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TAR-200

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TAR-200 - SunRISe-4 Study

Last Updated: 09/05/2025

SUMMARY

  • SunRISe-4 (NCT04919512) is an ongoing, phase 2, randomized, open-label, multicenter study evaluating the efficacy and safety of TAR-200 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.1-3
  • Necchi et al (2025)1 reported the interim efficacy and safety results for patients with MIBC who were randomized to receive either TAR-200 + cetrelimab therapy (cohort 1, n=79) or cetrelimab monotherapy (cohort 2, n=41).
    • Of the efficacy-evaluable population treated with the combination of TAR-200 + cetrelimab (n=53), the pathologic complete response (pCR) and pathologic overall response (pOR) rates were 42% (95% confidence interval [CI], 28-56) and 60% (95% CI, 46-74), respectively.
    • Of the efficacy-evaluable population treated with cetrelimab monotherapy (n=31), pCR and pOR rates were 23% (95% CI, 10-41) and 35% (95% CI, 19-55), respectively.
    • Patients experiencing ≥1 treatment-related adverse event (TRAE; any grade) were reported in 72.2% (57/79) and 43.9% (18/41) in TAR-200 + cetrelimab and cetrelimab monotherapy, respectively.
    • The most frequent TRAEs with TAR-200 + cetrelimab were grade 1-2 urinary events.
    • The rate of discontinuation due to TRAEs was 12.7% (10/79) with TAR-200 + cetrelimab.
  • Psutka et al (2025)4 presented preliminary perioperative outcomes (surgical, laboratory, and safety) for patients with MIBC who received TAR-200 + 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.

BACKGROUND

  • TAR-200 (JNJ-17000139) is an investigational intravesical drug releasing system (iDRS) that is designed to provide local release of gemcitabine in the bladder. TAR-200 contains gemcitabine and urea minitablets within a dual-lumen silicone tube for gradual release of gemcitabine by an osmotic delivery mechanism throughout the prescribed indwelling period.1,2,5-10
  • TAR-200 is inserted intravesically via urinary placement catheter, after which it self-coils into a bi-oval shape (see Figure: TAR-200 Intravesical System). Removal of TAR-200 can be achieved using grasping forceps and cystoscopy.8,11

TAR-200 Intravesical System5,6,9,12

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CLINICAL DATA

SunRISe-4 Study

Necchi et al (2025)1 summarized the interim efficacy and safety results of TAR-200 + cetrelimab therapy vs cetrelimab monotherapy in patients with MIBC who were ineligible for or decline neoadjuvant cisplatin-based chemotherapy.

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.1,4
    • RC could not take place before week 11 unless at investigator’s discretion. It could occur no later than 3 weeks from the week 12 visit.1 

SunRISe-4 Study Design1-4,11 

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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; IV, intravenously; MIBC, muscle-invasive bladder cancer; MRI, magnetic resonance imaging; pCR, pathologic complete response; pOR, pathologic overall response; Q4W, every 4 weeks; Q12W, every 12 weeks; R, randomization; RC, radical cystectomy; RECIST, Response Evaluation Criteria in Solid Tumors; RFS, recurrence-free survival; TURBT, transurethral resection of bladder tumor.
aPer the RECIST v1.1 or histologic evidence.
bPatients with variant histologic subtypes (except small-cell or neuroendocrine variants) were allowed if tumors demonstrated urothelial predominance.
cTAR-200 was placed intravesically via a transurethral placement catheter, then removed cystoscopically. Upon removal, a new TAR-200 could be placed immediately.
dThe pCR rate was defined as the proportion of patients with a pCR (no residual disease = ypT0N0) on analysis of the RC bladder specimen by central pathology review.
eRFS was defined as the time from first dose of any study treatment to the first evidence of radiographic progression (per RECIST v1.1) precluding radical cystectomy, radiographic evidence of nodal or metastatic disease after radical cystectomy, death due to any cause, or last study disease assessment.
fSafety assessed as frequency and grade of adverse events (CTCAE v.5) and laboratory abnormalities.

