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 CR

第2b阶段SunRISe-1研究显示，超过82%的患者达到了完全缓解（CR），并且超过一半的缓解者在完全缓解后一年仍然无癌。

Results reinforce potential of TAR-200 to transform outcomes for certain types of BCG-unresponsive, high-risk non-muscle invasive bladder cancer

结果证实了TAR-200在改善某些类型的BCG无反应、高风险非肌层浸润性膀胱癌的预后方面具有潜力。

LAS VEGAS

拉斯维加斯

,

，

April 26, 2025

2025年4月26日

/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from Cohort 2 of the pivotal Phase 2b SunRISe-1 study evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with certain types of bladder cancer. The findings demonstrate the highest complete response rate without reinduction with more than half of responders remaining cancer-free for at least 12 months.

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布了关键的2b期SunRISe-1研究的队列2的新数据，该研究评估了TAR-200——一种膀胱内吉西他滨释放系统——用于某些类型的膀胱癌患者。研究结果显示，在无需重新诱导治疗的情况下达到了最高的完全缓解率，超过一半的应答者在至少12个月内保持无癌状态。

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 tumors who are ineligible or refuse radical cystectomy (RC).

这些结果突显了TAR-200作为卡介苗（BCG）无反应、伴原位癌（CIS）的高风险非肌层浸润性膀胱癌（HR-NMIBC）患者的潜在突破性疗法，无论是否伴有乳头状肿瘤，且这些患者不适合或拒绝根治性膀胱切除术（RC）。

These results were featured in the .

这些结果被刊登在。

Paradigm-Shifting, Practice-Changing Clinical Trials in Urology

泌尿外科领域具有范式转变和实践变革意义的临床试验

plenary session at the

全体会议在

2025 American Urological Association (AUA) Annual Meeting

2025年美国泌尿协会 (AUA) 年会

.

。

1

1

'Treatment with TAR-200 has long-lasting effectiveness. More than 82 percent of patients achieved a complete response, and of those that initially responded to treatment, more than half showed no signs of cancer at one year,' said Joseph Jacob*, M.D., MCR, Associate Professor of Urology at Upstate Medical University and presenting author.

“TAR-200治疗具有持久的有效性。超过82%的患者达到了完全缓解，而在最初对治疗有反应的患者中，超过一半在一年后未显示癌症迹象，”医学博士、MCR、纽约上州医科大学泌尿学副教授兼报告作者约瑟夫·雅各布表示。

'These findings represent the highest complete response rate observed for patients with HR-NMIBC and underscore the potential of TAR-200 to provide long-lasting cancer control for patients.'.

“这些研究结果代表了HR-NMIBC患者中观察到的最高完全缓解率，并突显了TAR-200为患者提供持久癌症控制的潜力。”

'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.

“膀胱癌是全球十大最常见的癌症之一，但四十多年来治疗选择基本没有变化，如果最初的BCG治疗无效，患者的选择很少，”约翰逊约翰逊创新医药公司膀胱癌领域副总裁兼疾病领域负责人克里斯托弗·库蒂博士说道。

'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.'.

“TAR-200旨在通过一个简单而常规的程序，使药物能够持续直接输送到膀胱内，这对患者来说是一个福音。这些数据表明患者能够在较长时间内保持无癌状态，这对那些面临这一棘手疾病的人来说，标志着一个重大的进步。”

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. This high response rate translated into sustained disease control, with 52.9 percent of responders maintaining complete response at one year.

截至 2025 年 3 月，研究中 85 名入组患者中有 82.4% 达到完全缓解 (CR)（95% 置信区间 [CI]，72.6-89.8），这意味着治疗后癌症已无法检测到。如此高的缓解率转化为持续的疾病控制，52.9% 的缓解者在一年时仍保持完全缓解。

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. At 12 months, 86.6 percent (95 percent CI, 76.6-92.6) of responders remained cystectomy-free. Importantly, the treatment was well-tolerated, with most adverse events being mild urinary symptoms.

