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INLEXZO™

(gemcitabine intravesical system)

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INLEXZO™ (gemcitabine intravesical system)

Medical Information

INLEXZO - SunRISe-4 Study

Last Updated: 02/10/2026

SUMMARY

  • SunRISe-4 (NCT04919512) is an ongoing, phase 2, randomized, open-label, multicenter study evaluating the efficacy and safety of INLEXZO in combination with systemic cetrelimab, an investigational immunoglobulin G4 (IgG4) antibody that targets the programmed cell death protein-1 (PD-1) receptor, and systemic cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC) who are scheduled for radical cystectomy (RC) and refuse or are ineligible for platinum-based neoadjuvant chemotherapy. The primary endpoint is pathologic complete response (pCR).1-3
  • Necchi et al (2025)2 reported the primary efficacy and safety results for patients with MIBC who were randomized to receive INLEXZO + cetrelimab therapy (cohort 1, n=101) vs cetrelimab monotherapy (cohort 2, n=58). Exploratory biomarker analyses of urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) minimal residual disease (MRD) were reported in association with efficacy measures.
    • Of the population treated with the combination of INLEXZO + cetrelimab (n=88), the pCR and pathologic overall response (pOR) rates were 37.5% (95% confidence interval [CI], 27.4-48.5) and 53.4% (95% CI, 42.5-64.1), respectively. One-year recurrence-free survival rate was 77.4% (n=35 at risk; 95% CI, 66.6-85.1).
    • Of the population treated with cetrelimab monotherapy (n=46), the pCR and pOR rates were 28.3% (95% CI, 16.0-43.5) and 43.5% (95% CI, 28.9-58.9), respectively. One-year recurrence-free survival rate was 64.1% (n=20 at risk; 95% CI, 47.3-76.8).
    • One or more treatment-related adverse events (TRAEs; any grade) were reported in 81.2% (82/101) and 51.7% (30/58) of patients who received INLEXZO + cetrelimab and cetrelimab monotherapy, respectively.
    • Observed TRAEs (any grade) in patients who received INLEXZO + cetrelimab included dysuria (30.7%), pollakiuria (30.7%), micturition urgency (17.8%), fatigue (12.9%), hematuria (12.9%), hypothyroidism (10.9%), hyperthyroidism (10.9%), urinary tract infection (10.9%), and pruritius (5.0%).
    • The rate of discontinuation due to TRAEs was 20.8% (21/101) with INLEXZO + cetrelimab.
  • Necchi et al (2025)3 reported the interim efficacy and safety results for patients with MIBC who were randomized to receive either INLEXZO + cetrelimab therapy (cohort 1, n=79) or cetrelimab monotherapy (cohort 2, n=41), which were consistent with the primary analysis.
  • Psutka et al (2025)4 presented preliminary perioperative outcomes (surgical, laboratory, and safety) for patients with MIBC who received INLEXZO + cetrelimab therapy (cohort 1, n=79) or cetrelimab monotherapy (cohort 2, n=41).
    • In the RC-evaluable set (n=76; cohort 1, n=50; cohort 2, n=26):
      • Median time from neoadjuvant treatment initiation to RC was 13.5 weeks (range, 4.1-19.4); 84% (64/76) of patients underwent RC within the protocol-specified window (11-15 weeks).
      • The 30- and 90-day post-RC morbidity and mortality profiles in both cohorts were consistent with historical data.

Product labeling

BACKGROUND

  • INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature. INLEXZO is designed to provide local release of gemcitabine in the bladder. INLEXZO contains gemcitabine and urea minitablets within a dual-lumen silicone tube for gradual release of gemcitabine by an osmotic delivery mechanism through the prescribed indwelling period.3,5-10
  • INLEXZO is inserted intravesically via urinary placement catheter, after which it self-coils into a bi-oval shape (see Figure: INLEXZO iDRS). Removal of INLEXZO can be achieved using grasping forceps and cystoscopy.8,11

INLEXZO iDRS5,6,9,12

A graphic design of a train track AI-generated content may be incorrect.

CLINICAL DATA

SunRISe-4 Study

Necchi et al (2025)2 reported the primary efficacy and safety results of neoadjuvant INLEXZO + cetrelimab therapy vs cetrelimab monotherapy in patients with MIBC scheduled for RC and who were ineligible for or decline neoadjuvant cisplatin-based chemotherapy. Exploratory biomarker analyses of utDNA and ctDNA MRD were also included.

