TAR-200

Medical inquiries

Connect with my medical science liaison

Chat live

Available Monday - Friday 9AM - 4:30PM ET

Call me now

Available Monday - Friday 9AM - 7:30PM ET

Email your inquiry

Call 1-800-526-7736

Available Monday - Friday 9AM - 8PM ET

Live video

Available Monday - Friday 9AM - 4:30PM ET

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

TAR-200

Medical Information

+ Save link

TAR-200 - SunRISe-4 Study

Last Updated: 03/25/2025

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^,²
Necchi et al (2024)³ presented 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 36% (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 system that is designed to provide local release of gemcitabine in the bladder. TAR-200 contains gemcitabine and urea mini tablets within a dual-lumen silicone tube for gradual release of gemcitabine by an osmotic delivery mechanism throughout the prescribed indwelling period.¹^,⁵^-⁸
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 flexible cystoscopy.⁶^,⁸

TAR-200 Intravesical System¹^,⁶

CLINICAL DATA

SunRISe-4 Study

Study Design/Methods

Ongoing, phase 2, randomized, open-label, multicenter study designed to assess the efficacy and safety of TAR-200 in combination with systemic cetrelimab, an investigational IgG4 antibody that targets the PD-1 receptor, and systemic cetrelimab monotherapy as neoadjuvant therapy in patients with MIBC who are scheduled for RC and refuse or are ineligible for platinum-based neoadjuvant chemotherapy¹^,²
The study design is shown in Figure: SunRISe-4 Study Design.
The protocol-specified window for RC was 11-15 weeks.⁴

SunRISe-4 Study Design¹^-⁴

Abbreviations: CT, computed tomography; 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; 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.
^aProgressing or requiring treatment change in the last 24 months.
^bExcept for skin cancer, noninvasive cervical cancer, localized prostate cancer, breast cancer, and malignancy.
^cIn both cohorts, cetrelimab will be serially dosed IV over the same timeframe.
^dTAR-200 will be placed intravesically at the initial treatment visit and removed and replaced at 12-week intervals. Gemcitabine (225 mg) will be released once every 3 weeks (indwelling) for a period of 12 weeks.
^ePer the RECIST v1.1 or histologic evidence.

Results

Patient Characteristics

At the clinical cutoff date of May 31, 2024, the patient characteristics of both cohorts were reported as described in Table: Patient Characteristics in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups.
Patient characteristics were well-balanced between treatment cohorts.⁴

Patient Characteristics in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups³

Characteristic	TAR-200 + Cetrelimab Cohort 1 (n=79)	Cetrelimab Monotherapy Cohort 2 (n=41)
Age, years, median (range)	74.0 (54-85)	68.0 (48-80)
Sex, male, n (%)	68 (86.1)	34 (82.9)
Race, n (%)
White	52 (65.8)	29 (70.7)
Asian	18 (22.8)	10 (24.4)
Other	9 (11.4)	2 (4.9)
Region, n (%)
America	29 (36.7)	12 (29.3)
Asia	19 (24.1)	11 (26.8)
Western Europe	31 (39.2)	18 (43.9)
Nicotine use history, n (%)
Current	20 (25.3)	11 (26.8)
Former	39 (49.3)	22 (53.7)
Never	20 (25.3)	8 (19.5)
ECOG PS 1, n (%)	14 (17.7)	10 (24.4)
NAC, n (%)
Ineligible	31 (39.2)	15 (36.6)
Refusing	48 (60.8)	26 (63.4)
Residual disease (visibly incomplete TURBT), n (%)	16 (20.3)	6 (14.6)
Tumor stage, n (%)
cT2	62 (78.5)	35 (85.4)
cT3-4a	17 (21.5)	6 (14.6)
Urothelial carcinoma with variant histology, n (%)	16 (20.3)	11 (26.8)
Prior intravesical therapy, n (%)	10 (12.7)	8 (19.5)
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; NAC, neoadjuvant cisplatin-based chemotherapy; TURBT, transurethral resection of bladder tumor.

Efficacy

The efficacy analysis was performed on all treated patients who were RC evaluable or died prior to RC or had disease progression.
At a clinical cutoff date of May 31, 2024, TAR-200 + cetrelimab therapy showed higher pCR and pOR rates than cetrelimab monotherapy.³
The pCR and pOR rates of the efficacy-evaluable population for TAR-200 + cetrelimab (cohort 1) and cetrelimab monotherapy (cohort 2) 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) Groups³

	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)	36 (19-55)
Abbreviations: CI, confidence interval; NA, not applicable; pCR, pathologic complete response; pOR, pathologic overall response; TURBT, transurethral resection of bladder tumor. Note: pCR is defined as ypT0N0; pOR is defined as ≤ypT1N0.

