The first patient has been dosed in the

第一名患者已经给药

IDeate-Prostate01

IDEate-前列腺01

phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor.

评估研究性药物ifinatamab deruxtecan (I-DXd)与多西他赛在转移性去势抵抗性前列腺癌（mCRPC）患者中的疗效和安全性，这些患者在接受雄激素受体通路抑制剂治疗期间或之后出现疾病进展。

Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

Ifinatamab deruxtecan 是一种特别设计的、潜在的首创B7-H3导向的DXd抗体药物偶联物（ADC），由第一三共（TSE: 4568）发现，并由第一三共和默克公司（纽约证券交易所代码：MRK，在美国和加拿大以外地区称为MSD）共同开发。

While localized prostate cancer has a five-year survival rate of more than 90%, survival decreases to 31% in the advanced or metastatic stage.

虽然局部前列腺癌的五年生存率超过90%，但在晚期或转移阶段，生存率下降到31%。

Current standard of care for patients with mCRPC includes treatment with androgen receptor pathway inhibitors followed by taxane-based chemotherapy.

当前对mCRPC患者的治疗标准包括使用雄激素受体通路抑制剂，随后进行基于紫杉烷的化疗。

However, due to poor prognosis associated with previously treated mCRPC, many patients do not receive subsequent therapy, reinforcing the need for new approaches to improve outcomes.

然而，由于之前治疗过的mCRPC预后较差，许多患者未接受后续治疗，这进一步强调了需要新方法来改善结果。

“Despite the emergence of new therapies, the current treatment landscape for patients with metastatic castration-resistant prostate cancer is challenging, and there is a need for new treatments,” said Mark Rutstein, MD, Head, Therapeutic Area Oncology Development, Daiichi Sankyo. “Following the promising results seen in our earlier phase trial, IDeate-Prostate01 has been initiated to evaluate whether ifinatamab deruxtecan may replace standard taxane-based chemotherapy as a potential treatment strategy in patients with metastatic castration-resistant prostate cancer with disease progression during or after treatment with androgen receptor pathway inhibitors.”.

“尽管出现了新的疗法，转移性去势抵抗性前列腺癌患者的当前治疗前景仍充满挑战，因此需要新的治疗方法，”第一三共肿瘤学开发治疗领域负责人Mark Rutstein医学博士说道。“在我们早期试验中看到了令人鼓舞的结果后，IDeate-Prostate01研究已经启动，旨在评估ifinatamab deruxtecan是否可以替代标准的紫杉烷类化疗，成为在使用雄激素受体通路抑制剂治疗期间或之后疾病进展的转移性去势抵抗性前列腺癌患者的潜在治疗策略。”

“IDeate-Prostate01 marks the initiation of the third pivotal trial in the ifinatamab deruxtecan development program and reinforces our commitment to addressing critical unmet needs for patients,” said Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories.

“IDeate-Prostate01 标志着 ifinatamab deruxtecan 开发项目中第三项关键试验的启动，进一步彰显了我们致力于满足患者未被满足的关键需求的承诺，”默克研究实验室肿瘤学高级副总裁兼全球临床开发主管 Marjorie Green 医学博士表示。

“Our continued progress in the exploration of this potential first-in-class B7-H3 antibody drug conjugate in collaboration with Daiichi Sankyo, speaks to our pursuit of novel science in the hopes of making a difference for patients in need of new options.”.

“我们与第一三共合作，持续推进这种潜在的同类首个B7-H3抗体药物偶联物的探索，这表明了我们追求创新科学的决心，希望为需要新选择的患者带来改变。”

The initiation of IDeate-Prostate01 is based on results from the

IDeate-Prostate01 的启动是基于以下结果

IDeate-PanTumor01

泛肿瘤01

phase 1/2 trial previously

之前的第一/第二阶段试验

presented

展示

at the 2022 and 2023 European Society of Medical Oncology (ESMO) Congresses where ifinatamab deruxtecan showed promising responses in heavily pretreated patients with mCRPC.

在2022年和2023年欧洲肿瘤内科学会（ESMO）大会上，ifinatamab deruxtecan在经过多线治疗的mCRPC患者中显示出良好的反应。

About the IDeate-Prostate01 Trial

关于IDeate-Prostate01试验

IDeate-Prostate01

IDEate-前列腺01

is a multicenter, open-label, randomized phase 3 trial evaluating the safety and efficacy of ifinatamab deruxtecan (12 mg/kg) versus docetaxel (75 mg/m

是一项多中心、开放标签、随机的 3 期试验，评估 ifinatamab deruxtecan（12 mg/kg）与多西他赛（75 mg/m²）的安全性和有效性。

) plus corticosteroid in patients with mCRPC. Eligible patients must have received prior treatment with one or two androgen receptor pathway inhibitors and experienced disease progression during or after at least eight weeks of treatment.

