UroGen Announces Results from Subgroup Analyses of the Pivotal ENVISION Trial Evaluating Impact of Baseline Tumor Burden and Focality on Response to UGN-102
- Results presented at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU 2025)
- Treatment with UGN-102 resulted in durable complete response (CR) rates across subgroups with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
-
CR rates were:
-
82.8% for patients with a tumor burden ≤3 cm compared to73.2% for those with a tumor burden >3 cm -
79.3% for patients with multiple tumors compared to82.9% for those with single tumors
-
- CR rates and duration of response (DOR) patterns were similar across tumor burden and focality subgroups
"In this subgroup analysis on tumor burden and focality from the ENVISION study, the overall CR rate was consistent, and a majority of patients maintained their response 12 months after achieving CR at three months," said Sandip M. Prasad, M.D., Director of Urology at Morristown Medical Center and lead author of the study. "These results provide evidence of UGN-102’s potential to become an effective and durable treatment option for patients with recurrent LG-IR-NMIBC, regardless of tumor size or focality."
The ENVISION study included 240 patients with recurrent LG-IR-NMIBC who received at least one dose of UGN-102 and
“We are encouraged by these results, which highlight the potential of UGN-102 to provide durable responses in patients with recurrent LG-IR-NMIBC,” said Mark Schoenberg, M.D., Chief Medical Officer of UroGen. “These pre-specified subgroup analyses further strengthen the growing body of evidence supporting UGN-102 as a treatment option for patients dealing with the challenges of disease recurrence and the need for repeated surgeries.”
The ENVISION trial’s primary efficacy and safety results, previously presented, showed that UGN-102 delivered a
These findings further support UGN-102’s potential to alter the treatment landscape for patients with LG-IR-NMIBC, a condition where recurrence and progression remain significant clinical challenges.
UroGen initiated the submission of a rolling new drug application (NDA) to the
The most common treatment-emergent adverse events (TEAEs) in the ENVISION trial were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. The TEAEs were typically mild-to-moderate in severity and either resolved or were resolving. The ENVISION trial demonstrated a similar safety profile to that observed in other studies of UGN-102.
Study limitations include the small sample size of the comparator groups and the single arm design.
The analysis in another presentation titled, Treatment of Low-Grade Intermediate-Risk Non-Muscle-Invasive Bladder Cancer with UGN-102: Results of the Phase 3 ATLAS and ENVISION Studies highlights that in both studies, the CR rate in patients initially treated with UGN-102 was robust, with the majority of patients remaining event-free at 12 months after a three-month CR. A new analysis from the ATLAS trial highlights
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 by a trained healthcare professional. UroGen completed the NDA submission in August, ahead of schedule. The FDA accepted the NDA for UGN-102 and assigned a PDUFA goal date of June 13, 2025.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
In the
About ENVISION
The Phase 3 ENVISION trial is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 (mitomycin) for intravesical solution as a chemoablative therapy in patients with LG-IR-NMIBC. The Phase 3 ENVISION trial completed target enrollment with approximately 240 patients across 56 sites. Study participants received six once-weekly intravesical instillations of UGN-102. The primary endpoint evaluated the CR rate at the three-month assessment after the first instillation, and the key secondary endpoint evaluated durability over time in patients who achieved a CR at the three-month assessment. Learn more about the Phase 3 ENVISION trial at www.clinicaltrials.gov (NCT05243550).
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat low-grade upper tract urothelial cancer and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with LG-IR-NMIBC are designed to ablate tumors by non-surgical means. UroGen is headquartered in
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the ENVISION subgroup analyses providing evidence of UGN-102's potential to become an effective and durable treatment option for patients with recurrent LG-IR-NMIBC, regardless of tumor size or focality and further strengthening the growing body of evidence supporting UGN-102 as a treatment option for patients dealing with the challenges of disease recurrence and repeated surgeries; the potential benefits to patients and opportunities for UGN-102, if approved, including to alter the treatment landscape for patients with LG-IR-NMIBC; statements related to UroGen’s NDA submission and expected PDUFA target action date for UGN-102; the estimated annual
View source version on businesswire.com: https://www.businesswire.com/news/home/20250214991583/en/
INVESTOR CONTACT:
Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@urogen.com
609-460-3588 ext. 1093
MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
cindy.romano@urogen.com
609-460-3583 ext. 1083
Source: UroGen Pharma Ltd.