INLEXZO™
(gemcitabine intravesical system)
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INLEXZO™ (gemcitabine intravesical system)
Medical Information
INLEXZO - Comparison to Nadofaragene firadenovec-vncg
Last Updated: 09/10/2025
SUMMARY
- INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as 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 (2025)2
conducted a matching-adjusted indirect comparison (MAIC) study to compare the complete response (CR) rate at any time of INLEXZO vs United States (US) Food and Drug Administration (FDA)-approved novel agents (pembrolizumab, nadofaragene firadenovec-vncg [nadofaragene], and nogapendekin alfa inbakicept-pmln plus Bacillus Calmette-Guérin [BCG]) in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). - The adjusted CR rate at any time for INLEXZO vs nadofaragene was 84% vs 51% (absolute rate difference, 33% [95% confidence interval (CI), 20-45]; P<0.05).
- The MAIC methodology can only adjust for baseline characteristics that were observed and reported. The inconsistently reported or missing confounders across trials may impact 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.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.
MAIC STUDy
Study Design/Methods
- A systematic literature review was performed to identify published data on comparator regimens.
- To assess the feasibility of conducting a MAIC, an evaluation of study and patient characteristics, patient eligibility criteria, outcome definitions, and timepoints of trials investigating INLEXZO (SunRISe-1) and nadofaragene (CS-003) was performed to determine heterogeneity.
- An unanchored MAIC was conducted using individual patient data (IPD) from SunRISe-1 cohort 2, summary-level data for nadofaragene extracted from the US prescribing information (USPI), and primary journal publication of the comparator.
- 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 CS-003.
- Comparative efficacy was estimated for CR rate at any time.
Results
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) | CS-003 |
| 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 |
|
| 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 |
| 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 |
| Abbreviations: BCG, Bacillus Calmette-Guérin; CIS, carcinoma in situ; CR, complete response; HR, high-risk; nadofaragene, nadofaragene firadenovec-vncg; NMIBC, non-muscle invasive bladder cancer; TURBT, transurethral resection of bladder tumor; UC, urine cytology. | ||
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 (Cohort 2) INLEXZO (N=85)a | CS-003 Nadofaragene (N=98) |
|---|---|---|
| Median age, years (range) | 71 (40-88) | 70 (44-89) |
| Gender (%) | ||
| Male | 80 | 88 |
| Female | 20 | 12 |
| Race (%) | ||
| White | 87.1 | 92 |
| Non-White | 12.9 | 8 |
| ECOG (%) | ||
| 0 | 91.8 | 90 |
| 1+ | 8.2 | 10 |
| Median number of prior BCG instillation | 12 | 12 |
| Stage (%) | ||
| CIS + T1 | 10.6 | 5 |
| CIS + Ta | 22.4 | 19 |
| CIS + alone | 67.1 | 76 |
| Abbreviations: BCG, Bacillus Calmette-Guérin; CIS, carcinoma in situ; ECOG, Eastern Cooperative Oncology Group; nadofaragene, nadofaragene firadenovec-vncg; T1, tumor invades the subepithelial connective tissue; Ta, noninvasive papillary carcinoma. aClinical data cutoff: March 31, 2025. | ||
MAIC
- The adjusted CR rate at any time for INLEXZO vs nadofaragene was 84% vs 51% (absolute rate difference, 33% [95% CI, 20-45]; P<0.05).
Safety
- Safety results were not reported in the study.
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. [published online ahead of print July 30, 2025]. J Clin Oncol. doi:10.1200/jco-25-01651. |
| 2 |