TAR-200 monotherapy shows highest complete response with sustained benefits in 12-month data from Phase 2b SunRISe-1 study (Cohort 2)

TAR-200单药治疗在2b期SunRISe-1研究（队列2）的12个月数据中显示出最高的完全缓解率，并具有持续的益处。

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

第2b阶段SunRISe-1研究的第4组队列初步结果令人信服，显示了TAR-200单药治疗在仅乳头状、高风险非肌肉浸润性膀胱癌患者中的潜力。

RARITAN, N.J.

拉里坦，新泽西州

,

，

April 21, 2025

2025年4月21日

/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that new data from its leading oncology pipeline will be presented at the American Urological Association (AUA) 2025 Annual Meeting, taking place April 26-29 in Las Vegas. Among the highlights are the 12-month duration of response (DOR) data from the Phase 2b Cohort 2 SunRISe-1 study, evaluating TAR-200—an intravesical gemcitabine releasing system—for patients with Bacillus Calmette-Guérin (BCG)—unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS) with or without papillary disease.

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布，其领先的肿瘤学管线的新数据将在2025年美国泌尿协会（AUA）年会上公布，该会议将于4月26日至29日在拉斯维加斯举行。其中的重点包括来自2期Cohort 2 SunRISe-1研究的12个月反应持续时间（DOR）数据，该研究评估了TAR-200——一种膀胱内释放吉西他滨的系统——用于对卡介苗（BCG）无反应、高风险非肌层浸润性膀胱癌（HR-NMIBC）伴原位癌（CIS）且有或无乳头状病变的患者。

These findings will be featured in the .

这些发现将被刊登在 。

Practice-changing, Paradigm-shifting Clinical Trials in Urology

泌尿外科领域改变实践、转变范式的临床试验

plenary session on Saturday, April 26.

全体会议于4月26日星期六举行。

Bladder cancer ranks among the top ten most common cancers worldwide, affecting nearly a million people each year.

膀胱癌是全球十大最常见的癌症之一，每年影响近百万人口。

1

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.

尽管有了进展，但标准治疗方案在40多年来基本没有变化，如果初期的BCG疗法无效，患者的治疗选择仍然有限。

2

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.

TAR-200直接将药物持续递送到膀胱内，并且在临床前研究中已显示出能够渗透到膀胱组织层的深度。

3

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.

“膀胱癌患者需要更多有效且易于融入日常治疗的选择，特别是对于高危非肌层浸润性膀胱癌（HR-NMIBC）患者，这是一种复发率很高的疾病，常常需要做出艰难的、改变生活的决定，比如切除膀胱，”杨森制药全球肿瘤治疗领域负责人、医学博士Yusri Elsayed表示。

'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.'.

“TAR-200提供了一种新方法，临床数据显示其完全缓解率令人印象深刻，这意味着治疗后癌症已无法检测到。我们第二队列SunRISe-1研究中备受期待的12个月持续缓解结果进一步表明患者有望在临床上有意义的时间内保持无癌状态。”

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..

第二次全体会议报告将展示二期SunRISe-1研究第四组的初步结果，该研究评估了TAR-200单药治疗在BCG无反应、仅乳头状高危非肌层浸润性膀胱癌（HR-NMIBC）患者中的效果。在这一患者群体中，膀胱切除术仍然是标准治疗方法，但许多患者年龄较大、伴有严重合并症或不愿接受根治性手术，这使得治疗颇具挑战性。

4

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, U.S. President, Oncology, Solid Tumor, Johnson & Johnson Innovative Medicine.

“患者值得拥有比目前可用的治疗方案更多的选择。TAR-200 是一种突破性的早期膀胱癌疗法，旨在将药物持续局部释放到膀胱内——正是需要它的地方，”杨森美国肿瘤学、实体瘤总裁 Biljana Naumovic 表示。

'This innovation provides a bladder-sparing treatment option that can meaningfully improve outcomes while integrating seamlessly into any urology practice.'.

‘这项创新提供了一种保留膀胱的治疗选择，可以在显著改善疗效的同时，无缝融入任何泌尿科实践。’

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..

TAR-200由医疗专业人员在短暂的门诊或诊所内直接插入膀胱，无需麻醉。其设计可长期留置于膀胱内，不会干扰日常活动，并能在全天持续释放药物。迄今为止，作为SunRISe临床项目的一部分，TAR-200已被放置超过10,000次。

AUA 2025 Presentation Highlights:

AUA 2025 演示亮点：

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

评估TAR-200单药治疗BCG无反应、高风险非肌层浸润性膀胱癌（HR-NMIBC）伴或不伴乳头状病变的原位癌患者的2b期SunRISe-1研究的一年应答持续时间数据

(P2 Plenary Presentation).

