Johnson & Johnson unveils highly anticipated and potential practice-changing data in bladder cancer treatment at AUA
Johnson & Johnson (NYSE: JNJ) has revealed groundbreaking data for its TAR-200 bladder cancer treatment at the AUA 2025 Annual Meeting. The Phase 2b SunRISe-1 study demonstrated the highest complete response with sustained benefits in treating high-risk non-muscle invasive bladder cancer (HR-NMIBC).
TAR-200, an intravesical gemcitabine releasing system, has shown promising results for patients with BCG-unresponsive HR-NMIBC. The treatment is administered directly into the bladder through a brief outpatient procedure, requiring no anesthesia. To date, TAR-200 has been placed over 10,000 times in clinical trials.
The presentation highlights include 12-month duration response data from Cohort 2 and first results from Cohort 4 of the Phase 2b SunRISe-1 study. This innovation represents a significant advancement in bladder cancer treatment, which has remained largely unchanged for over 40 years, potentially offering a new bladder-sparing option for the nearly one million people affected by bladder cancer annually.
Johnson & Johnson (NYSE: JNJ) ha presentato dati rivoluzionari sul suo trattamento per il cancro alla vescica TAR-200 durante l'Assemblea Annuale AUA 2025. Lo studio di Fase 2b SunRISe-1 ha mostrato la più alta risposta completa con benefici duraturi nel trattamento del carcinoma della vescica non muscolo-invasivo ad alto rischio (HR-NMIBC).
TAR-200, un sistema intravescicale di rilascio di gemcitabina, ha evidenziato risultati promettenti per i pazienti con HR-NMIBC non responsivo al BCG. Il trattamento viene somministrato direttamente nella vescica tramite una breve procedura ambulatoriale, senza necessità di anestesia. Ad oggi, TAR-200 è stato impiantato oltre 10.000 volte negli studi clinici.
I punti salienti della presentazione includono i dati di risposta a 12 mesi del Gruppo 2 e i primi risultati del Gruppo 4 dello studio di Fase 2b SunRISe-1. Questa innovazione rappresenta un importante progresso nel trattamento del cancro alla vescica, che è rimasto sostanzialmente invariato per oltre 40 anni, offrendo potenzialmente una nuova opzione per preservare la vescica a quasi un milione di persone colpite ogni anno da questo tumore.
Johnson & Johnson (NYSE: JNJ) ha presentado datos innovadores sobre su tratamiento para el cáncer de vejiga TAR-200 en la Reunión Anual AUA 2025. El estudio de fase 2b SunRISe-1 mostró la mayor tasa de respuesta completa con beneficios sostenidos en el tratamiento del cáncer de vejiga no músculo invasivo de alto riesgo (HR-NMIBC).
TAR-200, un sistema intravesical de liberación de gemcitabina, ha demostrado resultados prometedores en pacientes con HR-NMIBC no respondedores al BCG. El tratamiento se administra directamente en la vejiga mediante un procedimiento ambulatorio breve, sin necesidad de anestesia. Hasta la fecha, TAR-200 se ha aplicado en más de 10,000 ocasiones en ensayos clínicos.
Los aspectos destacados de la presentación incluyen datos de respuesta a 12 meses del Cohorte 2 y los primeros resultados del Cohorte 4 del estudio de fase 2b SunRISe-1. Esta innovación representa un avance significativo en el tratamiento del cáncer de vejiga, que ha permanecido prácticamente sin cambios durante más de 40 años, ofreciendo potencialmente una nueva opción para preservar la vejiga a casi un millón de personas afectadas anualmente por este cáncer.
Johnson & Johnson (NYSE: JNJ)가 AUA 2025 연례 회의에서 방광암 치료제 TAR-200에 대한 획기적인 데이터를 공개했습니다. 2b상 SunRISe-1 연구는 고위험 비근육침윤성 방광암(HR-NMIBC) 치료에서 가장 높은 완전 반응률과 지속적인 효과를 입증했습니다.
TAR-200은 방광 내에 직접 투여하는 젬시타빈 방출 시스템으로, BCG에 반응하지 않는 HR-NMIBC 환자들에게 유망한 결과를 보여주고 있습니다. 치료는 마취 없이 짧은 외래 시술로 방광에 직접 투여됩니다. 지금까지 TAR-200은 임상시험에서 10,000회 이상 사용되었습니다.
발표 주요 내용은 2군 코호트의 12개월 반응 지속 데이터와 4군 코호트의 첫 결과를 포함합니다. 이 혁신은 40년 넘게 거의 변하지 않았던 방광암 치료에 중요한 진전을 의미하며, 매년 약 100만 명의 방광암 환자에게 방광 보존의 새로운 선택지를 제공할 수 있습니다.
Johnson & Johnson (NYSE : JNJ) a dévoilé des données révolutionnaires concernant son traitement du cancer de la vessie TAR-200 lors de la réunion annuelle AUA 2025. L'étude de phase 2b SunRISe-1 a démontré la réponse complète la plus élevée avec des bénéfices durables dans le traitement du cancer de la vessie non invasif à haut risque (HR-NMIBC).
TAR-200, un système de libération intravésicale de gemcitabine, a montré des résultats prometteurs chez les patients atteints de HR-NMIBC non réactifs au BCG. Le traitement est administré directement dans la vessie via une procédure ambulatoire courte, sans anesthésie. À ce jour, TAR-200 a été utilisé plus de 10 000 fois dans des essais cliniques.
Les points forts de la présentation incluent les données de réponse à 12 mois du Cohorte 2 ainsi que les premiers résultats du Cohorte 4 de l'étude de phase 2b SunRISe-1. Cette innovation représente une avancée majeure dans le traitement du cancer de la vessie, qui est resté largement inchangé depuis plus de 40 ans, offrant potentiellement une nouvelle option de préservation de la vessie pour près d'un million de personnes touchées chaque année par ce cancer.
Johnson & Johnson (NYSE: JNJ) hat auf dem AUA-Jahrestreffen 2025 bahnbrechende Daten zu seiner Blasenkrebsbehandlung TAR-200 vorgestellt. Die Phase-2b-Studie SunRISe-1 zeigte die höchste Komplettansprechrate mit anhaltenden Vorteilen bei der Behandlung von Hochrisiko-nicht-muskelinvasivem Blasenkrebs (HR-NMIBC).
TAR-200, ein intravesikales Gemcitabin-Freisetzungssystem, hat vielversprechende Ergebnisse bei Patienten mit BCG-resistentem HR-NMIBC gezeigt. Die Behandlung wird direkt durch einen kurzen ambulanten Eingriff in die Blase verabreicht und erfordert keine Anästhesie. Bis heute wurde TAR-200 in klinischen Studien über 10.000 Mal eingesetzt.
Die Präsentation umfasst unter anderem 12-Monats-Ansprechdaten aus Kohorte 2 sowie erste Ergebnisse aus Kohorte 4 der Phase-2b-Studie SunRISe-1. Diese Innovation stellt einen bedeutenden Fortschritt in der Blasenkrebsbehandlung dar, die sich seit über 40 Jahren kaum verändert hat, und bietet potenziell eine neue blasenerhaltende Option für fast eine Million Menschen, die jährlich an Blasenkrebs erkranken.
- Successful Phase 2b trial results showing highest complete response rate
- Treatment demonstrates sustained benefits in 12-month data
- Novel delivery system with proven tissue penetration
- Significant clinical experience with over 10,000 treatment applications
- Potential to address large market with nearly 1 million bladder cancer cases annually
- Still in Phase 2b trials, pending final approval
- to specific types of bladder cancer patients
- Requires regular in-office procedures for treatment administration
Insights
J&J's TAR-200 shows promising complete response with 12-month sustained benefits in bladder cancer, potentially offering bladder-sparing alternative to current treatments.
The data presented for TAR-200 in high-risk non-muscle invasive bladder cancer (HR-NMIBC) represents a potentially significant advancement in a therapeutic area that has seen minimal innovation for over 40 years. The selection of these results for the Practice-changing, Paradigm-shifting Clinical Trials plenary session at AUA underscores their clinical importance. What's particularly notable is the sustained duration of response at 12 months in Cohort 2, addressing a critical unmet need for BCG-unresponsive patients who currently face options beyond radical cystectomy (bladder removal).
The mechanism of TAR-200—an intravesical gemcitabine releasing system—offers several clinical advantages: it delivers medication directly to the tumor site, achieves better tissue penetration as demonstrated in pre-clinical studies, and can be administered in an outpatient setting without anesthesia. For patients with carcinoma in situ (CIS), who typically have worse prognosis, the reported complete response rate (meaning undetectable cancer following treatment) represents a meaningful clinical benefit.
