Johnson & Johnson's TAR-200 monotherapy demonstrates highest complete response rate reported to date with sustained clinical benefits in patients with certain types of bladder cancer

Phase 2b SunRISe-1 study shows more than 82 percent of patients achieved complete response (CR) with more than half of responders remaining cancer-free at one year after CR1 Results reinforce potential of TAR-200 to transform outcomes for certain types of high-risk non-muscle invasive bladder cancer1 BEERSE, Belgium, April 26, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced new data from Cohort 2 of the Phase 2b SunRISe-1 study evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with certain types of bladder cancer.1 The findings demonstrate the highest complete response rate without reinduction with more than half of responders remaining cancer-free for at least 12 months.1 These results highlight the potential of TAR-200 as a breakthrough for people with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumours who are ineligible or refuse radical cystectomy (RC).1 These results were featured in the Paradigm-Shifting, Practice-Changing Clinical Trials in Urology plenary session at the 2025 American Urological Association (AUA) Annual Meeting.1 “The durability of response we’re seeing with TAR-200 is particularly noteworthy in a population where recurrence is common and the standard of care treatment often comes at the cost of patient comfort and quality of life,” said Andrea Necchi, M.D., of Italy's Vita-Salute San Raffaele University and the IRCCS San Raffaele Hospital and Scientific Institute. “These data underscore the potential of TAR-200 to address significant unmet need in high-risk non-muscle invasive bladder cancer, delivering sustained, localised therapy through a novel intravesical gemcitabine releasing system that supports lasting disease management, without adding to the treatment burden.” “In high-risk non-muscle invasive bladder cancer where patients have typically faced limited treatment options, these TAR-200 data represent significant hope,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “Achieving the high and durable complete response rates observed in this population with a therapy designed to fit into patients’ lives, not interrupt them, reflects the real promise of innovation in bladder cancer care. With these results, TAR-200 offers the potential of not just advancing treatment, but helping shape a future where efficacy and quality of life go hand-in-hand.” As of March 2025, 82.4 percent of the 85 enrolled patients in the study achieved a complete response (CR) (95 percent Confidence Interval [CI], 72.6-89.8), meaning their cancer was undetectable following treatment.1 This high response rate translated into sustained disease control, with 52.9 percent of responders maintaining complete response at one year.1 The median duration of response (DOR) was 25.8 months (95 percent CI, 8.3-not estimable), indicating that many patients remained cancer-free for over two years without the need for reinduction therapy.1 At 12 months, 86.6 percent (95 percent CI, 76.6-92.6) of responders remained cystectomy-free.1 Importantly, the treatment was well-tolerated, with most adverse events being mild urinary symptoms.1 These findings show that TAR-200 offers a highly effective and durable treatment option for patients with certain types of BCG-unresponsive HR-NMIBC.1 “Bladder cancer is one of the ten most common cancers worldwide, yet treatment options have remained largely unchanged for over 40 years, leaving patients with few choices if initial BCG therapy does not work,” said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine. "TAR-200 is designed to allow for sustained delivery of medication directly into the bladder through a brief and routine procedure, which benefits patients. These data now show patients can remain cancer-free for a meaningful period of time, marking a significant step forward for those facing this challenging disease.” Most treatment-related adverse events (TRAEs) were mild and manageable.1 Overall, 71 patients (83.5 percent) experienced TRAEs, the majority of which were low-grade urinary symptoms, such as bladder irritation or discomfort.1 Eleven patients (12.9 percent) experienced grade 3 or higher TRAEs, and five patients (5.9 percent) reported serious TRAEs.1 Only three patients (3.5 percent) discontinued treatment due to TRAEs, and there were no treatment-related deaths.1 TAR-200 is inserted directly into the bladder by a healthcare professional in a brief outpatient procedure, without the need for anaesthesia.2 Designed to remain in the bladder, it does not interfere with daily activities and provides sustained release of treatment throughout the day. Earlier results from Cohort 2 were previously presented at the 2024 European Society of Medical Oncology (ESMO) Congress3 and at the 2024 American Urological Association (AUA) Annual Meeting.4 ____________________ About TAR-200 TAR-200 is an investigational intravesical gemcitabine releasing system designed to provide sustained, extended local release of gemcitabine into the bladder.5,6 The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with NMIBC in SunRISe-1,7 SunRISe-38 and SunRISe-5,9 and muscle invasive bladder cancer (MIBC) in SunRISe-4.10 About SunRISe-1, Cohort 2 SunRISe-1 (NCT04640623) is an ongoing Phase 2b, randomised, open-label, multicentre study evaluating the efficacy and safety of TAR-200, an intravesical gemcitabine releasing system, in patients with BCG-unresponsive HR-NMIBC who are ineligible for, or elected not to undergo, radical cystectomy.7 Cohort 2 specifically enrols patients with carcinoma in situ (CIS), with or without papillary disease, treating them with TAR-200 monotherapy.1 The primary endpoint for Cohort 2 is CR rate at any time point.1 Secondary endpoints include duration of response (DOR), overall survival (OS), pharmacokinetics, quality of life, safety and tolerability.1 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 muscle-invasive bladder cancer (MIBC) compared to low-risk NMIBC.11 HR-NMIBC makes up 15-44 percent of patients with NMIBC and is characterised by a high-grade, large tumour size, presence of multiple tumours, and CIS.11,12 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 About Johnson & JohnsonAt 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-Cilag International NV, Janssen Biotech, Inc., and Janssen-Cilag, S.A. are Johnson & Johnson companies. Cautions Concerning Forward-Looking StatementsThis 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. 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-Cilag International NV, Janssen Biotech, Inc., Janssen-Cilag, S.A. 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 most recent Annual Report on Form 10-K, 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 http://www.sec.gov, http://www.jnj.com, or on request from Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Biotech, Inc., Janssen-Cilag, S.A., 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. * Dr. Andrea Necchi has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Jacob, J., et al. TAR-200 monotherapy in patients with bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. 2025 American Urological Association Annual Meeting. April 26, 2025. 2 Jacob, J. M., et al (2025). TAR-200 in Patients With Bacillus Calmette–Guérin-Unresponsive High-Risk Non–Muscle-Invasive Bladder Cancer: Results From SunRISe-1 Study. Presentation at the American Urological Association (AUA) Annual Meeting, 2024. 3 J&J. 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. Available at: https://innovativemedicine.jnj.com/emea/newsroom/oncology/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. Accessed April 2025. 4 J&J. TAR-200 monotherapy shows greater than 80 percent complete response rate in patients with high-risk non-muscle-invasive bladder cancer. Available at: https://innovativemedicine.jnj.com/emea/newsroom/oncology/tar-200-monotherapy-shows-greater-than-80-percent-complete-response-rate-in-patients-with-high-risk-non-muscle-invasive-bladder-cancer. Accessed April 2025. 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 April 2025. 6 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. 7 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 to 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 April 2025. 8 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 April 2025. 9 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 April 2025. 10 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 April 2025. 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 12 Lerner S. Treatment of high-risk, non-muscle-invasive bladder cancer. Nature Reviews Urology. 2006:3: 398-399. CP-516401 April 2025

Johnson & Johnson's TAR-200 monotherapy demonstrates highest complete response rate reported to date with sustained clinical benefits in patients with certain types of bladder cancer

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