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TAR-200

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TAR-200 - SunRISe-2 Study

Last Updated: 02/03/2025

SUMMARY

SunRISe-2 (NCT04658862) is a prospective, multicenter, open-label, randomized, phase 3 study designed to evaluate the efficacy and safety of intravesical TAR-200 plus systemic cetrelimab, an investigational immunoglobulin G4 antibody that targets the programmed cell death protein-1 (PD-1) receptor, vs concurrent chemoradiotherapy in patients with muscle-invasive bladder cancer (MIBC) who refuse or are ineligible for radical cystectomy (RC).¹^-³
Following an Independent Data Monitoring Committee recommendation and pre-specified interim analysis, SunRISe-2 was discontinued because the pre-defined futility criteria were met.⁴
Efficacy and safety results have not been published.

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^,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
Preliminary safety and efficacy results from a phase 1b study in patients with MIBC who had TAR-200 placed prior to scheduled RC have been published.⁷

TAR-200 Intravesical System¹

A close up of a coin

Description automatically generated

CLINICAL DATA

SunRISe-2 Study

Study Design/Methods

Phase 3, prospective, multicenter, open-label, randomized study designed to evaluate the efficacy and safety of intravesical TAR-200 plus systemic cetrelimab, an investigational immunoglobulin G4 antibody that targets PD-1 receptor, vs concurrent chemoradiotherapy in patients with MIBC who refuse or are ineligible for RC.¹^,²^,⁹
Study enrollment does not require determination of PD-1 expression.¹
The study design is shown in Figure: SunRISe-2 Study Design.

SunRISe-2 Study Design¹^,²^,⁹

Abbreviations: BIW, twice weekly; c, clinical stage; CIS, carcinoma in situ; CrCl, creatinine clearance; ECOG PS, Eastern Cooperative Oncology Group performance status; Gy, gray; IV, intravenous; M, distant metastasis; MIBC, muscle-invasive bladder cancer; N, lymph node; ORR, overall response rate; OS, overall survival; QW, every week; Q3W, every 3 weeks; Q12W, every 12 weeks; R, randomization; RC, radical cystectomy; RECIST, Response Evaluation Criteria in Solid Tumors; SOC, standard of care; T, primary tumor; T1, tumor grade 1; Ta, tumor grade a.
^aTa/T1/CIS of the upper urinary tract (including the renal pelvis and ureter) is allowed to be included if treated with complete nephroureterectomy >24 months prior to the study.
^bInvestigator’s choice.
^cFor the bladder only.
^dDefined as the time from randomization to first bladder-intact event-free survival event, including histologically proven MIBC, clinical evidence of nodal or metastatic disease (per RECIST 1.1), RC, or death. ^eDefined as the time from randomization to first radiologic or histologic evidence of metastatic disease (per RECIST 1.1) or death.
^fComplete response + partial response.
^gDefined as the time from randomization to death.

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 23 January 2025.

References

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1	Williams SB, Cutie C, Keegan K, et al. Sunrise-2: a phase 3, multicenter, randomized study evaluating the efficacy of TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy in participants with muscle-invasive urothelial carcinoma of the bladder [abstract]. J Urol. 2021;206(Suppl. 3):e250. Abstract MP13-17.
2	Williams SB, Jessner W, Tammaro M, et al. SunRISe-2: a phase 3, multicenter, randomized study evaluating the efficacy of TAR-200 in combination with cetrelimab versus chemoradiotherapy in patients with muscle-invasive bladder cancer. Oral Presentation presented at: American Urological Association (AUA) Annual Meeting; May 3-6, 2024; San Antonio, TX.
3	Janssen Research & Development, LLC. A phase 3, multi-center, randomized study evaluating efficacy of TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy in participants with muscle-invasive urothelial carcinoma (MIBC) of the bladder who are not receiving radical cystectomy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 October 14]. Available from: https://clinicaltrials.gov/show/NCT04658862 NLM Identifier: NCT04658862.
4	Johnson & Johnson Statement on the SunRISe-2 Study. https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-the-sunrise-2-study Accessed 2024 October 10.
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;In Press.
9	Janssen Research and Development, LLC. A study of TAR-200 in combination with cetrelimab versus concurrent chemoradiotherapy in participants with muscle-invasive bladder cancer (MIBC) of the bladder. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 May 6]. Available from: https://clinicaltrials.gov/ct2/show/NCT04658862 NLM Identifier: NCT04658862.