SUMMARY

• INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature.¹ 
• Johnson & Johnson does not recommend any practices, procedures or usage that deviate from the product labeling or are not approved by the regulatory agencies.
• Please refer to the full prescribing information of INLEXZO for more information on the WARNINGS & PRECAUTIONS.
  • Risk of Metastatic Bladder Cancer with Delayed Cystectomy: Delaying cystectomy in patients with Bacillus Calmette-Guérin (BCG)-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.² 
• SunRISe-1 (NCT04640623) is an ongoing, phase 2b, randomized, open-label, 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; cohort 1), INLEXZO monotherapy (cohort 2), or cetrelimab monotherapy (cohort 3) in patients with BCG-unresponsive high risk NMIBC with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or decline radical cystectomy (RC). INLEXZO monotherapy is additionally being studied in patients with papillary-only high risk NMIBC (no CIS; cohort 4).^1,3
  • In patients treated with INLEXZO monotherapy (cohort 2, n=85), 25 patients had subsequent treatment, including 18 (21.2%) patients who underwent RC. Of the 70 responders, 12 (17.1%) patients underwent RC.¹ 
  • The 12- and 24-month Kaplan-Meier estimates of RC-free rates were 86.6% (95% confidence interval [CI], 76.6 to 92.6) and 75.5% (95% CI, 63.4 to 84.1) respectively.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.

The results of the SunRISe-1 study are also included in the INLEXZO product labeling. The total number of patients given INLEXZO monotherapy described above may vary from that in the INLEXZO product labeling due to the evaluation of different patient populations for efficacy and safety analyses. 

WARNING & PRECAUTIONS² 

Risk of Metastatic Bladder Cancer with Delayed Cystectomy

• Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal. The risk of developing muscle invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.
• Of the 83 evaluable patients with BCG-unresponsive CIS treated with INLEXZO in Cohort 2 of SunRISe-1, seven patients (8%) progressed to muscle invasive (T2 or greater) bladder cancer. Three patients (3.5%) had progression determined at the time of cystectomy. The median time between determination of persistent or recurrent CIS or T1 and progression to muscle invasive disease was 94 days.

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 tumors who are ineligible for or decline RC. INLEXZO monotherapy is additionally being studied in patients with papillary-only high-risk NMIBC (no CIS; cohort 4).^1,3

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

Study Design/Methods 

• Phase 2b, ongoing, randomized, open-label, parallel-cohort multicenter study 
• INLEXZO was given every 3 weeks until week 24, then every 12 weeks until week 96. 
• Primary endpoint: Overall complete response (CR) rate as determined by quarterly cystoscopy; quarterly central cytology; mandated bladder biopsy by central assessment at weeks 24 and 48; and local imaging performed every 24 weeks.
• Key secondary endpoints: Duration of response (DOR), overall survival (OS), safety, tolerability, pharmacokinetics, patient-reported outcomes (PROs).

Results 

Patient Characteristics

• The characteristics of patients treated with INLEXZO monotherapy in cohort 2 (n=85) are summarized in Table: Select Patient Characteristics in the INLEXZO Monotherapy Group (Cohort 2).¹ 

Cystectomy Rates 

• In patients treated with INLEXZO monotherapy (cohort 2, n=85), 25 patients had subsequent treatment, including 18 (21.2%) patients who underwent RC. Of the 70 responders, 12 (17.1%) patients underwent RC.
• Median time to RC was not estimable.
• The 12- and 24-month Kaplan-Meier estimates of RC-free rates were 86.6% (95% CI, 76.6 to 92.6) and 75.5% (95% CI, 63.4 to 84.1) respectively.

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 18 August 2025.