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）

2025-08-22·JCI Insight

Article

作者: Brown, Benjamin P ; Nahmias, Elliott F ; Gordetsky, Jennifer B ; Schaffer, Kerry R ; Antunovic, Monika ; Googel, Jared A ; Hurley, Paula J ; Sanchez, Violeta ; Hesterberg, Amanda B ; Graves, Diana ; Bergman, Riley E ; Watkins, Evan ; Ginther, Sarah E ; Davidson, Brad A ; Sheng, Quanhu ; Martin, Lillian B ; Park, Ben H ; Meiler, Jens ; Wong, Hong Yuen ; Rios, Brenda L ; Jackson, Jorgen ; Gonzalez-Ericsson, Paula I

Cancer-associated fibroblasts (CAFs) are part of the tumor microenvironment (TME) that enable cancer cells to establish metastases, but the mechanisms of these interactions are not fully known. Herein, we identified a paracrine mechanism in which CAF-secreted asporin (ASPN) activated ErbB signaling and subsequent migration of adjacent prostate cancer cells. Our data support that ASPN bound directly to the ligand binding domain of human epidermal growth factor 3 (HER3) and induced HER2/HER3 heterodimerization and activation of the PI3K, MAPK, and calcium pathways. Genetic and therapeutic inhibition of HER2/HER3 ablated ASPN-induced signaling and migration. Clinically, ASPN was detected in the stroma of HER2/HER3-expressing human metastatic prostate cancer, supporting the clinical relevance of these findings and highlighting a potential therapeutic vulnerability. Antibody-drug conjugate (ADC) therapies designed to target HER2 (trastuzumab-deruxtecan) or HER3 (patritumab-deruxtecan) significantly diminished prostate cancer cell growth in vitro and tumor size in vivo, despite Aspn in the TME. Collectively, these findings indicate ASPN functions as a HER3 ligand to induce cellular migration, and inhibition with anti-HER2 or anti-HER3 ADC therapies highlights potential clinical utility for patients with metastatic castration-resistant prostate cancer that expresses HER2 or HER3.

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.

2023-09-05·Molecular cancer therapeutics

Article

作者: Weng, Weining ; Shen, Yi ; Qian, Yu ; Chen, Caiwei ; Shao, Siyuan ; Meng, Tao ; Wang, Lijun ; Wang, Mingqiao ; Meng, Xun ; Zhou, Biao ; Pan, Rong ; Pu, Junyi ; Liu, Shuhui ; Ma, Linjie ; Zhang, Jianjian ; Hu, Wenhao ; Wang, Zhaohui

Abstract:

HER3 is a unique member of the EGFR family of tyrosine kinases, which is broadly expressed in several cancers, including breast, lung, pancreatic, colorectal, gastric, prostate, and bladder cancers and is often associated with poor patient outcomes and therapeutic resistance. U3-1402/Patritumab-GGFG-DXd is the first successful HER3-targeting antibody–drug conjugate (ADC) with clinical efficacy in non–small cell lung cancer. However, over 60% of patients are nonresponsive to U3-1402 due to low target expression levels and responses tend to be in patients with higher target expression levels. U3-1402 is also ineffective in more challenging tumor types such as colorectal cancer. AMT-562 was generated by a novel anti-HER3 antibody Ab562 and a modified self-immolative PABC spacer (T800) to conjugate exatecan. Exatecan showed higher cytotoxic potency than its derivative DXd. Ab562 was selected because of its moderate affinity for minimizing potential toxicity and improving tumor penetration purposes. Both alone or in combination therapies, AMT-562 showed potent and durable antitumor response in low HER3 expression xenograft and heterogeneous patient-derived xenograft/organoid models, including digestive system and lung tumors representing of unmet needs. Combination therapies pairing AMT-562 with therapeutic antibodies, inhibitors of CHEK1, KRAS, and tyrosine kinase inhibitor showed higher synergistic efficacy than Patritumab-GGFG-DXd. Pharmacokinetic and safety profiles of AMT-562 were favorable and the highest dose lacking severe toxicity was 30 mg/kg in cynomolgus monkeys. AMT-562 has potential to be a superior HER3-targeting ADC with a higher therapeutic window that can overcome resistance to generate higher percentage and more durable responses in U3-1402–insensitive tumors.