Study Design/Methods

  • Ongoing, phase 2, randomized, open-label, multicenter study1,3
  • The study design is shown in Figure: SunRISe-4 Study Design.
  • RC could be performed at week 12. The protocol-specific window for RC was 11-15 weeks.3,4
    • RC could not be performed before week 11 unless at the investigator’s discretion. It could not be performed later than 3 weeks from the week 12 visit.3 
  • Programmed death-ligand 1 (PD-L1) status was assessed by SP263 assay (Roche; LabCorp, Los Angeles, CA), utDNA MRD was assessed by UROAmp assay (Convergent Genomics, South San Francisco, CA), and ctDNA MRD was assessed by Natera Signatera Assay (Natera, Inc., Austin, TX).2

SunRISe-4 Study Design1-4,11,13 

Abbreviations: CT, computed tomography; CTCAE, Common Terminology Criteria for Adverse Events; cTNM, clinical stage-primary tumor [T], lymph node [N], distant metastasis [M]; ECOG PS, Eastern Cooperative Oncology Group performance status; EOS, end of study; FACT-Bl, Functional Assessment of Cancer Therapy-Bladder; GFR, glomerular filtration rate; IV, intravenously; MIBC, muscle-invasive bladder cancer; MRI, magnetic resonance imaging; pCR, pathologic complete response; pOR, pathologic overall response; Q12W, every 12 weeks; Q3W, every 3 weeks; Q4W, every 4 weeks; R, randomization; RC, radical cystectomy; RECIST, Response Evaluation Criteria in Solid Tumors; RFS, recurrence-free survival; TURBT, transurethral resection of bladder tumor.

aPer RECIST v1.1 or histologic evidence
bPatients with variant histologic subtypes (except small-cell or neuroendocrine variants) were allowed if tumors demonstrated urothelial predominance.
cCisplatin ineligibility was defined by Galsky criteria: GFR <60 mL/min/1.73 m2, CTCAE v5.0 grade ≥2 audiometric hearing loss, and/or CTCAE v5.0 grade ≥2 peripheral neuropathy.

dINLEXZO was placed intravesically via a transurethral placement catheter and then removed cystoscopically. Upon removal, a new INLEXZO could be placed immediately. The final INLEXZO was removed in the clinic or at the time of RC.
eProtocol specified window of weeks 11-15.
fClinical follow-up visits and laboratory tests, including urine culture at all visits.
gThe pCR rate was defined as the proportion of patients with pCR (no residual disease = ypT0N0) on analysis of RC bladder specimen by central pathology review.
hRFS was defined as the time from the first dose of any study treatment to the first evidence of radiographic progression (per RECIST v1.1) precluding RC, radiographic evidence of nodal or metastatic disease after RC, death due to any cause, or the last study disease assessment.
iSafety assessed as frequency and grade of adverse events (CTCAE v.5) and laboratory abnormalities.

Results

Patient Characteristics

Primary Analysis: Patient Characteristics in the INLEXZO + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups2  
Characteristic
Cohort 1:
INLEXZO + Cetrelimab
(n=101)
Cohort 2:
Cetrelimab Monotherapy
(n=58)
Age, median (IQR), years
74 (69-77)
69 (64-74)
Sex, male, n (%)
86 (85.1)
46 (79.3)
Race, n (%)
   White
72 (71.3)
43 (74.1)
   Asian
18 (17.8)
11 (19.0)
   Other
11 (10.9)
4 (6.9)
Geographic region, n (%)a
   America
40 (39.6)
21 (36.2)
   Asia
20 (19.8)
12 (20.7)
   Western Europe
41 (40.6)
25 (43.1)
Nicotine use, n (%)
   Current
26 (25.7)
12 (20.7)
   Former
51 (50.5)
34 (58.6)
   Never
1 (1.0)
0
   Unknown
23 (22.8)
12 (20.7)
ECOG PS, n (%)
   0
83 (82.2)
45 (77.6)
   1
18 (17.8)
13 (22.4)
Tumor stage at initial diagnosis, n (%)
   T2
79 (78.2)
49 (84.5)
   T3
19 (18.8)
8 (13.8)
   T4a
3 (3.0)
1 (1.7)
Prior intravesical therapy, n (%)
12 (11.9)
9 (15.5)
Residual disease (visibly incomplete TURBT), n (%)
19 (18.8)
8 (13.8)
PD-L1 status, n (%)b
   Low
33 (50.8)
23 (74.2)
   High
32 (49.2)
8 (25.8)
Urothelial carcinoma with variant histology, n (%)
22 (21.8)
16 (27.6)
Reason for not receiving neoadjuvant cisplatin-based chemotherapy, n (%)
   Ineligible
46 (45.5)
22 (37.9)
      Glomerular filtration rate <60 mL/min
29 (28.7)
15 (25.9)
      Grade ≥2 audiometric hearing loss
11 (10.9)
3 (5.2)
      Grade ≥2 peripheral neuropathy
4 (4.0)
3 (5.2)
      Multiple
2 (2.0)
1 (1.7)
   Refused
55 (54.5)
36 (62.1)
      Quality of life
34 (33.7)
32 (55.2)
      Age
10 (9.9)
2 (3.4)
      Patient comorbidity
3 (3.0)
1 (1.7)
      Patient decision
6 (5.9)
1 (1.7)
      Other
2 (2.0)
0
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; IQR, interquartile range; PD-L1, programmed death-ligand 1; TURBT, transurethral resection of bladder tumor. aAmerica includes the United States; Asia includes Israel and South Korea; Western Europe includes Belgium, France, Germany, Italy, Netherlands, Poland, Spain, and the United Kingdom.bPercentages are based on number of patients with available PD-L1 status data. Cohort 1 and cohort 2 included 65 and 31 patients with available data, respectively.
RC Outcomes
  • The median time to RC was 13.4 weeks (range, 2.6-19.4).
  • Of the treated patients, 134/159 (84.3%) underwent RC (efficacy-evaluable set), including 114/134 (85.1%) who had surgery on schedule at week 12 (within the protocol-specified window of weeks 11-15).
    • Of the included patients, 87% (88/101) and 79% (46/58) underwent RC in cohorts 1 and 2, respectively.
  • There were 9 patients who underwent RC before and 11 patients who underwent RC after the protocol-specified window.
Efficacy

Primary Analysis: Efficacy Endpoints in the INLEXZO + Cetrelimab (Cohort 1) and INLEXZO Monotherapy (Cohort 2) Groups2,13 
Endpoint
Cohort 1:
INLEXZO + Cetrelimab (n=88)
Cohort 2:
Cetrelimab Monotherapy (n=46)
pCR by central reviewa, % (95% CI)
n=33
37.5 (27.4-48.5)
n=13
28.3 (16.0-43.5)
pCR by local review, % (95% CI)
n=32
36.4 (26.4-47.3)
n=14
30.4 (17.7-45.8)
pOR by central review, % (95% CI)
n=47
53.4 (42.5-64.1)
n=20
43.5 (28.9-58.9)
pOR by local review, % (95% CI)
n=49
55.7 (44.7-66.3)
n=20
43.5 (28.9-58.9)
Based on tumor staging at screening, n (%) [95% CI]
   cT2
n=71
n=38
      pCR
28 (39.4) [28.0-51.7]
12 (31.6) [17.5-48.7]
      pOR
40 (56.3) [44.0-68.1]
16 (42.1) [26.3-59.2]
   cT3-4a
n=17
n=8
      pCR
5 (29.4) [10.3-56.0]
1 (12.5) [0.3-52.7]
      pOR
7 (41.2) [18.4-67.1]
4 (50.0) [15.7-84.3]
Based on TURBT completeness, n (%) [95% CI]
   Visibly complete
n=69
n=43
      pCR
26 (37.7) [26.3-50.2]
13 (30.2) [17.2-46.1]
      pOR
37 (53.6) [41.2-65.7]
20 (46.5) [31.2-62.3]
   Incomplete and ≤3 cm
n=19
n=3
      pCR
7 (36.8) [16.3-61.6]
0 (0.0) [0.0-70.8]
      pOR
10 (52.6) [28.9-75.6]
0 (0.0) [0.0-70.8]
12-month RFSb, % (95% CI)
77.4 (66.6-85.1)
64.1 (47.3-76.8)
Abbreviations: CI, confidence interval; pCR, pathologic complete response (defined as ypT0N0); pOR, pathologic overall response (defined as ≤ypT1N0); RC, radical cystectomy; RFS, recurrence-free rate; TURBT, transurethral resection of bladder tumor.
aData are shown for the efficacy-evaluable set (n=134) defined as patients who underwent cystectomy and had available centrally reviewed histopathology.
bRFS was defined as the time from first dose of any study treatment to first radiologic evidence of nodal or metastatic disease that precludes RC, first radiologic evidence of nodal or metastatic disease after RC, or death due to any cause.
  • Median RFS was not reached in either cohort.
Safety

Primary Analysis: TRAEs in the INLEXZO + Cetrelimab (Cohort 1) and INLEXZO Monotherapy (Cohort 2) Groups2 
Patients With ≥1 Event, n (%)
Cohort 1:
INLEXZO + Cetrelimab
(n=101)
Cohort 2:
Cetrelimab Monotherapy
(n=58)
Any Grade
Grade ≥3
Any Grade
Grade ≥3
Any TRAEa,b
82 (81.2)
16 (15.8)
30 (51.7)
6 (10.3)
   Dysuria
31 (30.7)
0
1 (1.7)
0
   Pollakiuria
31 (30.7)
1 (1.0)
0
0
   Micturition urgency
18 (17.8)
0
0
0
   Fatigue
13 (12.9)
2 (2.0)
7 (12.1)
0
   Hematuria
13 (12.9)
2 (2.0)
0
0
   Hypothyroidism
11 (10.9)
1 (1.0)
4 (6.9)
0
   Hyperthyroidism
11 (10.9)
0
3 (5.2)
0
   Urinary tract infection
11 (10.9)
3 (3.0)
0
0
   Lipase increased
8 (7.9)
1 (1.0)
4 (6.9)
1 (1.7)
   Bladde spasm
7 (6.9)
0
0
0
   Decreased appetite
7 (6.9)
0
0
0
   Asthenia
6 (5.9)
0
0
0
   Hyperamylasemia
6 (5.9)
0
4 (6.9)
1 (1.7)
   Urinary incontinence
6 (5.9)
1 (1.0)
0
0
   Bladder pain
5 (5.0)
1 (1.0)
0
0
   Constipation
5 (5.0)
0
1 (1.7)
0
   Diarrhea
5 (5.0)
0
3 (5.2)
0
   Pruritus
5 (5.0)
0
7 (12.1)
0
   Urethral pain
5 (5.0)
0
0
0
   Hyponatremia
3 (3.0)
1 (1.0)
3 (5.2)
2 (3.4)
   Arthralgia
2 (2.0)
0
4 (6.9)
0
   AST increased
2 (2.0)
1 (1.0)
4 (6.9)
1 (1.7)
   ALT increased
2 (2.0)
1 (1.0)
3 (5.2)
1 (1.7)
Immune-related TRAE
48 (47.5)
8 (7.9)
29 (50.0)
5 (8.6)
Serious TRAEc
14 (13.9)
-
3 (5.2)
-
TRAE leading to death
0
-
1 (1.7)d
-
TRAE leading to treatment discontinuatione
21 (20.8)
-
0
-
   TRAE leading to TAR-200 discontinuationf
18 (17.8)
-
-
-
   TRAE leading to cetrelimab discontinuationg
11 (10.9)
-
0
-
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; TRAE, treatment-related adverse event. aAE was categorized as related if assessed by investigator as possibly, probably, or very likely related to study treatment. Patients were counted only once for any given AE, regardless of the number of times the AE occurred. bTRAEs by preferred term are listed if events of any grade were reported in ≥5% of patients in either cohort. Select other grade ≥3 TRAEs included acute kidney injury (cohort 2, n=2 [3.4%]) and blood creatine phosphokinase increased (cohort 1, n=1 [1.0%]; cohort 2, n=1 [1.7%]).cThe most frequent serious TRAEs (reported in ≥2 patients) were hyponatremia (cohort 1, n=1 [1.0%]; cohort 2, n=2 [3.4%]), tubulointerstitial nephritis (cohort 1, n=2 [2.0%]; cohort 2, n=0), and urinary tract infection (cohort 1, n=2 [2.0%]; cohort 2, n=0). dCase of hyperglycemic hyperosmolar nonketotic syndrome. eTRAE leading to discontinuation of TAR-200, cetrelimab, or both. fSelect TRAEs leading to TAR-200 discontinuation were pollakiuria (n=4 [4.0%]), noninfective cystitis (n=3 [3.0%]), and bladder pain (n=2 [2.0%]).
gAll TRAEs leading to cetrelimab discontinuation included Graves’ disease, hyperthyroidism, ALT increased, lipase increased, diabetic ketoacidosis, hyperamylasemia, neutropenia, unilateral deafness, and asthenia (n=1 each).
Exploratory Biomarker Analyses

Exploratory utDNA MRD Analysis (Cohort 1 + Cohort 2)2,13 

Cohort 1
Cohort 2
Cohort 1 + Cohort 2
MRD+, % (n/N)
MRD+, % (n/N)
MRD+, % (n/N)
MRD-, % (n/N)
Baseline
77.8 (35/45)
90.9 (20/22)
82.1 (55/67)
17.9 (12/67)
Week 12
50 (19/38)
55.6 (15/27)
52.3 (34/65)
47.7 (31/65)
Abbreviations: MRD, minimal residual disease; MRD-, minimal residual disease negativity; MRD+, minimal residual disease positivity; utDNA, urinary tumor DNA.
  • Across both cohorts, there were 55 patients who had available utDNA and visibly complete TURBT and at baseline there were 81.8% who were utDNA+.
  • Across both cohorts, there were 12 patients who had available utDNA and visibly incomplete TURBT and at baseline there were 83.3% who were utDNA+.
  • ctDNA MRD results are summarized in Table: Exploratory ctDNA MRD Analysis (Cohort 1 + Cohort 2).

Exploratory ctDNA MRD Analysis (Cohort 1 + Cohort 2)13 
Cohort 1
Cohort 2
Cohort 1 + Cohort 2
MRD+, % (n/N)
MRD+, % (n/N)
MRD+, % (n/N)
Baseline
40 (12/30)
66.7 (8/12)
47.6 (20/42)
Week 12
20 (6/30)
33.3 (4/12)
23.8 (10/42)
Abbreviations: MRD, minimal residual disease; MRD+, minimal residual disease positivity; ctDNA, circulating tumor DNA.
  • Week 12 MRD- status and MRD clearance (defined as matching patients with baseline MRD+ and week 12 MRD- statuses) association with pathologic response are presented in Table: MRD Association With pCR (Cohort 1 + Cohort 2).
    • Of the 30 patients who were utDNA+ at baseline and had matched week 12 utDNA results, 14 (46.7%) had utDNA clearance at week 12 (n=7 each in cohort 1 and cohort 2).
    • Of the 20 patients who were ctDNA+ at baseline and had matched week 12 ctDNA results, 11 (55%) had ctDNA clearance at week 12 (7/12 in cohort 1 and 4/8 in cohort 2).

MRD Association With pCR (Cohort 1+ Cohort 2)2,13
pCR,
% (n/N)
Non-pCR,a
% (n/N)
P-Valueb
Week 12 MRD-
utDNA
81.5 (22/27)
21.2 (7/33)
5.4×10-6
ctDNA
93 (13/14)
68 (19/28)
0.12
MRD clearance (baseline MRD+ and week 12 MRD-)
utDNAc
80.0 (12/15)
13.3 (2/15)
0.0006
ctDNA
83 (5/6)
43 (6/14)
0.15
Abbreviations: ctDNA, circulating tumor DNA; MRD, minimal residual disease; MRD-, minimal residual disease negativity; MRD+, minimal residual disease positivity; pCR, pathologic complete response; pOR, pathologic overall response (defined as ≤ypT1N0); pPR, pathologic partial response; utDNA, urinary tumor DNA.
aNon-pCR includes pPR and pOR.
bFisher’s test.
cutDNA clearance was shown in 7 patients each in cohorts 1 and 2.
  • Results pertaining to the association of ctDNA MRD with RFS are presented in Table: ctDNA MRD Association With RFS.
    • Baseline and week 12 ctDNA-negative status were associated with longer RFS.

ctDNA MRD Association With RFS2,13
Hazard Ratio of ctDNA+ vs ctDNA- status (95% CI)
P-Valuea
Baseline ctDNA (n=44)
4.42 (0.91-21.3)
0.0431
Week 12 ctDNA (n=44)
4.66 (1.24-17.4)
0.0118
Abbreviations: CI, confidence interval; ctDNA, circulating tumor DNA; MRD, minimal residual disease; RFS, recurrence-free survival. aLog-rank test.

Psutka et al (2025)4 presented preliminary perioperative outcomes (surgical, laboratory, and safety) for patients with MIBC who received INLEXZO + cetrelimab therapy (cohort 1, n=79) or cetrelimab monotherapy (cohort 2, n=41).

Surgical Outcomes

Perioperative Surgical Outcomes in the INLEXZO + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups4
Patients, n (%)
INLEXZO + Cetrelimab
Cohort 1
(n=50)
Cetrelimab Monotherapy
Cohort 2
(n=26)
Method of RC
   Robotic
32 (64.0)
8 (30.8)
   Open
14 (28.0)
15 (57.7)
   Laparoscopic
4 (8.0)
3 (11.5)
Type of urinary diversion
   Incontinent diversions
      Ileal conduit
40 (80.0)
19 (73.1)
      Ureterocutaneostomy
1 (2.0)
0
   Continent diversions
      Neobladder
6 (12.0)
7 (26.9)
      Continent pouch
3 (6.0)
0
Abbreviation: RC, radical cystectomy.

Time to RC in the INLEXZO + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups4
Patients, n (%)
INLEXZO + Cetrelimab
Cohort 1
(n=50)
Cetrelimab Monotherapy
Cohort 2
(n=26)
Within protocol-specified window, n (%)
41 (82)
23 (88.5)
   Median time to RC, weeks (range)
13.6 (11.6-15.9)
12.4 (11.1-15.1)
Before protocol-specified window, n (%)
4 (8)
0
   Median time to RC, weeks (range)
8.4 (4.1-10.7)
NA
      PI decision, n (%)
2 (4)
0
      Other, n (%)
1 (2)
0
      Symptomatic progression, n (%)
1 (2)
0
After protocol-specified window, n (%)
5 (10)
3 (11.5)
   Median time to RC, weeks (range)
18.4 (16.0-19.4)
16.1 (12.4-18.0)
      PI decision, n (%)
1 (2)
1 (3.8)
      Other, n (%)
2 (4)
1 (3.8)
      Patient decision, n (%)
2 (4)
0
      Hematuria, n (%)
0
1 (3.8)
Abbreviations: NA, not applicable; PI, principal investigator; RC, radical cystectomy.
  • In INLEXZO + cetrelimab (cohort 1) and cetrelimab monotherapy (cohort 2) groups, there was no ECOG PS worsening in 90.4% (47/52) and 84.6% (22/26) of patients, respectively, when compared at week 6 to baseline.
Safety Outcomes
Post-RC Morbidity and Mortality

Post-RC Morbidity and Mortality (30 and 90 Days) in the INLEXZO + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups4
Patients With ≥1 Event, n (%)a
Within 30 Days Post-RC
Within 90 Days Post-RC
Overall
(n=60)
INLEXZO + Cetrelimab
Cohort 1
(n=38)
Cetrelimab Monotherapy
Cohort 2
(n=22)
Overall
(n=38)
INLEXZO + Cetrelimab
Cohort 1
(n=23)
Cetrelimab Monotherapy
Cohort 2
(n=15)
Post-RC Morbidity
   ≥1 TEAE
   any
   grade
48 (80.0)
29 (76.3)
19 (86.4)
31 (81.6)
18 (78.3)
13 (86.7)
   Serious
   TEAE
24 (40.0)
17 (44.7)
7 (31.8)
15 (39.5)
11 (47.8)
4 (26.7)
   Grade
   ≥3 TEAE
25 (41.7)
16 (42.1)
9 (40.9)
15 (39.5)
10 (43.5)
5 (33.3)
Post-RC Mortalityb
   Any
   cause
1 (1.7)
0
1 (4.5)c
2 (5.3)
1 (4.3)d
1 (6.7)c
Abbreviations: RC, radical cystectomy; TEAE, treatment-emergent adverse event.
aPatients who reached 30 or 90 days post-RC.
bNo deaths related to neoadjuvant treatment with INLEXZO or cetrelimab.
cThe cause of mortality was renal failure.
dThe cause of mortality was cardiorespiratory arrest.

