New data from TAR-200 Phase 2b SunRISe-1 study show 84 percent complete response rate in patients with high-risk non-muscle-invasive bladder cancer

Investigational TAR-200 monotherapy demonstrates high complete response rate without the need for reinduction or additive therapy in patients who are Bacillus Calmette-Guérin (BCG)-unresponsive¹

BEERSE, BELGIUM , Sept. 15, 2024 (GLOBE NEWSWIRE) — Janssen-Cilag International NV, a Johnson & Johnson company, today announced additional results from the pivotal Phase 2b SunRISe-1 study, supporting the safety and efficacy profile of investigational TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC), with carcinoma in situ.¹ New data were featured in a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress, taking place in Barcelona, Spain from 13-17 September 2024.¹

“The safety and efficacy profile observed across multiple patient cohorts in the SunRISe-1 study further support the potential of TAR-200 for patients with high-risk non-muscle invasive bladder cancer as an innovative targeted releasing system,” said Michiel S. van der Heijden, M.D., Ph.D., Medical Oncologist at Netherlands Cancer Institute. “These results support the potential of this novel treatment approach for patients who are not responsive to BCG immunotherapy and who face life-altering options, such as radical cystectomy.”

“At Johnson & Johnson, one of our key ambitions in solid tumour oncology is to enhance and evolve treatment delivery methods to drive forward approaches that improve both clinical outcomes, quality of life for patients, and prevent or delay disease progression,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology,  Johnson & Johnson Innovative Medicine. “High risk non-muscle-invasive bladder cancer presents a significant burden on patients and healthcare systems. These latest results from the SunRISe-1 study reinforce the bladder-sparing potential of TAR-200, as well as its potential to achieve deep and highly durable responses as monotherapy treatment and provide a crucial alternative for those unable or unwilling to undergo radical cystectomy.”

Pivotal Cohort 2 (TAR-200 monotherapy):
New results from all 85 patients enrolled in the pivotal Cohort show a high, centrally-confirmed, single-agent complete response (CR) rate of 83.5 percent (95 percent confidence interval [CI], 74-91).¹ Results show highly durable CRs without the need for reinduction, with 82 percent of patients maintaining response after a median follow-up of 9.2 months and an estimated 12-month CR rate of 57.4 percent based on the Kaplan-Meier curve.¹  The overall risk-benefit profile favours TAR-200 monotherapy (Cohort 2) in this patient population.¹ Earlier results from Cohort 2 were previously presented at the 2024 American Urological Association (AUA) Annual Meeting.²

Cohorts 1 and 3 (TAR-200 plus CET and CET monotherapy, respectively):
First results from Cohort 1 (TAR-200 plus CET) showed a 67.9 percent centrally-confirmed CR rate (95 percent CI, 54-80).¹ The first results from Cohort 3 (CET monotherapy) showed a 46.4 percent centrally-confirmed CR rate (95 percent CI, 28-66).¹ The CET monotherapy CR rate is numerically similar to previously published CR rates from this class of therapies.¹

“Our mission, to stay in front of cancer, drives us to innovate in ways that redefine treatment paradigms for patients with bladder cancer,” said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Innovative Medicine, Johnson & Johnson. “The data from our SunRISe clinical programme illuminate the possibility of an innovative approach in an outpatient setting with the potential to impact patient well-being and enhance the entire treatment experience.”

Low discontinuation rates due to treatment-related adverse events (TRAEs) were seen with TAR-200 (Cohort 2, six percent) and CET alone (Cohort 3, seven percent), with higher rates in the combination (Cohort 1, TAR-200 26 percent or CET 23 percent).¹ The most common (>20 percent) TRAEs of any grade across Cohort 1 and 2 were pollakiuria, dysuria, haematuria and urinary tract infection.¹ No treatment-related deaths were reported.¹

About SunRISe-1
SunRISe-1 (NCT04640623) is a randomised, parallel-assignment, open-label Phase 2 clinical study evaluating the safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone for BCG-unresponsive HR-NMIBC carcinoma in situ (CIS) patients who are ineligible for, or elected not to undergo, radical cystectomy.³ Participants are randomised to 1 of 4 cohorts: treatment with TAR-200 in combination with cetrelimab (Cohort 1), TAR-200 alone (Cohort 2), cetrelimab alone (Cohort 3), or TAR-200 alone for papillary disease only (Cohort 4).³ The primary endpoint for Cohorts 1-3 is CR rate at any time point. Secondary endpoints include DOR, overall survival, pharmacokinetics, quality of life, safety and tolerability. Cohorts 1 and 3 were closed to further enrollment effective June 1, 2023.³

