SUMMARY

• INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature.¹ 
• 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 Food and Drug Administration (FDA)-approved novel agents (pembrolizumab, nadofaragene firadenovec-vncg [nadofarogene], and nogapendekinalfa inbakicept-pmlnin combination with BCG [NAI + BCG]) for Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). Additionally, CR rate at the first disease assessment of INLEXZO was compared to NAI + BCG.
  • INLEXZO provided a statistically significant clinical benefit in CR rate (after adjustment) at any time compared to all 3 FDA-approved novel agents (absolute rate difference: vs pembrolizumab, 48% [95% CI, 35-61]; vs nadofarogene, 33% [95% CI, 20-45]; vs NAI + BCG, 22% [95% CI, 8-35]; P<0.05 for all comparisons).
  • An additional analysis showed the impact of reinduction on CR rate. INLEXZO had a significantly higher CR rate at the first disease assessment vs NAI + BCG (absolute rate difference, 37% [95% CI, 23-51], P<0.05). This was based on calculated data that excluded patients who received a second induction.
  • The MAIC methodology can only adjust for baseline characteristics that are observed and reported. The inconsistently reported or missing confounders across studies 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.

BACKGROUND

• INLEXZO is designed to provide local release of gemcitabine in the bladder. INLEXZO contains gemcitabine and urea mini tablets within a dual-lumen silicone tube for sustained release of gemcitabine by an osmotic delivery mechanism throughout the prescribed indwelling period.^1,3-6  
• INLEXZO is inserted intravesically via a urinary placement catheter, after which it self-coils into a bi-oval shape (see Figure: INLEXZO iDRS). Removal of INLEXZO can be achieved by using grasping forceps and cystoscopy.^5,7
• INLEXZO monotherapy (Cohort 2) is being studied in the phase 2b SunRISe-1 study for patients with BCG-unresponsive high risk NMIBC with CIS, with or without papillary tumors, who have refused or are ineligible for radical cystectomy.⁸

Matching-adjusted Indirect Comparison 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 FDA-approved novel agents for 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 SunRISe-1 and trials of FDA-approved novel agents (KEYNOTE-057, CS-003, and QUILT 3.032) was performed to determine heterogeneity.
• Three unanchored MAICs were conducted using individual patient data (IPD) from SunRISe-1 cohort 2 along with summarized data extracted from the US prescribing information (UPSI) and primary journal publications of the comparative treatments.
• Adjustment of imbalances in patient characteristics (tumor stage, prior doses of BCG instillation, Eastern Cooperative Oncology Group, age,gender and race) was done by weighting the INLEXZO IPD to match the reported baseline characteristics of the comparator trials.
• Comparative efficacy was estimated for CR rate at any time and at first disease assessment.

Results

• Characteristics of SunRISe-1, KEYNOTE-057, CS-003, and QUILT 3.032 studies are summarized in Table: Comparison of Treatment Characteristics and CR Definitions Among Trials Investigating Novel Agents for the Treatment of BCG-Unresponsive High-risk NMIBC With CIS.

Patient Characteristics

• Baseline characteristics across the 4 trials are included in Table: Baseline Characteristics of Patients in Trials Investigating Novel Agents for the Treatment of BCG-Unresponsive High-risk NMIBC With CIS).

MAIC

• After adjustment the 3 MAICs showed that INLEXZO provides a significantly higher CR rate at any time compared to all 3 FDA-approved novel agents (P<0.05).
• The adjusted CR at any time (absolute rate difference [95% CI]) of INLEXZO vs pembrolizumab, was 88% vs 41% (48% [95% CI, 35-61]); vs nadofarogene was 84% vs 51% (33% [95% CI, 20-45]); vs NAI + BCG was 84% vs 62% (22% [95% CI, 8-35]; P<0.05), respectively; P<0.05 for all comparisons.
• 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 assessed the impact of reinduction on the CR rate.
  • This was based on calculated data that excluded patients who received a second induction course of NAI + BCG.
• The adjusted CR at first disease assessment (absolute rate difference) of INLEXZO vs NAI + BCG was 83% vs 45% (37% [95% CI, 23-51]).
• 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) was conducted on 22 August 2025.