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- VesiGel (mitomycin intravesicular) / UroGen
Treatment of low-grade intermediate-risk non-muscle invasive bladder cancer with UGN-102: Results of the phase 3 ATLAS and ENVISION studies. () - Apr 23, 2025 - Abstract #ASCO2025ASCO_5572;
P3
These results demonstrate that treatment with UGN-102 results in a high and clinically meaningful durable CR rate in patients with newly diagnosed or recurrent LG-IR-NMIBC. UGN-102 may represent a valuable nonsurgical treatment option for these patients.
- VesiGel (mitomycin intravesicular) / UroGen
Duration of response (DoR) following treatment with UGN-102 in patients with recurrent, low-grade, intermediate-risk, non-muscle invasive, bladder cancer: 18-month DoR data from the phase 3 ENVISION trial. (Hall A - Posters and Exhibits; Poster Bd #: 398) - Apr 23, 2025 - Abstract #ASCO2025ASCO_1166;
P3
Patients who achieved an initial CR at 3 months had a high probability of remaining disease-free 18 months later. This data confirms that UGN-102 represents a valuable treatment option for patients with LG-IR-NMIBC.
- VesiGel (mitomycin intravesicular) / UroGen
Impact of tumor burden or focality in recurrent low-grade intermediate-risk non-muscle invasive bladder cancer on response to treatment with UGN-102: A substudy of the phase 3 ENVISION trial. (Hall A - Posters and Exhibits; Poster Bd #: 397) - Apr 23, 2025 - Abstract #ASCO2025ASCO_1156;
P3
Study limitations were the small sample size of comparator groups, single arm design, and post-hoc nature of the analysis. UGN-102 may represent a valuable treatment option for many patients with LG-IR-NMIBC.
- ||| VesiGel (mitomycin intravesicular) / UroGen
P3 data, Journal: Perceived impact on patient routines/responsibilities for surgery and a non-surgical primary treatment option in recurrent LG-IR-NMIBC: findings from the ENVISION phase 3 trial. (Pubmed Central) - Mar 6, 2025
P3
Patients perceived UGN-102 to be a favorable primary treatment alternative to traditional surgical resections for LG-IR-NMIBC. By focusing on the underexplored area of patient perceptions, this study provides key information urologists will need to conduct shared decision-making conversations.
- || Review, Journal: New Treatment Options for Non-Muscle-Invasive Bladder Cancer. (Pubmed Central) - Feb 11, 2025
Additionally, immune checkpoint inhibitors such as pembrolizumab and durvalumab have demonstrated potential for systemic treatments in BCG-unresponsive NMIBC and may show even more promise in combinations...For low-grade NMIBC, efforts are underway to de-escalate care through active surveillance and novel adjuvant therapies, reducing the need for repeated TURBT procedures. Together, these advancements highlight a promising shift toward personalized, bladder-preserving strategies that prioritize patient quality of life while addressing unmet needs in NMIBC management.
- ||| mitomycin intravesicular (UGN-103) / UroGen, VesiGel (mitomycin intravesicular) / UroGen
Trial completion date, Trial primary completion date: UTOPIA: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - Jan 31, 2025
P3, N=87, Recruiting, Sponsor: UroGen Pharma Ltd.
Together, these advancements highlight a promising shift toward personalized, bladder-preserving strategies that prioritize patient quality of life while addressing unmet needs in NMIBC management. Trial completion date: Mar 2026 --> Jul 2026 | Trial primary completion date: Mar 2025 --> Jul 2025
- ||| VesiGel (mitomycin intravesicular) / UroGen
P3 data, Journal: Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION). (Pubmed Central) - Jan 9, 2025
P3
Limitations of this study included lack of tumor sizing after the diagnostic biopsy. ClinicalTrials.gov Identifier: NCT05243550.
- VesiGel (mitomycin intravesicular) / UroGen
Treatment of low-grade intermediate-risk non-muscle-invasive bladder cancer with UGN-102: Results of the phase 3 ATLAS and ENVISION studies. (Level 1, West Hall; Poster Bd #: F4) - Jan 7, 2025 - Abstract #ASCOGU2025ASCO_GU_250;
P3
These results demonstrate that treatment with UGN-102 results in a high and clinically meaningful durable CR rate in patients with newly diagnosed or recurrent LG-IR-NMIBC. UGN-102 may represent a valuable non-surgical treatment option for these patients.