Results

Patient Characteristics

Patient Characteristics in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups1 
Characteristic
TAR-200 + Cetrelimab
Cohort 1
(n=79)
Cetrelimab Monotherapy
Cohort 2
(n=41)
Age, median (SD), years
73 (6.7)
67 (8.5)
Sex, male, n (%)
68 (86)
34 (83)
Race, n (%)
    White
52 (66)
29 (71)
    Asian
18 (23)
10 (24)
    Other
9 (11)
2 (5)
Region, n (%)
   USA
29 (37)
12 (29)
   Asia
19 (24)
11 (27)
   Western Europe
31 (39)
18 (44)
Nicotine use history, n (%)
   Current
20 (25)
11 (27)
   Former
39 (49)
22 (54)
   Never
20 (25)
8 (20)
ECOG PS, n (%)
   0
65 (82)
31 (76)
   1
14 (18)
10 (24)
Reasons for not receiving NAC, n (%)
   Ineligible
31 (39)
15 (37)
      GFR <60 mL/min
19 (24)
10 (24)
      Audiometric hearing loss (CTCAE grade ≥2)
8 (10)
2 (5)
      Peripheral neuropathy (CTCAE grade ≥2)
3 (4)
3 (7)
      Other
1 (1)
0
   Declined
48 (61)
26 (63)
      Quality of life
29 (37)
24 (59)
      Age
9 (11)
1 (2)
      Patient comorbidity
3 (4)
1 (2)
      Patient decision
3 (4)
0
      Other
4 (5)
0
Residual disease (visibly incomplete TURBT), n (%)
16 (20)
6 (15)
Tumor stage, n (%)
   cT2
62 (78)
35 (85)
   cT3-4a
17 (22)
6 (15)
Urothelial carcinoma with variant histology, n (%)
16 (20)
11 (27)
Prior intravesical therapy, n (%)
10 (13)
8 (20)
Abbreviations: 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; GFR, Glomerular filtration rate; NAC, neoadjuvant cisplatin-based chemotherapy; SD, standard deviation; TURBT, transurethral resection of bladder tumor.
Efficacy
  • The efficacy-evaluable population was comprised of patients who had adequate RC results or who had progression or death before undergoing RC (TAR-200 + cetrelimab, 67%, 53/79; cetrelimab monotherapy, 76%, 31/41). 
    • Overall, 14 patients had not received RC at the clinical cutoff, due to progressive disease (TAR-200 + cetrelimab cohort, n=1; cetrelimab monotherapy, n=4), withdrawing consent (TAR-200 + cetrelimab cohort, n=3; cetrelimab monotherapy, n=1), death (TAR-200 + cetrelimab cohort, n=2; cetrelimab monotherapy, n=1), receiving RC after the clinical cutoff (TAR-200 + cetrelimab, n=1), or was under pathological review at the time of the clinical cutoff (TAR-200 + cetrelimab, n=1).
  • At a clinical cutoff date of May 31, 2024, and a median follow-up of 23.5 weeks (interquartile range [IQR], 8.6-42.0 weeks), the pCR and pOR rates of the efficacy-evaluable population were reported as summarized in Table: pCR and pOR in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups.

pCR and pOR in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups1 

TAR-200 + Cetrelimab
Cohort 1
Cetrelimab Monotherapy
Cohort 2
Efficacy-evaluable population (cT2-cT4a)
53
31
   pCR, % (95% CI)
42 (28-56)
23 (10-41)
   pOR, % (95% CI)
60 (46-74)
35 (19-55)
Abbreviations: CI, confidence interval; cTNM, clinical stage-primary tumor [T], lymph node [N], distant metastasis [M]; pCR, pathologic complete response; pOR, pathologic overall response.
Note: pCR is defined as ypT0N0; pOR is defined as ≤ypT1N0.