The expansion of data to include Cohort 4 (papillary-only disease) broadens the potential application to another challenging patient population. With bladder cancer affecting nearly a million people annually worldwide and ranking among the top ten most common cancers, the clinical need is substantial. The extensive clinical experience with over 10,000 TAR-200 placements within the SunRISe program provides robust real-world implementation data that will be crucial for potential adoption into clinical practice.
J&J's TAR-200 demonstrates significant clinical progress in bladder cancer treatment, strengthening the company's oncology portfolio with potential market differentiation.
This development strengthens Johnson & Johnson's position in the oncology market through advancement of a novel drug delivery platform. The TAR-200 technology represents a potentially disruptive approach in bladder cancer treatment, a segment where therapeutic options have remained largely stagnant for decades. The expansion of clinical data across multiple patient cohorts demonstrates progressive de-risking of the program and increases the likelihood of achieving a differentiated product profile.
The presentation of these results at a premier urological conference in sessions designated as "practice-changing" signals potential for significant clinical adoption if regulatory approval is eventually secured. The bladder-sparing approach addresses a clear market need, as many patients with high-risk non-muscle invasive bladder cancer are elderly with comorbidities or unwilling to undergo radical cystectomy.
From a commercial perspective, TAR-200's design for in-office administration without anesthesia presents advantages for integration into urology practices. The technology platform appears versatile, as evidenced by the parallel development of TAR-210 for FGFR-altered bladder cancer, suggesting a potential franchise approach rather than a single-product strategy. The progression to Phase 3 trials (SunRISe-5) indicates J&J's confidence in the program and commitment to the therapeutic area. This advancement aligns with J&J's strategy of building strength in solid tumor oncology to complement their established position in hematologic malignancies.
TAR-200 monotherapy shows highest complete response with sustained benefits in 12-month data from Phase 2b SunRISe-1 study (Cohort 2)
Compelling first results from Cohort 4 of Phase 2b SunRISe-1 study show potential of TAR-200 monotherapy in patients with papillary-only, high-risk non-muscle invasive bladder cancer
Bladder cancer ranks among the top ten most common cancers worldwide, affecting nearly a million people each year.1 Despite advancements, standard treatment has remained largely unchanged for over 40 years, leaving patients with limited treatment options if initial BCG therapy does not work.2 TAR-200 delivers sustained medication directly into the bladder and, in a pre-clinical setting, has been shown to allow for depth of penetration across bladder tissue layers.3
"Patients with bladder cancer need more effective treatment options that are both tolerable and easily incorporated into everyday practice, especially for those with HR-NMIBC, a highly recurrent disease that often necessitates difficult, life-altering decisions like bladder removal," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. "TAR-200 provides a new approach, with clinical data showing an impressive complete response rate, meaning the cancer was undetectable following treatment. The highly anticipated 12-month duration of response findings from our Cohort 2, SunRISe-1 study further support the potential for patients to remain cancer-free for a clinically meaningful period."
A second plenary presentation will feature first results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating TAR-200 monotherapy in patients with BCG–unresponsive, papillary-only HR-NMIBC. In this patient population, bladder removal remains a standard treatment, but many patients are elderly, have significant comorbidities, or are unwilling to undergo radical surgery, making treatment challenging.4
"Patients deserve more than the currently available treatment options. TAR-200 is a groundbreaking therapy for early-stage bladder cancer, designed to deliver a sustained local release of medication directly into the bladder—right where it is needed," said Biljana Naumovic,
TAR-200 is inserted directly into the bladder by a healthcare professional in a brief outpatient, in-office procedure, without the need for anesthesia. Designed to remain in the bladder, it does not interfere with daily activities and provides sustained release of medication throughout the day. To date, TAR-200 has been placed more than 10,000 times as part of the SunRISe clinical program.
AUA 2025 Presentation Highlights:
- One-year duration of response data from the Phase 2b SunRISe-1 study evaluating TAR-200 monotherapy in patients with BCG–unresponsive, HR-NMIBC plus carcinoma in situ with or without papillary disease (P2 Plenary Presentation).
- First results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating TAR-200 monotherapy in patients with BCG–unresponsive papillary-only HR-NMIBC (P2 Plenary Presentation).
