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TAR-200

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TAR-200 - General Overview

Last Updated: 01/21/2025

BACKGROUND

TAR-200 (JNJ-17000139) is an investigational intravesical 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^-⁶
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.²
Safety and efficacy results from the TAR200101 (NCT02722538) and TAR-200-102 (NCT02720367) phase 1b studies conducted in patients with muscle invasive bladder cancer (MIBC) and non-muscle invasive bladder cancer (NMIBC), respectively, have been published.³^,⁴^,⁶ Safety and efficacy results from the TAR-200-103 (NCT03404791) phase 1 study in patients with MIBC who were unfit for curative intent therapy have also been published.⁵ A preclinical study comparing tissue penetration, distribution, and retention of gemcitabine and its active metabolites with TAR-200 vs. traditional standard intravesical instillation methods in minipigs has been presented.⁷

TAR-200 Intravesical System²

U.S. Regulatory review status

On December 4, 2023, Johnson & Johnson announced that the United States Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAR-200 for the potential future treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk NMIBC who are ineligible for or unwilling to undergo radical cystectomy (RC). The BTD is supported by data from a phase 2b open-label study (SunRISe-1, NCT04640623) which is evaluating the safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone for patients with BCG-unresponsive high-risk NMIBC carcinoma in situ (CIS) who are ineligible for or unwilling to undergo RC.⁸
On January 15, 2025, Johnson & Johnson announced it has initiated the submission of an original New Drug Application with the FDA for TAR-200 for the treatment of patients with BCG-unresponsive high-risk NMIBC with CIS, with or without papillary tumors. This submission is being reviewed by the FDA through the Real-Time Oncology Review program, which allows the FDA to review data before the complete application is formally submitted and helps ensure treatments are available for patients as soon as possible. The submission is supported by the data from the phase 2b SunRISe-1 registration study.⁹
Data from SunRISe-1 were featured at the European Society for Medical Oncology Annual Congress (ESMO) and the American Urological Association (AUA) Annual Meetings in 2023 and 2024.⁸^-¹⁴

CLINICAL STUDIES

TAR-200 is currently being evaluated by Janssen Research & Development, LLC in patients with NMIBC and MIBC in the clinical studies described in Table: Ongoing Clinical Studies.
Completed clinical studies evaluating the use of TAR-200 in patients with MIBC and NMIBC are described in Table: Completed Clinical Studies.

Ongoing Clinical Studies¹⁰^-²⁵

Phase/Study	Study Design	NCT Identifier
Phase 3
SunRISe-3¹⁵^,¹⁶	A phase 3, multicenter, randomized, open-label study evaluating efficacy and safety of TAR-200 in combination with cetrelimab or TAR-200 alone vs intravesical BCG in participants with BCG-naïve high-risk NMIBC	NCT05714202
SunRISe-5¹⁷^,¹⁸^,²⁴	A phase 3, multicenter, randomized, open-label study evaluating efficacy and safety of TAR-200 vs investigator’s choice of intravesical chemotherapy in participants with recurrent high-risk NMIBC who received BCG therapy and are ineligible for or have elected not to undergo RC	NCT06211764
Phase 2
SunRISe-1¹⁰^-¹⁴^,¹⁹^,²²^,²⁵	A 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 NMIBC unresponsive to intravesical BCG who are ineligible for or have elected not to undergo RC	NCT04640623
SunRISe-4²⁰^,²¹^,²³	A phase 2, randomized, multicenter, open-label study of TAR-200 in combination with cetrelimab and cetrelimab alone in participants with MIBC who are scheduled for RC and are ineligible for or refuse platinum-based neoadjuvant chemotherapy	NCT04919512
Abbreviations: BCG, bacillus Calmette-Guérin; MIBC, muscle invasive bladder cancer; NCT, national clinical trial; NMIBC, non-muscle invasive bladder cancer; RC, radical cystectomy.