- VesiGel (mitomycin intravesicular) / UroGen
Impact of tumor burden or focality in recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer on response to treatment with UGN-102: A substudy of the phase 3 ENVISION trial. (Level 1, West Hall; Poster Bd #: F3) - Jan 7, 2025 - Abstract #ASCOGU2025ASCO_GU_249;
P3
These results demonstrate that chemoablation using UGN-102 results in a high, clinically meaningful CRR in patients with recurrent LG-IR-NMIBC, regardless of tumor burden or multifocality. Study limitations were the small sample size of the comparator groups, single arm design, and post-hoc nature of the analysis.
- |||| mitomycin intravesicular (UGN-103) / UroGen, VesiGel (mitomycin intravesicular) / UroGen
Enrollment open: UTOPIA: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - Aug 18, 2024
P3, N=87, Recruiting, Sponsor: UroGen Pharma Ltd.
Study limitations were the small sample size of the comparator groups, single arm design, and post-hoc nature of the analysis. Not yet recruiting --> Recruiting
- | VesiGel (mitomycin intravesicular) / UroGen
Journal: Ablative therapy with UGN-102 for low-grade intermediate risk non-muscle-invasive bladder cancer: ready for primetime? (Pubmed Central) - May 9, 2024
Not yet recruiting --> Recruiting No abstract available
- | VesiGel (mitomycin intravesicular) / UroGen
Journal: Chemoablation with UGN-102 in intermediate-risk non-muscle invasive bladder cancer, are we there yet? (Pubmed Central) - May 9, 2024
No abstract available No abstract available
- |||||||| mitomycin intravesicular (UGN-103) / UroGen, VesiGel (mitomycin intravesicular) / UroGen
New P3 trial: UTOPIA: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - Mar 26, 2024
P3, N=87, Not yet recruiting, Sponsor: UroGen Pharma Ltd.
- VesiGel (mitomycin intravesicular) / UroGen
Response to Primary Chemoablation With UGN-102 in Patients with New or Recurrent LG IR NMIBC: Post-hoc Analysis of the ATLAS Trial (304A) - Mar 12, 2024 - Abstract #AUA2024AUA_2272;
No abstract available This post-hoc analysis of the prospective, randomized ATLAS trial demonstrates that primary treatment with UGN-102
- ||| VesiGel (mitomycin intravesicular) / UroGen
P3 data, Journal, Monotherapy: Letter: Treatment of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer with UGN-102 (Pubmed Central) - Feb 8, 2024
This post-hoc analysis of the prospective, randomized ATLAS trial demonstrates that primary treatment with UGN-102 No abstract available
- VesiGel (mitomycin intravesicular) / UroGen
Trial completion, Phase classification, Trial completion date: Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov) - Dec 12, 2023
P3, N=8, Completed, Sponsor: UroGen Pharma Ltd.
No abstract available Active, not recruiting --> Completed | Phase classification: P3b --> P3 | Trial completion date: May 2023 --> Feb 2023
- ||| VesiGel (mitomycin intravesicular) / UroGen
P3 data, Journal, Monotherapy: Treatment of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer with UGN-102 (Pubmed Central) - Sep 11, 2023
Active, not recruiting --> Completed | Phase classification: P3b --> P3 | Trial completion date: May 2023 --> Feb 2023 Primary, non-surgical chemoablation with UGN-102 for the management of LG IR NMIBC offers a potential therapeutic alternative to immediate TURBT monotherapy and warrants further investigation.
- | VesiGel (mitomycin intravesicular) / UroGen
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: ATLAS: A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Apr 3, 2023
P3, N=282, Terminated, Sponsor: UroGen Pharma Ltd.
Primary, non-surgical chemoablation with UGN-102 for the management of LG IR NMIBC offers a potential therapeutic alternative to immediate TURBT monotherapy and warrants further investigation. N=632 --> 282 | Trial completion date: Dec 2023 --> Mar 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Mar 2023; Alternate approach pursued
- ||||| VesiGel (mitomycin intravesicular) / UroGen
Enrollment closed: ENVISION: A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Dec 20, 2022
P3, N=220, Active, not recruiting, Sponsor: UroGen Pharma Ltd.
