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Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

The approval is supported by findings from the phase 3 ENVISION trial.

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From Past Challenges to Current Innovations in Treatment of NMIBC 

Video Series

TAR-200 Clinical Development Program in NMIBC

Video content above is prompted by the following:

Can you briefly mention other ongoing phase 3 studies with TAR-200?


Videos

Experts discuss challenges with the current standard of care in non–-muscle-invasive bladder cancer (NMIBC); review data and emerging treatment options for high-risk, non–-bacille Calmette-Guérin responsive NMIBC, including drug delivery systems;, and share practical considerations for the adoption of new and emerging treatment options in NMIBC.

Experts discuss the standard of care and the use of intravesical chemotherapy in the treatment of non–muscle-invasive bladder cancer (NMIBC).

Standard of Care and Intravesical Chemotherapy in NMIBC

Experts discuss the use of bacille Calmette-Guérin (BCG) as the standard treatment for high-risk non–muscle-invasive bladder cancer (NMIBC), when a patient is considered unresponsive to BCG, and how BCG shortages have impacted clinical practice and urologists in the community.

BCG for treatment of NMIBC

Experts discuss the frequency of cystectomy use in patients with non–muscle-invasive bladder cancer (NMIBC) and how often patients are requesting bladder-sparing treatments.

Cystectomy in NMIBC

Experts review different treatment delivery options available for the management of non–muscle-invasive bladder cancer (NMIBC), discuss the exciting developments in NMIBC with several delivery systems and agents under investigation, and provide information about TAR-200, a targeted release system utilizing continuous intravesical release of gemcitabine, including how TAR-200 is installed within the bladder.

New Intravesical Delivery Systems and TAR-200 in NMIBC

Experts discuss the patient demographics and clinical trial design of the phase 2b SunRISe-1 study investigating the use of TAR-200 as a monotherapy and in combination with cetrelimab (a PD-1 inhibitor), with results presented at the recent European Society for Medical Oncology 2024 Congress, as well as the safety and efficacy data from the SunRISe-1 trial.

TAR-200 Efficacy and Safety in High-Risk BCG- Unresponsive NMIBC (SunRISe-1)

Experts briefly mention other ongoing phase 3 studies investigating TAR-200 for the treatment of non–muscle-invasive bladder cancer (NMIBC).

Experts briefly discuss investigational mitomycin delivery systems UGN-102 and UGN-103, which are being evaluated in intermediate-risk non–muscle-invasive bladder cancer (NMIBC), and share their impressions of the safety and efficacy results from the ENVISION phase 3 trial for UGN-102.

Other Investigational Drug Delivery Systems in NMIBC

Experts share high-level results from the investigation of cretostimogene grenadenorepvec, an investigational targeted immunotherapy delivered intravesically for the treatment of non–muscle-invasive bladder cancer (NMIBC).

Cretostimogene Grenadenorepvec and Integration of Novel Therapies in High-Risk BCG-Unresponsive NMIBC

Experts briefly discuss 3 new FDA-approved treatments for patients who are unresponsive to bacille Calmette-Guérin (BCG) in the last 5 years—pembrolizumab, nogapendekin alfa inbakicept-pmln, and nadofaragene firadenovec—highlighting how each is administered, and share their impressions of the safety and efficacy of these agents.

FDA-Approved Treatments for BCG-Unresponsive NMIBC

Experts discuss where they are using FDA-approved treatments for bacille Calmette-Guérin (BCG)–unresponsive patients in their practice, how they choose between these treatments, and how these advances have impacted the timing of radical cystectomy for patients.

Use and Sequencing of Novel Treatments in NMIBC

Experts discuss how they communicate various treatment options for non–muscle-invasive bladder cancer (NMIBC) with patients and health care professionals.

Communication of Treatment Options for High-Risk NMIBC

Experts share their initial impressions of the available data on immunotherapies, including PD-L1 inhibitors durvalumab and sasanlimab, being evaluated in bacille Calmette-Guérin (BCG)–unresponsive patients with non–muscle-invasive bladder cancer (NMIBC).

Checkpoint Inhibitors for Treatment of NMIBC

Experts discuss the unmet needs in the treatment of non–muscle-invasive bladder cancer (NMIBC), highlighting areas where advancements are still needed.

Unmet Needs in NMIBC

Experts discuss whether novel delivery systems in non–muscle-invasive bladder cancer (NMIBC) could be easily adopted in clinical practice and the challenges they anticipate in operationalizing TAR-200 and other novel delivery systems in urology practices.

Operationalizing TAR-200 and Other Delivery Systems in Practice

Experts discuss the potential impact of FDA-approved novel delivery systems on patients’ quality of life and treatment adherence in the management of non–muscle-invasive bladder cancer (NMIBC).

Patient Communication and Treatment Adherence in NMIBC

Experts discuss their expectations regarding the uptake of new treatments in clinical practice for non–muscle-invasive bladder cancer and other relevant conditions.

Uptake of New Treatments in Urology Practice

Experts share their concluding thoughts on the recent progress and future outlook for the treatment of non–muscle-invasive bladder cancer (NMIBC).

TAR-200 Clinical Development Program in NMIBC

EP: 1.Standard of Care and Intravesical Chemotherapy in NMIBC

EP: 2.BCG for treatment of NMIBC

EP: 3.Cystectomy in NMIBC

EP: 4.New Intravesical Delivery Systems and TAR-200 in NMIBC

EP: 5.TAR-200 Efficacy and Safety in High-Risk BCG- Unresponsive NMIBC (SunRISe-1)

EP: 6.TAR-200 Clinical Development Program in NMIBC

EP: 7.Other Investigational Drug Delivery Systems in NMIBC

EP: 8.Cretostimogene Grenadenorepvec and Integration of Novel Therapies in High-Risk BCG-Unresponsive NMIBC

EP: 9.FDA-Approved Treatments for BCG-Unresponsive NMIBC

EP: 10.Use and Sequencing of Novel Treatments in NMIBC

EP: 11.Communication of Treatment Options for High-Risk NMIBC

EP: 12.Checkpoint Inhibitors for Treatment of NMIBC

EP: 13.Unmet Needs in NMIBC

EP: 14.Operationalizing TAR-200 and Other Delivery Systems in Practice

EP: 15.Patient Communication and Treatment Adherence in NMIBC

EP: 16.Uptake of New Treatments in Urology Practice

EP: 17.Final Thoughts and Clinical Trials in NMIBC