反应持续时间（DOR）的中位数为25.8个月（95%置信区间，8.3-无法估计），表明许多患者在无需再诱导治疗的情况下保持无癌状态超过两年。在12个月时，86.6%（95%置信区间，76.6%-92.6%）的应答者仍然无需膀胱切除术。重要的是，该治疗耐受性良好，大多数不良事件为轻度泌尿症状。

These findings show that TAR-200 offers a highly effective and durable treatment option for patients with certain types of BCG-unresponsive HR-NMIBC..

这些研究结果表明，TAR-200 对某些类型的 BCG 无反应的高危非肌层浸润性膀胱癌患者来说，是一种高效且持久的治疗选择。

Most treatment-related adverse events (TRAEs) were mild and manageable. Overall, 71 patients (83.5 percent) experienced TRAEs, the majority of which were low-grade urinary symptoms, such as bladder irritation or discomfort. Eleven patients (12.9 percent) experienced Grade 3 or higher TRAEs, and five patients (5.9 percent) reported serious TRAEs.

大多数治疗相关不良事件（TRAEs）为轻度且可控。总体而言，71例患者（83.5%）经历了TRAEs，其中大多数为低级别的泌尿系统症状，如膀胱刺激或不适。11例患者（12.9%）经历了3级或更高级别的TRAEs，5例患者（5.9%）报告了严重的TRAEs。

Only three patients (3.5 percent) discontinued treatment due to TRAEs, and there were no treatment-related deaths..

仅有三名患者（3.5%）因TRAEs而停止治疗，且没有发生与治疗相关的死亡。

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..

TAR-200由医疗专业人员在短暂的门诊手术中直接插入膀胱，无需麻醉。它设计为留在膀胱内，不会干扰日常活动，并能在全天持续释放治疗药物。截至目前，作为SunRISe临床项目的一部分，TAR-200已被放置超过10,000次。

Earlier results from Cohort 2 were previously presented at the

第2组的早期结果之前已展示在

2024 European Society of Medical Oncology (ESMO) Congress

2024年欧洲肿瘤内科学会（ESMO）大会

and at the

和在

2024 American Urological Association (AUA) Annual Meeting

2024年美国泌尿协会 (AUA) 年会

. In January 2025, Johnson & Johnson announced the initiation of a

2025年1月，强生公司宣布启动一项新的计划。

new drug application

新药申请

with the FDA for TAR-200 under the Real-Time Oncology Review (RTOR) program.

与FDA就TAR-200在实时肿瘤审评（RTOR）计划下进行合作。

____________________

____________________

About TAR-200

关于 TAR-200

TAR-200 is an investigational intravesical gemcitabine releasing system. In January 2025, Johnson & Johnson announced the initiation of a

TAR-200 是一种在研的膀胱内注射吉西他滨释放系统。2025年1月，强生公司宣布启动一项研究。

new drug application

新药申请

with the FDA for TAR-200 under the real-time oncology review (RTOR) program. In December 2023, the FDA

与FDA就TAR-200在实时肿瘤审评（RTOR）计划下进行合作。2023年12月，FDA

granted

授予

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 .

TAR-200获得突破性疗法认定（BTD），用于治疗对卡介苗（BCG）无反应且不适合或选择不接受根治性膀胱切除术的高风险非肌层浸润性膀胱癌（HR-NMIBC）伴原位癌（CIS）的成年患者。TAR-200的安全性和有效性正在针对肌层浸润性膀胱癌（MIBC）患者的2期和3期研究中进行评估。

SunRISe-4

太阳升起-4

, and NMIBC in

，以及NMIBC在

SunRISe-1

太阳升起-1

,

，

SunRISe-3

太阳升起-3

and

和

SunRISe-5

太阳升起-5

.

。

About SunRISe-1, Cohort 2

关于SunRISe-1，第二组

SunRISe-1 (

日出一号 (

NCT04640623

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 2 specifically enrolls patients with carcinoma in situ, with or without papillary disease, treating them with TAR-200 monotherapy.

) 是一项正在进行的 2b 期、随机、开放标签、多中心研究，评估 TAR-200（一种膀胱内注射吉西他滨释放系统）在对 BCG 无反应的高危非肌层浸润性膀胱癌 (HR-NMIBC) 患者中的疗效和安全性，这些患者不符合或选择不进行根治性膀胱切除术。第 2 组专门招募原位癌患者，无论是否伴有乳头状病变，并使用 TAR-200 单药治疗。

The primary endpoint for Cohort 2 is CR rate at any time point. Secondary endpoints include duration of response (DOR), overall survival (OS), pharmacokinetics, quality of life, safety and tolerability..

第2组的主要终点是任何时间点的CR率。次要终点包括反应持续时间（DOR）、总生存期（OS）、药代动力学、生活质量、安全性和耐受性。

About High-Risk Non-Muscle-Invasive Bladder Cancer

关于高风险非肌层浸润性膀胱癌

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.

高风险非肌层浸润性膀胱癌是一种非侵袭性膀胱癌，与低风险NMIBC相比，它更容易复发或扩散到膀胱内膜（称为尿路上皮）以外，并进展为肌层浸润性膀胱癌。

2,3

2,3

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.

高危非肌层浸润性膀胱癌 (HR-NMIBC) 占 NMIBC 患者的 15-44%，其特征为高级别、肿瘤体积大、多发肿瘤以及原位癌 (CIS)。

4

4

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.

目前，对于BCG治疗失败的非肌层浸润性膀胱癌（NMIBC）患者，根治性膀胱切除术是推荐的治疗方法，若在肌肉浸润性进展前进行，其癌症特异性生存率可超过90%。

5,6

5,6

Given that NMIBC typically affects older patients, many may be unwilling or unfit to undergo radical cystectomy.

由于NMIBC通常影响老年患者，许多人可能不愿意或不适合接受根治性膀胱切除术。

7

7

About Johnson & Johnson

关于强生公司

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.

在强生，我们相信健康就是一切。我们在医疗保健创新方面的实力使我们能够构建一个世界，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗方法更智能、更少侵入性，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们有能力在当今全面的医疗保健解决方案领域进行创新，以提供明日的突破性成果，并对人类健康产生深远影响。

Learn more at .

了解更多，请访问 。

https://www.jnj.com/

https://www.jnj.com/

or at

或在

www.innovativemedicine.jnj.com

www.innovativemedicine.jnj.com

. Follow us at

关注我们

@JNJInnovMed

@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.

杨森-西拉格国际公司、杨森研究与发展有限责任公司、杨森生物技术公司、杨森全球服务有限责任公司、杨森-西拉格股份有限公司和杨森科学事务有限责任公司均为强生公司旗下企业。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

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.

本新闻稿包含《1995年私人证券诉讼改革法案》中定义的关于产品开发以及TAR-200潜在益处和治疗影响的“前瞻性声明”。读者应注意不要依赖这些前瞻性声明。这些声明是基于对未来事件的当前预期。

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.

如果基本假设证明不准确，或已知或未知的风险或不确定性成为现实，实际结果可能会与杨森-西拉格国际公司、杨森研发有限责任公司、杨森生物技术公司、杨森全球服务有限责任公司、杨森-西拉格股份有限公司、杨森科学事务有限责任公司和/或强生公司的预期和预测有重大差异。

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.

风险和不确定性包括但不限于：产品研究和开发中固有的挑战和不确定性，包括临床成功的不确定性以及获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手推出的新产品和获得的专利；专利面临的挑战；产品功效或安全性问题导致的产品召回或监管行动；医疗保健产品和服务购买者的行为和支出模式的变化；适用法律法规的变更，包括全球医疗改革；以及控制医疗成本的趋势。

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.

这些风险、不确定性和其他因素的更多列表和描述，请参见强生公司最近的年度报告 Form 10-K，包括标题为“关于前瞻性陈述的警示声明”和“项目1A. 风险因素”的部分，以及强生公司随后的季度报告 Form 10-Q。

http://www.sec.gov

http://www.sec.gov

,

，

http://www.jnj.com

http://www.jnj.com

, or on request from

，或者应要求从

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

强生公司。杨森-西拉格国际股份有限公司、杨森研发有限责任公司、杨森生物科技公司、杨森全球服务有限责任公司、杨森-西拉格股份有限公司、杨森科学事务有限责任公司均不承担任何责任。

Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

强生公司承诺根据新信息或未来事件或发展更新任何前瞻性声明。

*Dr. Jacob has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

雅各布博士曾为强生公司提供咨询、顾问和演讲服务；他未因任何媒体工作获得报酬。

1

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.

Jacob, J., 等。TAR-200单药治疗卡介苗无反应的高危非肌层浸润性膀胱癌原位癌患者：SunRISe-1研究中1年的持久性及患者报告结果。2025年美国泌尿协会年会，2025年4月26日。

2

2

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.

Grab-Heyne K, Henne C, Mariappan P, 等。中高危非肌层浸润性膀胱癌：流行病学、负担及未满足需求概述。

Front Oncol.

前沿肿瘤学。

2023;13:1170124.

2023；13：1170124。

3

3

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 UK guidelines.

Lieblich A, Henne C, Mariappan P, Geiges G, Pöhlmann J, Pollock RF。非肌层浸润性膀胱癌的管理：欧洲和英国指南的比较。

J Clin Urol.

临床泌尿外科杂志。

2018;11(2):144-148.

2018；11（2）：144-148。

4

4

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).

Babjuk M, Burger M, Capoun O, 等。欧洲泌尿外科协会非肌层浸润性膀胱癌指南（Ta、T1 和原位癌）。

Eur Urol

欧洲泌尿外科杂志

. 2022;81(1):75-94. doi:10.1016/j.eururo.2021.08.010

. 2022;81(1):75-94. doi:10.1016/j.eururo.2021.08.010

5

5

Brooks NA, O'Donnell MA. Treatment options in non–muscle-invasive bladder cancer after BCG failure.

布鲁克斯 NA，奥唐奈 MA。卡介苗失败后非肌层浸润性膀胱癌的治疗选择。

Indian J Urol.

印度泌尿外科杂志。

2015;31(4):312-319. doi:10.4103/0970-1591.166475

2015;31(4):312-319. doi:10.4103/0970-1591.166475

6

6

Guancial EA, Roussel B, Bergsma DP, et al. Bladder cancer in the elderly patient: challenges and solutions.

Guanacial EA、Roussel B、Bergsma DP 等。老年患者的膀胱癌：挑战与解决方案。

Clin Interv Aging.

临床干预老龄化。

2015;10:939-949.

2015；10：939-949。

7

7

Chamie K, Litwin MS, Bassett JC, et al. Recurrence of high-risk bladder cancer: A population-based analysis.

Chamie K, Litwin MS, Bassett JC, 等。高危膀胱癌复发：一项基于人群的分析。

Cancer.

癌症。

2013;119(17):3219-3227.

2013；119（17）：3219-3227。

Media contact:

媒体联系人:

Investor contact:

投资者联系方式：

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肿瘤学科媒体关系

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Oncology_media_relations@its.jnj.com

肿瘤学媒体关系@its.jnj.com

investor-relations@its.jnj.com

投资者关系@its.jnj.com

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https://www.prnewswire.com/news-releases/johnson--johnsons-tar-200-monotherapy-demonstrates-highest-complete-response-rate-with-sustained-clinical-benefits-in-patients-with-certain-types-of-bladder-cancer-302438939.html

https://www.prnewswire.com/news-releases/johnson--johnsons-tar-200-单药治疗在某些类型的膀胱癌患者中显示出最高的完全缓解率并具有持续的临床益处-302438939.html

SOURCE Johnson & Johnson

来源：强生公司