This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
INLEXZO™ (gemcitabine intravesical system)
Medical Information
INLEXZO - Comparison to Nadofaragene firadenovec-vncg
Last Updated: 07/03/2026
SUMMARY
- INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as gem-iDRS and TAR-200 in literature.1
- No prospective, randomized, head-to-head trials comparing the efficacy and safety of INLEXZO with nadofaragene firadenovec-vncg have been conducted.
- Daneshmand et al (2026)2
conducted a matching-adjusted indirect comparison (MAIC) study to compare the relative treatment effect of INLEXZO vs United States (US) Food and Drug Administration (FDA)-approved novel agents (pembrolizumab, nadofaragene firadenovec-vncg [nadofaragene], and nogapendekin alfa inbakicept-pmln in combination with Bacillus Calmette-Guérin [BCG]) in BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) for patients from SunRISe-1 study with carcinoma in situ (CIS) ± papillary disease (Cohort 2) and papillary-only disease (Cohort 4). In patients with CIS ± papillary disease (Cohort 2), INLEXZO complete response (CR) rates at any time and at 12 months were assessed against nadofarogene. - The adjusted CR rate at any time for INLEXZO vs nadofaragene was 83% vs 51% (absolute rate difference, 32% [95% confidence interval (CI), 19%-45%]; P<0.001).
- The adjusted absolute CR rate difference at 12 months for INLEXZO vs nadofaragene was 20% (95% CI, 5%-35%), and the unadjusted difference was 20% (95% CI, 7%-34%).
- Limitations included that the MAIC methodology can only adjust for baseline characteristics that were observed and reported. Any confounders not consistently reported or missing across studies may affect internal validity. Differences in study designs and outcomes can introduce biases that cannot be fully addressed by MAICs.
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.
MAIC STUDy
Study Design/Methods
- A systematic literature review was performed to identify novel agents in the BCG-unresponsive high-risk NMIBC setting, which included nadofaragene (CS-003).
- Primary data source for the MAIC analyses was the patient-level data for INLEXZO monotherapy from SunRISe-1 study in Cohorts 2 and 4, and comparator data from US prescribing information (USPI) and primary publications of CS-003.
- Study and patient characteristics, patient eligibility criteria, outcome definitions, and reporting timing for SunRISe-1 and nadofaragene (CS-003) were evaluated to assess the feasibility of conducting a MAIC.
- Unanchored MAICs for the CIS cohort and papillary-only cohort were conducted using individual patient data (IPD) from SunRISe-1 Cohorts 2 and 4, respectively.
- Adjustment of imbalances in patient characteristics (tumor stage, prior doses of BCG instillation, Eastern Cooperative Oncology Group, age, gender, and race) was performed by weighting the INLEXZO IPD to match the baseline characteristics reported for CS003.
- The endpoints of interest for the MAIC analyses for SunRISe-1 Cohort 2 were CR rate at any time, CR rate at first disease assessment, and CR rate at 12 months.
- CR rate was defined as the percentage of patients achieving a CR at any time, at first disease assessment, or at 12 months from the first dose.
- CR rate at any time and at 12 months was compared between INLEXZO vs nadofarogene.
- The endpoint of interest for the MAIC analyses for SunRISe-1 Cohort 4 was overall DFS and DFS at 12 months.
- There was not sufficient power to test the difference between papillary cohorts for SunRISe-1 and CS-003 due to the small sample size of both cohorts.
- Limitations included that the MAIC methodology can only adjust for baseline characteristics that were observed and reported. Any confounders not consistently reported or missing across studies may affect internal validity. Differences in study designs and outcomes can introduce biases that cannot be fully addressed by MAICs.
Results
The results of the SunRISe-1 study for BCG-unresponsive high-risk NMIBC with CIS, with or without papillary tumors (Cohort 2) are also included in the INLEXZO product labeling. The efficacy results below may vary from those in the INLEXZO product labeling due to the evaluation of different patient populations in the efficacy analyses, contributing to differences in reported n-values and percentages.
Trial Characteristics
- Treatment characteristics and CR definitions across the SunRISe-1 and CS-003 trials are summarized in Table: Comparison of Treatment Characteristics and CR Definitions Among Trials Investigating INLEXZO or Nadofaragene for BCG-Unresponsive High-Risk NMIBC With CIS.
