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INLEXZO™

(gemcitabine intravesical system)

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INLEXZO™ (gemcitabine intravesical system)

Medical Information

INLEXZO - Comparison to Nogapendekin alfa inbakicept-pmin

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 nogapendekin alfa inbakicept 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 [NAI + 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 NAI + BCG was 84% vs 62% (absolute rate difference, 22% [95% confidence interval (CI), 8-35]; P<0.05).
    • An additional analysis assessed the impact of reinduction on CR rate. The CR rate at the first disease assessment for INLEXZO vs NAI + BCG was 83% vs 45% (absolute rate difference, 37% [95% CI, 23-51]; P<0.05). This analysis was based on calculated data that excluded patients who received a second induction.
    • 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

MAIC STUDy

Daneshmand et al (2025)2 conducted a MAIC study to compare the CR rate at any time and at the first disease assessment of INLEXZO vs NAI + BCG in patients with BCG-unresponsive high-risk NMIBC with CIS.

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 NAI + BCG (QUILT 3.032) was performed to determine heterogeneity.
  • An unanchored MAIC was conducted using individual patient data (IPD) from SunRISe-1 cohort 2, summary-level data for NAI + BCG 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 QUILT 3.032.
  • Comparative efficacy was estimated for CR rate at any time and at the first disease assessment.

Results

Trial Characteristics

Comparison of Treatment Characteristics and CR Definitions Among Trials Investigating INLEXZO or NAI + BCG for BCG-Unresponsive High-Risk NMIBC With CIS2
Product
INLEXZO
NAI + BCG
Trial
SunRISe-1 (Cohort 2) 
QUILT 3.032 
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
  • Induction: weekly for 6 consecutive weeks; if CR is not achieved at month 3, then a second induction may be administered
  • Maintenance: weekly for 3 weeks; administration of a maintenance dose at months 4, 7, 10, 13, and 19 for patients with stable disease
  • Additional maintenance: may be administered weekly for 3 weeks at months 25, 31, and 37 to patients with an ongoing CR at month 25 and later
Total number of doses
14 doses over 2 years
  • 21-24 doses over 2 years
  • 9 additional doses (optional year 3)
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 based on investigator assessment, cystoscopy, and local pathology results
Timing of CR assessment
Every 12 weeks through week 99 (year 2), then every 24 weeks thereafter through year 3
Every 3 months for up to 2 years
Abbreviations: BCG, Bacillus Calmette-Guérin; CIS, carcinoma in situ; CR, complete response; HR, high-risk; NAI + BCG, nogapendekin alfa inbakicept-pmln + BCG; NMIBC, non-muscle invasive bladder cancer; TURBT, transurethral resection of bladder tumor; UC, urine cytology.
Patient Characteristics

Baseline Patients Characteristics Across the SunRISe-1 and QUILT 3.032 Trials2
Characteristic
SunRISe-1 (Cohort 2)
INLEXZO
(N=85)a
QUILT 3.032
NAI + BCG
(N=77)
Median age, years (range)
71 (40-88)
73 (50-91)
Gender (%)
   Male
80
86
   Female
20
14
Race (%)
   White
87.1
90
   Non-White
12.9
10
ECOG (%)
   0
91.8
83
   1+
8.2
17
Median number of prior BCG instillation
12
12
Stage (%)
   CIS + T1
10.6
10
   CIS + Ta
22.4
21
   CIS + alone
67.1
69
Abbreviations: BCG, Bacillus Calmette-Guérin; CIS, carcinoma in situ; ECOG, Eastern Cooperative Oncology Group; NAI + BCG, nogapendekin alfa inbakicept-pmln + BCG; 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 NAI + BCG was 84% vs 62% (absolute rate difference, 22% [95% CI, 8-35]; P<0.05).
  • Considering that reinduction was allowed in QUILT 3.032, an analysis comparing the CR rate at the first disease assessment of INLEXZO vs NAI + BCG showed the impact of reinduction on the CR rate. The CR rate at the first disease assessment for INLEXZO vs NAI + BCG was 83% vs 45% (absolute rate difference, 37% [95% CI; 23-51], P<0.05).
    • This analysis was based on calculated data that excluded patients who received a second induction.
Safety
  • Safety results were not reported in the study.

LITERATURE SEARCH

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) conducted on 19 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, Côté S, Jain R, et al. Matching-adjusted indirect comparisons of TAR-200 vs. FDA-approved novel agents in Bacillus Calmette-Guérin-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ. Oral Presentation presented at: ISPOR - The Professional Society for Health Economics and Outcomes Research; May 16, 2025; Montreal, Quebec.