（P2全体会议报告）。

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

第2b期SunRISe-1研究的第4组队列的初步结果，评估TAR-200单药治疗在BCG无反应性乳头状高危非肌层浸润性膀胱癌（HR-NMIBC）患者中的效果

(P2 Plenary Presentation).

（P2全体会议报告）。

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 (

来自评估 TAR-210（一种厄达替尼膀胱内释药系统）与膀胱内化疗在纤维母细胞生长因子受体 (

FGFR

FGFR

)-altered intermediate-risk NMIBC

)-改变的中危非肌层浸润性膀胱癌

(Clinical Trials in Progress Presentation).

（正在进行的临床试验报告）。

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

正在进行的三期SunRISe-5试验的中期报告，评估TAR-200与膀胱内化疗在BCG治疗后复发的高危非肌层浸润性膀胱癌（HR-NMIBC）患者中的比较效果。

(Clinical Trials in Progress Presentation).

（正在进行的临床试验报告）。

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

使用雄激素受体通路抑制剂治疗的转移性去势敏感性前列腺癌患者的真实世界下次治疗时间和去势抵抗时间，包括同源重组修复改变与否的情况

(Oral Presentation #25-3830).

（口头报告 #25-3830）。

A complete list of Johnson & Johnson's sponsored abstracts is available on

强生公司赞助的摘要完整列表可在

JNJ.com

JNJ.com

.

。

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新的研究。

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

在实时肿瘤审查（RTOR）计划下，TAR-200与FDA。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获得了突破性疗法认定（BTD），用于治疗对BCG无反应且不适合或选择不进行根治性膀胱切除术的高危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 TAR-210

关于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 (

TAR-210 是一种在研的膀胱内释放厄达替尼的系统。TAR-210 的安全性和有效性正在一项 1 期研究中进行评估 (

NCT05316155

NCT05316155

) in patients with muscle-invasive bladder cancer (MIBC) and NMIBC.

) 肌肉浸润性膀胱癌 (MIBC) 和非肌肉浸润性膀胱癌 (NMIBC) 患者中。

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 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，更容易复发或扩散到膀胱内膜（称为尿路上皮）之外，并进展为侵袭性膀胱癌。

5,6

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.

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、存在多个肿瘤，伴或不伴原位癌 (CIS)。

7

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.

目前，根治性膀胱切除术被推荐用于BCG治疗失败的NMIBC患者，若在肌肉浸润性进展前进行，癌症特异性生存率可超过90%。

8,9

8,9

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

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

10

10

The high rates of recurrence and progression can pose significant morbidity and distress for these patients.

高复发率和进展率可能给这些患者带来显著的痛苦和困扰。

3,6

3,6

About Prostate Cancer

关于前列腺癌

Approximately 300,000 people are diagnosed with prostate cancer each year in the U.S.

每年在美国大约有30万人被诊断出患有前列腺癌。

11

11

Up to 40 percent of patients will be classified as high-risk.

高达40%的患者将被归类为高风险。

12

12

Despite advancements in treatment, disease recurrence remains substantial; up to 50 percent of patients within ten years of surgery experience recurrence and carry a significant risk of disease progression and death.

尽管治疗取得了进展，但疾病的复发仍然很高；手术后十年内，多达50%的患者会经历复发，并且面临显著的疾病进展和死亡风险。

13

13

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。我们在医疗创新方面的优势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，我们有能力在当今整个医疗解决方案领域进行创新，提供明天的突破性成果，并对人类健康产生深远影响。

Learn more at .

了解更多信息，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 Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen Scientific Affairs, LLC are Johnson & Johnson companies.

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和杨森科学事务有限责任公司是强生公司的子公司。

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, TAR-210 or BALVERSA

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、TAR-210或BALVERSA潜在益处和治疗影响的“前瞻性声明”。

®

®

(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.

(厄达替尼)。读者应注意不要依赖这些前瞻性声明。这些声明基于对未来事件的当前预期。如果基本假设被证明不准确，或已知或未知的风险或不确定性成为现实，实际结果可能与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、杨森科学事务有限责任公司和/或强生公司的预期和预测大相径庭。

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，包括临床成功和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、竞争对手的新产品和专利；专利挑战；产品功效或安全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 and other filings with the Securities and Exchange Commission.

