BASKING RIDGE, NJ AND RAHWAY, NJ, – Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy..

新泽西州巴斯金岭和新泽西州拉威——Ifinatamab deruxtecan（I-DXd）已被美国食品药品监督管理局（FDA）授予突破性疗法认定（BTD），用于治疗在铂类化疗期间或之后疾病进展的广泛期小细胞肺癌成年患者。

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 是由第一三共（TSE: 4568）发现的专门设计的潜在首创新药 B7-H3导向的DXd抗体药物偶联物（ADC），并由第一三共和默克公司（NYSE: MRK，在美国和加拿大以外地区称为MSD）共同开发。

The FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine is required to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over currently available medicines..

FDA的突破性疗法认定（BTD）旨在加速用于治疗严重疾病并满足重大未满足医疗需求的潜在新药的开发和监管审评。该药物需展示出令人鼓舞的初步临床结果，证明其在具有临床意义的终点上相较于现有药物有显著改善。

The FDA granted the BTD based on data from the

FDA 根据以下数据授予了 BTD

IDeate-Lung01

肺部IDEATE-Lung01

Phase 2 trial, with support from the

第二阶段试验，得到支持来自

IDeate-PanTumor01

泛肿瘤01号 идеат

Phase 1/2 trial. Results from the primary analysis of IDeate-Lung01 will be presented in a late-breaking oral presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25). This is the first BTD for ifinatamab deruxtecan and represents the first BTD since the start of the Daiichi Sankyo and Merck collaboration..

1/2期试验。IDeate-Lung01的主要分析结果将在国际肺癌研究协会（IASLC）主办的2025年世界肺癌大会（#WCLC25）上以最新突破性口头报告形式展示。这是ifinatamab deruxtecan获得的首个突破性疗法认定（BTD），也是自第一三共与默克合作以来的首个BTD。

“This Breakthrough Therapy Designation granted by the FDA to ifinatamab deruxtecan highlights the urgent need for new treatment options for patients with pretreated extensive-stage small cell lung cancer,” said Ken Takeshita, MD, global head, R&D, Daiichi Sankyo. “We are committed to advancing this medicine with the goal of bringing the first B7-H3 directed antibody drug conjugate to patients in order to transform the outcomes of those facing this aggressive disease.”.

“FDA授予ifinatamab deruxtecan突破性疗法认定，突显了先前接受过治疗的广泛期小细胞肺癌患者对新治疗方案的迫切需求，”第一三共全球研发负责人Ken Takeshita博士表示，“我们致力于推进这一药物的发展，目标是将首个靶向B7-H3的抗体药物偶联物带给患者，以改变那些面临这种侵袭性疾病患者的治疗结果。”

“Patients living with extensive-stage small cell lung cancer often have limited therapeutic options following disease progression after standard of care treatments,” said Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

“患有广泛期小细胞肺癌的患者在标准治疗后疾病进展，通常治疗选择有限，”默克研究实验室高级副总裁、全球临床开发主管兼首席医学官埃利亚夫·巴尔 (Eliav Barr) 医学博士表示。

“This Breakthrough Therapy Designation reinforces our confidence in the promise of ifinatamab deruxtecan to play an important role in the treatment of extensive-stage small cell lung cancer, and we are looking forward to sharing data at the upcoming IASLC 2025 World Conference on Lung Cancer that show the potential of this novel option.”.

“这一突破性疗法认定加强了我们对ifinatamab deruxtecan在广泛期小细胞肺癌治疗中发挥重要作用的信心，我们期待在即将召开的2025年国际肺癌研究协会世界肺癌大会上分享展示这一创新选择潜力的数据。”

About IDeate-Lung01

关于IDeate-Lung01

IDeate-Lung01

肺部创意01

is a global, multicenter, randomized, open-label, two-part Phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer who were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy.

是一项全球性、多中心、随机、开放标签、两部分的 2 期试验，评估 ifinatamab deruxtecan 在曾接受过至少一线含铂化疗且最多三线治疗的广泛期小细胞肺癌患者中的安全性和有效性。

Patients with asymptomatic brain metastases (untreated or previously treated) were eligible..

患有无症状脑转移（未经治疗或先前已治疗）的患者符合资格。

In the first part of the trial (dose optimization), patients were randomized 1:1 to receive ifinatamab deruxtecan 8 or 12 mg/kg intravenously Q3W. In the second part of the trial (dose expansion), patients received ifinatamab deruxtecan 12 mg/kg intravenously Q3W.

在试验的第一部分（剂量优化），患者被随机分配（1:1）接受每三周一次静脉注射8或12 mg/kg的ifinatamab deruxtecan。在试验的第二部分（剂量扩展），患者接受每三周一次静脉注射12 mg/kg的ifinatamab deruxtecan。

The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Secondary endpoints included duration of response, progression-free survival, disease control rate, time to response, overall survival, pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis. .

主要终点是由盲态独立中心审查（BICR）根据RECIST v1.1评估的客观缓解率（ORR）。次要终点包括缓解持续时间、无进展生存期、疾病控制率、缓解时间、总生存期、药代动力学和安全性。颅内ORR由BICR作为探索性分析进行评估。

IDeate-Lung01 enrolled 187 patients in Asia, Europe and North America. For more information about the trial, visit

IDeate-Lung01 在亚洲、欧洲和北美招募了 187 名患者。有关试验的更多信息，请访问

About IDeate-PanTumor01

关于IDeate-PanTumor01

IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label Phase 1/2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists..

IDeate-PanTumor01是一项全球性、多中心、首次人体试验的开放标签1/2期研究，评估ifinatamab deruxtecan在晚期/不可切除或转移性实体瘤患者中的安全性和有效性，这些患者的肿瘤对标准治疗无效或不耐受，或无可用的标准治疗。

The Phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose and recommended dose for expansion (RDE). The Phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous non-small cell lung cancer, metastatic castration-resistance prostate cancer or esophageal squamous cell carcinoma..

试验的第 1 阶段（剂量递增）部分正在评估 ifinatamab deruxtecan 递增剂量的安全性和耐受性，以确定最大耐受剂量和扩展剂量建议 (RDE)。试验的第 2 阶段（剂量扩展）部分正在评估 ifinatamab deruxtecan 在 12 mg/kg RDE 下对鳞状非小细胞肺癌、转移性去势抵抗性前列腺癌或食管鳞状细胞癌患者的安全性和有效性。

The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating overall response rate, duration of response, disease control rate, progression-free survival, overall survival and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints will also be assessed..

试验的剂量递增部分正在评估剂量限制性毒性和安全性。试验的剂量扩展部分正在评估总体缓解率、缓解持续时间、疾病控制率、无进展生存期、总生存期和安全性。还将评估药代动力学终点、探索性生物标志物和免疫原性终点。

IDeate-PanTumor01 enrolled approximately 250 patients in Asia and North America. For more information about the trial, visit

IDeate-PanTumor01 在亚洲和北美招募了大约 250 名患者。有关该试验的更多信息，请访问

About small cell lung cancer

关于小细胞肺癌

More than 2.48 million lung cancer cases were diagnosed globally in 2022. Small cell lung cancer (SCLC) is the second most common type of lung cancer, accounting for approximately 15% of cases. SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate.

2022 年全球诊断出超过 248 万例肺癌病例。小细胞肺癌 (SCLC) 是第二常见的肺癌类型，约占病例的 15%。SCLC 具有侵袭性，迅速进展到远处转移阶段，其五年生存率较低。

While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches..

虽然对于晚期小细胞肺癌患者，传统的标准治疗可能有助于改善预后，但还需要额外的后续治疗方案。

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

B7-H3是一种属于B7蛋白家族的跨膜蛋白，该家族蛋白与包括PD-1在内的CD28受体家族结合。B7-H3在多种癌症类型中过度表达，包括小细胞肺癌（SCLC），其过度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ifinatamab 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) 是一种潜在的首创 B7-H3导向抗体药物偶联物（ADC），目前正处于研究阶段。该药物采用第一三共公司专有的DXd ADC技术研发，由一种人源化的抗B7-H3 IgG1单克隆抗体组成，通过四肽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）相连。

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

Ifinatamab deruxtecan 已被美国 FDA、欧盟委员会、日本厚生劳动省和台湾食品药物管理局授予治疗小细胞肺癌（SCLC）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 monotherapy and in combination with other anticancer medicines across multiple cancers.

一项全面的全球临床开发计划正在进行中，评估 ifinatamab deruxtecan 单药治疗及与其他抗癌药物联合治疗在多种癌症中的疗效和安全性。

About the Daiichi Sankyo and Merck collaboration

关于第一三共和默克的合作

Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada) entered into a global collaboration in

第一三共和默克（在美国和加拿大以外地区称为MSD）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 & Co., Inc., Rahway, N.J., USA will maintain exclusive rights. Merck & Co., Inc., Rahway, N.J., USA 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，但默克公司（Merck & Co., Inc.，新泽西州拉威市，美国）将保留其在日本的独家权利。默克公司将全权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由单克隆抗体通过基于四肽的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.

，一种针对TROP2的抗体药物偶联物（ADC），正与阿斯利康全球共同开发和商业化。Patritumab deruxtecan（HER3-DXd）是一种靶向HER3的ADC，Ifinatamab deruxtecan（I-DXd）是一种靶向B7-H3的ADC，Raludotatug deruxtecan（R-DXd）是一种靶向CDH6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是一种针对TA-MUC1的抗体药物偶联物（ADC），由第一三共（Daiichi Sankyo）开发。

The second Daiichi Sankyo ADC platform 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.

第二个第一三共ADC平台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 ADC，是利用该平台进行临床开发的多个计划中的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.

如果那单抗 deruxtecan、帕特立单抗 deruxtecan、拉鲁多单抗 deruxtecan、DS-3939 和 DS-9606 是研究性药物，在任何国家均未获准用于任何适应症。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创新时都会遵循科学，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会与医疗需求交汇处的研究，并依托我们包含25种以上新型机制的多样化研发管线。

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.

通过在超过30种肿瘤类型中开展规模最大的临床开发项目之一，我们致力于推动突破性的科学发展，以塑造肿瘤学的未来。通过解决参与临床试验、筛查和治疗的障碍，我们正在紧急努力减少差异，帮助确保患者能够获得高质量的癌症护理。

About Merck

关于默克

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），我们围绕一个使命团结一致：我们利用前沿科学的力量来拯救和改善世界各地的生命。130多年来，我们通过开发重要的药物和疫苗为人类带来希望。