Management of Adverse Events Related to INLEXZO in the SunRISe-4 Study

  • Early removal of INLEXZO, dose delays, and dose interruptions of INLEXZO were permitted per protocol to manage adverse events.11  
  • Patients must have received at least one dose of periprocedural prophylactic antibiotics for any INLEXZO insertion and/or removal procedures to mitigate risk of urinary tract infection.11 
  • Anticholinergics, non-steroidal anti-inflammatory drugs, bladder analgesics, and short-course corticosteroids were permitted to treat urinary tract symptoms.11 

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 14 January 2026.

 

References

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1 Janssen Research & Development, LLC. A phase 2, open-label, multi-center, randomized study of TAR-200 in combination with cetrelimab and cetrelimab alone in participants with muscle-invasive urothelial carcinoma of the bladder who are scheduled for radical cystectomy and are ineligible for or refusing platinum-based neoadjuvant chemotherapy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 January 14]. Available from: https://clinicaltrials.gov/study/NCT04919512 NLM Identifier: NCT04919512.  
2 Necchi A, Guerrero-Ramos F, Crispen PL, et al. Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with MIBC: primary analysis and biomarker results of SunRISe-4. [published online ahead of print December 03, 2025]. J Clin Oncol. doi:10.1200/jco-25-02382.  
3 Necchi A, Guerrero-Ramos F, Crispen PL, et al. TAR-200 plus cetrelimab versus cetrelimab monotherapy as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or decline neoadjuvant cisplatin-based chemotherapy (SunRISe-4): interim analysis of a randomised, open-label phase 2 trial. Lancet Oncol. 2025;26(10):1312-1322.  
4 Psutka S, Herrera-Imbroda B, Crispen P, et al. Perioperative outcomes of neoadjuvant TAR-200 plus cetrelimab or cetrelimab alone in patients with muscle-invasive bladder cancer ineligible for or refusing neoadjuvant cisplatin-based chemotherapy. Oral Presentation presented at: European Association of Urology (EAU) Congress; March 21-24, 2025; Madrid, Spain.  
5 Douglass L, Schoenberg M. The future of intravesical drug delivery for non-muscle invasive bladder cancer. Bladder Cancer. 2016;2(3):285-292.  
6 Tan WS, Kelly JD. Intravesical device-assisted therapies for non-muscle-invasive bladder cancer. Nat Rev Urol. 2018;15(11):667-685.  
7 Daneshmand S, Pohar KS, Steinberg GD, et al. Effect of GemRIS (gemcitabine-releasing intravesical system, TAR-200) on antitumor activity in muscle-invasive bladder cancer (MIBC) [abstract]. J Clin Oncol. 2017;35(Suppl. 15). Abstract e16000.  
8 Daneshmand S, Kamat AM, Shore ND, et al. Development of TAR-200: a novel targeted releasing system designed to provide sustained delivery of gemcitabine for patients with bladder cancer. Urol Oncol. 2025;43(5):286-296.  
9 Daneshmand S, Brummelhuis ISG, Pohar KS, et al. The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial. Urol Oncol. 2022;40(7):344.e1-344.e9.  
10 Daneshmand S, Heijden MSV der, 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.  
11 Necchi A, Guerrero-Ramos F, Crispen PL, et al. Supplement to: TAR-200 plus cetrelimab versus cetrelimab monotherapy as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or decline neoadjuvant cisplatin-based chemotherapy (SunRISe-4): interim analysis of a randomised, open-label phase 2 trial. Lancet Oncol. 2025;26(10):1312-1322.  
12 Grimberg DC, Shah A, Inman BA. Overview of Taris GemRIS, a Novel Drug Delivery System for Bladder Cancer. Eur Urol Focus. 2020;6(4):620-622.  
13 Necchi A, Guerrero-Ramos F, Crispen PL, et al. Supplement to: Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with MIBC: primary analysis and biomarker results of SunRISe-4. [published online ahead of print December 03, 2026]. J Clin Oncol. doi:10.1200/jco-25-02382.