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INLEXZO™ (gemcitabine intravesical system)
Medical Information
INLEXZO - Cystectomy Rates After INLEXZO Treatment
Last Updated: 02/27/2026
SUMMARY
- INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as gem-iDRS and 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 carcinoma in situ (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
- Risk of Metastatic Bladder Cancer with Delayed Cystectomy: Delaying cystectomy in patients with Bacillus Calmette-Guérin (BCG)-unresponsive carcinoma in situ (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 + 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 non muscle-invasive bladder cancer (NMIBC) with 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
- SunRISe-4 (NCT04919512) is an ongoing, phase 2, randomized, open-label, multicenter study evaluating the efficacy and safety of INLEXZO + systemic cetrelimab, and systemic cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for RC and refuse or are ineligible for platinum-based neoadjuvant chemotherapy.4
,5 The primary endpoint was pathologic complete response (pCR). - Among patients with MIBC treated with INLEXZO + cetrelimab (cohort 1, n=101) or cetrelimab alone (cohort 2, n=58), the RCevaluable set comprised 134 patients (88 and 46, respectively).5
- Median time to RC was 13.6 weeks (range, 11.3-17.1) in cohort 1 and 13.0 weeks (range, 9.6-15.7) in cohort 2, with most patients (85.2% and 84.8%, respectively) undergoing RC within the protocol-specified window (11-15 weeks).5
PRODUCT LABELING
- INLEXZO (gemcitabine intravesical system) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/INLEXZO-pi.pdf.
- INLEXZO (gemcitabine intravesical system) [Instructions for Use]. Horsham, PA: Janssen Biotech, Inc; https://www.jnjlabels.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 + 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
| Characteristics | INLEXZO Monotherapy (Cohort 2) (n=85)a |
|---|---|
| Median age, years (range) | 71 (40-88) |
| Sex, male, n (%) | 68 (80) |
| Race, n (%) | |
| White | 74 (87.1) |
| Asian | 8 (9.4) |
| Black or African American | 2 (2.4) |
| Not reported/unknown | 1 (1.2) |
| Tumor stage, n (%) | |
| CIS only | 57 (67.1) |
| CIS + papillary disease | 28 (32.9) |
| CIS + Ta | 19 (22.4) |
| CIS + T1 | 9 (10.6) |
| Reason for not undergoing RC, n (%) | |
| Declined | 82 (96.5) |
| Preservation of bladder | 50 (58.8) |
| Preservation of sexual function | 1 (1.2) |
| Concern about quality of life after procedure | 29 (34.1) |
| Concern about mortality and morbidity risk of procedure | 2 (2.4) |
| Ineligible | 3 (3.5) |
| Age | 1 (1.2) |
| Medical and surgical comorbidities | 2 (2.4) |
| Abbreviations: CIS, carcinoma in situ; CPS, combined positive score; RC, radical cystectomy; T, tumor. aPatient characteristics are shown for all patients who received ≥1 dose of study drug in the full analysis set of INLEXZO monotherapy in CIS with or without papillary disease cohort (n=85). | |
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.
SunRISe-4 Study
SunRISe-4 is an ongoing, phase 2, randomized, open-label, multicenter study evaluating the efficacy and safety of INLEXZO in combination with systemic cetrelimab, and systemic cetrelimab alone as neoadjuvant therapy in patients with MIBC who are scheduled for RC and refuse or are ineligible for platinum-based neoadjuvant chemotherapy.4,5
- Psutka et al (2026)5 presented updated perioperative outcomes (surgical, laboratory, and safety) in patients with MIBC who received INLEXZO + cetrelimab therapy (cohort 1, n=101) or cetrelimab monotherapy (cohort 2, n=58), focusing on clinical decline, RC timing, and perioperative complications.
Study Design/Methods
- Phase 2 randomized (5:3), multicenter study.
- INLEXZO was administered every 3 weeks for 12 weeks, followed by RC within the protocolspecified window (11-15 weeks).
- Primary endpoint: pCR.
- Secondary endpoints: Recurrence-free survival, safety.
