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Low-Grade Intermediate-Risk Non–Muscle-Invasive Bladder Cancer

Actionable Clinical Data
Videos
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by William C. Huang, MD
The 2025 SESAUA annual meeting featured a bladder cancer session and a presentation by Dr. William Huang discussing results from the ENVISION trial assessing primary chemoablation of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102. Low-grade, intermediate-risk, non-muscle invasive bladder cancer is a persistent and recurrent cancer that is inadequately controlled by the current standard of care, TURBT.
Presented by Sandip M. Prasad, MD
The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Sandip Prasad discussing a substudy of the phase 3 ENVISION trial assessing the impact of tumor burden or focality in recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer on response to treatment with UGN-102.
Presented by Sandip M. Prasad, MD

The 2025 GU ASCO annual meeting featured a urothelial carcinoma session and a presentation by Dr. Sandip Prasad discussing results of the phase 3 ATLAS and ENVISION studies assessing treatment of low-grade intermediate-risk non-muscle-invasive bladder cancer with UGN-102. Low grade intermediate risk non-muscle invasive bladder cancer is a persistent, recurrent cancer inadequately controlled by TURBT, which is the current standard of care.

Presented by Vincent Bivens, MD
The 2024 SUO annual meeting included a urothelial carcinoma session, featuring a presentation by Dr. Vincent Bivens discussing home instillation of UGN-102 for primary chemoablation of recurrent low-grade intermediate risk non muscle invasive bladder cancer (NMIBC). Bladder cancer is the 6th most common cancer in the US, with approximately 83,000 incident cases annually, and at diagnosis, 75% of patients present with NMIBC.
Presented by Sandip M. Prasad, MD
The 2024 SUO annual meeting included a urothelial carcinoma session, featuring a presentation by Dr. Sandip Prasad discussing the ENVISION trial assessing primary chemoablation of recurrent low-grade intermediate risk NMIBC with UGN-102. Low-grade, intermediate-risk NMIBC is a persistent and recurrent cancer that is inadequately controlled by the current standard of care, TURBT.
Presented by William Huang, MD
The 2024 American Urological Association (AUA) Annual Meeting held in San Antonio, TX 2024 was host to a non-invasive bladder cancer podium session. Dr. William Huang presented a post hoc analysis of the ATLAS trial evaluating the response to primary chemoablation with UGN-102 in patients with new or recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).
Presented by Sandip M. Prasad, MD
The 2023 Society of Urologic Oncology (SUO) annual meeting held in Washington, D.C. between November 28th and December 1st, 2023, was host to a poster/abstract session. Dr. Sandip Prasad presented the results of the recently published phase 3 ATLAS trial comparing primary chemoablation with UGN 102 ± TURBT versus TURBT monotherapy in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).
Presented by Christine E. Lentowski, MS, MBS
The 2022 Society of Urologic Oncology annual meeting featured a session on bladder cancer, including a presentation by Christine Lentowski discussing the trial design of a phase 3 single-arm study of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle invasive bladder cancer.
Presented by Angela B. Smith, MD, MS
The 2022 Southeastern Section of the AUA’s annual meeting included a bladder cancer session and Dr. Angela Smith discussing results of OPTIMA II, a phase 2b, open-label, single arm trial assessing primary chemoablation of low-grade intermediate risk non-muscle invasive bladder cancer (NMIBC) using UGN-102. 
Presented by William Huang, MD
Most patients newly diagnosed with bladder cancer have non-muscle invasive disease (NMIBC). For patients with intermediate or high-risk NMIBC and those with carcinoma in situ (CIS), adjuvant treatment with BCG is guideline-recommended on the basis of proven benefits in disease recurrence.
Presented by William Huang, MD
 Low-grade intermediate-risk non-muscle-invasive bladder cancer can consist of multiple and/or recurrent low-grade Ta tumors. It has high rates of recurrence but a low risk of disease progression. Transurethral resection of bladder tumor (TURBT) plus intravesical therapy is considered the standard of care.
Publications
Peer-Reviewed Journal Abstracts

Low-grade intermediate-risk nonmuscle-invasive bladder cancer (LG IR NMIBC) is a chronic illness commonly treated by repetitive transurethral resection of bladder tumor (TURBT). We compared the efficacy and safety of intravesical chemoablation with UGN-102 (a reverse thermal gel containing mitomycin), with or without subsequent TURBT, to TURBT alone in patients with LG IR NMIBC.

The trial "OPTimized Instillation of Mitomycin for Bladder Cancer Treatment" (Optima II, clinicaltrials.gov: NCT03558503) was a Phase 2b trial evaluating a nonsurgical alternative as a primary treatment for non-muscle-invasive bladder cancer (NMIBC).

Low-grade intermediate-risk non-muscle-invasive bladder cancer (LG IR NMIBC) is a recurrent disease, thus requiring repeated transurethral resection of bladder tumors (TURBT) under general anesthesia.

