Johnson & Johnson's TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC
Johnson & Johnson (NYSE: JNJ) announced promising first results from Cohort 4 of the Phase 2b SunRISe-1 study evaluating TAR-200, an intravesical gemcitabine releasing system for bladder cancer treatment. The study demonstrated:
- Over 80% disease-free survival (DFS) rate without reinduction
- 94% of patients preserved their bladder, avoiding radical cystectomy
- 85.3% and 81.1% DFS rates at six and nine months respectively
- 95.6% progression-free survival rate at 9 months
Among 52 enrolled patients, TAR-200's safety profile showed mostly low-grade, quickly resolving treatment-related adverse events. Common side effects included dysuria (40.4%), pollakiuria (30.8%), and urgency (26.9%). The results support continued evaluation in the ongoing Phase 3 SunRISe-5 study comparing TAR-200 to chemotherapy in BCG-pretreated patients.
Johnson & Johnson (NYSE: JNJ) ha annunciato risultati promettenti dal primo gruppo della Coorte 4 dello studio di Fase 2b SunRISe-1 che valuta TAR-200, un sistema intravescicale a rilascio di gemcitabina per il trattamento del cancro alla vescica. Lo studio ha dimostrato:
- Oltre l'80% di sopravvivenza libera da malattia (DFS) senza necessità di reintroduzione del trattamento
- Il 94% dei pazienti ha mantenuto la vescica, evitando la cistectomia radicale
- Tassi di DFS dell'85,3% a sei mesi e dell'81,1% a nove mesi
- Un tasso di sopravvivenza senza progressione del 95,6% a 9 mesi
Tra i 52 pazienti arruolati, il profilo di sicurezza di TAR-200 ha mostrato principalmente eventi avversi correlati al trattamento di grado lieve e rapidamente risolutivi. Gli effetti collaterali più comuni sono stati disuria (40,4%), pollachiuria (30,8%) e urgenza (26,9%). I risultati supportano la prosecuzione della valutazione nello studio di Fase 3 SunRISe-5 in corso, che confronta TAR-200 con la chemioterapia in pazienti precedentemente trattati con BCG.
Johnson & Johnson (NYSE: JNJ) anunció resultados prometedores del primer grupo de la Cohorte 4 del estudio de Fase 2b SunRISe-1 que evalúa TAR-200, un sistema intravesical de liberación de gemcitabina para el tratamiento del cáncer de vejiga. El estudio demostró:
- Más del 80% de tasa de supervivencia libre de enfermedad (DFS) sin reinducción
- El 94% de los pacientes conservaron la vejiga, evitando la cistectomía radical
- Las tasas de DFS fueron 85.3% a los seis meses y 81.1% a los nueve meses
- Una tasa de supervivencia libre de progresión del 95.6% a los 9 meses
Entre 52 pacientes inscritos, el perfil de seguridad de TAR-200 mostró principalmente eventos adversos relacionados con el tratamiento de bajo grado y de rápida resolución. Los efectos secundarios más comunes fueron disuria (40.4%), polaquiuria (30.8%) y urgencia (26.9%). Los resultados respaldan la continuación de la evaluación en el estudio de Fase 3 SunRISe-5 en curso, que compara TAR-200 con quimioterapia en pacientes previamente tratados con BCG.
Johnson & Johnson (NYSE: JNJ)는 방광암 치료를 위한 방광 내 젬시타빈 방출 시스템인 TAR-200을 평가하는 2b상 SunRISe-1 연구의 4번째 코호트에서 유망한 초기 결과를 발표했습니다. 연구 결과는 다음과 같습니다:
- 재투여 없이 80% 이상의 무병 생존율(DFS)
- 환자의 94%가 방광을 보존하여 근치적 방광절제술을 피함
- 6개월 및 9개월 시점의 DFS율 각각 85.3%와 81.1%
- 9개월 시점의 무진행 생존율 95.6%
등록된 52명의 환자 중 TAR-200의 안전성 프로필은 주로 경등급이며 빠르게 해결되는 치료 관련 부작용을 보였습니다. 흔한 부작용으로는 배뇨통(40.4%), 빈뇨(30.8%), 그리고 절박뇨(26.9%)가 있었습니다. 이 결과는 BCG 전치료 환자에서 TAR-200과 화학요법을 비교하는 진행 중인 3상 SunRISe-5 연구에서의 추가 평가를 뒷받침합니다.
Johnson & Johnson (NYSE : JNJ) a annoncé des résultats prometteurs issus de la cohorte 4 de l'étude de phase 2b SunRISe-1 évaluant TAR-200, un système intravésical de libération de gemcitabine pour le traitement du cancer de la vessie. L'étude a démontré :
- Un taux de survie sans maladie (DFS) supérieur à 80 % sans réinduction
- 94 % des patients ont conservé leur vessie, évitant la cystectomie radicale
- Des taux de DFS de 85,3 % à six mois et 81,1 % à neuf mois
- Un taux de survie sans progression de 95,6 % à 9 mois
Parmi les 52 patients inclus, le profil de sécurité de TAR-200 a montré principalement des événements indésirables liés au traitement de faible grade et rapidement résolutifs. Les effets secondaires les plus fréquents étaient la dysurie (40,4 %), la pollakiurie (30,8 %) et l'urgence mictionnelle (26,9 %). Ces résultats soutiennent la poursuite de l'évaluation dans l'étude de phase 3 SunRISe-5 en cours, comparant TAR-200 à la chimiothérapie chez des patients préalablement traités par BCG.
Johnson & Johnson (NYSE: JNJ) gab vielversprechende erste Ergebnisse aus Kohorte 4 der Phase-2b-Studie SunRISe-1 bekannt, die TAR-200 bewertet, ein intravesikales Gemcitabin-Freisetzungssystem zur Behandlung von Blasenkrebs. Die Studie zeigte:
- Über 80 % krankheitsfreies Überleben (DFS) ohne Reinduktion
- 94 % der Patienten behielten ihre Blase und vermieden eine radikale Zystektomie
- DFS-Raten von 85,3 % nach sechs und 81,1 % nach neun Monaten
- Eine progressionsfreie Überlebensrate von 95,6 % nach 9 Monaten
Unter den 52 eingeschlossenen Patienten zeigte das Sicherheitsprofil von TAR-200 überwiegend leichtgradige, schnell abklingende behandlungsbedingte Nebenwirkungen. Häufige Nebenwirkungen waren Dysurie (40,4 %), Pollakisurie (30,8 %) und Harndrang (26,9 %). Die Ergebnisse unterstützen die weitere Evaluierung in der laufenden Phase-3-Studie SunRISe-5, die TAR-200 mit Chemotherapie bei BCG-vorbehandelten Patienten vergleicht.
- High disease-free survival rate of >80% without reinduction
- 94.2% of patients avoided radical cystectomy
- Strong progression-free survival rate of 95.6% at 9 months
- Well-tolerated safety profile with mostly low-grade adverse events
- No treatment-related deaths reported
- 7.7% of patients discontinued treatment due to adverse events
- 12-month disease-free survival data not yet mature
- 13.5% of patients experienced Grade ≥3 treatment-related adverse events
Insights
TAR-200 shows impressive 81% disease-free survival at 9 months, allowing 94% of bladder cancer patients to avoid radical surgery.
Johnson & Johnson's TAR-200 therapy demonstrates remarkable efficacy for a challenging patient population with options. The 85.3% and 81.1% disease-free survival rates at six and nine months respectively represent significant clinical outcomes for patients with BCG-unresponsive, high-risk non-muscle-invasive bladder cancer with papillary-only disease.
Most striking is the 94.2% bladder preservation rate at median follow-up of 12.8 months. This is transformative considering radical cystectomy (complete bladder removal) has been the standard approach—a procedure with profound quality-of-life consequences including urinary diversion systems and potential sexual dysfunction.
The efficacy across both Ta (82.1% DFS at 9 months) and T1 (79.4% DFS at 9 months) subtypes is particularly encouraging since T1 disease involves deeper tissue invasion, suggesting effective drug penetration throughout bladder tissue layers.
The 95.6% progression-free survival rate at nine months is especially meaningful since progression to muscle-invasive disease dramatically worsens prognosis and treatment options. The safety profile appears manageable with primarily low-grade urinary symptoms that resolved within a median of 3.7 weeks.
While these are interim results and 12-month data isn't yet mature, the selection for the "Paradigm-Shifting, Practice-Changing Clinical Trials" session indicates recognition of TAR-200's potential significance. The ongoing Phase 3 SunRISe-5 study will be crucial for confirming these findings against conventional chemotherapy and potentially establishing a new standard of care.
TAR-200's strong clinical data addresses major unmet need in bladder cancer, creating significant commercial opportunity for Johnson & Johnson.
These Phase 2b results represent a potential breakthrough in the bladder cancer treatment landscape. With nearly a million new bladder cancer cases worldwide annually and standard care unchanged for over 40 years, J&J has identified a substantial market opportunity with high unmet medical need.
TAR-200's novel delivery approach—an intravesical gemcitabine releasing system—offers meaningful innovation in a field with therapeutic advancement. The technology's patient-friendly administration (outpatient procedure without anesthesia) and compatibility with daily activities addresses important practical considerations that could drive adoption.
The impressive 81.1% disease-free survival rate at nine months and 94.2% bladder preservation rate directly address the primary concerns of both clinicians and patients. For urologists, these results offer a potential alternative to radical cystectomy while maintaining strong disease control. For patients, avoiding major surgery represents a tremendous quality-of-life benefit.
J&J has made substantial investment in the TAR-200 platform, with the technology having been "placed more than 10,000 times" across the clinical program. This extensive clinical development suggests strategic importance within J&J's oncology portfolio.
