Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.

开始日期2015-12-22

申办/合作机构

Daiichi Sankyo Co., Ltd.

NCT02350712

/ Completed临床1期

An Open Label, Phase 1B Safety Evaluation of Patritumab (U31287) in Combination With Cetuximab Plus Platinum Containing Therapy In Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to test a study drug called patritumab. Patritumab may work when combined with other medications that are approved in the UK for treating Squamous Cell Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. It is hoped that patritumab may have some benefit in treating patients with cancer. This study will help identify how much patritumab can be given in combination with cetuximab, and cisplatin or carboplatin. This study will show how safe and how well tolerated patritumab is when these medications are given together.

开始日期2014-12-01

申办/合作机构

Daiichi Sankyo Co., Ltd.

NCT02134015

/ Terminated临床3期

Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center, Two-Part Study of Patritumab (U3-1287) In Combination With Erlotinib in EGFR Wild-type Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Systemic Therapy

1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin.
2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.

开始日期2014-03-01

申办/合作机构

Daiichi Sankyo Co., Ltd.

[+1]

100 项与 Patritumab 相关的临床结果

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100 项与 Patritumab 相关的转化医学

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100 项与 Patritumab 相关的专利（医药）

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项与 Patritumab 相关的文献（医药）

2025-09-01·JOURNAL OF CLINICAL ONCOLOGY

Article

作者: Murakami, Haruyasu ; Sternberg, David W. ; Fan, Pang-Dian ; Kim, Dong-Wan ; Massarelli, Erminia ; Johnson, Melissa L. ; Felip, Enriqueta ; Fujimura, Masahiro ; Steuer, Conor E. ; Gold, Kathryn A. ; Truchon, Karine ; Hayashi, Hidetoshi ; Nishio, Makoto ; Baik, Christina S. ; Smit, Egbert F. ; Su, Wu-Chou ; Su, Xin ; Jänne, Pasi A. ; Kim, Sang-We

PURPOSE:

Patritumab deruxtecan (HER3-DXd; MK-1022) is an investigational HER3-directed antibody-drug conjugate composed of a human immunoglobulin G1 monoclonal antibody to HER3 (patritumab) covalently linked via a stable tetrapeptide-based cleavable linker to a topoisomerase I inhibitor payload that has shown durable antitumor activity in previously treated patients with EGFR -mutated advanced non–small cell lung cancer (NSCLC). We extend these observations to patients with advanced NSCLC with other/no identified driver genomic alterations.

METHODS:

Patients with advanced squamous or nonsquamous NSCLC without a common EGFR -activating mutation whose disease had progressed on previous therapies including platinum-based chemotherapy, immune checkpoint inhibitors, and targeted therapy (for patients with known actionable genomic alterations) received HER3-DXd 5.6 mg/kg intravenously once every 3 weeks. The primary end point was confirmed objective response rate (cORR).

RESULTS:

Forty-seven patients were treated with HER3-DXd (median treatment duration, 4.2 [range, 0.7-19.8] months). The cORR was 27.7% (95% CI, 15.6% to 42.6%), and the median duration of response was 8.1 (95% CI, 4.2 to not evaluable) months. The median progression-free survival was 5.5 (95% CI, 4.0 to 11.2) months, and the median overall survival was 15.2 (95% CI, 10.8 to 17.7) months. Similar efficacy was observed in patients with NSCLC harboring identified driver genomic alterations and in those without such genomic features. The rate of study drug discontinuation associated with treatment-emergent adverse events (TEAEs) was 12.8%. Study drug–related grade ≥3 TEAEs occurred in 51.1% of patients and were serious in 12.8% (none were associated with death). Adjudicated treatment-related interstitial lung disease occurred in five patients (10.6%; all grade 1 or 2).

CONCLUSION:

The previously reported efficacy and safety of HER3-DXd in heavily pretreated patients with EGFR -mutated NSCLC are also observed in those with other NSCLC subtypes and warrant further clinical evaluation.

2025-05-01·REVUE DES MALADIES RESPIRATOIRES

Pneumopathies interstitielles diffuses induites par les anticorps conjugués

Review

作者: Sagan, C ; Maurier, L ; Pons-Tostivint, E ; Chéné, A-L ; Hulo, P ; Chen, J

INTRODUCTION:

Antibody-drug conjugates (ADCs) represent a promising new therapeutic class in non-small-cell lung cancer (NSCLC) patients. Studies assessing ADC have highlighted a pulmonary toxicity profile in the form of interstitial lung disease (ILD).

STATE OF THE ART:

Several ADCs for NSCLC are currently being developed. In studies evaluating Trastuzumab-Deruxtecan (Her-2 target), incidence of drug-induced ILD ranged from 10.7 to 26.0%, and from 3.6 to 25.0% in those evaluating Datopotamab-Deruxtecan (TROP-2 target). Incidence of 9.9 and 5% of ILD was observed with Telisotuzumab-Vedotin (c-MET target) and Patritumab-Deruxtecan (Her-3 target), respectively. No cases of ILD have been reported with Sacituzumab-Govitecan (TROP-2 target) or Tusamitamab-Ravtansine (CEACAM5 target).

PERSPECTIVES:

Several risk factors for ADC-induced ILD seem to emerge, including respiratory comorbidities, renal insufficiency, or type and dosage of ADC. Current studies are focusing on the combination of ADC and immunotherapy, although there are few data now available on pulmonary toxicity profiles.

CONCLUSION:

Among the many ADCs being developed, several can cause ILD of varying grades and intensity. Knowledge of their risks, diagnostic and therapeutic modalities is required in order to quickly detect and treat ADC-induced ILD.

2025-01-01·Current medicinal chemistry

Review

作者: Ding, Ke ; Zhang, Jinwei ; Trinder, Amelia

HER3 (Human Epidermal Growth Factor Receptor 3) is frequently overexpressed in various cancers, including non-small cell lung cancer (NSCLC), with a prevalence of 83% in primary tumors. Its involvement in tumorigenesis and resistance to targeted therapies makes HER3 a promising target for cancer treatment. Despite being initially considered “undruggable” due to its lack of catalytic activity, significant progress has been made in the development of anti-HER3 therapeutics. Monoclonal antibodies such as lumretuzumab, seribantumab, and patritumab have shown potential in targeting HER3 to overcome resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). Additionally, antibody-drug conjugates (ADCs) like HER3-DXd (patritumab deruxtecan) are new drug candidates that have demonstrated selective delivery of cytotoxic chemicals to NSCLC cells by exploiting HER3's widespread expression, minimizing cytotoxicity. This review aims to evaluate the efficacy of current HER3 therapeutics in development and their therapeutic potential in NSCLC, incorporating evidence from clinical trials.