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Form 10-K年度报告，包括标题为“关于前瞻性陈述的警示说明”和“项目1A. 风险因素”的部分，以及强生公司随后的Form 10-Q季度报告和其他提交给证券交易委员会的文件。

Copies of these filings are available online at .

这些文件的副本可在线获取。

www.sec.gov

www.sec.gov

,

，

www.jnj.com

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..

或应强生公司要求。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、杨森科学事务有限责任公司以及强生公司均不承诺因新信息、未来事件或发展而更新任何前瞻性声明。

1

1

https://www.wcrf.org/preventing-cancer/cancer-statistics/bladder-cancer-statistics/

https://www.wcrf.org/preventing-cancer/cancer-statistics/bladder-cancer-statistics/

2

2

Dobruch J, Oszczudłowski M. Bladder Cancer: Current Challenges and Future Directions.

多布鲁奇 J，奥兹丘多洛夫斯基 M。膀胱癌：当前挑战与未来方向。

Medicina (Kaunas)

医学（考纳斯）

. 2021;57(8):749. Published 2021 Jul 24. doi:10.3390/medicina57080749

. 2021;57(8):749. 发表于2021年7月24日. doi:10.3390/medicina57080749

3

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.

普拉德雷 B. 等。PENELOPE：TAR-200 给药与标准膀胱内灌注后吉西他滨磷酸盐代谢物的组织渗透性比较（在小型猪模型中）。欧洲泌尿外科协会 2025，2025年3月23日。

4

4

Lebacle C, Loriot Y, Irani J. BCG-unresponsive high-grade non-muscle invasive bladder cancer: what does the practicing urologist need to know?.

Lebacle C，Loriot Y，Irani J。BCG无反应的高级别非肌层浸润性膀胱癌：执业泌尿科医生需要了解什么？

World J Urol.

世界泌尿外科杂志。

2021;39(11):4037-4046. doi:10.1007/s00345-021-03666-w

2021;39(11):4037-4046. doi:10.1007/s00345-021-03666-w

5

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.

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

Front Oncol.

前沿肿瘤学。

2023;13:1170124.

2023；13：1170124。

6

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 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。

7

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).

巴布久克 M，伯格 M，卡彭 O，等。欧洲泌尿外科协会非肌层浸润性膀胱癌（Ta、T1 和原位癌）指南。

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

8

8

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。BCG 治疗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

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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.

老年临床干预。

2015;10:939-949.

2015；10：939-949。

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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。

11

11

Key statistics for prostate cancer. American Cancer Society. Accessed September 2024.

前列腺癌的关键统计数据。美国癌症协会。2024年9月访问。

https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html

https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html

12

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Cooperberg MR, Cowan J, Broering JM, et al. High-risk prostate cancer in the United States, 1990-2007.

库珀伯格 MR，科恩 J，布罗林 JM 等。美国高危前列腺癌，1990-2007。

World J Urol.

世界泌尿外科杂志。

2008;26(3):211-218. doi: 10.1007/s00345-008-0250-7.

2008;26(3):211-218. doi: 10.1007/s00345-008-0250-7.

13

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Napodano G, Ferro M, Sanseverino R. High-risk prostate cancer: A very challenging disease in the field of uro-oncology.

纳波达诺 G，费罗 M，桑塞维里诺 R。高危前列腺癌：泌尿肿瘤学领域中极具挑战性的疾病。

Diagnostics (Basel).

诊断（巴塞尔）。

2021;11(3):400. doi: 10.3390/diagnostics11030400.

2021;11(3):400. doi: 10.3390/diagnostics11030400.

Media contact:

媒体联系人：

Oncology Media Relations

肿瘤学媒体关系

Oncology_media_relations@its.jnj.com

肿瘤学科媒体关系@its.jnj.com

Investor contact:

投资者联系人：

Lauren Johnson

劳伦·约翰逊

investor-relations@its.jnj.com

投资者关系@its.jnj.com

U.S. Medical Inquiries

美国医疗咨询

+1 800 526-7736

+1 800 526-7736

View original content to download multimedia:

查看原始内容以下载多媒体：

https://www.prnewswire.com/news-releases/johnson--johnson-unveils-highly-anticipated-and-potential-practice-changing-data-in-bladder-cancer-treatment-at-aua-302433399.html

https://www.prnewswire.com/news-releases/强生公司在泌尿外科协会年会上发布备受期待且可能改变膀胱癌治疗实践的重要数据-302433399.html

SOURCE Johnson & Johnson

来源：强生公司