Subgroup efficacy analyses of the efficacy-evaluable population for TAR-200 + cetrelimab (cohort 1) and cetrelimab monotherapy (cohort 2) were reported as summarized in Table: Efficacy in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Subgroups.

Efficacy in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Subgroups³

	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 (5-54)	20 (1-72)
pOR, % (95% CI)	39 (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 TAR-200 dose exposure
Received 1-2 doses of TAR-200 + cetrelimab^a	11	NA
pCR, % (95% CI)	27 (6-61)	NA
pOR, % (95% CI)	46 (17-77)	NA
Received 3 doses of TAR-200 + cetrelimab^a	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; NA, not applicable; pCR, pathologic complete response; pOR, pathologic overall response; TURBT, transurethral resection of bladder tumor Note: pCR is defined as ypT0N0; pOR is defined as ≤ypT1N0.^aPatients with ≤3 doses of TAR-200 may have missed or skipped a dose without discontinuing treatment or may have discontinued treatment due to TRAEs or for any other reason.

Safety

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.

Overall Safety Profile of the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups³

Patients With ≥1 Event, n (%)^a	TAR-200 + Cetrelimab Cohort 1 (n=79)	Cetrelimab Monotherapy Cohort 2 (n=41)
≥1 TRAE (any grade)^b	57 (72.2)	18 (43.9)
Dysuria	22 (27.8)	22 (18.3)
Pollakiuria	22 (27.8)	22 (18.3)
Micturition urgency	12 (15.2)	12 (10.0)
Hematuria	11 (13.9)	11 (9.2)
Serious TRAEs	9 (11.4)	1 (2.4)
TRAEs grade ≥3	9 (11.4)	2 (4.9)
TRAEs leading to discontinuation	10 (12.7)	0
TRAEs leading to TAR-200 discontinuation^c	7 (8.9)	NA
TRAEs leading to cetrelimab discontinuation^d	6 (7.6)	0
TRAEs leading to death	0	1 (2.4)^e
Abbreviations: AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; NA, not applicable; RC, radical cystectomy; TRAE, treatment-related adverse event. ^aMedian follow-up (post-RC) was 10.2 weeks. AEs were reported using CTCAE v5.0. ^bTRAEs occurring in ≥10% of patients in either treatment group are listed. ^cMost frequent TRAE leading to TAR-200 discontinuation was pollakiuria (n=2). ^dNo TRAE led to cetrelimab discontinuation in ≥2 patients.^eTRAE leading to death was reported as hyperglycemic, hyperosmolar nonketotic syndrome (n=1).

The most frequent TRAEs with TAR-200 + cetrelimab were grade 1-2 urinary events.
Grade ≥3 immune-related AEs were observed with TAR-200 + cetrelimab (cohort 1; 6.3%) and cetrelimab monotherapy (cohort 2; 4.9%).
Median time to RC for TAR-200 + cetrelimab (cohort 1) and cetrelimab monotherapy (cohort 2) was 13.7 weeks and 12.6 weeks, respectively.

Perioperative Outcomes

Surgical Outcomes

At the clinical cutoff date of May 31, 2024, perioperative surgical outcomes were assessed in the RC-evaluable set (n=76), which included patients who underwent RC across cohorts 1 (n=50) and 2 (n=26).⁴
Perioperative surgical outcomes of the RC-evaluable set are summarized in Table: Perioperative Surgical Outcomes in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups.

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 planned RC assessed in the RC-evaluable set (n=76) for TAR-200 + cetrelimab (cohort 1) and cetrelimab monotherapy (cohort 2) is summarized in Table: Time to RC in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups.⁴
- Median time from neoadjuvant treatment initiation to RC across both cohorts was 13.5 weeks (range, 4.1-19.4), and 84% (64/76) of patients underwent RC within the protocol-specified window.

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

The 30- and 90-day post-RC morbidity and mortality rates in the RC-evaluable set are summarized in Table: Post-RC Morbidity and Mortality (30 and 90 Days) in the TAR-200 + Cetrelimab (Cohort 1) and Cetrelimab Monotherapy (Cohort 2) Groups.⁴
- The morbidity and mortality profiles in both cohorts were consistent with historical data.
- No new immune-related TEAEs were reported post-RC.

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
Patients With ≥1 Event, n (%)^a	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 Mortality^b
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.

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 17 March 2025.

References

Show

1	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.
2	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 March 17]. Available from: https://clinicaltrials.gov/study/NCT04919512 NLM Identifier: NCT04919512.
3	Necchi A, Guerrero-Ramos F, Crispen PL, et al. TAR-200 plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or refuse neoadjuvant cisplatin-based chemotherapy: interim analysis of SunRISe-4. Oral Presentation presented at: European Society of Medical Oncology (ESMO) Congress; September 13-17, 2024; Barcelona, Spain.
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. [published online ahead of print January 15, 2025]. Urol Oncol. doi:10.1016/j.urolonc.2024.12.264.