- Trial-in-progress mini-oral presentation from the Phase 3 MoonRISe-1 study evaluating TAR-210, an erdafitinib intravesical drug-releasing system, versus intravesical chemotherapy in patients with fibroblast growth factor receptors (FGFR)-altered intermediate-risk NMIBC (Clinical Trials in Progress Presentation).
- Trial-in-progress presentation from the Phase 3 SunRISe-5 study evaluating TAR-200 compared to intravesical chemotherapy after treatment with BCG in patients with recurrent HR-NMIBC (Clinical Trials in Progress Presentation).
- Real-world time-to-next-treatment and time-to-castration-resistance among patients with metastatic castration-sensitive prostate cancer using androgen-receptor pathway inhibitors with and without homologous recombination repair alterations (Oral Presentation #25-3830).
A complete list of Johnson & Johnson's sponsored abstracts is available on JNJ.com.
About TAR-200
TAR-200 is an investigational intravesical gemcitabine releasing system. In January 2025, Johnson & Johnson announced the initiation of a new drug application with the FDA for TAR-200 under the real-time oncology review (RTOR) program. In December 2023, the FDA granted Breakthrough Therapy Designation (BTD) to TAR-200 for the treatment of adult patients with BCG—unresponsive HR-NMIBC with CIS who are ineligible for or have elected not to undergo radical cystectomy. The safety and efficacy of TAR-200 are being evaluated in Phase 2 and Phase 3 studies in patients with MIBC in SunRISe-4, and NMIBC in SunRISe-1, SunRISe-3 and SunRISe-5.
About TAR-210
TAR-210 is an investigational intravesical erdafitinib releasing system. The safety and efficacy of TAR-210 is being evaluated in a Phase 1 study (NCT05316155) in patients with muscle-invasive bladder cancer (MIBC) and NMIBC.
About High-Risk Non-Muscle-Invasive Bladder Cancer
High-risk non-muscle-invasive bladder cancer 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.5,6 HR-NMIBC makes up 15-44 percent of patients with NMIBC and is characterized by a high-grade, large tumor size, presence of multiple tumors, with or without CIS.7 Radical cystectomy is currently recommended for NMIBC patients who fail BCG therapy, with over 90 percent cancer-specific survival if performed before muscle-invasive progression.8,9 Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.10 The high rates of recurrence and progression can pose significant morbidity and distress for these patients.3,6
About Prostate Cancer
Approximately 300,000 people are diagnosed with prostate cancer each year in the
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 https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen Scientific Affairs, LLC 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, TAR-210 or BALVERSA® (erdafitinib). 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 materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen Scientific Affairs, LLC 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 behavior 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 www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen Scientific Affairs, LLC nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.
1 https://www.wcrf.org/preventing-cancer/cancer-statistics/bladder-cancer-statistics/
2 Dobruch J, Oszczudłowski M. Bladder Cancer: Current Challenges and Future Directions. Medicina (Kaunas). 2021;57(8):749. Published 2021 Jul 24. doi:10.3390/medicina57080749
3 Pradère B., et al. PENELOPE: Tissue penetration of gemcitabine phosphate metabolites following TAR-200 administration versus standard intravesical instillation in minipigs. EAU 2025. March 23, 2025.
4 Lebacle C, Loriot Y, Irani J. BCG-unresponsive high-grade non-muscle invasive bladder cancer: what does the practicing urologist need to know?. World J Urol. 2021;39(11):4037-4046. doi:10.1007/s00345-021-03666-w
5 Grab-Heyne K, Henne C, Mariappan P, et al. Intermediate and high-risk non–muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023;13:1170124.
6 Lieblich A, Henne C, Mariappan P, Geiges G, Pöhlmann J, Pollock RF. The management of non–muscle-invasive bladder cancer: a comparison of European and
7 Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022;81(1):75-94. doi:10.1016/j.eururo.2021.08.010
8 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
9 Guancial EA, Roussel B, Bergsma DP, et al. Bladder cancer in the elderly patient: challenges and solutions. Clin Interv Aging. 2015;10:939-949.
10 Chamie K, Litwin MS, Bassett JC, et al. Recurrence of high-risk bladder cancer: A population-based analysis. Cancer. 2013;119(17):3219-3227.
11 Key statistics for prostate cancer. American Cancer Society. Accessed September 2024. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html
12 Cooperberg MR, Cowan J, Broering JM, et al. High-risk prostate cancer in
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FAQ
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