）加皮质类固醇用于治疗mCRPC患者。符合条件的患者必须曾接受过一种或两种雄激素受体通路抑制剂的治疗，并在至少八周的治疗期间或之后出现疾病进展。

The dual primary endpoints of IDeate-Prostate01 are overall survival and radiographic progression-free survival. Secondary endpoints include objective response rate, time to first subsequent therapy, duration of response, time to pain progression, time to prostate-specific antigen (PSA) progression, PSA response, time to first symptomatic skeletal-related event and safety..

IDeate-Prostate01 的双重主要终点是总生存期和影像学无进展生存期。次要终点包括客观缓解率、至首次后续治疗的时间、缓解持续时间、至疼痛进展的时间、至前列腺特异性抗原（PSA）进展的时间、PSA 反应、至首次症状性骨骼相关事件的时间以及安全性。

IDeate-Prostate01 will enroll approximately 1,440 patients across Asia, Europe, North America and Oceania. For more information, please visit

IDeate-Prostate01 将在亚洲、欧洲、北美和大洋洲招募大约 1,440 名患者。欲了解更多信息，请访问

About Metastatic Castration-Resistant Prostate Cancer

关于转移性去势抵抗性前列腺癌

Prostate cancer is the second most common cancer in men, and the fifth leading cause of cancer death in men worldwide.

前列腺癌是男性中第二常见的癌症，也是全球男性癌症死亡的第五大原因。

Nearly 1.5 million prostate cancer cases were diagnosed in 2022, with approximately 400,000 deaths globally.

2022年诊断出近150万前列腺癌病例，全球约有40万人死亡。

While localized prostate cancer has a five-year survival rate of more than 90%, survival decreases to 31% in advanced or metastatic stage.

虽然局部前列腺癌的五年生存率超过90%，但在晚期或转移阶段，生存率下降到31%。

Approximately 10% to 20% of early-stage prostate cancer cases progress to metastatic disease within five years of treatment on hormonal therapies such as androgen deprivation therapy.

大约10%到20%的早期前列腺癌病例在使用激素疗法（如雄激素剥夺疗法）治疗后的五年内会发展为转移性疾病。

Current standard of care for patients with mCRPC includes treatment with androgen receptor pathway inhibitors followed by taxane-based chemotherapy. However, due to poor prognosis associated with previously treated mCRPC, many patients do not receive subsequent therapy, reinforcing the need for new approaches to improve outcomes..

目前，mCRPC患者的标准治疗方案包括使用雄激素受体通路抑制剂，随后进行以紫杉烷为基础的化疗。然而，由于先前接受过治疗的mCRPC预后较差，许多患者未能接受后续治疗，这进一步凸显了对改善结果的新方法的需求。

About B7-H3

关于B7-H3

B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1.

B7-H3是一种跨膜蛋白，属于B7家族蛋白，该家族蛋白与包括PD-1在内的CD28家族受体结合。

B7-H3 is overexpressed in a wide range of cancer types, including mCRPC and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target.

B7-H3 在多种癌症类型中过表达，包括转移性去势抵抗性前列腺癌（mCRPC），其过表达已被证明与不良预后相关，这使得 B7-H3 成为一个有前景的治疗靶点。

There are currently no B7-H3 directed medicines approved for the treatment of any cancer.

目前没有任何针对B7-H3的药物被批准用于治疗任何癌症。

About Ifinatamab Deruxtecan

关于伊菲纳单抗 Deruxtecan

Ifinatamab deruxtecan (I-DXd) is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers..

Ifinatamab deruxtecan（I-DXd）是一种研究性的潜在首创B7-H3导向的抗体药物偶联物（ADC）。该药物采用第一三共株式会社专有的DXd ADC技术研发，由一种人源化的抗B7-H3 IgG1单克隆抗体通过基于四肽的可裂解连接子与多个拓扑异构酶I抑制剂载荷（一种依沙替康衍生物，DXd）结合而成。

Ifinatamab deruxtecan has been granted orphan drug designation by the U.S. Food and Drug Administration, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of small cell lung cancer.

Ifinatamab deruxtecan 已被美国食品药品监督管理局、欧盟委员会、日本厚生劳动省和台湾食品药品监督管理局授予治疗小细胞肺癌的孤儿药资格。

About the Ifinatamab Deruxtecan Clinical Development Program

关于Ifinatamab Deruxtecan的临床开发计划

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan across multiple B7-H3 targetable cancers. Trials in combination with other anticancer treatments also are underway.

一项全面的全球临床开发计划正在进行中，评估 ifinatamab deruxtecan 在多种 B7-H3 可靶向癌症中的疗效和安全性。与其他抗癌治疗联合使用的试验也在进行中。

About the Daiichi Sankyo and Merck Collaboration

关于第一三共和默克的合作

Daiichi Sankyo and Merck entered into a global collaboration in

第一三共和默克公司建立了全球合作关系

October 2023

2023年10月

to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In

共同开发和商业化 patritumab deruxtecan (HER3-DXd)、ifinatamab deruxtecan (I-DXd) 和 raludotatug deruxtecan (R-DXd)，但在日本除外，Daiichi Sankyo 将保留独家权利。Daiichi Sankyo 将全权负责制造和供应。在…

August 2024

2024年8月

, the global co-development and co-commercialization agreement was expanded to include gocatamig (MK-6070/DS3280), which the companies will jointly develop and commercialize worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for gocatamig..

全球共同开发和共同商业化协议已扩展到包括戈卡替尼（MK-6070/DS3280），两家公司将在全球范围内联合开发和商业化该药物，但日本除外，在日本默克仍将保留独家权利。默克将单独负责戈卡替尼的生产和供应。

About the ADC Portfolio of Daiichi Sankyo

关于第一三共的ADC产品组合

The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

第一三共的ADC产品组合包括七个处于临床开发阶段的ADC，这些ADC由第一三共内部发现的两个不同的ADC技术平台构建而成。

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU.

在临床开发中进展最快的ADC平台是第一三共的DXd ADC技术，其中每个ADC由单克隆抗体通过四肽可裂解连接子连接多个拓扑异构酶I抑制剂载荷（艾沙替康衍生物，DXd）组成。目前DXd ADC产品组合包括ENHERTU。

, a HER2 directed ADC, and DATROWAY

，一种HER2导向的ADC，以及DATROWAY

, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA.

，这是一类由阿斯利康全球共同开发和商业化的TROP2导向的ADC。Patritumab deruxtecan（HER3-DXd）是一种HER3导向的ADC，Ifinatamab deruxtecan（I-DXd）是一种B7-H3导向的ADC，Raludotatug deruxtecan（R-DXd）是一种CDH6导向的ADC，这些药物正与美国新泽西州拉威市的默克公司（Merck & Co., Inc.）全球共同开发和商业化。

DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo..

DS-3939是一种由大冢制药开发的靶向TA-MUC1的抗体药物偶联物（ADC）。

The second consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.

第二种由连接到修饰的吡咯并苯二氮杂卓（PBD）有效载荷的单克隆抗体组成。DS-9606是一种针对CLDN6的PBD抗体药物偶联物（ADC），是利用该平台进行临床开发的计划中的多个ADC中的第一个。

Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

Ifinatamab deruxtecan、patritumab deruxtecan、raludotatug deruxtecan、DS-3939 和 DS-9606 是尚未在任何国家获批用于任何适应症的在研药物，其安全性和有效性尚未确定。

About Daiichi Sankyo

关于第一三共

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs.

第一三共是一家创新的全球医疗保健公司，致力于为社会的可持续发展做出贡献，通过发现、开发和提供新的护理标准来提升世界各地人们的生活质量。凭借120多年的经验，第一三共利用其世界级的科学技术，为癌症、心血管疾病及其他存在高度未满足医疗需求的疾病患者创造新的治疗模式和创新药物。

Merck’s Focus on Cancer

默克公司对癌症的关注

Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms.

每一天，我们在努力发现能够帮助患者的新方法时都遵循科学，无论他们处于癌症的哪个阶段。作为一家领先的肿瘤学公司，我们正在探索科学机遇与医疗需求交汇处的研究，并依托我们多样化的、包含25种以上新型机制的研发管线。

With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care.

通过在30多种肿瘤类型中开展规模最大的临床开发项目之一，我们致力于推进突破性的科学进展，这将塑造肿瘤学的未来。通过解决参与临床试验、筛查和治疗的障碍，我们紧急行动以减少差异，并帮助确保患者能够获得高质量的癌症治疗。

Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit .

我们坚定不移的承诺将使我们更接近为更多癌症患者带来生命的目标。欲了解更多信息，请访问。

About Merck

关于默克公司

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines.

在默克（美国和加拿大以外地区称为MSD），我们团结一致，致力于我们的使命：利用前沿科学的力量拯救生命并改善全球人类的生活。130多年来，我们通过研发重要的药物和疫苗，为人类带来了希望。

We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

我们立志成为全球首屈一指的研究密集型生物制药公司——今天，我们站在研究的最前沿，提供创新的健康解决方案，推动人类和动物疾病预防与治疗的进步。我们培养多元化和包容性的全球员工队伍，并每天负责任地运营，以确保为所有人和社区创造一个安全、可持续和健康的未来。