About TAR-200
TAR-200 is an investigational targeted releasing system designed to provide extended local release of gemcitabine into the bladder.^4,5  It is installed in a physician’s office setting during a 2-3 minute procedure with no anesthesia.⁶ The safety and efficacy of TAR-200 is being evaluated in Phase 2 and Phase 3 studies in patients with muscle-invasive bladder cancer in SunRISe-2 (NCT04658862)⁵ and SunRISe-4 (NCT04919512),⁶ NMIBC in SunRISe-1 (NCT04640623),³ SunRISe-3 (NCT05714202)⁷ and SunRISe-5 (NCT06211764).⁸

About Cetrelimab
Cetrelimab is an investigational programmed cell death receptor-1 (PD-1) monoclonal antibody being studied for the treatment of bladder cancer, prostate cancer, melanoma, and multiple myeloma as part of a combination treatment.^9,10 Cetrelimab is also being evaluated in multiple other combination regimens.

About High-Risk Non-Muscle-Invasive Bladder Cancer
High-risk non-muscle-invasive bladder cancer (HR-NMIBC) is a type of non-invasive bladder cancer that is more likely to recur or spread beyond the lining of the bladder, called the urothelium, and progress to invasive bladder cancer compared to low-risk NMIBC.¹¹ HR-NMIBC is characterised by a high-grade, large tumour size, presence of multiple tumours, and CIS.¹¹ Radical cystectomy is currently recommended for HR-NMIBC patients who fail BCG therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression.¹¹ Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.¹¹ The high rates of recurrence and progression can pose significant morbidity and distress for these patients.¹¹

About Johnson & Johnson 
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. 

Learn more at www.janssen.com/emea. Follow us at http://www.linkedin.com/company/jnj-innovative-medicine-emea/. Janssen Research & Development, LLC, Janssen Cilag S.A, Janssen Global Services, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV are Johnson & Johnson companies.

Cautions Concerning Forward-Looking Statements 
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TAR-200 or cetrelimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Cilag S.A, Janssen Global Services, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Cilag S.A, Janssen Global Services, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

© Janssen-Cilag International NV, Inc. 2024. All rights reserved.   

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*Dr. Michiel S.van der Heijden has provided consulting, advisory and speaking services to Johnson & Johnson; they have not been paid for any media work.

¹ van der Heijden M, et al. TAR-200 +/- Cetrelimab and Cetrelimab Alone in Patients With Bacillus Calmette-Guérin–Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer: Updated Results From SunRISe-1. 2024 European Society for Medical Oncology. September 15, 2024.

² Jacob J, et al. TAR-200 in Patients With Bacillus Calmette–Guérin-Unresponsive High-Risk Non–Muscle-Invasive Bladder Cancer: Results From SunRISe1 Study. American Urological Association Annual Meeting. May 2024.

³ Clinicaltrials.gov. A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive t2o Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (SunRISe-1). Available at: https://clinicaltrials.gov/study/NCT04640623. Accessed September 2024.

⁴ Tyson MD, 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. 2023:209:890-900.

⁵ Clinicaltrials.gov. A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder (SunRISe-2). Available at: https://clinicaltrials.gov/study/NCT04658862. Accessed September 2024. 

⁶ Clinicaltrials.gov. A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder (SunRISe-4). Available at: https://clinicaltrials.gov/study/NCT04919512. Accessed September 2024.

⁷ Clinicaltrials.gov. A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (SunRISe-3). Available at: https://clinicaltrials.gov/study/NCT05714202. Accessed September 2024.

⁸ Clinicaltrials.gov. 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). Available at: https://classic.clinicaltrials.gov/ct2/show/NCT06211764. Accessed September 2024.

⁹ National Centre for Biotechnology Information. First-in-human, open-label, phase 1/2 study of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced cancers. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8956549/. Accessed September 2024.

¹⁰ Rutkowski P, et al. Anti-PD-1 antibody cetrelimab (JNJ-63723283) in patients with advanced cancers: Updated phase I/II study results. Journal of Clinical Oncology. 2019; 37(8). https://doi.org/10.1200/JCO.2019.37.8_suppl.31.

¹¹ Brooks NA, O’Donnell MA. Treatment options in non-muscle-invasive bladder cancer after BCG failure. Indian J Urol. 2015;31(4):312-319. doi:10.4103/0970-1591.166475. Accessed September 2024.

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