboration during the AUA Innovation Nexus Conference on May 2. The AUA Innovation Nexus is a powerful forum to advance urologic discovery to solutions that improve patient care and save lives. Register here: View Source

State of Innovation in Urology

Reverse Pitch:
1-2 PM CDT

Showcase Panel:
Thursday May 2 between 2:45-4:45 PM CDT

Liz Barrett, President and CEO, UroGen Pharma & Other Speakers

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 completing its new drug application (NDA) submission for UGN-102 in September 2024 with a potential FDA decision as early as the first quarter of 2025.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

In the U.S. bladder cancer is the second most common urologic cancer in men. LG-IR-NMIBC represents approximately 22,000 newly diagnosed bladder cancer patients each year and an estimated existing 60,000 recurrent patients. Bladder cancer primarily affects older populations with the median age of diagnosis 73 years and an increased risk of comorbidities. Guideline recommendations for managing LG-IR-NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence and LG-IR-NMIBC patients are even more likely to recur and face repeat TURBT procedures.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.

About Upper Tract Urothelial Cancer

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 – 7,000 new or recurrent low-grade UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse.