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INLEXZO™ (gemcitabine intravesical system) SunRISe-1 study
Last updated: 01/15/2026
Overveiw1-3
SunRISe-1 (NCT04640623) is an ongoing, phase 2b, open-label, randomized, parallel-cohort, multicenter study evaluating the efficacy and safety of INLEXZO plus systemic cetrelimab (investigational IgG4 antibody targeting PD-1 receptor; cohort 1), INLEXZO monotherapy (cohort 2), or cetrelimab monotherapy (cohort 3) in patients with BCG-unresponsive high-risk NMIBC with CIS ± papillary disease who are ineligible for or decline RC.
INLEXZO monotherapy is additionally being studied in patients with BCG-unresponsive papillary-only high-risk NMIBC (no CIS; cohort 4).a
BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapyb
Persistent or recurrent high-risk NMIBC within 12 months of the last dose of BCG therapy
ECOG PS of 0-2
Study design1-3
Efficacy1,c
Primary efficacy endpoint
Cohorts 1-3: Overall centrally assessed CR rates at any time1,d
Cohort 2: 82.4% (95% CI, 72.6-89.8; n/N=70/85)
Cohort 1: 67.9% (95% CI, 53.7-80.1)
Cohort 3: 46.4% (95% CI, 27.5-66.1)
Cohort 4: DFS rates19
12-month: 74.3% (95% CI, 59.2-84.6)
Ta: 74.8% (95% CI, 54.3-87.1)
T1: 74.1% (95% CI, 48.5-88.3)
18-month: 69.2% (95% CI, 53.4-80.6)
Select secondary efficacy endpoints
Cohorts 1-3: median DOR, months1
Cohort 2: 25.8 (95% CI, 8.3-NE)
Cohort 1: NE
Cohort 3: 8.6 (95% CI, 2.8-NE)
Cohorts 1-3: 12-month DOR rate1
Cohort 2: 56.2% (95% CI, 43.4-67.1)
Cohort 1: 76.3% (95% CI, 58.1-87.4)
Cohort 3: 38.5% (95% CI, 14.1-62.8)
Safety1,3,4,5,19,c
Summary of TRAEs1,3
TRAE, %
Cohort 2 (n=85)
Cohort 4 (n=52)
Cohort 1 (n=53)
Cohort 3 (n=28)
Any-grade TRAEs
83.5
80.8
92.5
53.6
Grade ≥3 TRAEs
12.9
13.5
37.7
7.1
Serious TRAEs
5.9
5.8
15.1
3.6
TRAEs leading to treatment interruption
31.8
25.0
INLEXZO, 37.7
Cetrelimab, 20.8
7.1
TRAEs leading to treatment discontinuation
3.5
7.7
INLEXZO, 26.4
Cetrelimab, 24.5
7.1
The most frequent TRAEs included pollakiuria (43.5%) in cohort 2; dysuria (40.4% and 30.2%, respectively) in cohorts 4 and 1; and pruritus (10.7%) in cohort 3.1,3
No treatment-related deaths were reported.1
Cohorts 2 and 4: Tolerability
The INLEXZO insertion success rates were 99% (745/755) in cohort 2 and 99.8% (419/420) in cohort 4.4,5,19
Additional analyses6-9
Exploratory analyses of immune biomarker responses to INLEXZO monotherapy (cohort 2),6,7 MAICs of INLEXZO monotherapy (cohort 2) vs FDA-approved novel agents,8 and utDNA analyses9 have been presented.
Note: BCG, Bacillus Calmette-Guérin; CI, confidence interval; CIS, carcinoma in situ; CR, complete response; DFS, disease-free survival; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; FDA, Food and Drug Administration; IgG4, immunoglobulin G4; IV, intravenous; MAIC, matching-adjusted indirect comparison; NE, not estimable; NMIBC, non-muscle-invasive bladder cancer; PD-1, programmed cell death protein-1; Q12W, every 12 weeks; Q3W, every 3 weeks; R, randomization; RC, radical cystectomy; T, tumor; TRAE, treatment-related adverse event.
aPer protocol amendment 4. bAdequate BCG is defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or ≥2 of 6 doses of a second induction course. cData cutoff date for Cohorts 1-3 was March 31, 2025. Data cutoff date for Cohort 4 was July 03, 2025. dBased on negative central urine cytology and negative cystoscopy, or negative central urine cytology and positive cystoscopy with benign or low-grade NMIBC on central biopsy.
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer recommends gemcitabine intravesical system (INLEXZO) as a therapy option in Bacillus Calmette-Guérin (BCG)- unresponsive or BCG-intolerant high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS; with or without papillary) tumors (NCCN Category 2A).10
NCCN Categories of Evidence define Category 2A as based upon lower-level evidence, and there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.10
Please refer to the NCCN Guidelines for Bladder Cancer at www.nccn.org for current and complete recommendations for the use of gemcitabine intravesical system (INLEXZO).10
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.1,11-15
INLEXZO is inserted intravesically via urinary placement catheter, after which it self-coils into a bi-oval shape. Removal of INLEXZO can be achieved using grasping forceps and cystoscopy.11,16
INLEXZO iDRS12,13,15,17
SunRISe-1 (NCT04640623) is an ongoing, phase 2b, open-label, randomized, parallel-cohort, multicenter study evaluating the efficacy and safety of INLEXZO plus systemic cetrelimab (investigational IgG4 antibody targeting PD-1 receptor; cohort 1), INLEXZO monotherapy (cohort 2), or cetrelimab monotherapy (cohort 3) in patients with BCG-unresponsive high-risk NMIBC with CIS with or without papillary disease who are ineligible for or decline RC. INLEXZO monotherapy is additionally being studied in patients with BCG-unresponsive papillary-only high-risk NMIBC (no CIS; cohort 4a).1,2 An overview of patient enrollment is included below:
SunRISe-1 study design1-3,b,c
aPer protocol amendment 4. bPatients continued treatment with gemcitabine intravesical system for up to 2 years and cetrelimab for up to 18 months, or until confirmed high-risk disease persistence, recurrence, or progressive disease based on central urine cytology and/or central biopsy assessment or local biopsy/local imaging. cPatients with no treatment response (nonresponders) at any time were required to discontinue treatment and enter the follow-up phase. dAdequate BCG is defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or ≥2 of 6 doses of a second induction course. eDefined as the percentage of patients achieving a CR at any time posttreatment. CR was defined as ≥1 of the following: (1) negative cystoscopy and negative (including atypical) urine cytology, or (2) positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) urine cytology. Mandatory centrally assessed biopsies at weeks 24 and 48 and at any time as clinically indicated were included in the assessment of CR.1,2 fDefined as the time from the first dose of treatment to high-risk disease recurrence (high-grade Ta, any T1, or CIS), progression (progression to MIBC [T≥2], lymph node [N+] or distant disease [M+]), or death due to any reason.3
Primary endpoint1-3
Cohorts 1-3: Overall CR rate at any time
Overall CR rate is defined as the percentage of patients achieving a CR at any time posttreatment. CR was defined as ≥1 of the following: (1) negative cystoscopy and negative (including atypical) urine cytology, or (2) positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) urine cytology. Mandatory centrally assessed biopsies at weeks 24 and 48 and at any time as clinically indicated were included in the assessment of CR.1-3
Cohort 4: DFS rate
DFS rate is defined as the time from the first dose of treatment to high-risk disease recurrence (high-grade Ta, any T1, or CIS), progression (progression to MIBC [T≥2], lymph node [N+] or distant disease [M+]), or death due to any reason.3
Disease-response assessments based on cystoscopy and central urine cytology Q12W for up to 2 years, then Q24W until end of study; local imaging (CT/MRI) Q24W until the end of study; and central pathology (bladder biopsy/TURBT) at weeks 24 and 48 in cohorts 1-3 or as clinically indicated in cases of positive cystoscopy for cohorts 1-41
Secondary endpoints1-3
Cohorts 1-3: DOR
DOR is defined as the time from the first CR to the first evidence of recurrence or progression or death, whichever occurs first.3
All cohorts: OS, safety, tolerability, PK, and PROs
OS is defined as the time from the first dose of study treatment to death.3
AEs were recorded through the end of the 100-day safety follow-up visit and graded with the NCI CTCAE v5.0.3
PROs included EORTC QLQ-C30 and EORTC QLQ-NMIBC completed at weeks 0, 6, and 12, then Q12W and at 30- and 100-day safety follow-up.3
Exploratory endpoint1,3
Cohort 2: Time to cystectomy
Time to cystectomy is defined as the time from the first dose of study treatment to RC.3
The characteristics of patients receiving treatment in cohort 2 (INLEXZO monotherapy; CIS ± papillary disease; n=85), cohort 4 (INLEXZO monotherapy; papillary disease only; n=52), cohort 1 (INLEXZO + cetrelimab; n=53), and cohort 3 (cetrelimab monotherapy; n=28) were reported.1
Demographics and baseline disease characteristics of patients in cohorts 1-41,3,a
Characteristics
Cohort 2 INLEXZO monotherapy (n=85)
Cohort 4 INLEXZO monotherapy (n=52)
Cohort 1 INLEXZO + cetrelimab (n=53)b
Cohort 3 Cetrelimab monotherapy (n=28)
Median age, years (range)
71.0 (40–88)
71.0 (42–88)
74.0 (45–85)
69.5 (51–88)
Sex, n (%)
Male
68 (80.0)
37 (71.2)
46 (83.6)
21 (75.0)
Female
17 (20.0)
15 (28.8)
9 (16.4)
7 (25.0)
ECOG PS, n (%)
0
78 (91.8)
49 (94.2)
46 (86.8)
26 (92.9)
1
7 (8.2)
2 (3.8)
6 (11.3)
2 (7.1)
2
0
1 (1.9)
1 (1.9)
0
Tumor stage, n (%)
CIS only
57 (67.1)
–
39 (73.6)
18 (64.3)
CIS + papillary disease
28 (32.9)
–
14 (26.4)
9 (32.1)
CIS + Ta
19 (22.4)
–
10 (18.9)
6 (21.4)
CIS + T1
9 (10.6)
–
4 (7.5)
3 (10.7)
T1
–
–
–
1 (3.6)
Papillary disease
–
52 (100.0)
–
–
High-grade Ta
–
31 (59.6)
–
–
T1
–
21 (40.4)
–
–
PD-L1 status 1, n (%)c
CPS ≥10
12 (32.4)
–
2 (6.5)
4 (23.5)
CPS ≤10
25 (67.6)
–
29 (93.5)
13 (76.5)
PD-L1 status 2, n (%)c
CPS ≥1
23 (62.2)
–
10 (32.3)
6 (35.3)
CPS ≤1
14 (37.8)
–
21 (67.7)
11 (64.7)
Median total doses of prior BCG, n (range)
12 (7–42)
12 (8–45)
12 (7–35)
12 (7–30)
Median time from last BCG to diagnosis,d months (range)
3.2 (0.1–21.7)e
2.8 (0.3–9.9)
3.5 (0.3–11.5)
3.1 (0.3–10.2)
aData cutoff date: March 31, 2025. bPatient characteristics of age and sex are shown
for the enrolled analysis set (n=55). cPercentages are based on number of patients with
available data (cohort 1, n=31; cohort 2, n=37; cohort 3, n=17). dCohorts 1-3, CIS diagnosis;
cohort 4, diagnosis of high-grade papillary NMIBC. eTwo patients had >12 months from the last
BCG dose to CIS diagnosis (protocol deviation); all other patients had ≤12 months from the last BCG dose to CIS
diagnosis (per protocol). Note: Patient characteristics are shown for all patients who received ≥1 dose of
the study drug in the full analysis set for each cohort.
The results of the SunRISe-1 study are also included in the INLEXZO product labeling. The efficacy results below may vary from that 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.
Overall CR rates at any time
Overall CR rates in cohort 2 (INLEXZO monotherapy)1,18,a
Overall CR rate,b % (95% CI)
Cohort 2 INLEXZO monotherapy (n=85)
Centrally assessed rate at any time
82.4 (72.6-89.8) [n/N=70/85]c
Investigator-assessed
83.5 (73.9-90.7)c
KM-estimated rate posttreatment initiation
3-month
78.8 (68.6-86.9)
6-month
58.8 (47.6-69.4)
12-month
45.9 (35.0-57.0)
aData cutoff date: March 31, 2025. bResponse is based on
centrally reviewed urine cytology, local cystoscopy, and central biopsy (if available). A CR is defined as
having a negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive
cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally read
cytology at any timepoint. cOverall concordance between centrally and
investigator-assessed CR rate, 95.0%.
Additional efficacy measures1
Median time to response was 2.8 months.
In total, 96% of responses were achieved during the first disease assessment.
The remaining patients who achieved CR were nonevaluable for disease response at week 12 due to missing
samples or assessments, but they achieved CR at the subsequent evaluation.
CR rates across patient subgroups are summarized below:
The results of the SunRISe-1 study are also included in the INLEXZO product labeling. The efficacy results below may vary from that 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.
DOR rates
DORa rates in cohort 2 (INLEXZO monotherapy)1,18,b
Response
Cohort 2 INLEXZO monotherapy (n=85)
Number of responders, n
70
Median follow-up in responders, months (range)
20.2 (5-48)
Median DOR, months (95% CI)
25.8 (8.3-NE)
DOR of ≥12 months, % (n/N)
52.9 (37/70)
12-month KM-estimated DOR rate, % (95% CI)
56.2 (43.4-67.1)
Patients remained in CR, n
37
Patients with ongoing response,c % (n/N)
47.1 (33/70)d
aDOR is defined as the time from the first CR to the first evidence of
recurrence or progression or death, whichever occurs first.3 bData cutoff date: March
31, 2025. cResponse is based on centrally reviewed urine cytology, local cystoscopy, and central
biopsy (if available). A CR is defined as having a negative cystoscopy and negative (including atypical)
centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative
(including atypical) centrally read cytology at any timepoint. dOf the 70 responders, 37
(52.9%) were censored, including 4 (5.7%) who discontinued the study, started subsequent therapy, or missed ≥2
consecutive assessments; 11 responders completed 2 years of treatment.
Cohort 2: Additional efficacy outcomes1
Disease recurrence, disease progression, and time to RC cystectomy after INLEXZO treatment in cohort 2 reported in responders are summarized below:
Primary endpoint - DFS rates
At a median follow-up of 15.9 months (range, 4-20), median DFS was not reached (95% CI, NE-NE).19
DFS rates in cohort 4 (INLEXZO monotherapy)1,4,19,a
DFS rate, % (95% CI)
Cohort 4 INLEXZO monotherapy (n=52)
6-month
85.3 (71.6-92.7); n=40
High-grade Ta disease
85.7 (66.3-94.4); n=24
T1 disease
84.7 (59.7-94.8); n=16
9-month
81.1 (66.7-89.7); n=31
Ta disease
82.1 (62.3-92.1); n=20
T1 disease
79.4 (54.0-91.7); n=11
12-month
74.3 (59.2-84.6); n=29
High-grade Ta disease
74.8 (54.3-87.1); n=19
T1 disease
74.1 (48.5-88.3); n=10
18-month
69.2 (53.4-80.6); n=1
Note: Data cutoff date for 6-, 12-, and 18-month was July 03, 2025. Data cutoff date for 9-month DFS was March 31, 2025.
Secondary endpoints - PFS and OS1,3,4,19
NMIBC recurrence or progression occurred in 21.2% (11/52) of patients.1,4
Progression to MIBC was reported in 1.9% (1/52) of patients.4,19
Progression is defined as advancing to MIBC (T≥2), lymph node (N+), or distant disease (M+), or death due to any cause
Median PFS was not estimable.4,19
The 9-month PFS rate was 95.6% (95% CI, 83.5-98.9); n=32 (at risk).4
The 12-month PFS rate was 95.6% (95% CI, 83.5-98.9); n=27 (at risk).19
Median OS was not estimable.4,19
The 9-month OS rate was 98.0% (95% CI, 86.4-99.7); n=46 (at risk).4
The 12-month OS rate was 98.0% (95% CI, 86.6-99.7); n=41 (at risk).19
Deaths unrelated to the treatment occurred in 3.8% (2/52) of patients due to acute renal failure and congestive cardiac failure.1,3,19
Time to RC in cohort 419
There were 7.7% (4/52) patients who had RC.
The 12- and 18-month RC-free rates were 93.8% (95% CI, 81.9-97.9) and 91.0% (95% CI, 77.5-96.6), respectively.
Primary endpoint - Overall CR rates at any time
Overall CR rates in cohort 1 (INLEXZO + cetrelimab)1,a
Overall CR rate,b % (95% CI)
Cohort 1 INLEXZO + cetrelimab (n=53)
Centrally assessed rate at any time
67.9 (53.7-80.1)
Investigator-assessed
83.0 (70.2-91.9)
aData cutoff date: March 31, 2025. bResponse is based on
centrally reviewed urine cytology, local cystoscopy, and central biopsy (if available). A CR is defined as
having a negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive
cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally read
cytology at any timepoint.
Secondary endpoints - DOR and OS rates
DORa and OSb rates in cohort 1 (INLEXZO +
cetrelimab)1,c
Response
Cohort 1 INLEXZO + cetrelimab (n=53)
Median follow-up in responders, months (range)
33.4 (10-47)
Median DOR, months (95% CI)
NE
12-month KM-estimated DOR rate, % (95% CI)
76.3 (58.1-87.4)
Patients remained in CR, n (%)
20 (55.6)
12-month OS rate, % (95% CI)
98.0 (86.6-99.7)d
aDOR is defined as the time from the first CR to first evidence of recurrence or progression or death, whichever occurs first.3 bOS is defined as
the time from the first dose of study treatment to death.3 cData cutoff date:
March
31, 2025. dTotal number of deaths was 2 (3.8%). No deaths were treatment-related.3
Primary endpoint - Overall CR rates at any time
Overall CR rates in cohort 3 (cetrelimab monotherapy)1,a
Overall CR rate,b % (95% CI)
Cohort 3 Cetrelimab monotherapy (n=28)
Centrally assessed rate at any time
46.4 (27.5-66.1)
Investigator-assessed
50.0 (30.6-69.4)
aData cutoff date: March 31, 2025. bResponse is based on centrally reviewed urine cytology, local cystoscopy, and central biopsy (if available). A CR is defined as having a negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally read cytology at any timepoint.
Secondary endpoints - DOR and OS rates
DORa and OSb rates in cohort 3 (cetrelimab monotherapy)1,c
Response
Cohort 3 Cetrelimab monotherapy (n=28)
Median follow-up in responders, months (range)
29.2 (11-45)
Median DOR, months (95% CI)
8.6 (2.8-NE)
12-month KM-estimated DOR rate, % (95% CI)
38.5 (14.1-62.8)
12-month OS rate, % (95% CI)
100 (100-100)d
aDOR is defined as the time from the first CR to first evidence of
recurrence or progression or death, whichever occurs first.3 bOS is defined as
the time from the first dose of study treatment to death.3 cData cutoff date:
March
31, 2025. dNo deaths were reported.3
The results of the SunRISe-1 study are also included in the INLEXZO product labeling. The safety results below may vary from that in the INLEXZO product labeling due to the difference in evaluation of the individual safety events, contributing to differences in reported n-values and percentages.
Overall safety profile of cohort 2 (INLEXZO monotherapy)1,3,a
Patients with event, n (%)
Cohort 2 INLEXZO monotherapy (n=85)
Related AEsb
71 (83.5)
INLEXZO
63 (74.1)
Insertion procedure
30 (35.3)
Removal procedure
14 (16.5)
Urinary placement catheter
19 (22.4)
Related Grade ≥3 AEsb
11 (12.9)c
INLEXZO
9 (10.6)
Insertion procedure
1 (1.2)
Removal procedure
0
Urinary placement catheter
1 (1.2)
Related Serious AEsb
5 (5.9)d
INLEXZO
3 (3.5)
Insertion procedure
1 (1.2)
Removal procedure
0
Urinary placement catheter
1 (1.2)
Related AEs leading to INLEXZO interruptionb,e
27 (31.8)f
INLEXZO
21 (24.7)g
Insertion procedure
10 (11.8)
Removal procedure
5 (5.9)
Urinary placement catheter
6 (7.1)
Related AEs leading to INLEXZO discontinuationb,h
3 (3.5)i
INLEXZO
2 (2.4)
Insertion procedure
1 (1.2)
Removal procedure
1 (1.2)
Urinary placement catheter
0
Related AEs with fatal outcome
0
aData cutoff date: March 31, 2025. bAn AE was categorized as
related if the investigator determined that there was a possible, probable, or causal relationship between the
AE and INLEXZO or procedure. cOther grade ≥3 TRAEs included acute kidney injury, pseudomonal
cystitis, and urosepsis (n=1 each). Note, patients may have had ≥1 grade ≥3 TRAEs. dSerious
TRAEs (n=1 each) included cystitis with bladder pain (grade 2), pseudomonal cystitis (grade 3), UTI (grade 3),
urosepsis with acute kidney injury (grade 3), and urinary tract pain (grade 3). Note, patients may have had ≥1
serious TRAE. eNumber of patients who experienced AEs related to INLEXZO, insertion procedure,
removal procedure, or urinary placement catheter that led to interruption of INLEXZO. INLEXZO interruption is
defined as when a INLEXZO dose is skipped or INLEXZO is removed early. fMost patients had 1-2
skipped INLEXZO doses and most patients resumed treatment. Common reasons for interruption included urinary
tract pain (5.9%), pollakiuria (4.7%), and UTI (4.7%). gThe most frequent INLEXZO-related AEs
leading to interruption were urinary tract pain (5.9%), hematuria (4.7%), and pollakiuria (4.7%).
hNumber of patients who experienced AEs related to INLEXZO, insertion procedure, removal
procedure, or urinary placement catheter that led to discontinuation of INLEXZO. iTRAEs leading
to INLEXZO discontinuation included noninfective cystitis (n=2; 2.4%), pollakiuria (n=1; 1.2%), and urinary
tract disorder (n=1; 1.2%). Note, patients who discontinued may have had ≥1 TRAE. Note: Safety data are
shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted
only once for any given event, regardless of the number of times they actually experienced the event.
Median time to AE resolution was 3.0 weeks (range, 0.1+ to 150.3+).1
No treatment-related deaths were reported.1
Cohort 2: Most frequent TRAEs1,a
Most frequent ≥1 TRAEs,b n (%)
Cohort 2 INLEXZO monotherapy (n=85)
Any-gradec
Grade ≥3d
Pollakiuria
37 (43.5)
0
Dysuria
34 (40.0)
0
Micturition urgency
21 (24.7)
0
UTI
18 (21.2)
1 (1.2)
Hematuria
14 (16.5)
0
Urinary tract pain
9 (10.6)
4 (4.7)
Bladder pain
7 (8.2)
2 (2.4)
Bladder spasm
7 (8.2)
0
Noninfective cystitis
6 (7.1)
0
Urinary incontinence
5 (5.9)
0
Nocturia
4 (4.7)
0
Urethral pain
4 (4.7)
0
Urinary retention
4 (4.7)
1 (1.2)
Cystitis
3 (3.5)
1 (1.2)
Lower urinary tract symptoms
3 (3.5)
0
Pelvic pain
3 (3.5)
0
Abdominal pain
2 (2.4)
0
Abdominal pain lower
2 (2.4)
0
Asthenia
2 (2.4)
0
Constipation
2 (2.4)
0
Fatigue
2 (2.4)
0
Penile pain
2 (2.4)
0
Perineal pain
2 (2.4)
0
Urethral injury
2 (2.4)
0
Vulvovaginal pain
2 (2.4)
0
aData cutoff date: March 31, 2025. bAn AE was categorized as related if the investigator determined that there was a possible, probable, or causal relationship between the AE and INLEXZO or procedure. cAny-grade TRAEs by preferred term are listed if they were reported in ≥2% of patients. dOther grade ≥3 TRAEs included acute kidney injury, pseudomonal cystitis, and urosepsis (n=1 each). Note, patients may have had ≥1 grade ≥3 TRAEs. Note: Safety data are shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.
At the data cutoff date of March 31, 2025, the INLEXZO insertion success rates were 99% (745/755).5
Data cutoff: March 31, 2025
The overall safety profile of cohort 4 (INLEXZO monotherapy) is presented below.1,3
No treatment-related deaths were reported.1,3
Overall safety profile of cohort 4 (INLEXZO monotherapy)1,3
Patients with event, n (%)
Cohort 4 INLEXZO monotherapy (n=52)
Related AEsa
42 (80.8)
INLEXZO
38 (73.1)
Insertion procedure
19 (36.5)
Removal procedure
14 (26.9)
Urinary placement catheter
22 (42.3)
Related Grade ≥3 AEsa
7 (13.5)b
INLEXZO
5 (9.6)
Insertion procedure
4 (7.7)
Removal procedure
1 (1.9)
Urinary placement catheter
1 (1.9)
Related Serious AEsa
3 (5.8)c
INLEXZO
1 (1.9)
Insertion procedure
3 (5.8)
Removal procedure
1 (1.9)
Urinary placement catheter
1 (1.9)
Related AEs leading to INLEXZO interruptiona,d
13 (25.0)
INLEXZO
12 (23.1)
Insertion procedure
1 (1.9)
Removal procedure
0
Urinary placement catheter
3 (5.8)
Related AEs leading to INLEXZO discontinuationa,e
4 (7.7)f
INLEXZO
4 (7.7)
Insertion procedure
1 (1.9)
Removal procedure
0
Urinary placement catheter
0
Related AEs with fatal outcome
0
aAn AE was categorized as related if the investigator determined that there was a possible, probable, or causal relationship between the AE and INLEXZO or procedure. bOther grade ≥3 TRAEs included sepsis and spinal fracture (procedure related; n=1 each). Note, patients may have had ≥1 grade ≥3 TRAEs. cSerious TRAEs included sepsis, spinal fracture (procedure related), and UTI (n=1 each). dNumber of patients who experienced AEs related to INLEXZO, insertion procedure, removal procedure, or urinary placement catheter that led to interruption of INLEXZO. eNumber of patients who experienced AEs related to INLEXZO, insertion procedure, removal procedure, or urinary placement catheter that led to discontinuation of INLEXZO. fTRAEs leading to INLEXZO discontinuation included micturition urgency (n=4; 7.7%), dysuria (n=2; 3.8%), and pollakiuria (n=2; 3.8%). Note: Safety data are shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.
Data cutoff: July 03, 2025
No treatment-related deaths were reported.19
Most TEAEs were grade 1 or 2 and resolved promptly with a median resolution time of 3.3 weeks.19
Serious TRAEs occurred in 5.8% patients (n=3).19
Treatment was discontinued due to TRAEs in 7.7% patients (n=4).19
Any grade and grade ≥3 TRAEs were reported in 80.8% (42/52) and 13.5% (7/52) patients, respectively.19
Data cutoff: March 31, 2025
Cohort 4: Most frequent TRAEs1,3,a
Most frequent ≥1 TRAEs,b,c n (%)
Cohort 4 INLEXZO monotherapy (n=52)
Any-grade
Grade ≥3d
Dysuria
21 (40.4)
0
Pollakiuria
16 (30.8)
0
Micturition urgency
15 (28.8)
0
UTI
12 (23.1)
1 (1.9)
Hematuria
7 (13.5)
0
Bladder pain
5 (9.6)
2 (3.8)
Nocturia
5 (9.6)
0
Bladder spasm
4 (7.7)
0
Noninfective cystitis
4 (7.7)
0
Pruritus
4 (7.7)
0
Bladder irritation
3 (5.8)
0
Pelvic pain
3 (5.8)
1 (1.9)
Urinary incontinence
3 (5.8)
1 (1.9)
Urinary tract pain
3 (5.8)
0
Abdominal pain
2 (3.8)
0
Asthenia
2 (3.8)
0
Cystitis
2 (3.8)
0
Dry mouth
2 (3.8)
0
Lower urinary tract symptoms
2 (3.8)
0
Perineal pain
2 (3.8)
0
Urethral pain
2 (3.8)
0
aData cutoff date: March 31, 2025. bAn AE was categorized as
related if the investigator determined that there was a possible, probable, or causal relationship between the
AE and INLEXZO or procedure. cAny-grade and grade ≥3 TRAEs by preferred term are listed if they
were reported in ≥2% of patients and ≥2 patients, respectively. dOther grade ≥3 TRAEs included
sepsis and spinal fracture (procedure related; n=1 each). Note, patients may have had ≥1 grade ≥3
TRAEs. Note: Safety data are shown for all patients who received ≥1 dose of the study drug in the full
analysis set. Patients are counted only once for any given event, regardless of the number of times they
actually experienced the event.
The INLEXZO insertion success rates were 99.5% (387/389).4
Data cutoff: July 03, 2025
Cohort 4: Most frequent TRAEs19
Most frequent ≥1 TRAEs,a,b n (%)
Cohort 4 INLEXZO monotherapy (n=52)
Any-grade
Grade ≥3c
Dysuria
21 (40.4)
0
Pollakiuria
16 (30.8)
0
Micturition urgency
15 (28.8)
0
UTI
14 (26.9)
1 (1.9)
Hematuria
8 (15.4)
0
Bladder pain
5 (9.6)
2 (3.8)
Nocturia
5 (9.6)
0
Bladder spasm
5 (9.6)
0
Noninfective cystitis
4 (7.7)
0
Bladder irritation
3 (5.8)
0
Pelvic pain
3 (5.8)
1 (1.9)
Urinary incontinence
3 (5.8)
1 (1.9)
Urinary tract pain
3 (5.8)
0
aAn AE was categorized as related if the investigator determined that there was a possible, probable, or causal relationship between the AE and INLEXZO or procedure. bAny-grade and grade ≥3 TRAEs by preferred term are listed if they were reported in ≥2% of patients and ≥2 patients, respectively. cOther grade ≥3 TRAEs included sepsis and spinal fracture (procedure related; n=1 each). Note, patients may have had ≥1 grade ≥3 TRAEs. Note: Safety data are shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.
The INLEXZO insertion success rates were 99.8% (419/420).19
Overall safety profile of cohort 1 (INLEXZO + cetrelimab)1,3,a
Patients with event, n (%)
Cohort 1 INLEXZO + cetrelimab (n=53)b
Related AEsc
49 (92.5)
INLEXZO
42 (79.2)
Cetrelimab
34 (64.2)
Insertion procedure
15 (28.3)
Removal procedure
7 (13.2)
Urinary placement catheter
10 (18.9)
Related grade ≥3 AEsc
20 (37.7)d
INLEXZO
9 (17.0)
Cetrelimab
11 (20.8)
Insertion procedure
5 (9.4)
Removal procedure
1 (1.9)
Urinary placement catheter
1 (1.9)
Related serious AEsc
8 (15.1)e
INLEXZO
4 (7.5)
Cetrelimab
5 (9.4)
Insertion procedure
2 (3.8)
Removal procedure
1 (1.9)
Urinary placement catheter
0
Related AEs leading to INLEXZO interruptionc,f
20 (37.7)
INLEXZO
18 (34.0)
Insertion procedure
7 (13.2)
Removal procedure
1 (1.9)
Urinary placement catheter
4 (7.5)
Related AEs leading to cetrelimab interruptionc,g
11 (20.8)
Related AEs leading to INLEXZO discontinuationc,h
14 (26.4)
INLEXZO
12 (22.6)
Insertion procedure
2 (3.8)
Removal procedure
1 (1.9)
Urinary placement catheter
1 (1.9)
Related AEs leading to cetrelimab discontinuationc,i
13 (24.5)
Related AEs with fatal outcome
0
aData cutoff date: March 31, 2025. bTwo patients assigned to receive INLEXZO + cetrelimab received cetrelimab only. cAn AE was categorized as related if the investigator determined that there was a possible, probable, or causal relationship between the AE and INLEXZO or procedure. dOther grade ≥3 TRAEs included dermatitis, device difficult to use, device occlusion, gamma-glutamyl transferase increased, hepatitis, hypoglycemia, hyponatremia, hypophysitis, immune-mediated hepatitis, lipase increased, pelvic pain, procedural pain, sepsis, suprapubic pain, urosepsis, and vomiting (n=1 each). Note, patients may have had ≥1 grade ≥3 TRAE. eSerious TRAEs included UTI (n=2; 3.8%); and diarrhea, device difficult to use, device occlusion, hyponatremia, hypophysitis, immune-mediated hepatitis, noninfective cystitis, sepsis, stomatitis, urosepsis, and vomiting (n=1 each). Note, patients may have had ≥1 serious TRAE. fNumber of patients who experienced AEs related to INLEXZO, insertion procedure, removal procedure, or urinary placement catheter that led to interruption of INLEXZO. gNumber of patients who experienced AEs related to cetrelimab that led to interruption of cetrelimab. hNumber of patients who experienced AEs related to INLEXZO, insertion procedure, removal procedure, or urinary placement catheter that led to discontinuation of INLEXZO. iNumber of patients who experienced AEs related to cetrelimab that led to discontinuation of cetrelimab. Note: Safety data are shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.
No treatment-related deaths were reported.1
Most common TRAEs leading to INLEXZO or cetrelimab discontinuation were bladder pain (11.3%) and pollakiuria (5.7%).1
Cohort 1: Most frequent TRAEs1,3,a
Most frequent ≥1 TRAEs,b,c n (%)
Cohort 1 INLEXZO + cetrelimab (n=53)
Any-grade
Grade ≥3d
Dysuria
16 (30.2)
0
Pollakiuria
15 (28.3)
0
UTI
12 (22.6)
2 (3.8)
Hematuria
11 (20.8)
0
Diarrhea
10 (18.9)
1 (1.9)
AST Increased
9 (17.0)
2 (3.8)
Bladder pain
9 (17.0)
0
Noninfective cystitis
9 (17.0)
2 (3.8)
Micturition urgency
8 (15.1)
0
ALT Increased
7 (13.2)
1 (1.9)
Fatigue
7 (13.2)
0
Pruritus
7 (13.2)
0
Cystitis
6 (11.3)
0
Urinary incontinence
6 (11.3)
1 (1.9)
Rash
5 (9.4)
0
Urinary tract pain
5 (9.4)
1 (1.9)
Hyperthyroidism
4 (7.5)
0
Hypothyroidism
4 (7.5)
0
Urinary retention
4 (7.5)
1 (1.9)
Arthralgia
3 (5.7)
1 (1.9)
Arthritis
3 (5.7)
0
Asthenia
3 (5.7)
0
Bladder irritation
3 (5.7)
0
Bladder spasm
3 (5.7)
0
Rash maculo-papular
3 (5.7)
0
Myalgia
3 (5.7)
0
Stomatitis
3 (5.7)
1 (1.9)
Strangury
3 (5.7)
0
Urethral pain
3 (5.7)
1 (1.9)
aData cutoff date: March 31, 2025. bAn AE was categorized as related if the investigator determined that there was a possible, probable, or causal relationship between the AE and INLEXZO or procedure. cAny-grade and grade ≥3 TRAEs by preferred term are listed if they were reported in ≥5% of patients and ≥2 patients, respectively. Note: Safety data are shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event. dOther grade ≥3 TRAEs included dermatitis, device difficult to use, device occlusion, gamma-glutamyl transferase increased, hepatitis, hypoglycemia, hyponatremia, hypophysitis, immune-mediated hepatitis, lipase increased, pelvic pain, procedural pain, sepsis, suprapubic pain, urosepsis, and vomiting (n=1 each). Note, patients may have had ≥1 grade ≥3 TRAE.
Overall safety profile of cohort 3 (cetrelimab monotherapy)1,3,a
Patients with ≥1 event, n (%)
Cohort 3 Cetrelimab monotherapy (n=28)
Related AEsb
15 (53.6)
Related grade ≥3 AEb
2 (7.1)c
Related serious AEsb
1 (3.6)d
Related AEs leading to cetrelimab interruptionb,e
2 (7.1)
Related AEs leading to cetrelimab discontinuationb,f
2 (7.1)g
Related AEs with fatal outcome
0
aData cutoff date: March 31, 2025. bAn AE was categorized as related if the investigator determined that there was a possible, probable, or causal relationship between the AE and INLEXZO or procedure. cOther grade ≥3 TRAEs included hyperglycemia, neutropenia, and myopericarditis (n=1 each). Note, patients may have had ≥1 grade ≥3 TRAE. dSerious TRAE included myopericarditis (n=1). eNumber of patients who experienced AEs related to cetrelimab that led to interruption of cetrelimab. fNumber of patients who experienced AEs related to cetrelimab that led to discontinuation of cetrelimab. gTRAEs leading to cetrelimab discontinuation included myopericarditis and neutropenia (n=1 each). Note: Safety data are shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.
No treatment-related deaths were reported.1
Most frequent TRAEs in cohort 3 (cetrelimab monotherapy)1,3,a
Most frequent ≥1 TRAEs,b,c n (%)
Cohort 3 Cetrelimab monotherapy (n=28)
Any-grade
Grade ≥3d
Pruritus
3 (10.7)
0
Arthralgia
2 (7.1)
0
Diarrhea
2 (7.1)
0
Dry mouth
2 (7.1)
0
Fatigue
2 (7.1)
0
Hyperthyroidism
2 (7.1)
0
Hypothyroidism
2 (7.1)
0
Lipase increased
2 (7.1)
0
Psoriasis
2 (7.1)
0
Rash maculo-papular
2 (7.1)
0
aData cutoff date: March 31, 2025. bAn AE was categorized as related if the investigator determined that there was a possible, probable, or causal relationship between the AE and INLEXZO or procedure. cAny-grade TRAEs by preferred term are listed if they were reported in ≥5% of patients. dOther grade ≥3 TRAEs included hyperglycemia, neutropenia, and myopericarditis (n=1 each). Note, patients may have had ≥1 grade ≥3 TRAE. Note: Safety data are shown for all patients who received ≥1 dose of the study drug in the full analysis set. Patients are counted only once for any given event, regardless of the number of times they actually experienced the event.
Cohort 2: PROs
At baseline, mean EORTC QLQ-C30 GHS and PF scoresa were 75.0 (SD, 16.7) and 86.2 (SD, 17.3), respectively.1,b
Least squares meanc GHS and PF scores remained stable on INLEXZO monotherapy treatment, with changes not exceeding the ≥10-point threshold for a clinically meaningful change.1
Cohort 2: additional analyses
An exploratory analysis evaluated the association of response to INLEXZO monotherapy (cohort 2) with PD-L1 expression, TMB, and MSI.6
An exploratory analysis evaluated baseline genomic alterations and immune biomarkers (PD-L1, TMB, MSI, and utDNA MRD status) in response to INLEXZO monotherapy (cohort 2).7
A urine-based utDNA analysis was conducted and the baseline MRD status and Genomic Disease Burden were correlated with INLEXZO monotherapy (cohort 2) response (CR, DOR, and CR ≥12 months).9
An MAIC study was conducted on INLEXZO monotherapy (cohort 2) vs FDA-approved novel agents (pembrolizumab, nadofaragene firadenovec-vncg, and nogapendekinalfa inbakicept-pmlnin combination with BCG).8
Cohort 4: PROs
At baseline, mean EORTC QLQ-C30 GHS and PF scores were 77.1 (SD, 18.7) and 85.4 (SD, 16.8), respectively.19
Least squares mean GHS and PF scores remained stable on INLEXZO monotherapy treatment, with changes not exceeding the 10-point threshold for a clinically meaningful change.19
aGHS and PF scores range from 0 (worse) to 100 (better). bPatients who had a baseline measurement and ≥1 postbaseline value were included in the analysis. cLeast squares means were derived based on the mixed-effects model with repeated measures, in which the dependent variable was change from baseline in score; independent variables were baseline PRO score and visit as fixed effects and individual subject as random effect.
AE
Adverse event
M
Metastasis
BCG
Bacillus Calmette–Guérin
MAIC
Matching-adjusted indirect comparison
CI
Confidence interval
MIBC
Muscle-invasive bladder cancer
CIS
Carcinoma in situ
MRD
Minimal residual disease
CPS
Combined positive score
MRI
Magnetic resonance imaging
CR
Complete response
MSI
Microsatellite instability
CT
Computed tomography
mUC
Metastatic urothelial carcinoma
DFS
Disease-free survival
N
Node
DOR
Duration of response
NCCN
National Comprehensive Cancer Network
ECOG PS
Eastern Cooperative Oncology Group performance status
NCI CTCAE
National Cancer Institute Common Terminology Criteria for Adverse Events
EORTC QLQ-C30
European Organisation for Research and Treatment of Cancer
Quality-of-Life Questionnaire C30
NE
Not estimable
EORTC QLQ-NMIBC
European Organisation for Research and Treatment of Cancer
Quality of Life Questionnaire–Non-Muscle Invasive Bladder Cancer Module
NMIBC
Non–muscle-Invasive bladder cancer
FDA
Food and Drug Administration
OS
Overall survival
GHS
Global health status
PD-1
Programmed cell death protein-1
IDRS
Intravesical drug-releasing system
PD-L1
Programmed cell death-ligand 1
IgG4
Immunoglobulin G4
PD-L2
Programmed cell death-ligand 2
IV
Intravenous
PF
Physical functioning
KM
Kaplan–Meier
PFS
Progression-free survival
PK
Pharmacokinetics
T
Tumor
PRO
Patient-reported outcome
TMB
Tumor mutational burden
Q12W
Every 12 weeks
Tis
Tumor in situ
Q24W
Every 24 weeks
TRAE
Treatment-related adverse event
Q3W
Every 3 weeks
TURBT
Transurethral resection of bladder tumor
R
Randomization
UC
Urothelial carcinoma
RC
Radical cystectomy
utDNA
Urine tumor DNA
SD
Standard deviation
UTI
Urinary tract infection
A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 05 December 2025.
Daneshmand S, van der Hejiden 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.
Janssen Research & Development, LLC. Phase 2b clinical study evaluating efficacy and safety of TAR-200 in combination with cetrelimab, TAR- 200 alone, or cetrelimab alone in participants with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to intravesical bacillus Calmette-Guerin (BCG) who are ineligible for or elected not to undergo radical cystectomy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 December 05]. Available from: https://clinicaltrials.gov/study/NCT04640623 NLM Identifier: NCT04640623.
Daneshmand S, van der Hejiden MS, Jacob JM, et al. Supplement to: TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscleinvasive bladder cancer: results from the phase IIb SunRISe-1 study. J Clin Oncol. 2025;43(33):3578-3588.
Guerrero-Ramos F, Jacob JM, van der Hejiden MS, et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin-unresponsive papillary disease-only high-risk non-muscle-invasive bladder cancer: first results from cohort 4 of SunRISe-1. Oral Presentation presented at: American Urological Association (AUA) Annual Meeting; April 26-29, 2025; Las Vegas, NV.
Jacob JM, Guerrero-Ramos F, Necchi A, et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscleinvasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. Oral Presentation presented at: American Urological Association (AUA) Annual Meeting; April 26-29, 2025; Las Vegas, NV.
Xylinas E, Pieczonka CM, Jacob JM, et al. Association of PD-L1 expression with clinical response to TAR-200 in the phase 2b SunRISe-1 trial. Poster presented at: European Society for Medical Oncology (ESMO) Congress; September 13-17, 2024; Barcelona, Spain.
Guerrero-Ramos F, Daneshmand S, Kulkarni GS, et al. Association of molecular markers with clinical response to TAR-200 in the phase 2b SunRISe-1 trial in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. Poster presented at: European Society for Medical Oncology (ESMO) Congress; October 17-21, 2025; Berlin, Germany.
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: The Professional Society for Health Economics and Outcomes Research (ISPOR); May 16, 2025; Montreal, Quebec.
Kulkarni GS, Guerrero-Ramos F, Daneshmand S, et al. Baseline urinary tumor DNA, minimal residual disease and genomic disease burden in relation to clinical response to TAR-200 in the phase 2b SunRISe-1 trial. Poster presented at: 26th Annual Meeting of the Society of Urologic Oncology (SUO); December 2-5, 2025; Phoenix, AZ.
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.
Douglass L, Schoenberg M. The future of intravesical drug delivery for non-muscle invasive bladder cancer. Bladder Cancer. 2016;2(3):285-292.
Tan WS, Kelly JD. Intravesical device-assisted therapies for non-muscle-invasive bladder cancer. Nat Rev Urol. 2018;15(11):667-685.
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.
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.
Daneshmand S, van der Hejiden MS, Jacob JM, et al. Clinical protocol for: TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk nonmuscle- invasive bladder cancer: results from the phase IIb SunRISe-1 study. J Clin Oncol. 2025;43(33):3578-3588.
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.
Pieczonka CM, Daneshmand S, Van der Heijden MS, et al. Gemcitabine intravesical system (Gem-iDRS) monotherapy in Bacillus Calmette- Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: characterization of recurrence, progression, and time to cystectomy. Poster presented at: 26th Annual Meeting of the Society of Urologic Oncology (SUO); December 2-5, 2025; Phoenix, AZ.
Daneshmand S, Cahn D, Zainfeld D, et al. Gemcitabine intravesical system (Gem-iDRS) monotherapy in patients with Bacillus Calmette-Guérinunresponsive papillary disease-only high-risk non-muscle-invasive bladder cancer: 1-year disease-free survival results from SunRISe-1. Oral Presentation presented at: 26th Annual Meeting of the Society of Urologic Oncology (SUO); December 2-5, 2025; Phoenix, AZ.
SunRISe-1 patient enrollment
Patients were enrolled between March 2021 and April 2024 at 142 sites in 14 countries.1
Three CIS cohorts were originally designed to enroll 200 patients randomized 2:1:1 to cohorts 1-3.1
In June 2023, INLEXZO monotherapy development was prioritized in the CIS population, and enrollment in cohorts 1 and 3 was closed on the basis of the more favorable risk-benefit profile observed with INLEXZO monotherapy in this setting based on the totality of evidence.1
The protocol was amended to expand the INLEXZO monotherapy cohort to add an additional cohort of 80 patients for INLEXZO monotherapy in patients with papillary-only high-risk NMIBC (cohort 4).1
Reinduction was not allowed for nonresponders per study protocol.1,4,5
CIS, carcinoma in situ; NMIBC, non-muscle-invasive bladder cancer.
Additional demographics and baseline disease characteristics of patients in cohorts 1-41,3,a
Characteristics
Cohort 2 INLEXZO monotherapy (n=85)
Cohort 4 INLEXZO monotherapy (n=52)
Cohort 1 INLEXZO + cetrelimab (n=53)b
Cohort 3 Cetrelimab monotherapy (n=28)
Race, n (%)
White
74 (87.1)
45 (86.5)
45 (81.8)
27 (96.4)
Asian
8 (9.4)
6 (11.5)
7 (12.7)
1 (3.6)
Black or African American
2 (2.4)
1 (1.9)
1 (1.8)
0
Not reported/unknown
1 (1.2)
-
2 (3.6)
0
Geographic region,c n (%)
America
23 (27.1)
18 (34.6)
12 (21.8)
10 (35.7)
Asia Pacific
10 (11.8)
5 (9.6)
7 (12.7)
1 (3.6)
EMEA
52 (61.2)
29 (55.8)
36 (65.5)
17 (60.7)
Nicotine use, n (%)
Current
7 (8.2)
7 (13.5)
7 (12.7)
7 (25.0)
Former
50 (58.8)
29 (55.8)
24 (43.6)
13 (46.4)
Never
28 (32.9)
16 (30.8)
24 (43.6)
8 (28.6)
Reason for not undergoing RCd, n (%)
Declined
82 (96.5)
42 (82.4)
51 (96.2)
28 (100)
Preservation of bladder
50 (58.8)
24 (47.1)
30 (56.6)
15 (53.6)
Preservation of sexual function
1 (1.2)
0
0
0
Concern about quality of life after procedure
29 (34.1)
17 (33.3)
20 (37.7)
10 (35.7)
Concern about mortality and morbidity risk of procedure
2 (2.4)
1 (2.0)
1 (1.9)
3 (10.7)
Ineligible
3 (3.5)
9 (17.6)
2 (3.8)
0
Age
1 (1.2)
3 (5.9)
1 (1.9)
-
High American Society of Anesthesiologists class score
-
1 (2.0)
-
-
Medical and surgical comorbidities
2 (2.4)
5 (9.8)
1 (1.9)
-
aData cutoff date: March 31, 2025. bCohort 1: Patient characteristics of race,
geographic region, and nicotine use are shown for the enrolled analysis set (n=55). cAmerica
includes Canada and the United States; Asia Pacific includes Australia, Japan, and South Korea; EMEA includes
Belgium, France, Germany, Greece, Italy, the Netherlands, Portugal, Russia, and Spain. dCohort
4: Percentages are based on number of patients with available data (n=51). Note: Patient characteristics
are shown for all patients who received ≥1 dose of the study drug in the full analysis set for each cohort.