Results
Patient Characteristics
- At the clinical cutoff date of May 9, 2025, a total of 134 patients had undergone RC. Patient characteristics for those who underwent RC are summarized in Table: Patient Characteristics in the INLEXZO + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups Undergoing RC.
| Characteristic | INLEXZO + Cetrelimab Cohort 1 (n=88) | Cetrelimab Monotherapy Cohort 2 (n=46) |
|---|---|---|
| Age, years, median (IQR) | 74 (54-85) | 69 (43-82) |
| Sex, male, n (%) | 73 (83.0) | 37 (80.4) |
| Race, n (%) | ||
| White | 63 (71.6) | 35 (76.1) |
| Asian | 17 (19.3) | 8 (17.4) |
| Other/Multiple/Not reported | 8 (9.1) | 3 (6.5) |
| Nicotine use, n (%) | ||
| Current | 23 (26.1) | 11 (23.9) |
| Former | 47 (53.4) | 27 (58.7) |
| Never | 1 (1.1) | 0 |
| Unknown | 17 (19.3) | 8 (17.4) |
| ECOG PS 0, n (%) | 74 (84.1) | 36 (78.3) |
| Tumor stage, n (%) | ||
| cT2 | 71 (80.7) | 38 (82.6) |
| cT3-4a | 17 (19.3) | 8 (17.4) |
| Residual disease (visibly incomplete), n (%) | 19 (21.6) | 3 (6.5) |
| Urothelial carcinoma with variant histology, n (%) | 20 (22.7) | 13 (28.3) |
| Neoadjuvant chemotherapy, n (%) | ||
| Ineligible | 40 (45.5) | 20 (43.5) |
| Refused | 48 (54.5) | 26 (56.5) |
| Prior intravesical therapy, n (%) | 8 (9.1) | 7 (15.2) |
| Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; IQR, interquartile range; RC, radical cystectomy; T, tumor. | ||
Surgical Approaches
- Surgical approaches used in the RC-evaluable set are summarized in Table: Surgical Approaches in the INLEXZO + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups.
| Patients, n (%) | INLEXZO + Cetrelimab Cohort 1 (n=88) | Cetrelimab Monotherapy Cohort 2 (n=46) |
|---|---|---|
| Method of RC | ||
| Robotic | 55 (62.5) | 18 (39.1) |
| Open | 23 (26.1) | 21 (45.7) |
| Laparoscopic | 10 (11.4) | 7 (15.2) |
| Type of urinary diversiona | ||
| Incontinent diversions | ||
| Ileal conduitb | 70 (79.5) | 35 (76.1) |
| Ureterocutaneostomy | 1 (1.1) | 0 |
| Continent diversions | ||
| Neobladder | 11 (12.6) | 10 (21.7) |
| Continent pouch | 5 (5.7) | 1 (2.2) |
| Margins assessed | ||
| Yes | 88 (100.0) | 46 (100.0) |
| Abbreviations: RC, radical cystectomy. aFor INLEXZO + cetrelimab, type of urinary diversion was captured for 87 patients. bIncluding Bricker, Bricker type, and urostomy. | ||
- Time to RC in the RC-evaluable patients for INLEXZO + cetrelimab (cohort 1) and cetrelimab monotherapy (cohort 2) is summarized in Table: Time to RC in the INLEXZO + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups.
| INLEXZO + Cetrelimab Cohort 1 (n=88) | Cetrelimab Monotherapy Cohort 2 (n=46) | |
|---|---|---|
| Within protocol-specified window, n (%) | 75 (85.2) | 39 (84.8) |
| Median time to RC, weeks (range) | 13.6 (11.3-17.1) | 13.0 (9.6-15.7) |
| Before protocol-specified window, n (%) | 8 (9.1) | 1 (2.2) |
| Median time to RC, weeks (range) | 9.4 (2.6-11.0) | 12.7 (12.7-12.7) |
| Investigator decision, n (%) | 2 (2.3) | 1 (2.2) |
| Other, n (%) | 2 (2.3) | 0 |
| Symptomatic progression, n (%) | 2 (2.3) | 0 |
| Local progression, n (%) | 1 (1.1) | 0 |
| Patient decision, n (%) | 1 (1.1) | 0 |
| After protocol-specified window, n (%) | 5 (5.7) | 6 (13.0) |
| Median time to RC, weeks (range) | 18.4 (16.0-19.4) | 16.5 (12.4-19.0) |
| Other, n (%) | 2 (2.3) | 3 (6.5) |
| Investigator decision, n (%) | 1 (1.1) | 2 (4.3) |
| Patient decision, n (%) | 2 (2.3) | 0 |
| Hematuria, n (%) | 0 | 1 (2.2)a |
| Abbreviation: RC, radical cystectomy.aRC was delayed because of grade 2 hematuria during neoadjuvant cetrelimab therapy. | ||
Literature Search
A literature search of MEDLINE®
References
| 1 | Daneshmand S, Heijden MSV der, Jacob JM, et al. TAR-200 for Bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study. J Clin Oncol. 2025;43(33):3578-3588. |
| 2 | |
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