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NMIBC with CIS: Evidence, Practice & Emerging Research

Actionable Clinical Data
Videos
Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Mukul Singhal, PhD
The American Urological Association's 2026 Annual Meeting, was host to the IP50: Bladder Cancer: Non-Invasive IV Session. Dr. Mukul Singhal presented interactive poster IP50-28: Quality care measures among patients with high-risk non-muscle invasive bladder cancer with papillary carcinoma or CIS receiving front-line BCG or other intravesical therapies.
Presented by Scott Flanders, PhD
The American Urological Association's 2026 Annual Meeting, was host to the IP50: Bladder Cancer: Non-Invasive IV Session. Dr. Scott Flanders presented interactive poster IP50-12: An Indirect Treatment Comparison (ITC) of Nogapendekin Alfa Inbakicept-pmln plus Bacillus Calmette–Guérin (NAI+BCG) and TAR-200 in patients with BCG-unresponsive, Non-Muscle Invasive Bladder Cancer CIS ± Papillary (NMIBC).
Presented by Evanguelos N. Xylinas, MD, MS
The 2026 European Association of Urology (EAU) annual meeting featured a surgical and non-surgical treatment of non-muscle invasive bladder cancer session and a presentation by Dr. Evanguelos Xylinas discussing the SunRISe-1 trial and peri-procedural prophylactic antibiotic use with gemcitabine intravesical system monotherapy.
Presented by Siamak Daneshmand, MD
At SUO 2025, Dr. Siamak Daneshmand presented the 1-year disease-free survival (DFS) results from SunRISe-1 evaluating the gemcitabine intravesical system (Gem-iDRS), INLEXZO™ (gemcitabine intravesical system; formerly TAR-200), as monotherapy in patients with BCG-unresponsive, papillary-only, high-risk, non-muscle invasive bladder cancer (NMIBC).
Presented by Girish Kulkarni, MD, PhD
The 2025 Society of Urologic Oncology (SUO) Annual Meeting was host to a bladder cancer poster session. Dr. Girish Kulkarni presented an ad hoc analysis of the phase 2b SunRISe-1 Trial evaluating baseline urinary tumor DNA (utDNA), minimal residual disease (MRD), and genomic disease burden in relation to clinical response to INLEXZO™ (gemcitabine intravesical system; formerly TAR-200).
Presented by Felix Guerrero-Ramos, MD, PhD, FEBU
The 2025 European Society for Medical Oncology (ESMO) Annual Congress, held in Berlin, Germany was host to a urothelial carcinoma poster session. Dr. Felix Guerrero-Ramos presented the results of an exploratory analysis of the phase 2b SunRISe-1 trial in patients with BCG-unresponsive NMIBC
Presented by Yair Lotan, MD
The 2025 South Central AUA annual meeting included a session on bladder cancer, featuring a presentation from Dr. Yair Lotan discussing 1-year outcomes of TAR-200 monotherapy in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer CIS. Patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer have a high risk of disease progression and limited treatment options.
Presented by Felix Guerrero-Ramos, MD, PhD, FEBU
Dr. Felix Guerrero Ramos presented the first results from Cohort 4 of SunRISe-1, evaluating TAR-200 monotherapy in patients with bacillus Calmette-Guerin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer (NMIBC).
Presented by Joseph Jacob, MD, MCR
The American Urological Association's 2025 Annual Meeting, in Las Vegas, Nevada, was host to the Plenary Session: Paradigm-Shifting, Practice-Changing Clinical Trials in Urology. Dr. Joseph Jacob discussed TAR-200 monotherapy in patients with bacillus Calmette-Guerin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes.
Presented by Peter Clark, MD
The 2025 SESAUA annual meeting featured a bladder cancer session and a presentation by Dr. Peter Clark discussing results of the SunRISe-1 study assessing TAR-200 in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer.
Presented by Siamak Daneshmand, MD
The 2024 SUO annual meeting included a urothelial carcinoma session, featuring a presentation by Dr. Sia Daneshmand discussing safety and tolerability of TAR-200 monotherapy in patients with BCG-unresponsive high risk non muscle invasive bladder cancer (NMIBC) in SunRISE-1.
Presented by Michiel van der Heijden, MD, PhD
The 2024 IBCN annual meeting included a session on novel therapies and outcome measures in clinical trials, featuring a presentation by Dr. Michiel van der Heijden discussing results from SunRISe-1, assessing TAR-200 + cetrelimab, TAR-200 alone, or cetrilumab alone in patients with BCG unresponsive high-risk non muscle invasive bladder cancer (NMIBC).
Presented by Michiel S. Van der Heijden, MD, PhD
 The 2024 ESMO annual meeting included a session on urothelial carcinoma, featuring a presentation by Dr. Michiel Van der Heijden, discussing updated results from SunRISe-1 assessing TAR-200 +/- cetrelimab and cetrelimab alone in patients with BCG-unresponsive high-risk NMIBC. Unfortunately, patients with BCG unresponsive high-risk NMIBC have limited treatment options. Standard of care for these patients is radical cystectomy,
Presented by Evanguelos Xylinas, MD, PhD
The 2024 ESMO annual meeting included a session on urothelial carcinoma, featuring a presentation by Dr. Evanguelos Xylinas discussing the association of PD-L1 expression with clinical response to TAR-200 in the phase 2b SunRISe-1 trial.
Presented by Joseph Jacob, MD, MCR
he 2024 American Urological Association (AUA) annual meeting featured a plenary session, and a presentation by Dr. Joseph Jacob discussing results from the SunRISe-1 study assessing TAR-200 in patients with BCG-unresponsive high risk non-muscle invasive bladder cancer.
Presented by Andrea Necchi, MD
The 2024 European Association of Urology (EAU) annual meeting featured a session on non-muscle invasive bladder cancer, and a presentation by Dr. Andrea Necchi discussing results from SunRISe-1 in patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer receiving TAR-200 monotherapy.
Presented by Joseph M. Jacob, MD
The 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium featured a urothelial carcinoma session and a presentation by Dr. Joseph Jacob discussing reasons for refusal of or ineligibility for radical cystectomy in patients with BCG–unresponsive high-risk non–muscle-invasive bladder cancer (NMIBC) from the SunRISe-1 study.
Presented by Joost Boormans, MD, PhD
At the 2023 ESMO Annual Congress, Dr. Joost Boormans discussed the abstracts, "LBA104 - First safety and efficacy results of the TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations" and "LBA105 - Results From SunRISe-1 in Patients (Pts) With Bacillus Calmette–Guérin (BCG)-Unresponsive High-Risk Non–Muscle-Invasive Bladder Cancer (HR NMIBC) Receiving TAR-200 Monotherapy".
Presented by Andrea Necchi, MD
The 2023 European Society of Medical Oncology (ESMO) Annual Congress held in Madrid, Spain between October 20th and 24th, 2023 was host to a non-prostate, genitourinary tumors mini oral session. Dr. Andrea Necchi presented the late-breaking abstract results from SunRISe-1 in patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) receiving TAR-200 monotherapy.
Presented by Siamak Daneshmand, MD
At the 2023 AUA annual meeting, Dr. Siamak Daneshmand presented the first results from SunRISe-1 in patients with BCG-unresponsive high-risk non–muscle-Invasive bladder cancer (NMIBC) receiving TAR-200 in combination with Cetrelimab, TAR-200 alone, or Cetrelimab alone.
Presented by Michiel Simon Van Der Heijden MD, PhD
On the second day of the American Society for Clinical Oncology (ASCO) Genitourinary Cancer Symposium 2022 in Trials in Progress Poster Session B, Dr. Van Der Heijden presented the rationale and design of the SunRISe-1 trial of TAR-200 plus cetrelimab, TAR-200 alone, or cetrelimab alone in patients with high-risk nonmuscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guérin (BCG).
Presented by Michiel S. Van der Heijden, MD, PhD
In the on-demand poster session of the European Society for Medical Oncology (ESMO) Annual Congress, Dr. Michiel Van der Heijden presented on the design of the SunRISe-1 trial (NCT04640623).
Publications
Articles and Abstracts

