Phase 1 trial demonstrates encouraging clinical activity of investigational immunotherapy for relapsed or refractory multiple myeloma

第一阶段试验显示，研究性免疫疗法对复发或难治性多发性骨髓瘤具有令人鼓舞的临床活性。

Novel investigational dual-antigen-targeting immunotherapy binds to B-cell maturation antigen (BCMA) and GPRC5D on myeloma cells, as well as CD3 on T-cells

新型研究性双抗原靶向免疫疗法可结合骨髓瘤细胞上的B细胞成熟抗原（BCMA）和GPRC5D，以及T细胞上的CD3。

CHICAGO

芝加哥

,

，

June 3, 2025

2025年6月3日

/PRNewswire/ -- Johnson & Johnson announced today initial Phase 1 results of JNJ-79635322 (JNJ-5322), a novel investigational trispecific antibody (TsAb) in patients with relapsed or refractory multiple myeloma. Among the 36 patients who received the recommended phase 2 dose (RP2D), the overall response rate (ORR) was 86.1 percent.

/PRNewswire/ -- 今天，强生公司宣布了JNJ-79635322（JNJ-5322）的初步1期临床试验结果，这是一种用于治疗复发或难治性多发性骨髓瘤患者的新型三特异性抗体（TsAb）。在接受推荐的2期剂量（RP2D）的36名患者中，总缓解率（ORR）为86.1%。

In the 27 patients who were naive to BCMA and GPRC5D directed therapies, the ORR was 100 percent at the RP2D. Findings were featured in an oral presentation at the .

在27名未接受过BCMA和GPRC5D导向治疗的患者中，RP2D下的ORR为100%。研究结果在某次会议的口头报告中展示。

2025 American Society of Clinical Oncology (ASCO) Annual Meeting

2025年美国临床肿瘤学会（ASCO）年会

(Abstract #

（摘要 #

7505

7505

). The study will also be featured as one of the six best abstracts during the Plenary Abstracts Session at the

). 该研究还将在全体会议摘要会议上作为六个最佳摘要之一展示。

2025 European Hematology Association (EHA) Congress

2025年欧洲血液学协会（EHA）大会

(Abstract #

（摘要 #

S100

S100

).

）。

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JNJ-5322 has a novel and distinct structure that builds upon the experience with two approved first-in-class bispecific antibodies: teclistamab and talquetamab. Unlike these bispecific antibodies, JNJ-5322 is a single molecule that simultaneously binds to three distinct targets (BCMA and GPRC5D on multiple myeloma cells, as well as CD3 on T-cells).

JNJ-5322具有一个新颖且独特的结构，该结构基于两种已获批的首创双特异性抗体（teclistamab和talquetamab）的经验。然而，与这些双特异性抗体不同，JNJ-5322是一个能够同时结合三个不同靶点（多发性骨髓瘤细胞上的BCMA和GPRC5D，以及T细胞上的CD3）的单一分子。

JNJ-5322 targets two myeloma antigens, with the goal of overcoming tumor heterogeneity and preventing the development of resistance..

JNJ-5322靶向两种骨髓瘤抗原，旨在克服肿瘤异质性并防止耐药性的发展。

In the Phase 1, first-in-human study (

在第一阶段，首次人体研究 (

NCT05652335

NCT05652335

), researchers investigated escalating doses of JNJ-5322 in heavily pretreated patients with relapsed or refractory multiple myeloma. In the trial, 126 patients received JNJ-5322 with a median follow-up of 8.2 months. The recommended RP2D of 100 mg Q4W consists of one step-up dose of 5 mg and monthly dosing with 100 mg thereafter..

研究人员在重度预处理的复发或难治性多发性骨髓瘤患者中研究了JNJ-5322的递增剂量。在试验中，126名患者接受了JNJ-5322治疗，中位随访时间为8.2个月。推荐的RP2D为100 mg Q4W，包括一个5 mg的起始剂量，随后每月一次100 mg的维持剂量。

'The response rate with JNJ-5322 is encouraging as we explore the potential of this trispecific antibody for the treatment of relapsed or refractory multiple myeloma patients,' said Niels van de Donk, M.D., Ph. D., VU University Medical Center, Amsterdam, Netherlands. 'In addition to its monthly dosing and promising efficacy, the results indicate a promising safety profile and that further study of JNJ-5322 is warranted.'.

“JNJ-5322的反应率令人鼓舞，因为我们正在探索这种三特异性抗体在治疗复发或难治性多发性骨髓瘤患者中的潜力，”荷兰阿姆斯特丹VU大学医学中心的Niels van de Donk博士表示。“除了每月一次的给药和颇具前景的疗效外，结果还显示出良好的安全性，这表明有必要对JNJ-5322进行进一步研究。”

'These promising data are a major step forward as Johnson & Johnson works to transform outcomes in oncology with next-generation immunotherapies, building on our leading portfolio of complementary and combinable therapies. We look forward to seeing the results of planned Phase 2 and Phase 3 studies,' said Jordan Schecter, M.D., Vice President, Research & Development, Multiple Myeloma, Johnson & Johnson Innovative Medicine.

“这些令人鼓舞的数据是强生公司迈出的重要一步，我们致力于通过下一代免疫疗法改变肿瘤学的治疗结果，这建立在我们领先的互补和可组合疗法组合的基础上。我们期待看到计划中的二期和三期研究的结果，”强生创新医学部多发性骨髓瘤研发副总裁乔丹·谢克特博士表示。

'We hope to redefine what's possible in terms of efficacy and safety, creating another strong treatment option clinicians can choose based on the needs of their patients with relapsed or refractory multiple myeloma.'.

“我们希望重新定义疗效和安全性的可能性，为临床医生提供另一个强有力的选择，以满足复发或难治性多发性骨髓瘤患者的需求。”

The most common adverse event was cytokine release syndrome (CRS), occurring in 59 percent of patients, but no events were Grade 3 or higher. Twenty-eight percent of patients experienced Grade 3 or higher infections. Five patients had dose-limiting toxicities, and four treatment emergent patient deaths due to adverse events were reported, with one death caused by adenoviral encephalitis related to the drug..

最常见的不良事件是细胞因子释放综合征 (CRS)，发生在 59% 的患者中，但没有发生 3 级或更高级别的事件。28% 的患者经历了 3 级或更高级别的感染。五名患者出现剂量限制性毒性，并报告了四例因不良事件导致的治疗相关患者死亡，其中一例死亡是由与药物相关的腺病毒脑炎引起的。

Taste-related AEs were reported in 58 percent of patients, majority Grade 1. The incidence of other GPRC5D-related oral AEs was low, with dry mouth reported in 17 percent of patients (no Grade 2 at RP2D) and dysphagia reported in less than 4 percent of patients (no reported events at the RP2D). In addition, grade 1/2 weight loss occurred in 6% (RP2D) and 12% (all doses) of patients, with no Grade ≥3 weight loss events..

与味觉相关的不良事件（AEs）在58%的患者中报告，大多数为1级。其他与GPRC5D相关的口腔不良事件发生率较低，其中17%的患者报告口干（在RP2D剂量下无2级事件），不到4%的患者报告吞咽困难（在RP2D剂量下无报告事件）。此外，1/2级体重减轻发生在6%（RP2D剂量）和12%（所有剂量）的患者中，未出现≥3级的体重减轻事件。

About Multiple Myeloma

关于多发性骨髓瘤

Multiple myeloma is a blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.

多发性骨髓瘤是一种影响浆细胞的血液癌症，浆细胞是一种存在于骨髓中的白细胞。

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2

In multiple myeloma, these malignant plasma cells proliferate and replace normal cells in the bone marrow.

在多发性骨髓瘤中，这些恶性的浆细胞增殖并取代骨髓中的正常细胞。

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Multiple myeloma is the second most common blood cancer worldwide and remains an incurable disease.

多发性骨髓瘤是全球第二常见的血液癌症，仍然是一种无法治愈的疾病。

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In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 will die from the disease.

据估计，2024年美国将有超过35,000人被诊断出患有多发性骨髓瘤，超过12,000人将死于该疾病。

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People with multiple myeloma have a 5-year survival rate of 59.8 percent. While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections..

多发性骨髓瘤患者的五年生存率为 59.8%。虽然一些被诊断为多发性骨髓瘤的人最初没有症状，但大多数患者因可能出现的症状而被诊断出来，这些症状包括骨折或疼痛、红细胞计数低、疲倦、钙水平高、肾脏问题或感染等。

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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，并且解决方案是个性化的。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保健解决方案领域进行创新，以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，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 and Janssen Biotech, Inc., and Janssen Global Services, LLC are Johnson & Johnson companies.

Janssen Research & Development, LLC、Janssen Biotech, Inc. 以及 Janssen Global Services, LLC 均为 Johnson & Johnson 旗下公司。

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 JNJ-79635322. 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JNJ-79635322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 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.

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，实际结果可能与强生公司的预期和预测大相径庭。风险和不确定性包括但不限于：产品研发固有的挑战和不确定性，包括临床成功的不确定性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、竞争对手推出的新产品和取得的专利；对专利的挑战；因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、不确定性及其他因素的进一步列表和描述，请参见强生公司最近的年度报告 Form 10-K，特别是标题为“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 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。

http://www.sec.gov

http://www.sec.gov

,

，

http://www.jnj.com

http://www.jnj.com

, or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

，或者应Johnson & Johnson的要求。Johnson & Johnson不承担因新信息或未来事件或发展而更新任何前瞻性声明的责任。

*

*

Niels van de Donk, M.D., Ph. D., VU University Medical Center, Amsterdam, Netherlands

尼尔斯·范·德·东克，医学博士，哲学博士，阿姆斯特丹自由大学医学中心，荷兰阿姆斯特丹

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

，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。

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NWCJ van de Donk, et. al. First-in-human study of JNJ-79635322 (JNJ-5322), a novel, next-generation trispecific antibody (TsAb), in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Initial phase 1 results. ASCO 2025. June 3, 2025.

NWCJ van de Donk等。首次人体研究：JNJ-79635322（JNJ-5322），一种新型的下一代三特异性抗体（TsAb），用于治疗复发/难治性多发性骨髓瘤（RRMM）患者：初步1期结果。ASCO 2025，2025年6月3日。

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Rajkumar SV. Multiple Myeloma: 2020 Update on Diagnosis, Risk-Stratification and Management

Rajkumar SV。多发性骨髓瘤：2020年关于诊断、风险分层和管理的更新

.

。

Am J Hematol

美国血液学杂志

. 2020;95(5):548-5672020;95(5):548-567.

. 2020;95(5):548-5672020;95(5):548-567.

http://www.ncbi.nlm.nih.gov/pubmed/32212178

http://www.ncbi.nlm.nih.gov/pubmed/32212178

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National Cancer Institute. Plasma Cell Neoplasms. Accessed August 2024. Available at:

国家癌症研究所。浆细胞肿瘤。2024年8月访问。可访问网址：

https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq

https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq

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4

Multiple Myeloma. City of Hope, 2022. Multiple Myeloma: Causes, Symptoms & Treatments. Accessed August 2024. Available at:

多发性骨髓瘤。希望之城，2022。多发性骨髓瘤：原因、症状与治疗。2024年8月访问。可用链接：

https://www.cancercenter.com/cancer-types/multiple-myeloma

https://www.cancercenter.com/cancer-types/multiple-myeloma

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American Cancer Society. Myeloma Cancer Statistics. Accessed August 2024. Available at:

美国癌症协会。骨髓瘤癌症统计。2024年8月访问。可用链接：

https://cancerstatisticscenter.cancer.org/types/myeloma

https://cancerstatisticscenter.cancer.org/types/骨髓瘤

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American Cancer Society. What is Multiple Myeloma? Accessed August 2024. Available at:

美国癌症协会。什么是多发性骨髓瘤？2024年8月访问。可用链接：

https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html

https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html

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American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. Accessed August 2024. Available at:

美国癌症协会。多发性骨髓瘤的早期检测、诊断和分期。2024年8月访问。可用链接：

https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html

https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html

Media contact:

媒体联系人：

Oncology Media Relations

肿瘤学媒体关系

Oncology_media_relations@its.jnj.com

肿瘤学媒体关系@its.jnj.com

Investor contact:

投资者联系方式：

Lauren Johnson

劳伦·约翰逊

investor-relations@its.jnj.com

投资者关系@its.jnj.com

U.S. medical inquiries:

美国医学询问：

+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/early-results-from-johnson--johnsons-trispecific-antibody-show-promising-response-in-heavily-pretreated-multiple-myeloma-patients-302471267.html

https://www.prnewswire.com/news-releases/强生公司的三特异性抗体早期结果显示在多线治疗后的多发性骨髓瘤患者中具有良好的反应-302471267.html

SOURCE Johnson & Johnson

来源：强生公司