Completed Clinical Studies³^-⁶^,²⁶^-²⁸

Phase/Study	Study Design	NCT Identifier
Phase 1
TAR-200-103⁵^,²⁶	A multicenter study evaluating safety and efficacy of TAR-200 in subjects with MIBC who are ineligible for or refuse cisplatin-based chemotherapy and who are unfit for RC	NCT03404791
TAR-200-102⁶^,²⁷	A phase 1b, multicenter, open-label study evaluating safety, tolerability and preliminary efficacy of TAR-200 in subjects with NMIBC	NCT02720367
TAR-200-101³^,⁴^,²⁸	A phase 1b, multicenter, open-label study evaluating safety, tolerability and preliminary efficacy of TAR-200 in subjects with MIBC	NCT02722538
Preclinical
Project Penelope⁷	A preclinical study comparing tissue penetration, distribution, and retention of gemcitabine and its active metabolites with TAR-200 vs. traditional standard intravesical instillation methods in minipigs	-
Abbreviations: MIBC, muscle invasive bladder cancer; NCT, national clinical trial; NMIBC, non-muscle invasive bladder cancer; RC, radical cystectomy.

For more information regarding ongoing and completed clinical studies, please visit clinicaltrials.gov.

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 15 January 2025.

References

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1	Douglass L, Schoenberg M. The future of intravesical drug delivery for non-muscle invasive bladder cancer. Bladder Cancer. 2016;2(3):285-292.
2	Tan WS, Kelly JD. Intravesical device-assisted therapies for non-muscle-invasive bladder cancer. Nat Rev Urol. 2018;15(11):667-685.
3	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.
4	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.
5	Tyson MD, Morris D, Palou J, et al. Safety, tolerability, and preliminary efficacy of TAR-200 in patients with muscle-invasive bladder cancer who refused or were unfit for curative-intent therapy: a phase 1 study. J Urol. 2023;209(5):890-900.
6	van Valenberg FJP, van der Heijden AG, Cutie CJ, et al. The safety, tolerability, and preliminary efficacy of a gemcitabine-releasing intravesical system (TAR-200) in American Urological Association-defined intermediate-risk non-muscle-invasive bladder cancer patients: a phase 1b study. Eur Urol Open Sci. 2024;62:8-15.
7	Daneshmand S, Wuyts K, Meulder MD, et al. Penelope: tissue penetration of gemcitabine phosphate metabolites following TAR-200 administration vs standard intravesical installation in mini pigs. Poster presented at: Society of Urologic Oncology (SUO) Annual Meeting; December 4-6, 2024; Dallas, TX.
8	Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer. 2023-12-18. Available via: https://www.jnj.com/johnson-johnsons-investigational-tar-200-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-high-risk-non-muscle-invasive-bladder-cancer
9	New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer. 2025-01-15. Available via: https://innovativemedicine.jnj.com/our-innovation/focus-areas/oncology/new-drug-application-initiated-with-u-s-fda-for-tar-200-the-first-and-only-intravesical-drug-releasing-system-for-patients-with-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer
10	Necchi A, Jacob JM, Daneshmand S. Results from SunRISe-1 in patients (pts) with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) receiving TAR-200 monotherapy. Oral presentation presented at: European Society for Medical Oncology (ESMO) Congress; October 20-24, 2023; Madrid, Spain.
11	Daneshmand S, Van der Heijden MS, Jacob JM, et al. First results from SunRISe-1 in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer receiving TAR-200 in combination with cetrelimab, TAR-200, or cetrelimab alone. Oral presentation presented at: American Urological Association (AUA) Annual Meeting; April 28-May 01, 2023; Chicago, IL.
12	Jacob JM, Necchi A, Daneshmand S, et al. TAR-200 in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: results from SunRISe-1 study. Oral presentation presented at: American Urological Association (AUA) Annual Meeting; May 03-06, 2024; San Antonio, TX.
13	Van der Heijden MS, Cutie CJ, Hampras S, et al. SunRISe-1: phase 2b study of TAR-200 plus cetrelimab, TAR-200 alone, or cetrelimab alone in participants with high-risk non-muscle-invasive bladder cancer unresponsive to Bacillus Calmette-Guérin who are ineligible for or decline radical cystectomy. Poster presented at: American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU); February 17-19, 2022; San Francisco, CA and Virtual.