TAR-200 is a first-in-class intravesical drug-releasing system designed to provide sustained delivery of gemcitabine in the bladder. TAR-200 alone or in combination with cetrelimab (PD-1 inhibitor) could improve outcomes in patients with bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) ineligible for or refusing radical cystectomy.

Press Releases
Official Announcements on Clinical Developments
  • INLEXZO permanent J-code (J9183) effective April 1
Reno, Nevada (UroToday.com) -- Johnson & Johnson (NYSE:JNJ) announced the permanent Healthcare Common Procedure Coding System (HCPCS) J-code for INLEXZO™ (gemcitabine intravesical system) is now in effect. Adult patients living with certain types of Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who have historically had limited options before possible bladder removal may benefit from a more standardized billing pathway for this therapy. The unique identifier, J9183, assigned by the Centers for Medicare & Medicaid Services (CMS), can be used by U.S. government and commercial payers, as well as physicians and their office staff, in the billing and reimbursement process for INLEXZO.

Investigational TAR-200 monotherapy demonstrates high complete response rate without the need for reinduction or additive therapy in patients who are Bacillus Calmette-Guérin (BCG)-unresponsive

Reno, Nevada (UroToday.com) -- Johnson & Johnson (NYSE:JNJ) announced additional results from the pivotal Phase 2b SunRISe-1 study, supporting the safety and efficacy profile of investigational TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC). New data were featured in a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress (Abstract #LBA85).

The following section provides broader disease-state context and emerging research across high-risk NMIBC.
Content below is educational and investigational.

Videos
Clinical Conversations by Experts

Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Sima Porten, MD, MPH
At the 2025 AUA Annual Meeting, Dr. Sima Porten presented SunRISe-5, a phase III, randomized, open-label study comparing TAR-200 to intravesical chemotherapy after bacillus Calmette-Guérin (BCG) in recurrent, high-risk (HR), non–muscle-invasive bladder cancer (NMIBC).
Presented by Sima Porten, MD, MPH
At the 2024 Society of Urologic Oncology (SUO) annual meeting, Dr. Sima Porten presented SunRISe-5, a phase III randomized, open-label study of TAR-200 compared with intravesical chemotherapy after bacillus Calmette-Guerin (BCG) in recurrent, high-risk, non-muscle invasive bladder cancer (NMIBC).
Presented by James W.F. Catto
The 2024 European Association of Urology (EAU) annual meeting featured a session on non-muscle invasive bladder cancer, and a presentation by Dr. James Catto discussing the trial design of SunRISe-3, assessing TAR-200 plus cetrelimab or TAR-200 versus intravesical BCG in patients with BCG-naive high-risk non–muscle-invasive bladder cancer.
Presented by Andrea Necchi, MD
During the 2023 ESMO annual meeting, Dr. Andrea Necchi presented the study framework for SunRISe-3, a phase 3 randomized trial of TAR-200 plus cetrelimab or TAR-200 monotherapy versus intravesical BCG in patients with BCG-naïve, high-risk, non-muscle invasive bladder cancer (NMIBC).