251

项与 Patritumab 相关的新闻（医药）

2026-02-26

·FierceBiotech

Bristol Myers\' $800M ADC hits primary survival endpoints in phase 3 breast cancer trial

In a Chinese phase 3 trial of a Bristol Myers Squibb antibody-drug conjugate, progression-free and overall survival were significantly better on izalontamab brengitecan than on chemotherapy.\n A Chinese phase 3 trial of Bristol Myers Squibb’s antibody-drug conjugate has hit its dual primary survival endpoints, providing further validation of the Big Pharma\'s $800 million bet on the candidate.BMS paid SystImmune $800 million upfront in 2023 for ex-China rights to the EGFR×HER3 bispecific ADC, izalontamab brengitecan (iza-bren). The deal, which marked BMS’ entry into the ADC space, covered a drug candidate with the potential to tackle cancer cell proliferation and survival by blocking EGFR and HER3 while simultaneously delivering a cytotoxic payload to tumor cells. Since then, phase 3 studies run by SystImmune’s parent company, Sichuan Biokin Pharmaceutical, have hit primary endpoints, leading to filings for approval in forms of esophageal and throat cancers in China. Biokin reported a third late-stage win Thursday.The latest data come from a phase 3 trial that gave iza-bren to people with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). Participants’ cancers had previously progressed after taxane therapy. TNBC patients who had previously received certain other drugs, including ADCs, were excluded from the trial. At a prespecified interim analysis, progression-free and overall survival were significantly better on iza-bren than on physician’s choice of chemotherapy, achieving the trial’s dual primary endpoints. No data from the trial are publicly available, with the companies holding the results back for an upcoming medical meeting. The implications of the phase 3 victory for BMS are unclear. While Biokin targeted the post-taxane population, BMS’ phase 2/3 TNBC trial is enrolling first-line patients who are ineligible for anti-PD-1/L1 checkpoint inhibitors such as Merck & Co.’s Keytruda. EGFR and HER3 are often overexpressed in TNBC, an aggressive tumor that lacks the receptors and proteins that enable treatment of other breast cancers. Merck is targeting some similar biology with its Daiichi Sankyo-partnered, HER3-directed ADC patritumab deruxtecan. The Big Pharma began a phase 3 study of the drug candidate in hormone receptor-positive, HER2-negative unresectable locally advanced or metastatic breast cancer last year. BioNTech started a phase 1/2 trial of an EGFR×HER3 bispecific ADC in advanced solid tumor patients in August.

$Bristol Myers\' $800M ADC hits primary survival endpoints in phase 3 breast cancer trial$

临床3期抗体药物偶联物临床结果临床终止

2026-02-25

·第一三共中国

Patritumab deruxtecan治疗实体瘤概念性验证2期研究HERTHENA-PanTumor01 (U31402-277)在中国启动

2026年2月25日，U31402-277/HER3-DXd 治疗局部晚期或转移性实体瘤的II 期研究成功在中国完成首例受试者给药！这标志着该研究迈出了重要的第一步。我们期待与各方继续紧密合作，加速HER3-DXd的临床开发进程。研究团队将全力以赴，高质量、高效率地推进HER3-DXd的临床开发，期待早日将这一创新疗法带给中国的晚期实体瘤患者。关于U31402-277临床研究 U31402-277研究是一项HER3-DXd 治疗局部晚期或转移性实体瘤的II 期、多中心、多队列、开放性、概念验证研究。U31402-277研究的主要疗效终点是经研究者评估的客观缓解率（ORR）。次要终点包括治疗的安全性和耐受性等。更多研究相关信息，可登陆https://clinicaltrials.gov及http://www.chinadrugtrials.org.cn网站查询。关于肺癌/乳腺癌/胃癌肺癌是全球最常见癌症和癌症相关死亡的主要原因之一。2022年全球估计有250万例新发肺癌病例（占所有新发癌症病例的12.4%）和180 万例肺癌相关死亡病例（占全球癌症死亡病例的18.7%）。1非小细胞肺癌（NSCLC）占所有肺癌的80%-85%。在Non-AGA的晚期或转移性NSCLC患者中，全身化疗仍是一线治疗的主要选择。ICI 和PBC 治疗期间出现疾病进展的患者可选择的治疗方案有限，且获益较为短暂，NonAGA NSCLC 患者亟需更有效且可耐受的治疗方案。一项已发表的回顾性流行病学研究显示，83%的 NSCLC 患者的肿瘤细胞表达 HER3。2ERBB3/HER3 癌基因在肺癌细胞中过表达，且较高的HER3 表达水平与较差的预后相关3。乳腺癌是全球女性中发病率最高的恶性肿瘤，也是女性癌症相关死亡的首要原因。4HR+/HER2-乳腺癌占所有病例的70%，发病率显著高于其他亚型，5年OS率随分期下降，远处转移患者仅约30%。5 HER3高表达（IHC 2+/3+）见于30%-45%的乳腺癌患者，与较差的生存预后相关。6, 7, 8, 9评价 HER-3 表达水平有助于识别预后较差的患者亚群，在这些患者中进一步评价靶向HER-3 抗肿瘤药物治疗转移性乳腺癌的有效性。胃癌是全球第五大常见癌症。近年来，免疫检查点抑制剂（ICI）联合化疗的引入改善了转移性胃癌患者一线治疗的治疗前景。10纳武利尤单抗联合化疗，帕博利珠单抗联合氟嘧啶类药物和含铂化疗（PBC）可作为一线治疗方案。11, 12含曲妥珠单抗或德曲妥珠单抗方案也可作为HER2阳一线治疗或二线治疗方案。13, 14 关于HER3 HER3是EGFR受体酪氨酸激酶家族的成员之一，与细胞的异常增殖和存活有关。15据估计，大约83%的NSCLC肿瘤表达HER3蛋白，可能与转移发生率增加、生存率下降和对标准治疗的耐药性有关。16, 17, 18 　　关于Patritumab deruxtecan Patritumab deruxtecan (HER3-DXd, U3-1402) 是第一三共肿瘤管线中DXd ADC之一。采用第一三共专有的DXd ADC技术设计，由人源化HER3抗体与拓扑异构酶I抑制剂有效载荷，通过稳定的可裂解四肽连接子组合而成。　　关于第一三共与默沙东合作第一三共与默沙东于2023年10月达成全球合作，共同开发并商业化 Patritumab Deruxtecan (HER3-DXd)、Ifinatamab Deruxtecan (I-DXd)和Raludotatug deruxtecan (R-DXd)，且第一三共拥有日本市场独家权益，第一三共将全权负责生产和供应。2024年08月，合作协议扩展到MK-6070，双方将共同在全球范围内开发和商业化该药物，且默沙东拥有日本市场独家权益。默沙东将全权负责MK-6070的生产和供应。　　　关于第一三共第一三共是一家为社会可持续发展做贡献的创新型全球医疗保健公司，致力于发现、开发和提供新的标准疗法，以提高世界各地患者的生活质量。第一三共专注制药行业120余年，凭借其世界一流的科学和技术，为癌症、心血管疾病和其他医疗需求远未得到满足的疾病患者研发新的治疗方法和创新药物。如欲了解更多信息，请访问www.daiichisankyo.com。参考文献： 1.Filho AM, Laversanne M, Ferlay J, Colombet M, Piñeros M, Znaor A, Parkin DM, Soerjomataram I, Bray F. The GLOBOCAN 2022 cancer estimates: Data sources, methods, and a snapshot of the cancer burden worldwide. Int J Cancer. 2025 Feb 3;156(7):1336-1346. 2.Scharpenseel H, Hanssen A, Loges S, et al. EGFR and HER3 expression in circulating tumor cells and tumor tissue from non-small cell lung cancer patients. Sci Rep. 2019;9(1):7406. 3.Ocana A, Vera-Badillo F, Seruga B, et al. HER3 overexpression and survival in solid tumors: a meta-analysis. J Natl Cancer Inst. 2013; 105(4):266-73. 4.Arnold M, Morgan E, Rumgay H, et al. Current and future burden of breast cancer: Global statistics for 2020 and 2040[J]. The Breast, 2022, 66: 15-23. 5.Female Breast Cancer Subtypes - Cancer Stat Facts [Internet]. SEER. [cited 2025 May 14]. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html 6.Ocana A, Vera-Badillo F, Seruga B, et al. HER3 overexpression and survival in solid tumors: a meta-analysis. J Natl Cancer Inst. 2013; 105(4):266-73. 7.Chiu CG, Masoudi H, Leung S, Voduc DK, Gilks B, Huntsman DG, Wiseman SM. HER-3 overexpression is prognostic of reduced breast cancer survival: a study of 4046 patients. Ann Surg. 2010 Jun;251(6):1107-16 8.Fuchs IB, Siemer I, Bühler H, Schmider A, Henrich W, Lichtenegger W, Schaller G, Kuemmel S. Epidermal growth factor receptor changes during breast cancer metastasis. Anticancer Res. 2006 Nov;26(6B):4397-4401 9.Witton CJ, Reeves JR, Going JJ, Cooke TG, Bartlett JM. Expression of the HER1-4 family of receptor tyrosine kinases in breast cancer. J Pathol. 2003 Jul;200(3):290-7 10.Janjigian YY, Shitara K, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021; 398(10294):27-40. 11.Janjigian YY, Shitara K, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021; 398(10294):27-40. 12.Ryu MH, et al. 178P KEYNOTE-859 update: Pembrolizumab + chemotherapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer. Ann Oncol. 2024 Dec;35(Suppl 6):S1473-S1474. 13.Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010; 376(9742):687-97. 14.Shitara K, Bang YJ, Iwasa S, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer. N Engl J Med. 2020; 382(25):2419-30. 15.Mishra R, Patel H, Alanazi S, et al. HER3 signaling and targeted therapy in cancer[J]. Oncology reviews, 2018, 12(1): 355. 16.Zhang Y L, Yuan J Q, Wang K F, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis[J]. Oncotarget, 2016, 7(48): 78985. 17.Müller-Tidow C, Diederichs S, Bulk E, et al. Identification of metastasis-associated receptor tyrosine kinases in non–small cell lung cancer[J]. Cancer research, 2005, 65(5): 1778-1782. 18.Scharpenseel H, Hanssen A, Loges S, et al. EGFR and HER3 expression in circulating tumor cells and tumor tissue from non-small cell lung cancer patients[J]. Scientific reports, 2019, 9(1): 7406. 声明: 1.本材料不用于任何推广目的，相关信息亦不应作为治疗或使用建议。如有相关问题请咨询医疗卫生专业人士。 2.本文涉及未在中国获批的产品或适应症，第一三共不推荐任何未获批药品/适应症的使用。

2026-02-19

·BioSpace

ENHERTU® Type II Variation Application Validated in the EU as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer

Based on DESTINY-Breast05 phase 3 trial results, which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1 If approved, Daiichi Sankyo and AstraZeneca’s ENHERTU has the potential to become a new standard of care in this early breast cancer setting TOKYO & MUNICH--(BUSINESS WIRE)--The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU ® (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The application is based on data from the DESTINY-Breast05 phase 3 trial presented at the 2025 European Society for Medical Oncology (#ESMO25) Congress and subsequently published in The New England Journal of Medicine . In the trial, ENHERTU demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) versus trastuzumab emtansine (T-DM1) in patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy. “Patients who have residual invasive disease despite neoadjuvant therapy face a heightened risk of recurrence and are in need of better options following neoadjuvant treatment and surgery,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “This validation in the EU is an important step toward bringing ENHERTU to eligible patients earlier in the treatment journey to help reduce the risk of disease recurrence and progression to metastatic disease.” Additional regulatory submissions for ENHERTU also are underway in the EU, including in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer based on data from DESTINY-Breast09 and for previously treated HER2 positive unresectable or metastatic solid tumors based on data from DESTINY-PanTumor02 , DESTINY-CRC02 and DESTINY-Lung01 . About DESTINY-Breast05 DESTINY-Breast05 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus T-DM1 in patients with HER2 positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy. The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomization until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed disease-free survival. Other secondary endpoints include overall survival, distant recurrence-free interval, brain metastases-free interval and safety. DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov . About Post Neoadjuvant Treatment for HER2 Positive Early Breast Cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally. 1 In Europe, approximately 557,000 cases of breast cancer are diagnosed annually, with more than 144,000 deaths. 1 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer. 2 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer. 2 Approximately one in five cases of breast cancer is considered HER2 positive. 3 For patients with HER2 positive early breast cancer, achieving pathologic complete response (pCR) with neoadjuvant treatment is the earliest indicator of improved long-term survival. 4 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence. 5,6,7,8,9 Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death and current treatment options have shown limited impact on central nervous system recurrence. 10 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%. 11 Post-neoadjuvant therapy represents a key opportunity to minimize the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients. 12,13 About ENHERTU ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial. ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 , DESTINY-Gastric02 and/or DESTINY-Gastric04 trials. ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02 , DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the ENHERTU Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and DATROWAY ® in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU and DATROWAY, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 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 need. For more information, please visit . ________________________________ References 1 World Health Organization. Breast Fact Sheet . Accessed February 2026. 2 Cheng X, et al. Genes . 2024;15(7):903. 3 Tarantino P, et al. Ann Oncol . 2023;34(8):645-659. 4 Spring LM, et al. Clin Cancer Res . 2020;26(12):2838-2848. 5 Schneeweiss A, et al. Ann Oncol . 2013;24(9):2278-2284. 6 Swain SM, et al. Ann Oncol . 2018;29(3):646-653. 7 Huober J, et al. J Clin Oncol . 2022;40(25):2946-2956. 8 Masuda N, et al. Breast Cancer Res Treat . 2020;180(1):135-146. 9 Gao HF, et al. Presented at ASCO Annual Meeting 2025. 10 Geyer CE, et al. N Engl J Med . 2025;392(3):249-257. 11 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer. Accessed February 2026. 12 von Minckwitz G, et al. N Engl J Med . 2019;380(7):617-628. 13 Zaborowski AM and Wong SM. BJS . 2023;110(7):765-772. Contacts Media Contacts: Global: Jennifer Brennan Daiichi Sankyo, Inc. jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) EU: Simone Jendsch-Dowé Daiichi Sankyo Europe GmbH simone.jendsch-dowe@daiichisankyo.com +49 (89) 78080 (office) Japan: Daiichi Sankyo Co., Ltd. DS-PR_jp@daiichisankyo.com Investor Relations Contact: DaiichiSankyoIR_jp@daiichisankyo.com

临床3期临床结果引进/卖出上市批准抗体药物偶联物

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

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌	临床3期	匈牙利	Daiichi Sankyo Development Ltd.	2014-07-02
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

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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)	糧構餘鹽鬱顧淵衊廠鹽(憲膚衊獵窪襯製淵範積) = 蓋糧積遞襯遞鏇醖鑰壓築淵艱糧壓憲憲顧構獵 (鏇蓋齋鑰廠蓋蓋膚壓構, 獵齋鬱淵膚餘淵艱鹽鬱 ~ 鹽衊鏇糧醖壓遞憲艱製) 更多	-	2021-06-16
				Erlotinib+U3-1287 (Phase 2: U3-1287 9 mg/kg + Erlotinib)	糧構餘鹽鬱顧淵衊廠鹽(憲膚衊獵窪襯製淵範積) = 夢觸遞艱鹹繭製鬱簾衊築淵艱糧壓憲憲顧構獵 (鏇蓋齋鑰廠蓋蓋膚壓構, 壓醖鏇夢蓋鏇襯糧範範 ~ 衊夢憲壓構築構觸選憲) 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	窪製遞簾齋衊鹽蓋築網(遞糧淵築積夢窪繭網獵) = 蓋餘衊餘餘膚膚窪顧築顧糧糧鑰願鑰憲鏇餘窪 (衊願鏇網鏇襯窪膚鹹艱 ) 更多	不佳	2019-12-01
				Placebo	窪製遞簾齋衊鹽蓋築網(遞糧淵築積夢窪繭網獵) = 願蓋襯憲範積鑰醖範顧顧糧糧鑰願鑰憲鏇餘窪 (衊願鏇網鏇襯窪膚鹹艱 ) 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	衊艱壓蓋餘遞膚製壓窪(醖窪夢選鹽築壓獵壓糧) = 獵夢鏇簾醖淵廠衊鹹醖艱構糧憲膚鬱餘襯繭壓 (蓋築淵繭醖構製網鬱壓 ) 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)	糧艱襯製選鹹願鹽壓鏇(艱糧構壓壓淵構蓋簾製) = 憲鬱襯醖積製窪鑰廠顧範範艱齋襯夢鑰積鑰積 (鬱願膚襯網鑰鏇範遞艱, 遞網鹹簾積夢鹹衊鏇鬱 ~ 廠鏇簾製選築製鏇襯醖) 更多	-	2019-01-07
				Placebo+Cetuximab+Carboplatin+Cisplatin (Placebo)	糧艱襯製選鹹願鹽壓鏇(艱糧構壓壓淵構蓋簾製) = 醖鑰顧衊窪壓憲鑰顧餘範範艱齋襯夢鑰積鑰積 (鬱願膚襯網鑰鏇範遞艱, 積襯積顧壓鏇遞廠襯範 ~ 醖選糧壓鹽構醖壓願窪) 更多
NCT02134015 (HER3-Lung, CTgov)	临床3期	转移性非小细胞肺癌	145	Placebo+Erlotinib (Placebo + Erlotinib)	淵齋獵壓獵願繭蓋鑰膚 = 鬱襯遞積鹹蓋顧窪願淵餘艱簾蓋齋糧選鹽鹹網 (構齋壓選觸窪製獵衊繭, 鑰鑰艱衊觸衊簾繭網襯 ~ 網選糧廠糧鏇構遞繭艱) 更多	-	2018-01-23
				Erlotinib+Patritumab (Patritumab + Erlotinib)	淵齋獵壓獵願繭蓋鑰膚 = 鹹鑰選鏇襯艱艱窪範鏇餘艱簾蓋齋糧選鹽鹹網 (構齋壓選觸窪製獵衊繭, 鑰網構鑰夢糧簾齋鏇鑰 ~ 選鬱壓艱築鑰鹽鏇遞襯) 更多
NCT01211483 (HERALD, ASCO2016)	临床2期	非小细胞肺癌	212	Patritumab + Erlotinib	積蓋繭醖顧憲簾鏇壓願(簾廠繭醖廠醖顧餘製壓): 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	醖餘餘築鏇構艱構獵鏇(艱鑰遞憲蓋選製範製艱) = 窪齋鏇壓廠選獵糧網齋衊遞餘選艱淵簾網觸顧 (觸艱遞餘衊齋範廠壓淵 ) 更多	-	2014-05-20
				Patritumab 9 mg/kg every three weeks	醖餘餘築鏇構艱構獵鏇(艱鑰遞憲蓋選製範製艱) = 積鏇選鑰廠鹽艱觸壓觸衊遞餘選艱淵簾網觸顧 (觸艱遞餘衊齋範廠壓淵 ) 更多
NCT01211483 (HERALD, ASCO2014)	临床2期	非小细胞肺癌	215	High Dose Patritumab	壓積積衊鏇衊積網鏇艱(鏇艱簾醖簾簾繭網糧鏇) = 餘遞鏇網餘簾遞壓鬱醖顧積壓製衊夢壓遞醖襯 (醖顧艱鏇壓簾築鹽餘觸 )	-	2014-05-20
				Low Dose Patritumab	壓積積衊鏇衊積網鏇艱(鏇艱簾醖簾簾繭網糧鏇) = 淵醖積淵夢蓋淵鏇夢衊顧積壓製衊夢壓遞醖襯 (醖顧艱鏇壓簾築鹽餘觸 )