14	Van der Heijden MS, Simone G, Bögemann M, et al. TAR-200 in combination with cetrelimab (CET), TAR-200 alone, or CET alone in patients with Bacillus Calmette–Guérin (BCG)-unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC): results from SunRISe-1. Oral presentation presented at: European Society for Medical Oncology (ESMO) Congress; September 13–17, 2024; Barcelona, Spain.
15	Janssen Research & Development, LLC. A phase 3, open-label, multi-center, randomized study evaluating the efficacy and safety of TAR-200 in combination with cetrelimab or TAR-200 alone versus intravesical Bacillus Calmette-Guérin (BCG) in participants with BCG-naïve high-non-muscle invasive bladder cancer. In: Clinical Trials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 - [cited 2023 December 15]. Available from: https://clinicaltrials.gov/ct2/show/NCT05714202 NLM Identifier: NCT05714202.
16	Necchi A, Catto J, Powles T, et al. SunRISe-3: TAR-200 plus cetrelimab or TAR-200 versus intravesical Bacillus Calmette-Guérin (BCG) in patients with BCG-naïve high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Poster presented at: European Society for Medical Oncology (ESMO) Congress; October 20-24, 2023; Madrid, Spain.
17	Janssen Research & Development, LLC. A study of TAR-200 versus intravesical chemotherapy in participants with recurrent high-risk non-muscle-invasive bladder cancer (HR-NMIBC) after Bacillus Calmette-Guérin (BCG) (SunRISe-5). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 July 16]. Available from: https://clinicaltrials.gov/study/NCT06211764 NLM Identifier: NCT06211764.
18	Porten S, Bhanvadia S, Najmi S, et al. SunRISe-5: a phase 3, randomized, open-label study of TAR-200 compared with intravesical chemotherapy after Bacillus Calmette-Guérin in recurrent high-risk non-muscle-invasive bladder cancer. Oral presentation presented at: American Urological Association (AUA) Annual Meeting; May 03-06, 2024; San Antonio, TX.
19	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 2023 December 15]. Available from: https://clinicaltrials.gov/ct2/show/NCT04640623 NLM Identifier: NCT04640623.
20	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.
21	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 2023 December 15]. Available from: https://clinicaltrials.gov/ct2/show/NCT04919512 NLM Identifier: NCT0491952.
22	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.
23	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 platinum-based chemotherapy: interim analysis of SunRISe-4. Oral presentation presented at: European Society for Medical Oncology (ESMO) Congress; September 13–17, 2024; Barcelona, Spain.
24	Porten S, Bhanvadia S, Najmi S, et al. SunRISe-5: a phase 3, randomized, open-label study of TAR-200 compared with intravesical chemotherapy after Bacillus Calmette-Guerin in recurrent high-risk non-muscle invasive bladder cancer. Poster presented at: Society of Urologic Oncology (SUO) Annual Meeting; December 4-6, 2024; Dallas, Tx.
25	Daneshmand S, Zainfeld D, Pieczonka C, et al. Safety and tolerability of TAR-200 monotherapy in patients with Bacillus Calmette-Guérin-unresponsive high-risk non–muscle-invasive bladder cancer in SunRISe-1. Poster presented at: Society of Urologic Oncology (SUO) Annual Meeting; December 4-6, 2024; Dallas, TX.
26	Janssen Research & Development, LLC. A multicenter study evaluating safety and efficacy of TAR-200 in subjects with muscle-invasive urothelial carcinoma of the bladder who are ineligible for or refuse cisplatin-based chemotherapy and who are unfit for radical cystectomy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 - [cited 2024 July 16]. Available from: https://clinicaltrials.gov/study/NCT03404791 NLM Identifier: NCT03404791.
27	Taris Biomedical LLC. A phase 1b, multicenter, open-label study evaluating safety, tolerability and preliminary efficacy of GemRIS 225 mg in subjects with non-muscle-invasive urothelial carcinoma of the bladder. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 July 16]. Available from: https://clinicaltrials.gov/study/NCT02720367 NLM Identifier: NCT02720367.
28	Janssen Research & Development, LLC. A phase 1b, multicenter, open label study evaluating safety, tolerability and preliminary efficacy of GemRIS 225 mg in subjects with muscle-invasive transitional cell carcinoma of the bladder. In: Clinical Trials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 - [cited 2024 July 16]. Available from: https://clinicaltrials.gov/study/NCT02722538 NLM Identifier: NCT02722538.