205

项与 Patritumab 相关的新闻（医药）

2025-08-27

·Biotech前瞻

默沙东Her3 ADC依然难舍，唯一仅剩三期首例入组，国内跟进者众多，何去何从？

点击蓝字关注我们本期看点 Her3靶点，既往一直被认为是不可成药靶点。随着ADC在肿瘤免疫领域的高速发展，HER3也成为研发布局的热门靶点之一。2025年ASCO上， Patritumab deruxtecan（HER3-DXd）的最新 III 期临床数据公布，虽然统计学上，主要研究终点PFS有意义，但仅延长0.4个月的中位 PFS 增益，并不足以令临床惊艳；再加上 ILD（间质性肺炎）导致的死亡病例，令原本寄予厚望的 HER3-DXd 面临“疗效微弱＋毒性风险”双重质疑。最终，第一三共和默沙东因确证性试验未达生存终点撤回HER3-DXd的FDA申请，更是坐实了该靶点的难成药性。但近日，默沙东悄然开始布局乳腺癌三期，依然难以舍弃。国内众多布局Her3 靶点的企业，相应的产品能否破局呢？本期内容 01 默沙东/第一三共丨HER3-DXd 02 Her3成药的困难性及其潜力 03 Her3 ADC 丨国内布局者 04 总结与展望【01 默沙东/第一三共丨HER3-DXd】乳腺癌 2025年8月27日，默沙东宣布，HERTHENA-Breast04三期临床试验已完成首例患者给药。该试验旨在评估在不可切除的局部晚期或转移性激素受体（HR）阳性、HER2阴性（IHC 0、IHC 1+ 或 IHC 2+/ISH-）乳腺癌患者中，研究性药物 Patritumab Deruxtecan（HER3-DXd）与研究者选择的标准治疗方案相比的疗效与安全性。这类患者均在辅助治疗或一线转移性治疗中接受过内分泌治疗及CDK4/6抑制剂治疗后出现疾病进展。这也是Patritumab Deruxtecan目前进行的唯一一项三期临床试验。由此可见，默沙东迫切寻求K药后时代下的潜力产品，即使Patritumab Deruxtecan既往在肺癌领域遭遇重大打击，依然开展乳腺癌的大三期。让我们回顾下既往的晦暗时刻。肺癌第一三共和默沙东因确证性试验未达生存终点撤回HER3-DXd的FDA申请 2024年6月26日，FDA已对默沙东/第一三共期望加速批准的Her3-Dxd的BLA给予完整回复函，此次拒绝批准是因为第三方生产问题，没有任何安全性和有效性问题。但早在一年前，默沙东曾在 HERTHENA-Lung02 顶线公布中宣称 PFS“达标”，但并未强调“临床相关性”。但遗憾的是，最终，默沙东/第一三共宣布，已自愿撤回patritumab deruxtecan的生物制品许可申请（BLA），该药物原计划作为潜在治疗方案，用于此前接受过两种或以上系统治疗的局部晚期或转移性EGFR突变非小细胞肺癌（NSCLC）成人患者。 HER3-DXd是默沙东在2023年秋季支付40亿美元首付给第一三共和的三个ADC资产之一，合作进行共同开发和商业化。在签署协议时，HER3-DXd被认为是最接近上市的药物。此次决定部分基于3期HERTHENA-Lung02试验的总体生存（OS）顶线结果，该结果在2025 ASCO 年会上公布：标题： Patritumab deruxtecan(HER3-DXd)用于三代EGFR-TKI治疗后耐药的EGFR突变(EGFRm)晚期非小细胞肺癌(NSCLC)患者：III期HERTHENA-Lung02研究研究设计HERTHENA-Lung02（NCT05338970）是一项针对三代 EGFR-TKI 耐药后 EGFR 突变（Ex19del 或 L858R）晚期非小细胞肺癌（NSCLC）患者的随机、开放标签 III 期研究。 HERTHENA-Lung02 研究设计 586 名患者按 1:1 随机接受 HER3-DXd 或铂类化疗（PBC），主要终点为中央独立影像委员会（BICR）评估的无进展生存期（PFS），关键次要终点为总生存期（OS）。关键数据中位 PFS：HER3-DXd 5.8 个月 vs PBC 5.4 个月（HR 0.77；95% CI 0.63–0.94；P=0.011） 6 个月 PFS 率：50% vs 38% ORR）35.2% vs 25.3% 中位缓解持续时间（DoR）：5.7 个月 vs 5.4 个月脑转移亚组：颅内 PFS 5.4 个月 vs 4.2 个月（HR 0.75；95% CI 0.53–1.06）安全性：HER3-DXd 组 ≥3 级不良事件 73%（主因 ≥3 级血小板减少 30%）；药物相关 ILD 共 14 例（5%，含 2 例死亡）。