Gemcitabine Intravesical System Use Is Practical and Straightforward in NMIBC

The gemcitabine intravesical system (formerly TAR-200; Inlexzo) improved the experiences of both health care providers and patients with non-muscle invasive bladder cancer (NMIBC), according to findings from a qualitative study conducted by the investigators of the phase 2b SunRISe-1 (NCT04640623) and phase 3 SunRISe-3 (NCT05714202) trials presented during the 26th Annual Meeting of the Society of Urologic Oncology.1

Health care providers (n = 18) and allied health care professionals (n = 6) who were interviewed for the study indicated that insertions and removals of the gemcitabine intravesical system were “straightforward” and that most could be performed in less than 5 minutes in various non-surgical settings. Additionally, approximately 5% to 10% of cases were complex, mostly due to prostatic enlargement or urethral stricture in male patients or prolapsed anatomy in female patients, adding only 1 to 2 minutes. Removals and subsequent insertions could often be performed during the same visit.

“Findings indicate that the insertions and removals of [the] gemcitabine intravesical system are generally perceived as straightforward, efficient, and feasible across various clinical settings, as reported by the health care providers and allied health care professionals [who participated] in the trial,” Joshua J. Meeks, MD, PhD, the Edward M. Schaeffer, MD, PhD Professor of Urology and an associate professor of urology, biochemistry, and molecular genetics at Northwestern University Feinberg School of Medicine in Chicago, Illinois, and his coauthors wrote in a poster presentation of the data.

In September 2025, the FDA approved the gemcitabine intravesical systemfor the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors.2 The regulatory decision was supported by data from SunRISe-1 which demonstrated that patients who received monotherapy with the gemcitabine intravesical system (n = 83) achieved a complete response rate of 82% (95% CI, 72%-90%)

How was the qualitative study conducted?

The study authors conducted virtual, 60-minute, semi-structured, open-ended, 1-on-1 qualitative interviews between April 2025 and June 2025 with 18 health care providers from 13 states and 6 allied health care professionals from 5 practices across 5 states.1 The interviews aimed to determine the preferences of health care providers in terms of gemcitabine intravesical system preparation, insertion, removal, monitoring, adverse effect (AE) management, care model designs, and their perceived future practice patterns in the real-world setting. The interviews were audio-recorded, and transcripts were coded using NVivo qualitative data analysis software. Findings were analyzed in aggregate and summarized descriptively.

Most health care providers (n = 18) were male (94.4%), White or Caucasian (83.3%), not Hispanic, Latino, or Spanish (88.9%), practiced in an urban setting (66.7%), and practiced in a community setting (66.7%). The health care providers had been practicing for 5 years or less (5.6%), 6 to 10 years (27.8%), 11 to 15 years (16.6%), 16 to 20 years (16.6%), or over 20 years (33.3%). They had treated 1 to 4 (22.2%), 5 to 10 (22.2%), 11 to 20 (27.8%), or 21 to 50 (27.8%) patients with the gemcitabine intravesical system at the time of the interview.

What other feedback did respondents provide about the use of the gemcitabine intravesical system?

Allied health care professionals said that the preparation and cleanup of the gemcitabine intravesical system took no longer than 30 minutes overall. The gemcitabine intravesical system was also found to be generally easy to store and manage in practice.

More than 50% of health care providers anticipated that the insertion and removal of the gemcitabine intravesical system could be transitioned to advanced practice providers in a real-world setting. Allied health care professionals reported having an interest in having advanced practice providers trained to perform insertions and removals once the system is made commercially available.

In terms of AE management, the respondents indicated that lidocaine jelly was often used prior to the procedure for comfort. Additionally, video instructions were described as the most utilized manufacturer materials. The gemcitabine intravesical system was also found to be better tolerated and less time-consuming than other intravesical treatments, including BCG and chemotherapy, with more local and mild AEs.

“Trial investigators considered [the] gemcitabine intravesical system to be better tolerated, with local and mild AEs, and less time-consuming than other intravesical treatments, including BCG and chemotherapy,” Meeks and his coauthors wrote. “Findings complement the previously reported clinical trial data and suggest that [the] gemcitabine intravesical system could offer a treatment approach that is both patient- and provider-friendly.”

Disclosures: Meeks reported holding consulting or advisory roles with Johnson & Johnson.

References

1. Meeks J, Lin D, Raymundo E, et al. Physician experiences with TAR-200 in high-risk non-muscle invasive bladder cancer: a qualitative study of SunRISe trial investigators. Presented at: Society of Urologic Oncology Annual Meeting; December 2-5, 2025; Phoenix, Arizona. Abstract 40.
2. FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer. FDA. September 9, 2025. Accessed December 4, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gemcitabine-intravesical-system-non-muscle-invasive-bladder-cancer