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INLEXZO™ (gemcitabine intravesical system)

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INLEXZO - Use in BCG-Unresponsive High-Risk NMIBC With Papillary Tumors Only

Last Updated: 09/10/2025

Click on the following link to related section within the document: SunRISe-1 Study
Abbreviations: AE, adverse event; BCG, Bacillus Calmette-Guérin; CI, confidence interval; CIS, carcinoma in situ; DFS, disease-free survival; IgG4, immunoglobulin G4; M, metastasis; MIBC, muscle-invasive bladder cancer; N, nodes; NE, not estimable; NMIBC, non-muscle-invasive bladder cancer; OS, overall survival; PD-1, programmed cell death protein-1; PK, pharmacokinetics; PRO, patient-reported outcome; Q3W, every 3 weeks; Q12W, every 12 weeks; RC, radical cystectomy; T, tumor; TRAE, treatment-related adverse event.
aDaneshmand (2025).1 bDaneshmand (2025; supplement).2 cClinicalTrials.gov NCT04640623 (2025).3 dPer protocol amendment 4.1 ePatients 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 fDFS rate is defined as the time from the first dose of treatment to high-risk disease recurrence (high-grade Ta, any T1, or CIS), progression (progression to MIBC [T≥2], lymph node [N+] or distant disease [M+]), or death due to any reason.2 gData cutoff date of March 31, 2025.1 hGuerrero-Ramos (2025).4 iProgression is defined as advancing to MIBC (T≥2), lymph node (N+), or distant disease (M+), or death due to any cause. Deaths unrelated to the treatment occurred in 3.8% (2/52) of patients due to acute renal failure and congestive cardiac failure.1,2 jAn AE was categorized as related if the investigator determined that there was a possible, probable, or causal relationship between the AE and INLEXZO or procedure.2 kSafety data are shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.2 lReported in ≥2% of patients.2 mReported in ≥2 patients.2 nPatients may have had ≥1 grade 3 TRAE.2 oNumber of patients who experienced AEs related to INLEXZO, insertion procedure, removal procedure, or urinary placement catheter that led to interruption of INLEXZO.2 pNumber of patients who experienced AEs related to INLEXZO, insertion procedure, removal procedure, or urinary placement catheter that led to discontinuation of INLEXZO.2

Product labeling

CLINICAL DATA

SunRISe-1 Study

SunRISe-1 (NCT04640623) is an ongoing, phase 2b, open-label, randomized, parallel-cohort, multicenter study evaluating the efficacy and safety of INLEXZO (gemcitabine intravesical system), an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature.1-3

The SunRISe-1 study is assessing INLEXZO plus cetrelimab (investigational immunoglobulin G4 [IgG4] antibody targeting programmed cell death protein-1 [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).1-3

Daneshmand et al (2025)1 summarized the 1-year results of the SunRISe-1 study, including INLEXZO monotherapy in patients with BCG-unresponsive high-risk NMIBC with papillary-only disease (cohort 4).

Study Design/Methods

  • Phase 2b, ongoing, randomized, open-label, parallel-cohort, multicenter study1,3
    • Patients were enrolled between March 2021 and April 2024 at 142 sites in 14 countries.1
    • Three CIS cohorts were originally designed to enroll 200 patients randomized 2:1:1 to cohorts 1-3.1
    • In June 2023, INLEXZO monotherapy development was prioritized in the CIS population, and enrollment in cohorts 1 and 3 was closed on the basis of the more favorable risk-benefit profile observed with INLEXZO monotherapy in this setting based on the totality of evidence.1
    • The protocol was amended to expand the INLEXZO monotherapy cohort to add an additional cohort of 80 patients for INLEXZO monotherapy in patients with papillary-only high-risk NMIBC (cohort 4).1
    • Reinduction was not allowed for nonresponders per study protocol.4 
  • Patients in cohort 4 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
  • Select inclusion criteria:
    • Age ≥18 years
    • Histologically confirmed diagnosis of persistent or recurrent high-risk NMIBC papillary disease only (any T1, high-grade tumor [T]a) without CIS within 12 months of completion of the last dose of BCG therapy
    • Negative or atypical local urine cytology at screening (for High-Grade Urothelial Carcinoma [HGUC])3
    • Ineligible for or have elected not to undergo RC
    • BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy3
      • Adequate BCG therapy is defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or ≥2 of 6 doses of a second induction course
    • Eastern Cooperative Oncology Group performance status of 0-2
  • Select exclusion criteria3:
    • Muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (UC)
    • UC or histological variant at any site outside of the urinary bladder
    • Prior therapy with anti-PD-1 agent, anti-programmed death‑ligand 2 (PD‑L2) agent, or agent targeting co-inhibitory T-cell receptor
  • Primary endpoint: Disease-free survival (DFS) rate
    • DFS is defined as the time from the first dose of treatment to high-risk disease recurrence (high-grade Ta, any T1, or CIS), progression (progression to muscle-invasive bladder cancer [muscle-invasive bladder cancer (MIBC); T≥2], lymph node [N+] or distant disease [M+]), or death due to any reason)2
  • Key secondary endpoints: Overall survival (OS), safety, tolerability, pharmacokinetics (PK), and patient-reported outcomes (PROs)1-3

Results

Patient Characteristics
  • The characteristics of patients treated with INLEXZO monotherapy in cohort 4 (n=52) are summarized in Table: Patient Characteristics in the INLEXZO Monotherapy Group (Cohort 4).

Patient Characteristics in the INLEXZO Monotherapy Group (Cohort 4)2
Characteristics
INLEXZO Monotherapy (Cohort 4)
(n=52)a
Median age, years (range)
71.0 (42-88)
Sex, n (%)
   Male
37 (71.2)
   Female
15 (28.8)
Race, n (%)
   White
45 (86.5)
   Asian
6 (11.5)
   Black or African American
1 (1.9)
Geographic region,b n (%)
   America
18 (34.6)
   Asia Pacific
5 (9.6)
   EMEA
29 (55.8)
Nicotine use, n (%)
   Current
7 (13.5)
   Former
29 (55.8)
   Never
16 (30.8)
ECOG PS, n (%)
   0
49 (94.2)
   1
2 (3.8)
   2
1 (1.9)
Tumor stage, n (%)
   Papillary disease
52 (100.0)
      High-grade Ta
31 (59.6)
      T1
21 (40.4)
Median total doses of prior BCG, n (range)
12 (8-45)
Median time from last BCG to high-grade papillary NMIBC diagnosis, months (range)
2.8 (0.3-9.9)
Reason for not undergoing RC,c n (%)
   Declined
42 (82.4)
      Preservation of bladder
24 (47.1)
      Preservation of sexual function
0
      Concern about quality of life after procedure
17 (33.3)
      Concern about mortality and morbidity risk of procedure
1 (2.0)
   Ineligible
9 (17.6)
      Age
3 (5.9)
      High American Society of Anesthesiologists class score
1 (2.0)
      Medical and surgical comorbidities
5 (9.8)
Abbreviations: BCG, Bacillus Calmette-Guérin; ECOG PS, Eastern Cooperative Oncology Group performance status; EMEA, Europe, Middle East, and Africa; NMIBC, non-muscle-invasive bladder cancer; RC, radical cystectomy; T, tumor.
aData cutoff date: March 31, 2025.
bAmerica includes Canada and the United States; Asia Pacific includes Australia, Japan, and South Korea; EMEA includes Belgium, France, Germany, Greece, Italy, the Netherlands, Portugal, Russia, and Spain.
cPercentages are based on number of patients with available data (n=51).
Note: Patient characteristics are shown for all patients who received ≥1 dose of the study drug in the full analysis set (n=52).
Efficacy
Primary Endpoint - DFS Rates
  • At the data cutoff date of March 31, 2025, the DFS rates in cohort 4 are summarized in Table: DFS Rates in the INLEXZO Monotherapy Group (Cohort 4).
  • At a median follow-up of 12.8 months (range, 4-17), median DFS was not estimable (NE).
  • Patients who had RC included 5.8% (3/52).4

DFS Rates in the INLEXZO Monotherapy Group (Cohort 4)1,4
DFS Rate, % (95% CI)
INLEXZO Monotherapy (Cohort 4)
(n=52)a
6-month
85.3 (71.6-92.7); n=40
   Ta disease
85.7 (66.3-94.4); n=24
   T1 disease
84.7 (59.7-94.8); n=16
9-month
81.1 (66.7-89.7); n=31
   Ta disease
82.1 (62.3-92.1); n=20
   T1 disease
79.4 (54.0-91.7); n=11
12-month
70.2 (51.6-82.8)
   Ta disease
70.0 (44.8-85.4)
   T1 disease
72.2 (44.8-87.6)
Abbreviations: CI, confidence interval; DFS, disease-free survival; T, tumor.
aData cutoff date: March 31, 2025.
Secondary Endpoints - Progression-Free Survival and OS
  • NMIBC recurrence or progression occurred in 21.2% (11/52) of patients.1,4
    • Progression to MIBC was reported in 1.9% (1/52) of patients.4
    • Progression is defined as advancing to MIBC (T≥2), lymph node (N+), or distant disease (M+), or death due to any cause.
  • Deaths unrelated to the treatment occurred in 3.8% (2/52) of patients due to acute renal failure and congestive cardiac failure.1,2
  • Median progression-free survival (PFS) and OS were NE.4
  • The 9-month PFS rate was 95.6% (95% confidence interval [CI], 83.5-98.9); n=32 (at risk).4
  • The 9-month OS rate was 98.0% (95% CI, 86.4-99.7); n=46 (at risk).4
Safety