EMEA, Europe, Middle East, and Africa; RC, radical cystectomy.
Cohort 2
Consistent modality of cystoscopy at baseline and postbaseline were observed in 91.8% of patients.1
White light cystoscopy was the most frequently used modality; 1 patient had blue light cystoscopy at baseline and white light cystoscopy at follow-up.1
CR rates across patient subgroups in cohort 23,a
Subgroup
Cohort 2 INLEXZO monotherapy (n=85)
CR rate n/N (%)
95% CI
Overall
70/85 (82.4)
72.6–89.8
Age, years
<65
21/24 (87.5)
67.6–97.3
65 to <75
28/32 (87.5)
71.0–96.5
≥75
21/29 (72.4)
52.8–87.3
Race
White
59/74 (79.7)
68.8–88.2
Non-White
11/11 (100.0)
71.5–100.0
Sex
Female
16/17 (94.1)
71.3–99.9
Male
54/68 (79.4)
67.9–88.3
Region
Asia Pacific
10/10 (100.0)
69.2–100.0
EMEA
42/52 (80.8)
67.5–90.4
America
18/23 (78.3)
56.3–92.5
Tumor stage
CIS (Tis)
47/57 (82.5)
70.1–91.3
CIS + papillary disease
23/28 (82.1)
63.1–93.9
ECOG PS
0
64/78 (82.1)
71.7–89.8
≥1
6/7 (85.7)
42.1–99.6
Nicotine use
Current/former
48/57 (84.2)
72.1-92.5
Never
22/28 (78.6)
59.0-91.7
PD-L1 status 1
CPS <10 (negative)
20/25 (80.0)
59.3-93.2
CPS ≥10 (positive)
11/12 (91.7)
61.5-99.8
PD-L1 status 2
CPS <1 (negative)
13/14 (92.9)
66.1-99.8
CPS ≥1 (positive)
18/23 (78.3)
56.3-92.5
Reason for not receiving RC at screening
Ineligible
2/3 (66.7)
9.4-99.2
Declined
68/82 (82.9)
73.0-90.3
Prior intravesical BCG doses
7-9
23/25 (92.0)
74.0-99.0
10-14
22/30 (73.3)
54.1-87.7
>14
25/30 (83.3)
65.3-94.4
BCG strain
Tice
51/58 (87.9)
76.7-95.0
Non-Tice
19/27 (70.4)
49.8-86.2
aData cutoff date: March 31, 2025.
BCG, Bacillus Calmette-Guérin; CI, confidence interval; CIS, carcinoma in situ; CPS, combined positive score; CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; EMEA, Europe, Middle East, and Africa; PD-L1, programmed death ligand 1; RC, radical cystectomy; Tis, tumor in situ.
Disease recurrence and progression in cohort 21,18,a
Outcome, n (%)
Cohort 2 INLEXZO monotherapy All patients (n=85)
Cohort 2 INLEXZO monotherapy Responders (n=70)
Patients with disease persistence (nonresponders only), recurrence, or progressionb
41 (48.2)
30 (42.9)
High-risk NMIBC recurrencec
30 (35.2)
23 (32.9)
Positive cytology only
2 (2.4)
1 (1.4)
CIS and/or Ta only
23 (27.1)
18 (25.7)
T1 (± CIS)
5 (5.9)
4 (5.7)
≥T2 progression
7 (8.2)
4 (5.7)
T2–T4a
5 (5.9)
2 (2.9)
N1
1 (1.2)
1 (1.4)
M1a
1 (1.2)
1 (1.4)
No evidence of diseased
4 (4.7)
3 (4.3)
aData cutoff date: March 31, 2025. bDisease persistence, recurrence, or progression event was based on positive central cytology, high-grade central pathology, or positive imaging. All results are based on the highest stage from local TURBT results, investigator-assessed clinical stage, and pathologic stage after cystectomy. Patients who discontinued the study before disease evaluation are excluded. Note, upper tract UC occurring after treatment initiation was reported in 1 patient and was not included in the response assessment. cIncludes patients with high-grade Ta, CIS, or T1 or patients with positive central cytology (n=5) or high-risk NMIBC from central pathology (n=2) but no evidence of high-risk NMIBC by investigator. Note, no cases of low-grade Ta recurrence were reported. dPatients had positive central cytology or high-grade disease by central pathology but no disease based on local assessment.
CIS, carcinoma in situ; M, metastasis; N, node; NMIBC, non-muscle-invasive bladder cancer; T, tumor; TURBT, transurethral resection of bladder tumor; UC, urothelial carcinoma.
The 6- and 12-month OS rates were 98.7% (95% CI, 91.2-99.8) and 94.7% (95% CI, 86.5-98).
Total number of deaths in cohort 2 was 7 (8.2%). No deaths were treatment-related.
Among the 33 patients with centrally assessed disease recurrence or progression, 3 deaths unrelated to treatment were reported.
Time to RC in cohort 21,18
In total, 25 patients received subsequent treatment.
Of the 85 patients, 18 (21.2%) underwent RC.
Of the 70 responders, 12 (17.1%) underwent RC.
Median time to cystectomy was not estimable.
The estimated 12- and 24-month RC-free rates were 86.6% (95% CI, 76.6-92.6) and 75.5% (95% CI, 63.4-84.1), respectively.
Of the 18 patients who underwent RC, 15 had TNM staging performed locally by the investigator, with the majority classified as TIS/CIS.
Summary of Pathology at RC1,18
Outcome, n (%)
Cohort 2 INLEXZO monotherapy (n=85)
Patients with RC
18 (21.2)
Patients with TNM staginga
15 (17.6)
TIS/CIS
10 (11.8)
T2
2 (2.4)
T4a
2 (2.4)
M1a
1 (1.2)b
aAll results based on stage from pathologic stage after RC. bPatients also had N+
disease.
CIS, carcinoma in situ; M, metastasis; N, node; RC, radical cystectomy; T, tumor; TIS, tumor in situ.