N=632 --> 282 | Trial completion date: Dec 2023 --> Mar 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Mar 2023; Alternate approach pursued Recruiting --> Active, not recruiting
- || VesiGel (mitomycin intravesicular) / UroGen
Retrospective data, Review, Journal: A Systematic Review and Meta-analysis of Chemoablation for Non-muscle-invasive Bladder Cancer. (Pubmed Central) - Dec 16, 2022
Despite the lack of long-term outcomes, chemoablation appears to be a promising treatment option for well-selected NMIBC patients and can potentially help avoid unnecessary TURBT, specifically in some elderly patients with intermediate-risk NMIBC. Further well-designed studies with larger cohorts are necessary to address the differential tolerability and long-term anticancer efficacy of this resurging approach.
- VesiGel (mitomycin intravesicular) / UroGen
Enrollment closed, Trial completion date: Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov) - Dec 16, 2022
P3b, N=8, Active, not recruiting, Sponsor: UroGen Pharma Ltd.
Further well-designed studies with larger cohorts are necessary to address the differential tolerability and long-term anticancer efficacy of this resurging approach. Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> May 2023
- |||| VesiGel (mitomycin intravesicular) / UroGen
Clinical: A phase 3 single-arm study of UGN-102 as primary chemoablative therapy in patients with low-grade intermediate-risk #NMIBC. Presented by Christine Lentowski, MS, MBA @UroGenPharma. #SUO22 written coverage by @zklaassen_md > https://t.co/3qR0RjkL0H @UroOnc (Twitter) - Dec 2, 2022
- VesiGel (mitomycin intravesicular) / UroGen
LONG-TERM OUTCOMES OF TREATMENT WITH UGN-102 FOR PRIMARY CHEMOABLATION OF LOW-GRADE INTERMEDIATE RISK NON-MUSCLE INVASIVE BLADDER CANCER (LG IR NMIBC) (Sapphire ABEFIJMN) - Nov 20, 2022 - Abstract #SUO2022SUO_337;
P2b, P3
These data suggest continued durability in patients treated with UGN-102. Use of UGN-102 as primary chemoablative treatment in patients with LG IR NMIBC is being evaluated by the currently enrolling phase 3 ENVISION trial (NCT05243550).
- VesiGel (mitomycin intravesicular) / UroGen
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 (LG IR NMIBC) (Sapphire ABEFIJMN) - Nov 20, 2022 - Abstract #SUO2022SUO_328;
P3
This study is recruiting (NCT05243550).
- ||||| VesiGel (mitomycin intravesicular) / UroGen
Clinical: Proud of our team - First Patient in Texas to receive intravesical UGN-102 as part of the ENVISION Clinical Trial for Low Grade Intermediate Risk NMIBC #bladder cancer @BladderCancerUS @UroGenPharma @HMethodistUro @HMethodistMD @EfstathiouEleni https://t.co/BllPkxgj6T (Twitter) - Oct 23, 2022
- |||| VesiGel (mitomycin intravesicular) / UroGen
Join us on October 18th at 9:00 AM ET for a webinar, featuring @garysteinbergmd and @UroWCH who will discuss the non-muscle invasive #bladdercancer treatment landscape and @UroGenPharma’s investigational Phase 3 asset UGN-102. Register here: https://t.co/vgAqf81e9g (Twitter) - Oct 12, 2022
- ||| VesiGel (mitomycin intravesicular) / UroGen
.@UroGenPharma to Host Thought Leader Webinar on UGN-102 and Non-Muscle Invasive #BladderCancer including @garysteinbergmd and @UroWCH. Click here for more: https://t.co/29mpEgEXa6 (Twitter) - Oct 12, 2022
- ||| VesiGel (mitomycin intravesicular) / UroGen
$URGN UroGen Pharma to Host Thought Leader Webinar on UGN-102 and Non-Muscle Invasive Bladder Cancers https://t.co/kDw9Mdvmsc #cancer (Twitter) - Oct 11, 2022
- ||| VesiGel (mitomycin intravesicular) / UroGen
Journal, Adverse events: Minimal Patient-Reported Side Effects for a Chemoablative Gel (UGN-102) Used as Frontline Treatment in Adults with Non-Muscle-Invasive Bladder Cancer. (Pubmed Central) - Aug 12, 2022
P2b
A nonsurgical, chemoablative gel (UGN-102) used as a primary treatment for NMIBC offers a more patient-centered therapeutic approach than standard treatments.