Efficacy in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Subgroups1 
TAR-200 + Cetrelimab
Cohort 1
Cetrelimab Monotherapy
Cohort 2
Subgroup based on tumor stage
   cT2 subgroup, n
40
26
      pCR, % (95% CI)
48 (32-64)
23 (9-44)
      pOR, % (95% CI)
68 (51-81)
31 (14-52)
   cT3-cT4a subgroup, n
13
5
      pCR, % (95% CI)
23 (5-57)
20 (1-72)
      pOR, % (95% CI)
38 (14-68)
60 (15-95)
Subgroup based on completeness of TURBT
   Visibly incomplete resection (≤3 cm) at TURBT, n
9
4
      pCR, % (95% CI)
56 (21-86)
0 (0-60)
      pOR, % (95% CI)
67 (30-93)
0 (0-60)
   Visibly complete resection at TURBT, n
44
27
      pCR, % (95% CI)
39 (24-55)
26 (11-46)
      pOR, % (95% CI)
59 (43-74)
41 (22-61)
Subgroups based on number of TAR-200 dosesa
   Received 1 or 2 doses of TAR-200 + cetrelimab
11
NA
      pCR, % (95% CI)
27 (6-61)
NA
      pOR, % (95% CI)
46 (17-77)
NA
   Received 3 doses of TAR-200 + cetrelimab
10
NA
      pCR, % (95% CI)
30 (7-65)
NA
      pOR, % (95% CI)
50 (19-81)
NA
   Received 4 doses of TAR-200 + cetrelimab
32
NA
      pCR, % (95% CI)
50 (32-68)
NA
      pOR, % (95% CI)
69 (50-84)
NA
Abbreviations: CI, confidence interval; cTNM, clinical stage-primary tumor [T], lymph node [N], distant metastasis [M]; NA, not applicable; pCR, pathologic complete response; pOR, pathologic overall response; TRAEs, treatment-related adverse events; TURBT, transurethral resection of bladder tumor.
Note: pCR is defined as ypT0N0; pOR is defined as ≤ypT1N0.
aThe subgroup analysis for the number of TAR-200 doses was performed post-hoc.
Safety
  • The safety population was comprised of patients who received at least one dose of any study treatment (n=120; TAR-200 + cetrelimab, n=79; cetrelimab monotherapy, n=41). 
    • Overall, 25% (20/79) of patients in the TAR-200 + cetrelimab cohort and 22% (9/41) of patients in the cetrelimab monotherapy cohort remained on treatment and had not reached the RC window.
  • The median follow-up (post-RC) in both cohorts was 10.2 weeks (IQR, 1.1-36.9). 
  • At the clinical cutoff date of May 31, 2024, the overall safety profiles of TAR-200 + cetrelimab (cohort 1) and cetrelimab monotherapy (cohort 2) were reported as summarized in Table: Overall Safety Profile of the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups.
  • No treatment-emergent or treatment-related deaths occurred in the TAR-200 + cetrelimab cohort. 

Overall Safety Profile of the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups11
Patients With ≥1 Event, n (%)
TAR-200 + Cetrelimab
Cohort 1
(n=79)
Cetrelimab Monotherapy
Cohort 2
(n=41)
AE (any cause)
69 (87.3)
38 (92.7)
   TRAEs
57 (72.2)
18 (43.9)
SAEs
36 (45.6)
13 (31.7)
   Treatment-related SAEs
9 (11.4)
1 (2.4)
Grade ≥3 AEs
38 (48.1)
15 (36.6)
   Grade ≥3 TRAEs
9 (11.4)
2 (4.9)
AEs (any cause) leading to treatment discontinuation
14 (17.7)
0
   TRAEs leading to treatment discontinuationa
10 (12.7)
0
      TAR-200 discontinuation
7 (8.9)
-
      Cetrelimab discontinuation
6 (7.6)
0
AEs (any cause) leading to death
4 (5.1)
2 (4.9)
   TRAEs leading to death
0
1 (2.4)b
Immune-related AEs
29 (36.7)
18 (43.9)
   Grade ≥3 immune-related AEs
5 (6.3)
2 (4.9)
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; RC, radical cystectomy; SAE, serious adverse events; TRAE, treatment-related adverse event.
aMost frequent TRAE leading to TAR-200 discontinuation was pollakiuria (n=2).
bTRAE leading to death was reported as hyperglycemic hyperosmolar nonketotic syndrome (n=1).
  • A summary of TRAEs are reported in Table: Select TRAEs in TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups.
  • Grade 1 or 2 TRAEs were reported in 48/79 (61%) of patients in the TAR-200 + cetrelimab cohort.1 
  • The most frequent TRAEs with TAR-200 + cetrelimab were grade 1-2 urinary events.1 
  • Grade 3 TRAEs occurring in the TAR-200 + cetrelimab cohort included (n=1 each): urinary bladder hemorrhage, blood creatine phosphokinase increased, aphthous ulcer, and urethritis.
  • Grade 4 TRAEs occurring in the TAR-200 + cetrelimab cohort included (n=1 each): diabetic ketoacidosis, immune-mediated arthritis, and neutropenia. No grade 5 TRAEs occurred in the TAR-200 + cetrelimab cohort.
  • One patient treated with cetrelimab monotherapy had an acute kidney injury (grade 4) and died from hyperglycemic hyperosmolar nonketotic syndrome (grade 5). The patient was counted only once under the worst toxicity grade.