Physician-Scientist Commentaries
Peer-reviewed Abstract Supplemental Commentaries
Press Releases
Official Announcements on Clinical Developments
  • UGN-102 demonstrated 82.3% duration of response (DOR) at 12 months in patients who achieved complete response at 3 months
  • 79.6% complete response rate at 3 months in patients treated with UGN-102
  • Safety profile consistent with prior clinical trials of UGN-102

Reno, Nevada (UroToday.com) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the presentation of the Phase 3 ENVISION trial’s efficacy and safety results at the Society of Urologic Oncology (SUO) annual meeting in Dallas, TX. These results, published online in the Journal of Urology in October, demonstrate that treatment with investigational therapy UGN-102, a mitomycin-based intravesical solution, resulted in a high and clinically meaningful complete response rate that was durable in patients with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC).
  • The Kaplan-Meier Estimate of Duration of Response at 12 Months in Patients Who Achieved a Complete Response at Three Months was 82.3%
  • Patients Receiving UGN-102 had a 79.6% Complete Response Rate at Three Months
  • Side Effect Profile Consistent with Previous Clinical Trials of UGN-102
Reno, Nevada (UroToday.com) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, announced that new long-term durability of response results from the Phase 3 ENVISION study of investigational drug UGN-102 in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) were published online in the Journal of Urology.
Reno, Nevada (UroToday.com) UroGen Pharma Ltd., a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced positive topline data from its Phase 3 trials ATLAS and ENVISION studying UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Both ATLAS and ENVISION trials met their primary endpoints.
Reno, Nevada (UroToday.com) UroGen Pharma Ltd. a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that The Journal of Urology published data from the Phase 3 ATLAS trial for investigational agent UGN-102 (mitomycin) for intravesical solution in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), that demonstrated superiority to transurethral resection of bladder tumor surgery (TURBT) with a 55% reduction of risk for recurrence, progression, or death in patients who received UGN-102.
-- Results from this ongoing, noninterventional rollover study were presented at the 23rd Annual Society of Urological Oncology (SUO) Meeting in San Diego

Reno, Nevada (UroToday.com) -- UroGen Pharma Ltd., a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, announced new data from the OPTIMA II study designed to obtain long-term follow-up data on UGN-102 that shows median duration of response (DOR) of 24.4 months for UroGen’s investigational drug UGN-102 currently in Phase 3 development for low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The study (Abstract #193) was presented at SUO on December 2.
-- ENVISION Study Design Similar to Successful UGN-102 Phase 2b OPTIMA II Trial --

Reno, Nevada (UroToday.com) -- UroGen Pharma Ltd., a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, today announced the initiation of its Phase 3 ENVISION study of UGN-102 (mitomycin) for intravesical solution, in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).
Study explores opportunity to shift from clinic to home instillation of this promising non-surgical treatment

Potential to transform care and access to treatment for this growing patient population

San Francisco, CA (UroToday.com) -- UroGen Pharma Ltd., a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, announced that the first patient has received their first dose in its home instillation study of UGN-102 in patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
  • Clinically Meaningful Response and Sustained Durability Underscore Potential for UGN-102 to Become a Non-Surgical Primary Therapeutic Treatment for Patients with Highly Recurrent LG IR-NMIBC
    • 65% Complete Response (CR) Rate at Three Months
    • 61% of Patients Remain in CR at 12 Months
  • Data Supports Ongoing Phase 3 Development of UGN-102 in LG IR-NMIBC as an Alternative to Surgery

San Francisco, CA (UroToday.com) -- UroGen Pharma Ltd. announced The Journal of Urology® published results from the Phase 2b OPTIMA II trial, a Phase 2b, open-label, single-arm trial studying UGN-102 (mitomycin) for intravesical solution as primary non-surgical therapy for low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). The study was published online and will be in the January print edition of The Journal of Urology®.
  • 65% Complete Response in Patients with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
  • Patients who Achieved a Complete Response and Underwent an Evaluation at Each Timepoint, 97%, 86% and 85% Remained Disease Free at Six, Nine and 12 Months Following Initiation of Therapy, Respectively
  • Positive Data Continue to Validate UroGen’s Proprietary Technology Platform and Value of Intravesical Therapy Dwell Time
  • American Urological Association Abstract Presentations Available Online In Lieu of Annual Meeting

San Francisco, CA (UroToday.com) -- UroGen Pharma Ltd. announced the presentation of positive interim data from the Phase 2b OPTIMA II trial evaluating the safety and efficacy of investigational agent UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). The study was accepted for the 2020 American Urological Association (AUA) Annual Meeting, published as a supplement to the April 2020 issue of The Journal of Urology® and presented as part of the AUA Virtual Experience. The presentation can be accessed via the AUA website here.
  • Complete Response (CR) Rate of 65% at Three Months
  • Of those with CR, 97% and 85% of Patients Remained Free of Disease at Six and Nine Months Follow-Up, Respectively
  • Detailed Results Presentation to be Shared Virtually via American Urological Association (AUA) in mid-May

San Francisco, CA (UroToday.com) -- UroGen Pharma Ltd. announced positive interim data analysis of UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC). These data were featured in a late-breaking abstract published in the April Supplement to The Journal of Urology. The detailed results presentation will be available online via the American Urological Association (AUA) in mid-May 2020.