Overall Safety Profile of the INLEXZO Monotherapy Group (Cohort 4)1,2
Patients With ≥1 Event, n (%)
INLEXZO Monotherapy (Cohort 4)
(n=52)a
Related AEsb
42 (80.8)
   INLEXZO
38 (73.1)
   Insertion procedure
19 (36.5)
   Removal procedure
14 (26.9)
   Urinary placement catheter
22 (42.3)
Related grade ≥3 AEsb
7 (13.5)c
   INLEXZO
5 (9.6)
   Insertion procedure
4 (7.7)
   Removal procedure
1 (1.9)
   Urinary placement catheter
1 (1.9)
Related serious AEsb
3 (5.8)d
   INLEXZO
1 (1.9)
   Insertion procedure
3 (5.8)
   Removal procedure
1 (1.9)
   Urinary placement catheter
1 (1.9)
Related AEs leading to INLEXZO interruptionb,e
13 (25.0)
   INLEXZO
12 (23.1)
   Insertion procedure
1 (1.9)
   Removal procedure
0
   Urinary placement catheter
3 (5.8)
Related AEs leading to INLEXZO discontinuationb,f
4 (7.7)g
   INLEXZO
4 (7.7)
   Insertion procedure
1 (1.9)
   Removal procedure
0
   Urinary placement catheter
0
Related AEs with fatal outcome
0
Abbreviations: AE, adverse event; TRAE, treatment-related adverse event; UTI, urinary tract infection.
aData cutoff date: March 31, 2025.
bAn AE was categorized as related if the investigator determined that there was a possible, probable, or causal relationship between the AE and INLEXZO or procedure.
cOther grade ≥3 TRAEs included sepsis and spinal fracture (procedure related; n=1 each). Note, patients may have had ≥1 grade ≥3 TRAEs.
dSerious TRAEs included sepsis, spinal fracture (procedure related), and UTI (n=1 each).
eNumber of patients who experienced AEs related to INLEXZO, insertion procedure, removal procedure, or urinary placement catheter that led to interruption of INLEXZO.
fNumber of patients who experienced AEs related to INLEXZO, insertion procedure, removal procedure, or urinary placement catheter that led to discontinuation of INLEXZO.
gTRAEs leading to INLEXZO discontinuation included micturition urgency (n=4; 7.7%), dysuria (n=2; 3.8%), and pollakiuria (n=2; 3.8%).
Note: Safety data are shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.

Most Frequent TRAEs in the INLEXZO Monotherapy Group (Cohort 4)1,2
Most Frequent ≥1 TRAEs,a,b n (%)
INLEXZO Monotherapy (Cohort 4)
(n=52)c
Any-Grade
Grade ≥3d
Dysuria
21 (40.4)
0
Pollakiuria
16 (30.8)
0
Micturition urgency
15 (28.8)
0
UTI
12 (23.1)
1 (1.9)
Hematuria
7 (13.5)
0
Bladder pain
5 (9.6)
2 (3.8)
Nocturia
5 (9.6)
0
Bladder spasm
4 (7.7)
0
Noninfective cystitis
4 (7.7)
0
Pruritus
4 (7.7)
0
Bladder irritation
3 (5.8)
0
Pelvic pain
3 (5.8)
1 (1.9)
Urinary incontinence
3 (5.8)
1 (1.9)
Urinary tract pain
3 (5.8)
0
Abdominal pain
2 (3.8)
0
Asthenia
2 (3.8)
0
Cystitis
2 (3.8)
0
Dry mouth
2 (3.8)
0
Lower urinary tract symptoms
2 (3.8)
0
Perineal pain
2 (3.8)
0
Urethral pain
2 (3.8)
0
Abbreviations: AE, adverse event; TRAE, treatment-related adverse event; UTI, urinary tract infection.
aAn AE was categorized as related if the investigator determined that there was a possible, probable, or causal relationship between the AE and INLEXZO or procedure.
bAny-grade and grade ≥3 TRAEs by preferred term are listed if they were reported in ≥2% of patients and ≥2 patients, respectively.
cData cutoff date: March 31, 2025.
dOther grade ≥3 TRAEs included sepsis and spinal fracture (procedure related; n=1 each). Note, patients may have had ≥1 grade ≥3 TRAEs.
Note: Safety data are shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.
Tolerability
  • At the data cutoff date of March 31, 2025, the INLEXZO insertion success rate was 99.5% (387/389).4

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 22 August 2025.

References

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1 Daneshmand S, Van der Heijden MS, 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. [published online ahead of print July 30, 2025]. J Clin Oncol. doi:10.1200/jco-25-01651.  
2 Daneshmand S, van der Hejiden MS, Jacob JM, et al. Supplement to: TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study. [published online ahead of print July 30, 2025]. J Clin Oncol. doi:10.1200/jco-25-01651.  
3 Janssen Research & Development, LLC. Phase 2b clinical study evaluating efficacy and safety of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone in participants with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to intravesical Bacillus Calmette-Guérin (BCG) who are ineligible for or elected not to undergo radical cystectomy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 August 22]. Available from: https://clinicaltrials.gov/show/NCT04640623 NLM Identifier: NCT04640623.  
4 Guerrero-Ramos F, Jacob JM, Van der Heijden MS, et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guerin-unresponsive papillary disease-only high-risk non-muscle-invasive bladder cancer: first results from cohort 4 of SunRISe-1. Oral Presentation presented at: American Urological Association (AUA) Annual Meeting; April 26-29, 2025; Las Vegas, NV.