Introduction:

TAR-200 is a novel intravesical gemcitabine-releasing system under investigation for treating patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) and MIBC. Results from the SunRISe-1 trial demonstrate a favorable safety profile and durable complete responses with TAR-200 monotherapy, addressing a significant unmet need for patients who are ineligible or who decline radical cystectomy.  Given the novelty of TAR-200, this study aims to understand the treatment experiences of trial investigators, to inform future clinical practice, and to enhance the management of patients with HR-NMIBC treated with TAR-200.

Methods:

Physicians specializing in urology who were principal investigators (PIs) of the SunRISe-1 or SunRISe-3 trials in the United States were invited to participate in virtual, 60-minute, semi-structured, open-ended, 1-on-1 qualitative interviews between April and June 2025. Interviews elicited physicians’ practices in TAR-200 preparation, insertion, removal, monitoring, management of adverse events (AEs), care model designs, and their perceived future practice patterns with TAR-200 in a real-world (RW) setting. The study sponsor was blinded to the identity of the participants included in the research. Interviews were audio-recorded, and transcripts were coded using NVivo qualitative data analysis software to identify key themes. Results were analyzed in aggregate and summarized descriptively.

Results:

Seventeen participants representing unique trial sites from 13 states completed interviews (Table 1). Participants considered TAR-200 insertions and removals to be quick and “straightforward”, with majority <5 minutes and could be performed in various non-surgical settings (Table 2). Removals and subsequent insertions were often performed during the same visit. Participants indicated ~5-10% of their cases were complex, mostly among men and often due to prostatic enlargement, urethral stricture, or prolapsed anatomy, adding 1-2 minutes. Lidocaine jelly was often utilized before procedures for comfort. Video instructions were described as the most utilized manufacturer materials. Participants considered TAR-200 to be better tolerated, with local and mild AEs, and less time-consuming than other intravesical treatments, including BCG and chemotherapy. Over half reported anticipating insertion and removal could be transitioned to advanced practice providers (APPs) in RW settings when TAR-200 gains FDA approval.  

Conclusion:

This is the first study exploring physicians’ experiences of TAR-200 for HR-NMIBC. Findings indicate that the insertions and removals of TAR-200 are generally perceived as straightforward, efficient, and feasible across various clinical settings, as reported by trial PIs. Alongside clinical trial data, findings from this qualitative study support that TAR-200 could address unmet needs in HR-NMIBC by providing a patient- and provider-friendly treatment approach. Additional interviews with allied healthcare professionals (AHCPs) who assisted PIs in preparing and administering TAR-200 are ongoing and will be reported in the poster.

Funding: Johnson & Johnson