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INLEXZO™ (gemcitabine intravesical system)
Medical Information
INLEXZO - Comparison to Pembrolizumab
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 pembrolizumab 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 patients with 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 pembrolizumab. For the relative treatment effect comparison for patients with papillaryonly disease (Cohort 4), INLEXZO disease-free survival (DFS) rate at 12 months and overall DFS were assessed against pembrolizumab. - In patients with CIS ± papillary disease, the adjusted CR rate at any time for INLEXZO vs pembrolizumab was 88% vs 41% (absolute rate difference, 47% [95% confidence interval (CI), 34%-61%]; P<0.001).
- The adjusted absolute CR rate difference at 12 months for INLEXZO vs pembrolizumab was 26% (95% CI, 7%-44%), and the unadjusted difference was 27% (95% CI, 14%-40%).
- In patients with papillary-only disease (Cohort 4), INLEXZO significantly improved DFS versus pembrolizumab, with a 64% risk reduction (adjusted hazard ratio [HR], 0.36 [95% CI, 0.20-0.64) and a higher 12‑month DFS (adjusted rate difference, 29% [11.6%-46.2%]).
- 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 pembrolizumab (KEYNOTE-057).
- 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 the US prescribing information (USPI) and primary publications of KEYNOTE-057.
- Study and patient characteristics, patient eligibility criteria, outcome definitions, and reporting timing for SunRISe-1 and pembrolizumab (KEYNOTE-057) 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 KEYNOTE-057.
- 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 pembrolizumab.
- The endpoint of interest for the MAIC analyses for SunRISe-1 Cohort 4 was overall DFS and DFS at 12 months.
- DFS was compared between INLEXZO (SunRISe-1 Cohort 4) vs pembrolizumab (KEYNOTE-057 Cohort B).
- 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 KEYNOTE-057 trials are summarized in Table: Comparison of Treatment Characteristics and CR Definitions Among Trials Investigating INLEXZO or Pembrolizumab for BCG-Unresponsive High-Risk NMIBC With CIS.
| Product | INLEXZO | Pembrolizumab |
|---|---|---|
| Trial | SunRISe-1 (Cohort 2)a | KEYNOTE-057b,c |
| Mode of delivery | Intravesical drug releasing system | IV infusion |
| Dosing regimen | Every 3 weeks for the first 6 months, then every 12 weeks for up to 2 years | 200 mg every 3 weeks or 400 mg every 6 weeks for up to 2 years |
| Total number of doses | 14 doses over 2 years | 16 or 34 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 | Prior therapy with an anti-PD-1, anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor |
| 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 | Absence of low-grade Ta, HR disease, and progressive disease (central review) by negative results for cystoscopy (with TURBT/biopsies, as applicable), UC, and computed tomography urography imaging |
| 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 | Every 12 weeks for 2 years and then every 24 weeks for 3 years |
| 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 | Prior therapy with an anti-PD-1, anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor |
| 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:
| DFS of HR NMIBC was defined as the time from first dose to the first occurrence of HR NMIBC or worse (per central pathology/radiology review). The 12‑month DFS rate is the proportion of patients without HR NMIBC or worse at 12 months. |
| K-M figure reported | K-M graph reported, patients at risk (n=52)a | K-M graph reported, patients at risk (n=132)d |
| Abbreviations: BCG, Bacillus Calmette-Guérin; CIS, carcinoma in situ; CR, complete response; DFS, disease-free survival; HR, high-risk; IV, intravenous; K-M, Kaplan-Meier; L2, ligand 2; MIBC, muscle-invasive bladder cancer; NA, not applicable; 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 KEYNOTE-057 trials after matching are included in Table: Baseline Patients Characteristics Across the SunRISe-1 and KEYNOTE-057 Trials.
| Characteristic | SunRISe-1 INLEXZO | KEYNOTE-057 Pembrolizumab | ||
|---|---|---|---|---|
| Cohort 2 (CIS ± Papillary) n=85 | Cohort 4 (Papillary Only) n=52 | CIS ± Papillary n=96 | Papillary Only n=132 | |
| Median age, years (range) | 71 (40-88) | 71 (42-88) | 73 (44-92) | 72 (37-87) |
| Gender (%) | ||||
| Male | 80 | 71 | 84 | 79 |
| Female | 20 | 30 | 16 | 21 |
| Race (%) | ||||
| White | 87 | 87 | 67 | 66 |
| Non-White | 13 | 14 | 33 | 34 |
| ECOG (%) | ||||
| 0 | 92 | 94 | 73 | 77 |
| 1+ | 8 | 6 | 27 | 23 |
| Median number of prior BCG instillation | 12 | 12 | 12 | 10 |
| Tumor Stage (%) | ||||
| CIS + T1 | 11 | T1: 60 | 13 | T1: 43 |
| CIS + Ta | 22 | Ta: 40 | 25 | Ta: 57 |
| CIS + alone | 67.1 | NA | 63 | NA |
| Abbreviations: BCG, Bacillus Calmette-Guérin; CIS, carcinoma in situ; ECOG, Eastern Cooperative Oncology Group; NA, not applicable; 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 pembrolizumab was 88% vs 41% (absolute rate difference, 47% [95% CI, 34%-61%]; P<0.001). The unadjusted absolute rate difference was 41% (95% CI, 28%-54%).
- The adjusted absolute CR rate difference at 12 months for INLEXZO vs pembrolizumab was 26% (95% CI, 7%-44%), and the unadjusted difference was 27% (95% CI, 14%40%).
- Safety results were not reported in the study.
MAIC in BCG-unresponsive High-risk NMIBC with Papillary Disease Only (Cohort 4)
- INLEXZO significantly improved DFS versus pembrolizumab, with a 64% risk reduction (adjusted HR, 0.36 [95% CI, 0.20-0.64) and a higher 12‑month DFS (adjusted rate, 29% [11.6%-46.2%]).
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 | |
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