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, open-label, randomized, parallel-cohort, multicenter study evaluating the efficacy and safety of INLEXZO plus systemic cetrelimab (investigational IgG4 antibody targeting PD-1 receptor; cohort 1), INLEXZO monotherapy (cohort 2), or cetrelimab monotherapy (cohort 3) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease who are ineligible for or decline radical cystectomy (RC). INLEXZO monotherapy is additionally being studied in patients with BCG-unresponsive papillary-only high-risk NMIBC (no CIS; cohort 4, per protocol amendment).^1-3 
  • As of March 31, 2025, 85 patients were treated with INLEXZO monotherapy (cohort 2).¹ 
  • The most common treatment-related adverse events (TRAEs; any grade) associated with renal and urinary disorders are reported in Incidence of TRAEs Associated With Renal and Urinary Disorders in the INLEXZO Monotherapy Group (Cohort 2).¹
  • The most frequent grade ≥3 TRAEs associated with renal and urinary disorders included urinary tract pain (4 [4.7%] patients) and bladder pain (2 [2.4%] patient).¹

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.
• Prophylactic antibiotics may be used at the discretion of the treating urologist with each INLEXZO insertion and removal.⁴
• Instruct patients to drink adequate fluids (approximately 1,500 mL per day) during therapy with INLEXZO to ensure adequate urine production for drug release and to improve INLEXZO tolerability.⁴

CLINICAL DATA

SunRISe-1 Study

The results of the SunRISe-1 study are also included in the INLEXZO product labeling. The incidence of adverse reactions described below may vary from that in the INLEXZO product labeling due to the evaluation of different patient populations for safety analyses, contributing to differences in reported percentages.

Daneshmand et al (2025)¹ summarized the 1-year results, including the TRAEs associated with renal and urinary disorders with INLEXZO monotherapy in BCG-unresponsive high-risk NMIBC with CIS with or without papillary disease (cohort 2).

Study Design/Methods

• Phase 2b, ongoing, randomized, open-label, parallel-cohort, multicenter study^1-3
• Patients in cohort 2 received INLEXZO (indwelling) monotherapy every 3 weeks for the first 24 weeks (6 months) and then every 12 weeks through week 96 (year 2).^1-3
  • Patients continued treatment with INLEXZO for up to 2 years or until confirmed high-risk disease persistence, recurrence, or progressive disease based on central urine cytology and/or central biopsy assessment or local biopsy/local imaging.¹ 

Results

• As of March 31, 2025, a total of 85 patients were enrolled in the INLEXZO monotherapy group (cohort 2).¹ 
• The most common renal and urinary disorder TRAEs are summarized in Table: Incidence of TRAEs Associated With Renal and Urinary Disorders in the INLEXZO Monotherapy Group (Cohort 2).

• Serious TRAEs (n=1 each) included cystitis with bladder pain (grade 2), pseudomonal cystitis (grade 3), urinary tract infection (grade 3), urosepsis with acute kidney injury (grade 3), and urinary tract pain (grade 3).¹ 
  • Note, patients may have had ≥1 serious TRAE.
• The most frequent INLEXZO-related AEs leading to interruption were urinary tract pain (5.9%), hematuria (4.7%), and pollakiuria (4.7%).¹ 
  • INLEXZO interruption is defined as when an INLEXZO dose is skipped or INLEXZO is removed early.
  • Most patients had 1-2 skipped INLEXZO doses and most patients resumed treatment.
• TRAEs leading to INLEXZO discontinuation included noninfective cystitis (n=2; 2.4%), pollakiuria (n=1; 1.2%), and urinary tract disorder (n=1; 1.2%).¹ 
  • Note, patients who discontinued may have had ≥1 TRAE.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 19 August 2025.

Summarized in this response are relevant data limited to INLEXZO monotherapy (cohort 2) of the phase 2b SunRISe-1 study in patients with BCG-unresponsive HR-NMIBC with CIS with or without papillary tumors.