TAR-200 plus cetrelimab treatment results in tumour size reduction in those with muscle-invasive disease, potentially improving surgical outcomes and lowering risk of recurrence1
BEERSE, BELGIUM , Sept. 16, 2024 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, announced today interim data from the ongoing Phase 2 SunRISe-4 study showing neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) achieved nearly double the pathological complete response (pCR) rate compared to CET alone in patients with muscle-invasive bladder cancer (MIBC) who are ineligible or refuse neoadjuvant platinum-based chemotherapy and are scheduled for radical cystectomy (RC).1 These data were featured as a late-breaking oral presentation at the European Society of Medical Oncology (ESMO) 2024 Congress, taking place in Barcelona, Spain from 13-17 September.1
"These findings from the SunRISe-4 study show for the first time that an intravesical treatment with TAR-200, combined with a systemic PD-1 inhibitor, could potentially result in a complete pathological response in a high proportion of patients, as well as allowing a tolerable approach," said Andrea Necchi, M.D., of Italy’s Vita-Salute San Raffaele University and the IRCCS San Raffaele Hospital and Scientific Institute and a presenting author* of the study. “These preliminary findings show a potential for a future change in the local treatment of muscle invasive bladder carcinoma using TAR-200.”
In the interim analysis of the SunRISe-4 study, the centrally confirmed pathologic complete response (pCR, [T0]) rate was 42 percent with neoadjuvant TAR-200 plus CET (n=53) compared to 23 percent (95 percent confidence interval [CI], 28-56; 10-41) with CET alone (n=31) in patients with histologically proven, non-metastatic MIBC.1 The pathological overall response (pOR) rate (defined as the proportion of patients ≤pT1) was 60 percent compared to 36 percent, respectively (95 percent CI, 46-74; 19-55).1
"The SunRISe-4 study demonstrates for the first time the benefit of adding TAR-200 to checkpoint inhibition as a neoadjuvant treatment for patients with muscle-invasive bladder cancer,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “Targeted releasing systems represent a potentially transformative approach to bladder cancer treatment, by allowing for continuous, low-dose delivery of gemcitabine directly to the tumour site. This approach could enhance treatment efficacy, offering a more tolerable alternative to chemotherapy prior to radical cystectomy."
In a subgroup analysis of patients with organ-confined disease (cT2), those treated with TAR-200 plus CET (n=40) showed a 48 percent pCR rate compared to 23 percent pCR with CET alone (n=26, 95 percent CI, 32-64; 9-44, respectively) and 68 percent were downstaged (≤ pT1) at the time of radical cystectomy, potentially improving surgical outcomes and reducing risk of recurrence.1
“With these promising results, TAR-200 plus cetrelimab as a neoadjuvant therapy before radical cystectomy could potentially alter how bladder cancer is treated,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Innovative Medicine, Johnson & Johnson. “This investigational innovative approach may offer a possible alternative for many patients who are not eligible for the current standard of pre-operative treatments.”
Treatment-related adverse events (TRAEs) occurred in 72 percent of patients treated with TAR-200 combined with CET and 44 percent of patients treated with CET alone with the majority being Grade 1-2.1 Nine percent of patients discontinued treatment with TAR-200 and eight percent discontinued treatment with CET in the combined treatment cohort due to TRAEs; no patients discontinued treatment due to TRAEs when treated with CET alone.1
About SunRISe-4
SunRISe-4 (NCT04919512) is an open-label, multicentre, randomised Phase 2 study assessing the efficacy and safety of neoadjuvant TAR-200 + cetrelimab (CET) (anti-programmed death-1 antibody) or neoadjuvant CET alone in patients with MIBC scheduled for RC who are ineligible for or refuse neoadjuvant platinum-based chemotherapy.2
About TAR-200
TAR-200 is an investigational targeted releasing system designed to provide extended local release of gemcitabine into the bladder.2,3 It is installed in a physician’s office setting during a 2-3 minute procedure with no anesthesia.4 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),2 NMIBC in SunRISe-1 (NCT04640623),6 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 Muscle-Invasive Bladder Cancer
Muscle-invasive bladder cancer (MIBC) is a severe form of bladder cancer where the tumour penetrates the muscular layer of the bladder wall, significantly increasing the risk of metastasis.11 Approximately 25 percent of bladder cancer cases are diagnosed as MIBC at the time of initial presentation.12 Early detection and timely intervention are crucial for managing MIBC, as delayed treatment can lead to poor prognosis.13
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. and 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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*Prof. Andrea Necchi has provided consulting, advisory, and speaking services to Johnson & Johnson; they have not been paid for any media work.
1 Necchi A, 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. 2024 European Society for Medical Oncology. 16 September, 2024.
2 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.
3 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.
4 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.
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, 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 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 National Collaborating Centre for Cancer (UK). Bladder Cancer: Diagnosis and Management. London: National Institute for Health and Care Excellence (NICE); 2015 Feb. (NICE Guideline, No. 2.) 5, Managing muscle-invasive bladder cancer. Available from: https://www.ncbi.nlm.nih.gov/books/NBK356289/.
12 Krishna SR, Konety BR. Current Concepts in the Management of Muscle Invasive Bladder Cancer. Indian J Surg Oncol. 2017 Mar;8(1):74-81. doi: 10.1007/s13193-016-0586-1. Epub 2016 Dec 15. PMID: 28127187; PMCID: PMC5236024.
13 Chu AT, et al. Delays in Radical Cystectomy for Muscle-Invasive Bladder Cancer. Cancer. 2019 15;125(12):2011-2017.
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