- VesiGel (mitomycin intravesicular) / UroGen
Trial completion date, Trial primary completion date: Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov) - Aug 10, 2022
P3b, N=10, Recruiting, Sponsor: UroGen Pharma Ltd.
A nonsurgical, chemoablative gel (UGN-102) used as a primary treatment for NMIBC offers a more patient-centered therapeutic approach than standard treatments. Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Dec 2022
- VesiGel (mitomycin intravesicular) / UroGen
Longitudinal Health-Related Quality of Life Outcomes in Adults with Non-Muscle-Invasive Bladder Cancer Receiving a Chemoablative Gel as a Primary Treatment (Optima II: Phase 2b; single arm; open-label trial) (Room 228) - Apr 10, 2022 - Abstract #AUA2022AUA_2924;
P2b
Patients receive six weekly instillations of UGN-102, a mitomycin-containing reverse thermal gel...Conclusions : Adults with LG NMIBC receiving a nonsurgical, chemoablative gel as a primary treatment maintained their HRQOL through 3 months, and interviewed patients would recommend the gel to other patients. A Phase 3 trial is warranted.
- |||| VesiGel (mitomycin intravesicular) / UroGen
Primary chemoablation of low-grade intermediate-risk non-muscle-invasive #BladderCancer using UGN-102, a mitomycin-containing reverse thermal gel #OPTIMAII. Presented by @UroWCH @nyulangone. #AUA21 written coverage by @WallisCJD @UofT > https://t.co/m5AIRlCcD6 @AmerUrological (Twitter) - Mar 25, 2022
- |||| VesiGel (mitomycin intravesicular) / UroGen
Primary chemoablation of low-grade intermediate-risk #NMIBC using #UGN102, a mitomycin-containing reverse thermal gel #OPTIMAII. Presented by @angiesmith_uro @UNCurology. #SESAUA2022 written coverage by @zklaassen_md @GACancerCenter > https://t.co/QAOsaoCSyS @SES_AUA (Twitter) - Mar 17, 2022
- |||| VesiGel (mitomycin intravesicular) / UroGen
Primary chemoablation of low-grade intermediate-risk non-muscle-invasive #BladderCancer using UGN-102, a mitomycin-containing reverse thermal gel #OPTIMAII. Presented by @UroWCH @nyulangone. #AUA21 written coverage by @WallisCJD @UofT > https://t.co/m5AIRlCcD6 @AmerUrological (Twitter) - Feb 21, 2022
- |||||||||| VesiGel (mitomycin intravesicular) / UroGen
New P3 trial: ENVISION: A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Feb 17, 2022
P3, N=220, Recruiting, Sponsor: UroGen Pharma Ltd.
- ||| VesiGel (mitomycin intravesicular) / UroGen
@UroGenPharma announces start of pivotal single-arm phase 3 trial for UGN-102, an investigational non-surgical treatment for low-grade intermediate-risk #NMIBC. #ReadNow details on UroToday > https://t.co/lpqI1FAiDY #ENVISION @MSchoenbergMD (Twitter) - Feb 4, 2022
- |||| VesiGel (mitomycin intravesicular) / UroGen
Primary chemoablation of low-grade intermediate-risk non-muscle-invasive #BladderCancer using UGN-102, a mitomycin-containing reverse thermal gel #OPTIMAII. Presented by @UroWCH @nyulangone. #AUA21 written coverage by @WallisCJD @UofT > https://t.co/m5AIRlCcD6 @AmerUrological (Twitter) - Jan 28, 2022
- || VesiGel (mitomycin intravesicular) / UroGen
Clinical, P2b data, Journal: Primary Chemoablation of Low-Grade Intermediate-Risk Non-Muscle-Invasive Bladder Cancer Using UGN-102, A Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial. (Pubmed Central) - Jan 21, 2022
Nonsurgical primary chemoablation of LG IR NMIBC using UGN-102 resulted in significant treatment response with sustained durability. UGN-102 may provide an alternative to repetitive surgery for patients with LG IR NMIBC.