The selection for presentation at the American Urological Association's "Paradigm-Shifting, Practice-Changing Clinical Trials" session signals recognition of TAR-200's potential commercial significance. If the ongoing Phase 3 SunRISe-5 study confirms these results, TAR-200 could establish a new standard of care for BCG-unresponsive NMIBC—a position that would drive sustained revenue growth within J&J's specialty pharmaceuticals segment.
First results from SunRISe-1 (Cohort 4) show strong disease-free survival rates across high-grade papillary tumors, demonstrating the potential for bladder preservation with 94 percent of patients avoiding radical cystectomy
95 percent progression-free survival rate at 9-months signals the promise of TAR-200 in this high-risk patient population
"The majority of patients remained free of cancer recurrence during this critical early study period, highlighting the potential of TAR-200 as a highly effective treatment for these patients who may have limited options beyond bladder removal," said Félix
"Surgical removal of the bladder has long been the standard of care for patients suffering from BCG-unresponsive HR-NMIBC with papillary-only disease, a life-altering procedure that drastically impacts a patient's quality of life," said Christopher Cutie, M.D., Vice President, Disease Area Leader, Bladder Cancer, Johnson & Johnson Innovative Medicine. "These results demonstrate that TAR-200 can be a meaningful alternative to surgery that is both effective and well-tolerated while preserving the bladder."
First results of this interim analysis from Cohort 4 of the SunRISe-1 study demonstrated 85.3 percent and 81.1 percent DFS rates at six and nine months, respectively, in patients with BCG-unresponsive, HR-NMIBC with papillary-only disease treated with TAR-200 monotherapy. These high DFS rates are particularly encouraging given the significant risk of recurrence in this population.2 Among patients with high-grade Ta and T1 disease, DFS rates remained consistently strong—85.7 percent and 84.7 percent at six months, and 82.1 percent and 79.4 percent at nine months, respectively. The strong DFS across both subtypes—despite their differing depths of invasion—underscores the potential of TAR-200 to deliver sustained tissue penetration. Notably, 94.2 percent of patients avoided radical cystectomy at median follow-up of 12.8 months. The early progression-free and overall survival rates of 95.6 percent and 98 percent at nine months, respectively, are reassuring as disease progression or death were highly uncommon among patients treated with TAR-200.1 While 12-month DFS data is not yet mature, these preliminary findings show that TAR-200's sustained intravesical gemcitabine delivery may potentially offer durable disease control while minimizing the need for invasive procedures. These results support continued evaluation in the ongoing Phase 3 SunRISe-5 study (NCT06211764), comparing TAR-200 to chemotherapy in patients with BCG-pretreated, papillary-only HR-NMIBC.
Among the 52 patients enrolled, the safety profile of TAR-200 monotherapy was consistent with prior studies, with no new safety signals observed. Most treatment-related adverse events (TRAEs) were low grade and resolved quickly, with a median duration of 3.7 weeks. Common TRAEs included dysuria (40.4 percent), pollakiuria (30.8 percent), and urgency (26.9 percent). Grade ≥3 TRAEs occurred in 13.5 percent of patients, most frequently bladder pain (3.8 percent). Three patients (5.8 percent) experienced serious TRAEs, and only four (7.7 percent) discontinued treatment due to TRAEs. No treatment-related deaths were reported.1
Bladder cancer ranks among the top ten most common cancers worldwide, affecting nearly a million people each year.3 Despite advancements, the standard of care has remained largely unchanged for over 40 years, leaving patients with limited treatment options if initial BCG therapy does not work.4 TAR-200 delivers sustained medication directly into the bladder, offering a fresh approach to treat early-stage bladder cancer.
TAR-200 is inserted directly into the bladder by a healthcare professional in a brief outpatient procedure, without the need for anesthesia. Designed to remain in the bladder, it does not interfere with daily activities and provides sustained release of treatment throughout the day. To date, TAR-200 has been placed more than 10,000 times as part of the SunRISe clinical program.
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 SunRISe-1, Cohort 4
SunRISe-1 (NCT04640623) is an ongoing Phase 2b, randomized, open-label, multicenter 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. Cohort 4 specifically enrolls patients with papillary-only disease, treating them with TAR-200 monotherapy. The primary end-point of Cohort 4 is disease-free survival (DFS) rate at 12 months. Key secondary end points included safety and tolerability.
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 muscle 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, and 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 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-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A. 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. 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-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A., 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 http://www.sec.gov, http://www.jnj.com, or on request from
Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC, Janssen-Cilag, S.A., Janssen Scientific Affairs, LLC nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
*Dr.
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2 Shalata AT, Shehata M, Van Bogaert E, et al. Predicting Recurrence of Non-Muscle-Invasive Bladder Cancer: Current Techniques and Future Trends. Cancers (
3 World Health Organization. Bladder Cancer. https://www.iarc.who.int/cancer-type/bladder-cancer/. Accessed March 2025.
4 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
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.
Media contact: Oncology_media_relations@its.jnj.com
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