担忧的事情发生了，ADC的间质性肺炎问题再次暴露出来。且PFS为主要终点，HR值为0.77，非常巧妙的数值，而OS获益问题，再次也暴露出来。上一次争论的焦点还是康方生物的PD-1/VEGF双抗与K药的巅峰对决，究竟OS最终能否真正做出差异。 02 Her3成药的困难性及其潜力靶向HER3的肿瘤药物研发，之所以进展缓慢。主要是由于HER3本身结合力较低，不具有如HER2等其他家族成员的内在激酶活性，且没有合适的反映HER3激活与否的Biomarker，进而给药物研发带来非常大的困扰。但鉴于Her3靶点正常成人的胃肠道、生殖系统、皮肤、神经系统、泌尿道和内分泌系统中均有表达而HER3蛋白的过度表达与许多癌症相关，包括前列腺癌、膀胱癌和乳腺癌等。基于此，不少研发机构也将注意力由竞争激烈的HER2转移到HER3上，期冀这个与HER2同家族的靶点，也能作为肿瘤治疗的新靶点。 Her2/Her3 双抗率先突破 2024年12月4日，Merus宣布FDA批准其HER2/HER3双抗Zenocutuzumab上市，用于治疗NRG1+ 胰腺癌和非小细胞肺癌，商品名为Bizengri。开创性的里程碑事件，意味着既往被认为不可成药Her3靶点，终于以双抗的形式获批上市了。那国内一众布局Her3 ADC的企业，是否能够获得激励呢？在ADC领域，已经突破Her2靶点限制，在Trop2、CLDN15.2、Her3靶点上实现了非常多的令人惊艳的BD，本文聚焦Her3靶点 ADC的研发进展。国内已经有几家企业走在了前列。如恒瑞的Her3 ADC、信达生物的Her3 ADC、百利天恒的EGFR×HER3双抗ADC。【03 Her3 ADC 丨国内布局者】恒瑞丨Her3 ADC丨SHR-A2009 恒瑞在chinadrugtrials.org 网站上注册了一项SHR-A2009（Her3 ADC）的III期临床试验，标题为：SHR-A2009对比含铂化疗治疗表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗失败的EGFR突变晚期或转移性非小细胞肺癌的随机对照、开放性、多中心III期研究牵头专家为吴一龙教授，计划全国招募500例患者，研究终点为PFS。宜联生物丨Her3 ADC 2023年10月12日，宜联生物宣布与BioNTech达成合作，双方将合作开发新一代的HER3 ADC。 BioNTech将向宜联生物支付7000万美元首付款，以及额外开发、监管和商业化里程碑付款，潜在总金额超过10亿美元。该协议的完成将受制于常规交易达成条件，包括根据哈特-斯科特-罗丁诺（“HSR”）反垄断改进法案的批准。康方生物丨Her3 ADC丨AK138D1 2024年8月29日，双抗赛道的龙头企业，康方生物发布了2024年H1财报，在众多管线布局中，AK138D1（Her3 ADC）印入眼帘，也即意味着康方生物开始谋划布局ADC赛道，在双抗肿瘤赛道和自身免疫疾病领域接连获得诸多利好之际，手握充足现金流，聚焦未来潜力重磅领域，也是明智之举。AK138D1已于2024年7月递交IND（新药研究申请）。预计在2024年下半年进入I期临床剂量爬坡阶段。正在探索与康方双抗联用的可能性。映恩生物丨Her3 ADC丨DB-1310 2025年4月25日，中国创新药企映恩生物（DualityBio）与全球制药巨头阿斯利康（AstraZeneca）达成合作，共同研发映恩自主研发的HER3靶向ADC新药DB-1310与阿斯利康第三代EGFR抑制剂奥希替尼（Tagrisso®，通用名Osimertinib）联合疗法的I/II期临床探索研究。根据协议，阿斯利康将为该研究提供奥希替尼药物，用于评估DB-1310与奥希替尼二线联合治疗EGFR突变晚期非小细胞肺癌（NSCLC）的潜力。 04 总结与展望 HER3-DXd 在晚期 EGFRm NSCLC 中所获数据暗示：单纯依赖 HER3 靶点尚难撼动既有治疗格局。国内追随者应从本次教训中汲取要领——在患者分层、载荷与连接子设计、组合策略以及生物标志物挖掘上多下功夫，方能在激烈的 ADC 赛道上赢得属于自己的“临床差异化”优势。尤其是在靶点模仿追随方面，要聚焦产品的安全性，其次才是疗效。 ★

临床3期抗体药物偶联物ASCO会议临床结果加速审批

2025-08-27

·Antibody Research

默沙东HER3-DXd转战乳腺癌，大概率也拉跨

▎追溯 2025年8月27日，默沙东宣布，HERTHENA-Breast04三期临床试验已完成首例患者给药。该试验旨在评估在不可切除的局部晚期或转移性激素受体（HR）阳性、HER2阴性（IHC 0、IHC 1+ 或 IHC 2+/ISH-）乳腺癌患者中，研究性药物 Patritumab Deruxtecan（HER3-DXd）与研究者选择的标准治疗方案相比的疗效与安全性。这类患者均在辅助治疗或一线转移性治疗中接受过内分泌治疗及CDK4/6抑制剂治疗后出现疾病进展。 Patritumab Deruxtecan 是一种针对 HER3 的、经过特别设计的 DXd抗体偶联药物（ADC），由第一三共（Daiichi Sankyo，东京证券交易所代码：4568）发现，并由第一三共与默沙东（Merck，在美国和加拿大以外地区称为MSD）共同开发。默沙东似乎对HER3-DXD并不打算轻易放弃，毕竟那么贵买来的。而HER3-DXD先前已经在肺癌败北。 2025年5月29日，第一三共和默沙东公布Patritumab deruxtecan （HER3-DXd）的生物制品许可申请(BLA)寻求在美国加速批准，该申请基于HERTHENA-Lung01第 2 期试验，用于治疗先前接受过两种或两种以上全身疗法治疗的局部晚期或转移性 EGFR 突变非小细胞肺癌 (NSCLC) 成年患者，现已自愿撤回。撤回生物制品许可申请 (BLA) 的决定基于验证性 HERTHENA-Lung02 3 期试验的顶线总生存期 (OS) 结果（该结果未达到统计学显著性），以及与美国食品药品监督管理局 (FDA) 的讨论。该决定与2024 年 6 月收到的完整回复函 (Complete Response Letter)无关，该函概述了对第三方生产设施的检查结果。在5月25日，本公众号断言HER3-DXD效果不佳，OS恐难达标。一语成谶，如今再看，其乳腺癌可能依旧拉垮。在这要提的一点是，TROP2-DXD并未在乳腺癌获得OS优势，基于DS8201，TRODELVY的上市，后线用药复杂化，对于HER3这种表达没有亮点还有副作用的靶点，几乎很难取得好的效果。关于HERTHENA-Breast04 HERTHENA-Breast04 是一项开放标签、随机、三期临床试验，旨在评估 Patritumab Deruxtecan（5.6 mg/kg）单药治疗相较于医生选择的治疗方案，在不可切除的局部晚期或转移性HR阳性、HER2阴性（IHC 0、IHC 1+ 或 IHC 2+/ISH-）乳腺癌成人患者中的安全性与疗效。这些患者此前均已接受过内分泌治疗及CDK4/6抑制剂治疗。入组患者需符合以下条件：不再适合接受额外的内分泌治疗；尚未接受过针对晚期或转移性疾病的化疗或抗体偶联药物（ADC）；在晚期/转移性一线内分泌 + CDK4/6抑制剂治疗中出现疾病进展，或在辅助内分泌 + CDK4/6抑制剂治疗期间或结束后24个月内复发。患者将按 1:1随机分组，接受Patritumab Deruxtecan治疗，或医生选择的治疗方案，包括化疗（紫杉醇、白蛋白结合型紫杉醇、卡培他滨、脂质体多柔比星）或HER2靶向ADC（曲妥珠单抗德鲁斯替康）。随机分层因素包括：HER2表达水平、治疗意向（化疗 vs. 曲妥珠单抗德鲁斯替康）、HER3表达水平（高 vs. 低，依据IHC）以及是否存在脏器转移。主要研究终点：由盲法独立中心评审的无进展生存期（PFS）和总生存期（OS）。次要终点：客观缓解率（ORR）、缓解持续时间（DoR）及安全性。 HERTHENA-Breast04 计划在亚洲、欧洲、北美和南美招募约 1000名患者。详情可见 ClinicalTrials.gov。关于HR阳性、HER2阴性乳腺癌 2022年全球乳腺癌新发病例超过200万，死亡病例约67万。虽然早期乳腺癌患者生存率较高，但约30%晚期或转移性患者在诊断后五年仍存活。约70%的乳腺癌病例被归类为HR阳性、HER2阴性（HER2评分为IHC 0、IHC 1+ 或 IHC 2+/ISH-）。这类患者在初始治疗后若发生疾病进展，预后往往较差，凸显了额外治疗选择的必要性。欢迎加入我的知识星球，可提供专业的免费咨询，同时可以获得Antibody Research生物药随谈回放视频。公众号已经建立读者实名讨论微信群，可以添加微信（zhuisu2210）后进群，添加时请主动注明姓名、企业、职位。

临床结果抗体药物偶联物临床3期申请上市临床成功

2025-08-27

·merck.com

HERTHENA-Breast04 Phase 3 Trial of Patritumab Deruxtecan Initiated in Patients with Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer Previously Treated with Endocrine Therapy

August 27, 2025 7:00 am ET BASKING RIDGE, N.J. & RAHWAY, N.J.--(BUSINESS WIRE)-- The first patient has been dosed in the HERTHENA-Breast04 phase 3 trial evaluating the efficacy and safety of investigational patritumab deruxtecan (HER3-DXd) versus investigator’s choice of treatment in patients with unresectable locally advanced or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer with disease progression following endocrine and CDK4/6 inhibitor therapy in either the adjuvant or first-line metastatic settings. Patritumab deruxtecan is a specifically engineered HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being developed jointly by Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada). While survival rates are high for those diagnosed with early-stage breast cancer, only about 30% of patients initially diagnosed with advanced disease or having metastatic progression are expected to live five years following diagnosis.1 Patients with HR positive, HER2 negative metastatic breast cancer experience poor outcomes if they progress following initial treatment, highlighting the need for additional options.2 “Despite significant development in the treatment landscape, HR positive, HER2 negative metastatic breast cancer is a highly complex and challenging disease with an overall poor prognosis,” said Mark Rutstein, MD, Head, Therapeutic Area Oncology Development, Daiichi Sankyo. “The promising clinical activity observed in our early phase studies including ICARUS-Breast01 suggest that patritumab deruxtecan has the potential to become a meaningful new treatment option for this specific type of breast cancer.” “The initiation of HERTHENA-Breast04 demonstrates our ongoing commitment to researching innovative approaches that may help treat some of the most challenging cancers,” said Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. “These patients need new options, and we continue to pursue cutting-edge science to develop therapies that may lead to improved treatment outcomes.” The initiation of HERTHENA-Breast04 is based on results from ICARUS-Breast01 and a phase 1/2 breast cancer trial previously published in Journal of Clinical Oncology in June 2022, where patritumab deruxtecan showed promise in patients with metastatic breast cancer. About HERTHENA-Breast04 HERTHENA-Breast04 is an open-label, randomized, phase 3 trial evaluating the safety and efficacy of patritumab deruxtecan (5.6 mg/kg) monotherapy versus physician’s choice of treatment in adult patients with unresectable locally advanced or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine and CDK4/6 inhibitor therapy. Patients in the trial should not be eligible to receive additional endocrine therapy and should not have received chemotherapy or an ADC for advanced or metastatic disease. Further, patients must have experienced disease progression on first-line endocrine and CDK4/6 inhibitor therapy in the advanced or metastatic setting or relapse on or within 24 months of adjuvant endocrine and CDK4/6 inhibitor therapy. Patients will be randomized 1:1 to receive patritumab deruxtecan or physician’s choice of treatment, consisting of either chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, liposomal doxorubicin) or HER2 directed ADC (trastuzumab deruxtecan). Randomization will be stratified by HER2 expression and treatment intent (chemotherapy versus trastuzumab deruxtecan), HER3 expression (low versus high per IHC) and presence of visceral disease. The dual primary endpoints of HERTHENA-Breast04 are progression-free survival by blinded independent central review and overall survival. Secondary endpoints include objective response rate, duration of response and safety. HERTHENA-Breast04 will enroll approximately 1,000 patients across Asia, Europe, North America, and South America. For more information, please visit ClinicalTrials.gov. About Hormone Receptor Positive, HER2 Negative Breast Cancer More than 2 million cases of breast cancer were diagnosed in 2022, with approximately 670,000 deaths globally.3 While survival rates are high for those diagnosed with early-stage breast cancer, only about 30% of patients initially diagnosed with advanced disease or having metastatic progression are expected to live five years following diagnosis.1 Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (as measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).4,5 Patients with HR positive, HER2 negative metastatic breast cancer experience poor outcomes if they progress following initial treatment, highlighting the need for additional options.2 About HER3 HER3 is a member of the HER family of receptor tyrosine kinases.6 HER3 is broadly expressed in about 90% of breast tumors.7,8,9 HER3 is associated with poor treatment outcomes, including shorter relapse-free survival and significantly reduced survival.10,11 There is currently no HER3 directed therapy approved for the treatment of any cancer. About Patritumab Deruxtecan Patritumab deruxtecan (HER3-DXd) is an investigational HER3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. About the Patritumab Deruxtecan Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of patritumab deruxtecan across multiple cancers. Trials in combination with other anticancer medicines also are underway. About the Daiichi Sankyo and Merck Collaboration Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada) entered into a global collaboration in October 2023 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 August 2024, 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. About the ADC Portfolio of Daiichi Sankyo 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. 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®, a HER2 directed ADC, and 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, N.J., USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. 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. 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. About Daiichi Sankyo 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. For more information, please visit www.daiichisankyo.com. Merck’s Focus on Cancer 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. 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. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit www.merck.com/research/oncology. About Merck 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. 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. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). ____________________ References: 1. DeSantis CE, et al. CA Cancer J Clin. 2019;69(6):438-51. 2. Tolaney SM, et al. ESMO Open. 2024;9(9):103691. 3. World Health Organization. International Agency for Research on Cancer. Cancer Fact Sheet. Accessed July 2025. 4. Giaquinto AN, et al. CA Cancer J Clin. 2022;72(6):524-541. 5. Martin J, et al. Oncologist. 2022 Apr 25;27(6):441–446. 6. Mishra R, et al. Onco Rev. 2018; 12(355):45-62. 7. Naidu R, et al. Br J Cancer. 1998;78:1385-1390. 8. Ocana A, et al. J Natl Cancer Inst. 2013 Feb 20;105(4):266-73. 9. Kogawa T, et al. J Clin Oncol. 2018; (suppl; abstr 2512). 10. Gandullo-Sánchez L et al. J Exp Clin Cancer Res. 2022; 41:310. 11. Yu HA, et al. Annals of Oncology. 2024; 35(5): P437-447. Media Contacts: Merck Julie Cunningham (617) 519-6264 julie.cunningham@merck.com John Infanti (609) 500-4714 john.infanti@merck.com Daiichi Sankyo Global/US Media: Jennifer Brennan jennifer.brennan@daiichisankyo.com (908) 900-3183 Japan Media: DS-PR@daiichisankyo.co.jp Investor Contacts: Merck Peter Dannenbaum (732) 594-1579 peter.dannenbaum@merck.com Steven Graziano (732) 594-1583 steven.graziano@merck.com Daiichi Sankyo DaiichiSankyoIR_jp@daiichisankyo.com

临床3期引进/卖出临床结果抗体药物偶联物

100 项与 Patritumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Patritumab	-	DB12090

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性非小细胞肺癌	临床3期	美国	Daiichi Sankyo Co., Ltd.	2014-03-01
转移性非小细胞肺癌	临床3期	比利时	Daiichi Sankyo Co., Ltd.	2014-03-01
转移性非小细胞肺癌	临床3期	加拿大	Daiichi Sankyo Co., Ltd.	2014-03-01
转移性非小细胞肺癌	临床3期	捷克	Daiichi Sankyo Co., Ltd.	2014-03-01
转移性非小细胞肺癌	临床3期	德国	Daiichi Sankyo Co., Ltd.	2014-03-01
转移性非小细胞肺癌	临床3期	匈牙利	Daiichi Sankyo Co., Ltd.	2014-03-01
转移性非小细胞肺癌	临床3期	意大利	Daiichi Sankyo Co., Ltd.	2014-03-01
转移性非小细胞肺癌	临床3期	波兰	Daiichi Sankyo Co., Ltd.	2014-03-01
转移性非小细胞肺癌	临床3期	西班牙	Daiichi Sankyo Co., Ltd.	2014-03-01
转移性非小细胞肺癌	临床3期	英国	Daiichi Sankyo Co., Ltd.	2014-03-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01211483 (HERALD, CTgov)	临床1/2期	晚期非小细胞肺癌	222	Erlotinib+U3-1287 (Phase 2: U3-1287 18 mg/kg + Erlotinib)	遞觸觸獵糧範構糧壓淵(艱繭鏇繭遞淵遞憲壓淵) = 觸願獵憲積遞簾遞淵鹽鹽艱衊鹽獵構艱繭窪網 (鬱積窪糧醖衊鬱醖繭襯, 鏇衊齋遞夢艱遞廠網窪 ~ 遞蓋構鑰鏇鬱憲衊襯廠) 更多	-	2021-06-16
				Erlotinib+U3-1287 (Phase 2: U3-1287 9 mg/kg + Erlotinib)	遞觸觸獵糧範構糧壓淵(艱繭鏇繭遞淵遞憲壓淵) = 艱鹹鏇鹹觸積淵醖網鬱鹽艱衊鹽獵構艱繭窪網 (鬱積窪糧醖衊鬱醖繭襯, 鹹觸鹽構壓夢積糧襯餘 ~ 壓艱餘築遞憲鑰製醖衊) 更多
NCT02633800 (Pubmed \| Eur J Cancer)	临床2期	转移性头颈部鳞状细胞癌一线 HER3 activation \| heregulin (HRG)	-	Patritumab	顧艱衊襯簾窪鬱糧蓋淵(憲選鬱窪襯製築築獵觸) = 鹹遞鹹鑰製廠壓範築觸夢遞餘構積淵鏇構鑰積 (膚鏇鏇選獵淵衊積醖繭 ) 更多	不佳	2019-12-01
				Placebo	顧艱衊襯簾窪鬱糧蓋淵(憲選鬱窪襯製築築獵觸) = 積壓蓋窪範獵憲鏇廠膚夢遞餘構積淵鏇構鑰積 (膚鏇鏇選獵淵衊積醖繭 ) 更多
NCT02350712 (Pubmed \| Clin Cancer Res) 人工标引	临床1期	头颈部鳞状细胞癌一线	15	Cetuximab+cisplatin+carboplatin+Patritumab	廠窪壓築襯鹽獵鹹糧糧(構衊製觸廠鹽糧窪築膚) = 遞鏇淵窪繭憲製範壓鑰願觸淵獵範選淵築築鏇 (糧觸鑰觸醖範衊餘鬱遞 ) 更多	积极	2019-01-15
NCT02633800 (CTgov)	临床2期	转移性头颈部鳞状细胞癌	87	Cetuximab+Patritumab+Carboplatin+Cisplatin (Patritumab)	壓範鑰製築壓構鹹廠衊(鬱蓋膚衊壓製鹹餘衊窪) = 觸鑰廠糧襯糧繭鬱蓋憲築顧積餘積廠鬱廠願範 (繭鏇顧蓋廠窪顧製獵願, 繭糧壓範膚鹹網壓觸遞 ~ 製廠窪廠獵築醖蓋襯網) 更多	-	2019-01-07
				Placebo+Cetuximab+Carboplatin+Cisplatin (Placebo)	壓範鑰製築壓構鹹廠衊(鬱蓋膚衊壓製鹹餘衊窪) = 構鑰襯網鏇鹽夢鏇鹽壓築顧積餘積廠鬱廠願範 (繭鏇顧蓋廠窪顧製獵願, 衊構襯簾襯糧顧鹹鑰膚 ~ 繭製壓觸膚醖積艱廠構) 更多
NCT02134015 (HER3-Lung, CTgov)	临床3期	转移性非小细胞肺癌	145	Placebo+Erlotinib (Placebo + Erlotinib)	積蓋築廠範醖襯艱夢範 = 鬱夢選窪餘築範鏇獵製鬱廠遞製夢製膚網鬱願 (膚積積襯艱壓鹹壓築顧, 築顧鏇淵壓鑰鹽築構齋 ~ 遞獵鑰簾構鹽膚醖襯糧) 更多	-	2018-01-23
				Erlotinib+Patritumab (Patritumab + Erlotinib)	積蓋築廠範醖襯艱夢範 = 襯膚夢繭憲願糧夢願願鬱廠遞製夢製膚網鬱願 (膚積積襯艱壓鹹壓築顧, 鑰醖鹹衊鹽廠範憲製願 ~ 遞艱廠衊築鹹餘蓋顧觸) 更多
NCT01211483 (HERALD, ASCO2016)	临床2期	非小细胞肺癌	212	Patritumab + Erlotinib	簾構膚襯艱夢鹽選餘鹽(鹽鹹醖鏇選鹽獵鹽網範): HR = 0.41 (95% CI, 0.18 ~ 0.9), P-Value = 0.02	积极	2016-05-20
				Placebo + Erlotinib
NCT01211483 (ASCO2014)	临床1/2期	晚期非小细胞肺癌	145	Patritumab 18 mg/kg every three weeks	願積壓網壓選顧簾範觸(齋構鏇壓顧齋壓鹽襯遞) = 積蓋鏇糧簾憲壓艱遞積鑰積醖構選夢製顧壓廠 (衊夢遞鏇壓遞選淵築顧 ) 更多	-	2014-05-20
				Patritumab 9 mg/kg every three weeks	願積壓網壓選顧簾範觸(齋構鏇壓顧齋壓鹽襯遞) = 衊蓋積觸製獵構選鹽選鑰積醖構選夢製顧壓廠 (衊夢遞鏇壓遞選淵築顧 ) 更多
NCT01211483 (HERALD, ASCO2014)	临床2期	非小细胞肺癌	215	High Dose Patritumab	構鑰廠壓醖願齋網壓襯(醖齋艱廠淵願構構願蓋) = 願艱蓋夢鏇廠蓋鹹顧繭壓醖構鹹遞網醖襯襯網 (壓襯鹽鏇齋醖鏇醖壓淵 )	-	2014-05-20
				Low Dose Patritumab	構鑰廠壓醖願齋網壓襯(醖齋艱廠淵願構構願蓋) = 遞範蓋獵鏇膚淵繭鏇襯壓醖構鹹遞網醖襯襯網 (壓襯鹽鏇齋醖鏇醖壓淵 )