- ||||| VesiGel (mitomycin intravesicular) / UroGen
Clinical: First patient dosed in @UroGenPharma's home instillation study of #UGN102 in patients with low-grade intermediate risk non-muscle invasive #BladderCancer (LG IR-NMIBC). #ReadNow details on UroToday > https://t.co/DT5zkuZo5M @MSchoenbergMD #NMIBC (Twitter) - Jan 3, 2022
- |||| VesiGel (mitomycin intravesicular) / UroGen
Primary chemoablation of low-grade intermediate-risk non-muscle-invasive #BladderCancer using UGN-102, a mitomycin-containing reverse thermal gel #OPTIMAII. Presented by @UroWCH @nyulangone. #AUA21 written coverage by @WallisCJD @UofT > https://t.co/m5AIRlCcD6 @AmerUrological (Twitter) - Dec 27, 2021
- | VesiGel (mitomycin intravesicular) / UroGen
New P3 trial: Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov) - Nov 29, 2021
P3b, N=10, Recruiting, Sponsor: UroGen Pharma Ltd.
- ||||| VesiGel (mitomycin intravesicular) / UroGen
Enrollment closed: ATLAS: A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Nov 15, 2021
P3, N=632, Active, not recruiting, Sponsor: UroGen Pharma Ltd.
UGN-102 may provide an alternative to repetitive surgery for patients with LG IR NMIBC. Recruiting --> Active, not recruiting
- || VesiGel (mitomycin intravesicular) / UroGen
$URGN UroGen Pharma Unveils New Phase 3 Development Plan for UGN-102 at Spotlight Event https://t.co/7t1LiwLyyL (Twitter) - Nov 10, 2021
- || VesiGel (mitomycin intravesicular) / UroGen
UGN-102 May Provide Alternative to Repetitive Surgery in Low-Grade Intermediate-Risk NMIBC https://t.co/Zj5fX6P285 via @OncLive with @MSchoenbergMD (Twitter) - Nov 2, 2021
- || VesiGel (mitomycin intravesicular) / UroGen
UGN-102 May Provide Alternative to Repetitive Surgery in Low-Grade Intermediate-Risk NMIBC @JUrology #blcsm #oncology https://t.co/zEBsxc9edD (Twitter) - Oct 19, 2021
- |||| VesiGel (mitomycin intravesicular) / UroGen
Clinical: Study finds UGN-102 well-tolerated in patients with NMIBC https://t.co/tBltaBHtgj #urology #urologist #NMIBC #bladdercancer @UroWCH @NYUUrology (Twitter) - Oct 19, 2021
- ||| VesiGel (mitomycin intravesicular) / UroGen
Dr. Huang discusses UGN-102 as treatment alternative for NMIBC https://t.co/yrNNcnFthO #urology #urologist #NMIBC #bladdercancer @UroWCH @nyulangone (Twitter) - Oct 8, 2021
- ||||| VesiGel (mitomycin intravesicular) / UroGen
Clinical: The @JUrology publishes results of the phase 2b study of #UGN102 in patients with low-grade intermediate risk non-muscle invasive #BladderCancer. #ReadNow details on UroToday > https://t.co/NNRGGdqoUq @UroGenPharma @UroWCH #OPTIMAII (Twitter) - Oct 7, 2021
- ||||| VesiGel (mitomycin intravesicular) / UroGen
Clinical: ⚡️ Nonsurgical primary chemoablation with the mitomycin-containing reverse thermal gel UGN-102 may be an alternative to repetitive surgery for pts with low-grade NMIBC. @UrologyTimes #bladdercancer https://t.co/TIEBzwUffD (Twitter) - Oct 7, 2021
- |||| VesiGel (mitomycin intravesicular) / UroGen
Clinical: UGN-102 effective in patients with low-grade NMIBC https://t.co/QPVD9mbCJc #urology #urologist #NMIBC #bladdercancer @UroWCH @nyulangone (Twitter) - Oct 6, 2021