| Product | INLEXZO | Nadofaragene |
|---|---|---|
| Trial | SunRISe-1 (Cohort 2)a | CS-003b,c |
| Mode of delivery | Intravesical drug releasing system | Intravesical instillation |
| Dosing regimen | Every 3 weeks for the first 6 months, then every 12 weeks for up to 2 years |
|
| Total number of doses | 14 doses over 2 years |
|
| Key inclusion | Adult with BCG-unresponsive HR NMIBC CIS ± papillary disease | |
| Key exclusion | Prior therapy with an anti-PD-1, anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor | Patients with life expectancy <2 years, patients with prior treatment with adenovirus-based drugs and hypersensitivity to IFN alfa2b |
| Definition of CR | Negative cystoscopy and negative (including atypical) centrally read UC, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally read UC at any time, and biopsy at weeks 24 and 48 | Negative results for cystoscopy (with TURBT/biopsies, as applicable) and UC |
| CR at first disease assessment | Percentage of patients achieving CR at first disease assessment following treatment initiation | NA |
| CR at 12 months | Percentage of patients achieving CR at 12 months from treatment initiation | Percentage of patients achieving CR at 12 months from treatment initiation |
| Timing of CR assessment | Every 12 weeks through week 99 (year 2), then every 24 weeks thereafter through year 3 | 3, 6, 9, and 12 months |
| Key inclusion | Adult with BCG-unresponsive HR NMIBC papillary disease (high-grade Ta, any T1) | |
| Key exclusion | Prior therapy with an anti-PD-1, anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor | Patients with life expectancy <2 years, patients with prior treatment with adenovirus-based drugs and hypersensitivity to IFN alfa2b |
| DFS/RFS definition | DFS was defined as the time from first dose of study treatment to the occurrence of one of the following events, whichever occurs first:
| RFS was defined as the time from first dose to the first recurrence of highgrade disease (including progression to MIBC or death). Patients without recurrence were censored at the last assessment without highgrade disease. |
| K-M figure reported | K-M graph reported, patients at risk (n=52)a | K-M graph reported, patients at risk (n=48)d |
| Abbreviations: BCG, Bacillus Calmette-Guérin; CIS, carcinoma in situ; CR, complete response; DFS, disease-free survival; HR, high-risk; IFN, interferon; K-M, Kaplan-Meier; L2, ligand 2; MIBC, muscle-invasive bladder cancer; NA, not applicable; nadofaragene, nadofaragene firadenovec-vncg; NMIBC, non-muscle invasive bladder cancer; PD-1, programmed-cell death 1; RFS, remission free survival; Ta, noninvasive papillary carcinoma; TURBT, transurethral resection of bladder tumor; UC, urine cytology.aDaneshmand, et al. J Clin Oncol. 2025;43(33):3578-3588.b | ||
Patient Characteristics
- Baseline patient characteristics across the SunRISe-1 and CS-003 trials after matching are included in Table: Baseline Patients Characteristics Across the SunRISe-1 and CS-003 Trials.
| Characteristic | SunRISe-1 INLEXZO | CS-003 Nadofaragene | ||
|---|---|---|---|---|
| Cohort 2 (CIS ± Papillary) n=85 | Cohort 4 (Papillary Only) n=52 | CIS ± Papillary n=98 | Papillary Only n=48 | |
| Median age, years (range) | 71 (40-88) | 71 (42-88) | 70 (44-89) | 71 (64-78) |
| Gender (%) | ||||
| Male | 80 | 71 | 88 | 68 |
| Female | 20 | 30 | 12 | 32 |
| Race (%) | ||||
| White | 87 | 87 | 92 | 94 |
| Non-White | 13 | 14 | 8 | 6 |
| ECOG (%) | ||||
| 0 | 92 | 94 | 90 | 86 |
| 1+ | 8 | 6 | 10 | 14 |
| Median number of prior BCG instillation | 12 | 12 | 12 | NR |
| Tumor Stage (%) | ||||
| CIS + T1 | 11 | T1: 60 | 5 | T1: 30 |
| CIS + Ta | 22 | Ta: 40 | 19 | Ta: 70 |
| CIS + alone | 67.1 | NA | 76 | NA |
| Abbreviations: BCG, Bacillus Calmette-Guérin; CIS, carcinoma in situ; ECOG, Eastern Cooperative Oncology Group; NA, not applicable; nadofaragene, nadofaragene firadenovec-vncg; NMIBC, non-muscle invasive bladder cancer; T1, tumor invades the subepithelial connective tissue; Ta, noninvasive papillary carcinoma. | ||||
MAIC in BCG-unresponsive High-risk NMIBC With CIS ± Papillary Disease (Cohort 2)
- The adjusted CR rate at any time for INLEXZO vs nadofaragene was 83% vs 51% (absolute rate difference, 32% [95% CI, 19%-45%]; P<0.001).
- The adjusted absolute CR rate difference at 12 months for INLEXZO vs nadofaragene was 20% (95% CI, 5%-35%), and the unadjusted difference was 20% (95% CI, 7%34%).
- Safety results were not reported in the study.
MAIC in BCG-unresponsive High-risk NMIBC with Papillary Disease Only (Cohort 4)
- Comparisons of INLEXZO and nadofaragene were not feasible in CS-003 due to the limited sample size of the papillary cohort (n=48).
LITERATURE SEARCH
A literature search of MEDLINE®
References
| 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. J Clin Oncol. 2025;43(33):3578-3588. |
| 2 | |
| 3 |
Would you like to clear and leave your conversation? Message history will be lost.