Select TRAEs in TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups1 
TRAEsa, n (%)
TAR-200 + Cetrelimab
Cohort 1
(n=79)
Cetrelimab Monotherapy
Cohort 2
(n=41)
Overall
(n=120)
Grade 1-2b
Grade 3
Grade 1-2b
Grade 3
Dysuria
22 (28)
0
0
0
22 (28)
Pollakiuria
21 (27)
1 (1)
0
0
22 (18)
Micturition urgency
12 (15)
0
0
0
12 (10)
Hematuria
9 (11)
2 (3)
0
0
11 (9)
Urethral pain
5 (6)
0
0
0
5 (4)
Bladder pain
4 (5)
0
0
0
4 (3)
Bladder spasm
4 (5)
0
0
0
4 (3)
Lipase increased
4 (5)
0
0
1 (2)
5 (4)
Fatigue
6 (8)
1 (1)
3 (7)
0
10 (8)
Asthenia
4 (5)
0
0
0
4 (3)
Diarrhea
2 (3)
0
3 (7)
0
5 (4)
Hyperamylasemia
5 (6)
0
1 (2)
1 (2)
7 (6)
Pruritus
1 (1)
0
4 (10)
0
5 (4)
Urinary tract infection
7 (9)
0
0
0
7 (6)
Hyperthyroidism
6 (8)
0
1 (2)
0
7 (6)
Hypothyroidism
4 (5)
1 (1)
1 (2)
0
6 (5)
Urinary tract pain
2 (3)
1 (1)
0
0
3 (3)
Abbreviations: TRAE, treatment-related adverse event.
aPatients were counted only once for any given event, regardless of the number of times the event occurred. The event with the worst toxicity was used.
bTotal any-grade TRAEs by preferred term occurring in ≥5% of patients in either cohort are reported.
Radical Cystectomy Outcomes
  • The median time to RC was 13.7 weeks (IQR, 12.7-14.6) with TAR-200 + cetrelimab and 12.6 weeks (IQR, 12.0-14.4) with cetrelimab monotherapy. 
  • There were 8 patients who underwent RC beyond week 15 due to scheduling delays and treatment-emergent adverse events (TEAEs), 12 patients who underwent RC at week 11, and 4 patients who underwent RC prior to week 11. 

Psutka et al (2025)4 presented preliminary perioperative outcomes (surgical, laboratory, and safety) for patients with MIBC who received TAR-200 + cetrelimab therapy (cohort 1, n=79) or cetrelimab monotherapy (cohort 2, n=41).

Surgical Outcomes

Perioperative Surgical Outcomes in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups4
Patients, n (%)
TAR-200 + 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 TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups4
Patients, n (%)
TAR-200 + 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 TAR-200 + 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 TAR-200 + 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)
TAR-200 + Cetrelimab
Cohort 1
(n=38)
Cetrelimab Monotherapy
Cohort 2
(n=22)
Overall
(n=38)
TAR-200 + 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 TAR-200 or cetrelimab.
cThe cause of mortality was renal failure.
dThe cause of mortality was cardiorespiratory arrest.

Management of Adverse Events Related to TAR-200 in the SunRISe-4 Study

  • Early removal of TAR-200, dose delays, and dose interruptions of TAR-200 were permitted per protocol to manage adverse events.11  
  • Patients must have received at least one dose of periprocedural prophylactic antibiotics for any TAR-200 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 28 August 2025.

References

Show
1 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. [published online ahead of print August 27, 2025]. Lancet Oncol. 2025:1-11. doi:10.1016/s1470-2045(25)00358-4.  
2 Psutka SP, Cutie CJ, Bhanvadia SK, et al. SunRISe-4: TAR-200 plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant platinum-based chemotherapy. Poster presented at: American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU); February 16-18, 2023; San Francisco, CA and Virtual.  
3 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 2025 August 18]. Available from: https://clinicaltrials.gov/study/NCT04919512 NLM Identifier: NCT04919512.  
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, Van der Heijden MS, Jacob JM, et al. TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study. [published online ahead of print July 30, 2025]. J Clin Oncol. doi:10.1200/jco-25-01651.  
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. [published online ahead of print August 27, 2025]. Lancet Oncol. 2025. doi:10.1016/s1470-2045(25)00358-4.  
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.