SUMMARY  

• INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature.¹ 
• SunRISe-1 (NCT04640623) is an ongoing, phase 2b, randomized, open-label, parallel-cohort, multicenter study evaluating the efficacy and safety of intravesical INLEXZO plus systemic cetrelimab (an investigational immunoglobulin G4 [IgG4] antibody that targets the programmed cell death protein-1 [PD-1] receptor), INLEXZO monotherapy, or cetrelimab monotherapy in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high‑risk, non-muscle-invasive bladder cancer (NMIBC) who are ineligible for or decline radical cystectomy (RC).^1,2  
  • The INLEXZO insertion success rate was 98.7% (745/755) in patients with BCG-unresponsive high-risk NMIBC with carcinoma in situ (CIS) with or without papillary disease treated with INLEXZO monotherapy (cohort 2).^1,3 
  • The total number of attempted but unsuccessful insertions of INLEXZO was 1.3% (10/755).³ 

Product labeling

• INLEXZO (gemcitabine intravesical system) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INLEXZO-pi.pdf.
• INLEXZO (gemcitabine intravesical system) [Instructions for Use]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-instructions-for-use/INLEXZO-ifu.pdf.

Clinical data

SunRISe-1 Study

SunRISe-1 is an ongoing phase 2b study designed to assess the efficacy and safety of intravesical INLEXZO plus systemic cetrelimab (cohort 1), INLEXZO monotherapy (cohort 2), or cetrelimab monotherapy (cohort 3) in patients with BCG-unresponsive high-risk NMIBC with CIS with or without papillary disease who are ineligible for or decline RC. INLEXZO monotherapy is additionally being studied in patients with papillary-only HR-NMIBC (no CIS; cohort 4).^1,2

Daneshmand et al (2025)¹ summarized the 1-year results of INLEXZO monotherapy (cohort 2), including insertion rates of INLEXZO.

Study Design/Methods

• Phase 2b, randomized, open-label, parallel-cohort, multicenter study.^1,2 
• INLEXZO was given every 3 weeks until week 24, then every 12 weeks until week 96.^1,2 
• INLEXZO was inserted intravesically via urinary placement catheter (UPC) shaft and green stylet, after which it self-coils into a bi-oval shape.^4,5  
• An INLEXZO insertion procedure attempt began when the healthcare provider inserted the distal tip of the UPC shaft into the patient's urethra.³ 
• A successful INLEXZO insertion was defined as obtaining transurethral access to the bladder using clear catheter shaft of the UPC with the ability to fully advance the green stylet until INLEXZO was deployed into the bladder.³

Results

Insertion Rates

• At the data cutoff date of March 31, 2025, 85 patients were treated with INLEXZO monotherapy (cohort 2).¹ 
• The INLEXZO insertion success rate was 98.7% (745/755) in cohort 2.³
• The total number of attempted but unsuccessful insertions of INLEXZO was 1.3% (10/755), occurring in 7 patients.³ 
  • The reasons for the 10 attempted but unsuccessful insertions, included bladder stenosis, device failure, device error, anatomical abnormality (large prostate), urethral stricture, urologist suspected progression, could not advance catheter through the urethra, defect in UPC, hemorrhage/pain, and bladder pain (n=1 patient each). 
  • All 7 patients had successful subsequent INLEXZO insertions. 

Literature Search

A literature search of MEDLINE^®, Embase, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 22 August 2025.