Qualitative data show high usability of gemcitabine intravesical system

A qualitative assessment of trial investigators’ experiences with the gemcitabine intravesical system (Inlexzo, formerly TAR-200) found that health care professionals consider the system “straightforward” and practical to implement, according to a poster presented at the 2025 Society of Urology Oncology Annual Meeting in Phoenix, Arizona.¹

The FDA approved the gemcitabine intravesical system for adult patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors on September 9, 2025. The approval was supported by data from cohort 2 of the phase 2b SunRISe-1 trial (NCT04640623), which showed a complete response (CR) rate of 82% (95% CI, 72 to 90) in patients with BCG-unresponsive NMIBC with CIS. Further, 51% of patients remained in CR for at least 1 year.²

For the current study, the authors, led by 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, sought to qualitatively evaluate SunRISe-1 and SunRISe-3 investigators’ experience with the gemcitabine intravesical system, which, the authors noted in their poster, “could inform future clinical practice and enhance the management of patients treated with [the gemcitabine intravesical system] for NMIBC.”

To this end, the authors invited health care providers (HCPs) specializing in urology who served as investigators for SunRISe-1 or SunRISe-3 as well as allied health care professionals (AHCPs) involved with the trials to participate in virtual, hour-long, semi-structure, open-ended 1-on-1 qualitative interviews. The interviews were designed to assess preparation, insertion, removal, and monitoring of the gemcitabine intravesical system, along with adverse event (AE) management and care model designs.

A total of HCPs from 13 states completed interviews for the study, along with 6 AHCPs across 5 states. Regarding the participant characteristics, 12 (66.7%) HCPs practiced in an urban setting and 6 (33.3%) practiced in a suburban setting. Of the 6 AHCPs, 3 (50.0%) practiced in an urban setting and 3 practiced in a suburban setting. Twelve (66.7%) HCPs were in community practice and 6 (33.3%) were in academic practice. All 6 AHCPs were in community practice. At the time the interviews took place, 4 (22.2%) HCPs had treated 1 to 4 patients with the gemcitabine intravesical system, 4 (22.2%) had treated 5 to 10 patients, 5 (27.8%) had treated 11 to 20 patients, and 5 (27.8%) had treated 21 to 50 patients.

According to the authors, the HCPs and AHCPs described insertion and removal of the system to be “straightforward” and done in less than 5 minutes. They added that removals and subsequent insertions were often performed in the same patient visit. Participants estimated preparation and clean-up to take no more than 30 minutes. HCPs estimated that 5% to 10% of the cases they performed were complex. These mostly occurred in male patients, with prostatic enlargement or urethral stricture often cited as causes for difficulty. In female patients, prolapsed anatomy was cited as a factor in case complexity. The HCPs noted these elements added 1 to 2 minutes to the cases.

In terms of AEs, the use of lidocaine jelly before procedures for patient comfort was frequent. Of materials provided by the manufacturer, participants reported using video instructions the most. According to the AHCPs who were interviewed, the patient education process took approximately 30 minutes to complete and comprised “explaining the…system and procedure, using manufacturers’ educational materials as needed, and discussing side effects and mitigation strategies,” the authors wrote in their poster. Compared with intravesical treatments such as BCG and chemotherapy, HCPs said they felt the gemcitabine intravesical system was better tolerated and was associated with local and mild AEs.

The participants also discussed the logistics of providing the treatment. More than 50% of the HCPs who were interviewed said they anticipated that the practice of inserting and removing the system could be transferred to advanced practice providers (APPs) in real-world settings. Further, AHCPs expressed interest in APPs being trained on insertion and removal of the system.

The poster also included a selection of quotations from HCP participants. Said one participant in academic practice of the role in APPs in administering the treatment, “It is so easy to imagine some of the APPs learning how to do it, just because it’s an easy thing. They’re in-clinic more often than I am, like 2 days a week, but I’m operating 3 days a week. If I go to a meeting or vacation, I don’t want to interrupt people’s treatment.”

Overall, the authors concluded in their poster, the 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.”

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. https://suo-abstracts.secure-platform.com/a/gallery/rounds/24/details/4436

2. U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated. News release. Johnson & Johnson. September 9, 2025. Accessed December 3, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated