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Last update 27 Feb 2026

Patritumab Deruxtecan

Last update 27 Feb 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

HER3-DXd, Patritumab-DX-8951 conjugate, 帕妥珠单抗德鲁替康

+ [7]

Target

HER3 x Top I

Action

antagonists, inhibitors

Mechanism

HER3 antagonists(Receptor tyrosine-protein kinase erbB-3 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsRespiratory DiseasesNervous System Diseases+ [5]

Active Indication

Hormone receptor positive breast cancerHormone receptor positive HER2 negative breast cancerEGFR-mutated non-small Cell Lung Cancer+ [49]

Inactive Indication

Early Stage Breast CarcinomaHR Positive/HER2 Negative/Node positive breast cancer

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Merck Sharp & Dohme LLC

Daiichi Sankyo Co., Ltd.

Daiichi Sankyo, Inc.

+ [4]

Inactive Organization

Merck & Co., Inc.

License Organization

Merck Sharp & Dohme Corp.

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.

+ [1]

Drug Highest PhasePhase 3

First Approval Date-

RegulationPriority Review (United States), Breakthrough Therapy (United States)

Structure/Sequence

Boost your research with our ADC technology data.

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Sequence Code 193897L

Source: *****

Sequence Code 9984986H

Source: *****

Clinical Trials associated with Patritumab Deruxtecan

NCT07286149

/ Not yet recruitingPhase 1/2

KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn:
* About the safety of MK-1084 and if people tolerate it when taken with other treatments
* How many people have the cancer respond (get smaller or go away) to the treatments

Start Date23 Feb 2026

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

NCT07060807

/ RecruitingPhase 3

An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic.
* HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread
* HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2
* Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles
* Metastatic means the cancer has spread to other parts of the body
Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

Start Date21 Jul 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

NCT05620914

/ WithdrawnPhase 2IIT

A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases

The purpose of this study is to determine if the study drug, patritumab deruxtecan (HER3-DXd), can be measured in brain tumor tissue after recieving one dose of patritumab deruxtecan before surgery.

Start Date01 Jul 2025

Sponsor / Collaborator

Duke University

[+1]

100 Clinical Results associated with Patritumab Deruxtecan

100 Translational Medicine associated with Patritumab Deruxtecan

100 Patents (Medical) associated with Patritumab Deruxtecan

Literatures (Medical) associated with Patritumab Deruxtecan

01 Feb 2026·CANCER TREATMENT REVIEWS

Intracranial activity of antibody-drug conjugates in advanced non-small cell lung cancer: What have we accomplished so far?

Review

Author: Remon, Jordi ; Hendriks, Lizza E L ; Huang, Derek De-Rui ; Cheo, Seng Wee ; Voon, Pei Jye ; Saw, Stephanie P L ; Addeo, Alfredo ; Li, Molly S C ; Menis, Jessica

Antibody-drug conjugates (ADCs) represent a rapidly evolving class of therapeutics in non-small cell lung cancer (NSCLC), offering targeted delivery of cytotoxic payloads to tumor cells while minimizing off-target toxicity. Although ADCs have demonstrated promising results in NSCLC, their efficacy in treating central nervous system (CNS) metastases has been uncertain due to concerns over blood-brain barrier (BBB) penetration and the lack of dedicated CNS-specific evaluations in clinical trials. However, emerging evidence challenges this paradigm. While earlier-generation ADCs such as T-DM1 exhibited limited CNS efficacy, newer ADCs employing optimized linkers and cytotoxins demonstrate more favorable efficacy and toxicity profiles. Selected agents, including trastuzumab deruxtecan, datopotamab deruxtecan and patritumab deruxtecan, have all shown intracranial responses in patients with advanced NSCLC with brain metastases (BM). Proposed mechanisms facilitating CNS activity include BBB disruption by BM, membrane-permeable and highly potent cytotoxic payloads, and bystander effects that enable tumor cell killing beyond the target antigen. Nevertheless, several limitations remain, including variability in trial designs, limited number of patients with untreated CNS disease, and a lack of CNS-specific endpoints. Given the high incidence of BM in NSCLC and their significant impact on patient outcomes, there is an urgent need to better understand the intracranial activity of ADCs and whether they can prevent the development of CNS metastases, especially as some of these ADCS are being tested in the curative-intent setting. This review synthesizes current evidence and highlights ongoing trials, with a focused examination of the evolving role of ADCs in the management of BM.

31 Dec 2025·OncoImmunology

Patritumab deruxtecan induces immunogenic cell death

Article

Author: Sauvat, Allan ; Liu, Peng ; Cerrato, Giulia ; Zhao, Liwei ; Doffe, Flora ; Forveille, Sabrina ; Pan, Yuhong ; Kepp, Oliver ; Leduc, Marion ; Kroemer, Guido

Antibody-drug conjugates (ADCs) enable targeted delivery of cytotoxic payload to cancer cells. Here, we characterized the mode of action of the ADC patritumab deruxtecan, which is a monoclonal antibody specific for Erb-B2 Receptor Tyrosine Kinase 3 (ERBB3, best known as HER3) coupled to the topoisomerase-I inhibitor DXd. Patritumab deruxtecan decreased viability and induced the relocation of calreticulin fused to green fluorescent protein (CALR-GFP) to the periphery of human osteosarcoma U2OS cells engineered to express HER3 but not in their parental counterparts only expressing the CALR-GFP biosensor. Patritumab deruxtecan as well as its payload DXd induced various traits of immunogenic cell death (ICD) including antibody detectable calreticulin membrane exposure, exodus of high mobility group protein B1 (HMGB1), as well as the release of ATP into cell culture supernatants. Moreover, DXd causes rapid inhibition of DNA-to-RNA transcription, which is a key predictor for ICD. Mouse cancer cells treated with DXd were able to vaccinate syngeneic immunocompetent mice against tumor challenge. Tumor-free mice developed immune memory that led to the rejection of syngeneic tumors after rechallenge. In conclusion, patritumab deruxtecan is equipped with a cytotoxic payload that induces hallmarks of ICD in vitro and elicits antitumor immunity in vivo.

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

Author: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

113

News (Medical) associated with Patritumab Deruxtecan

19 Feb 2026

·www.biospace.com

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

Phase 3Clinical ResultLicense out/inDrug ApprovalADC

04 Feb 2026

·www.businesswire.com

DS3790 Enters Clinical Development as First DXd ADC in Hematology from Industry-Leading ADC Portfolio of Daiichi Sankyo

TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--The first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS3790 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. DS3790 is a specifically engineered, potential first-in-class CD37 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568). CD37 is a transmembrane protein that plays a role in regulating cell survival and is overexpressed on malignant B-cells, making it a promising therapeutic target.1 Currently, there are no CD37 directed therapies approved for any type of cancer. “The initiation of this trial of DS3790 with its novel CD37 target marks a significant milestone as our first DXd antibody drug conjugate in hematology,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “DS3790 expands our portfolio to seven DXd antibody drug conjugates, all developed using our in-house technology, underscoring our dedication to scientific innovation to create new medicines for patients with cancer.” About the Phase 1/2 Trial The multicenter, open-label, multi-cohort, first-in-human phase 1/2 trial will assess the safety and efficacy of DS3790 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The first part of the trial (dose escalation) is evaluating DS3790 as a monotherapy to determine the recommended dose for expansion. The second part of the trial (dose expansion) will consist of multiple expansion cohorts to further evaluate DS3790 as a monotherapy. Following the assessment of preliminary safety and efficacy in the monotherapy part of the trial, subsequent cohorts will evaluate DS3790 in combination with other targeted therapies in both dose escalation and dose expansion phases. The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events, as well as efficacy endpoints including overall response, disease control rate, duration of response, time to response, progression-free survival and overall survival. Pharmacokinetics and biomarker endpoints also will be assessed. The trial is expected to enroll approximately 420 patients across multiple sites globally, including Asia, Europe and North America. For more information, please visit ClinicalTrials.gov. About CD37 CD37 is a transmembrane protein that plays a role in regulating cell survival and is overexpressed in various B-cell hematological malignancies.1 B-cells, which are a type of white blood cell (B-lymphocyte) that help the body fight infection, can uncontrollably multiply and fail to function properly.2 Because of its high prevalence on B-cells, CD37 is considered a promising therapeutic target for the treatment of B-cell cancers.3 Currently, there are no CD37 directed therapies approved for any type of cancer. About B-cell Non-Hodgkin Lymphoma More than 604,000 cases of non-Hodgkin lymphoma were diagnosed in 2021, with approximately 267,000 deaths globally.4 B-cell non-Hodgkin lymphoma accounts for more than 85% of all non-Hodgkin lymphoma cases with a five-year survival rate of 74%.5 While advances in targeted therapies have improved outcomes in B-cell non-Hodgkin lymphoma, many patients with relapsed or refractory disease continue to face limited treatment durability and poor long-term survival.6 About DS3790 DS3790 is an investigational, potential first-in-class CD37 directed ADC. Designed using the proprietary DXd ADC technology of Daiichi Sankyo, DS3790 is comprised of a humanized anti-CD37 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. 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 www.daiichisankyo.com. References: Moore K, et al. J Pathol . 1987; 152 (1): 13-21. Mayo Clinic. Diffuse large B-cell lymphoma . Accessed November 2025. Payandeh Z, et al. Biotechnol Lett . 2018; 40 (11-12): 1459-66. Li T, et al. Ann Hematol . 2025; doi:10.1007/s00277-025-06559-9. Cleveland Clinic. Non-Hodgkin Lymphoma . Accessed November 2025. Ayyappan A, et al. J Hematol Oncol . 2019; 12 (82): 1.

ADC

19 Jan 2026

·www.biospace.com

ENHERTU® Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

Based on DESTINY-Breast09 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s ENHERTU in combination with pertuzumab significantly improved progression-free survival versus current first-line standard of care in HER2 positive metastatic breast cancer TOKYO & MUNICH--(BUSINESS WIRE)--The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU ® (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer. 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/Nasdaq: 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-Breast09 phase 3 trial presented during a special late-breaking oral session at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting and subsequently published in The New England Journal of Medicine . In the trial, ENHERTU in combination with pertuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for patients with HER2 positive metastatic breast cancer. “This validation in the EU is an important step in moving us closer to offering ENHERTU in combination with pertuzumab as a potential new first-line treatment option for patients with HER2 positive metastatic breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Following the recent approval in the U.S. for this indication, we look forward to working closely with the EMA to bring ENHERTU to eligible patients in the EU who may benefit from improved outcomes in a setting where the standard of care has not changed in more than a decade.” About DESTINY-Breast09 DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2 positive metastatic breast cancer. Patients were randomized 1:1:1 to receive either ENHERTU monotherapy with a pertuzumab matching placebo; ENHERTU in combination with pertuzumab; or THP. Randomization was stratified by prior treatment ( de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status. The primary endpoint of DESTINY-Breast09 is PFS as assessed by blinded independent central review in both the ENHERTU monotherapy and ENHERTU combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, objective response rate, duration of response, pharmacokinetics and safety. The investigational arm assessing ENHERTU monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis. DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov . About HER2 Positive Metastatic 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 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or that have progressed to metastatic disease are expected to live five years following diagnosis. 2 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer. 3 HER2 protein overexpression may occur as a result of HER2 gene amplification. 3 Approximately one in five cases of breast cancer are considered HER2 positive. 4 HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer. 4 While HER2 targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade. 5,6,7 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death. 8,9 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 (immunohistochemistry [IHC] 3+ or in-situ hybridization [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 , DESTINY-Gastric04 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 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 six 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 is being developed by Daiichi Sankyo. Additional ADCs being developed by Daiichi Sankyo include DS-9606, which consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload and DS3610, which consists of an antibody attached to a novel immunomodulatory payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS-9606 and DS-3610 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 January 2026. 2 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes . Accessed January 2026. 3 Cheng X. Genes (Basel). 2024;15(7):903. 4 Tarantino P, et al. Ann Oncol . 2023;34(8):645-659. 5 Swain SM, et al. Lancet Oncol . 2020;21(4):519-530. 6 Blumenthal G, et al. Clinical Cancer Research . 2013;19(18). 7 Tripathy D, et al. The Oncologist . 2020;25(2):e214-e222. 8 Hall PS, et al. Presented at SABCS Annual Meeting 2023. Poster #PO3-16-11. 9 Hartkopf AD, et al. Geburtshilfe Frauenheilkd . 2024;84(5):459–469. Contacts Media Contacts: G lobal: 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

Clinical ResultPhase 3Drug ApprovalASCOLicense out/in

100 Deals associated with Patritumab Deruxtecan

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	United States	Merck & Co., Inc.	22 Dec 2023
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	United States	Daiichi Sankyo Co., Ltd.	22 Dec 2023
Hormone receptor positive breast cancer	Phase 3	United States	Merck Sharp & Dohme LLC	17 Oct 2025
Hormone receptor positive breast cancer	Phase 3	China	Merck Sharp & Dohme LLC	17 Oct 2025
Hormone receptor positive breast cancer	Phase 3	Japan	Merck Sharp & Dohme LLC	17 Oct 2025
Hormone receptor positive breast cancer	Phase 3	Argentina	Merck Sharp & Dohme LLC	17 Oct 2025
Hormone receptor positive breast cancer	Phase 3	Australia	Merck Sharp & Dohme LLC	17 Oct 2025
Hormone receptor positive breast cancer	Phase 3	Brazil	Merck Sharp & Dohme LLC	17 Oct 2025
Hormone receptor positive breast cancer	Phase 3	Canada	Merck Sharp & Dohme LLC	17 Oct 2025
Hormone receptor positive breast cancer	Phase 3	Chile	Merck Sharp & Dohme LLC	17 Oct 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06686394 (HERTHENA-Breast01, ESMO_ASIA2025)	Phase 1/2	Advanced HER2-Positive Breast Carcinoma HER2+ \| HER3-expressing	81	HER3-DXd + trastuzumab	hwnkohzhbk(mbmdhzmojv) = The geometric mean ratios (GMRs) for Ctrough were within 71.9–104.5% for HER3-DXd ADC, 71.4–106.4% for total HER3-DXd antidrug antibody, and 79.0–90.3% for free DXd payload across all comparisons. The 90% CIs for AUC24s were 83.0–109.2% for HER3-DXd ADC, 80.6–110.8% for total HER3-DXd antidrug antibody, and 84.4–106.0% for free DXd payload. idwkjnqkju (kbtuxuycmy )	Positive	05 Dec 2025
NCT06686394 (HERTHENA-Breast01, ESMO_ASIA2025)	Phase 1/2		81	HER3-DXd + trastuzumab + pertuzumab		Positive	05 Dec 2025
NCT05865990 (TUXEDO-3, Pubmed \| Lancet Oncol)	Phase 2	Brain metastases	21	Patritumab deruxtecan (HER3-DXd) 5·6 mg/kg	jpcxrisgob(fxyutrnrri) = unqkjgydba ozzrbrcxvk (jfxxtfuzgj ) View more	Positive	01 Nov 2025
NCT05865990 (TUXEDO-3, Pubmed \| Lancet Oncol)	Phase 2	Non-Small Cell Lung Cancer	20	Patritumab deruxtecan (HER3-DXd) 5·6 mg/kg	awrdsqzqsn(ljqverdsha) = neutropenia in three (15%) patients and febrile neutropenia in two (10%). hzoxoggkeh (ziecbltbxv ) View more	Positive	01 Nov 2025
NCT06172478 (HERTHENA-PanTumor01, Pubmed \| Future Oncol)	Phase 2	Advanced Malignant Solid Neoplasm	100	Patritumab deruxtecan (HER3-DXd)	jkhjunlxum(uaslregeio) = csqfkhmkvi eclemmtfmm (bzpqvjhqlk ) View more	Positive	21 Oct 2025
NCT04965766 (ICARUS-BREAST01, Pubmed \| Nat Med)	Phase 2	Advanced breast cancer HR+ \| HER2-	99	Patritumab deruxtecan	essqjrplig(hxkrgttpdr) = gzjrxzjlfx pshaqrpkkj (dgmxzwjidb, 44.8 - 62.1)	Positive	01 Oct 2025
NCT03260491 (Pubmed \| J Clin Oncol) Manual	Phase 1	Non-Small Cell Lung Cancer	47	HER3-DXd	iracyvqzce(bswncehttf) = srdfxjtgzm tbyiywrlcz (vmtnnptydp, 15.6 - 42.6) View more	Positive	24 Jun 2025
NCT05338970 (HERTHENA-Lung02, ASCO2025) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR Exon 19 Deletion \| EGFR L858R	586	Patritumab deruxtecan (HER3-DXd)	mniuosejbb(ejcwatdxaw) = lhmntkqbjx xfihygbstw (lqnngbalqo, 5.5 - 6.8) View more	Positive	30 May 2025
NCT05338970 (HERTHENA-Lung02, ASCO2025) Manual	Phase 3		586	Platinum-based chemotherapy (PBC)	mniuosejbb(ejcwatdxaw) = rbvyrmkmjc xfihygbstw (lqnngbalqo, 5.0 - 5.6) View more	Positive	30 May 2025
NCT05865990 (TUXEDO-3, ASCO2025)	Phase 2	Advanced Malignant Solid Neoplasm \| Metastatic breast cancer \| Advanced Lung Non-Small Cell Squamous Carcinoma ... HER3 View more	61	HER3-DXd 5.6 mg/kg	xkzezfffls(cmcoezlqjt) = wftxygwyup jhyvjvkxdr (iuyuhgacif )	Positive	30 May 2025
NCT04479436 (CTgov)	Phase 2	Metastatic Colorectal Carcinoma	40	Patritumab Deruxtecan (Cohort 1: HER3 High (IHC 3+, 2+))	ncjyhawsba = rxciecsewv aqdwaoivhe (xbgrehnpji, iinuuneodi - bxxceednoh) View more	-	18 May 2025
NCT04479436 (CTgov)	Phase 2	Metastatic Colorectal Carcinoma	40	Patritumab Deruxtecan (Cohort 2: HER3 Low/Negative (IHC 1+, 0))	ncjyhawsba = cfrwsluvay aqdwaoivhe (xbgrehnpji, tftaohlbox - epyjdcgsaa) View more	-	18 May 2025
NCT05569811 (SOLTI VALENTINE, ESMO_BC2025)	Phase 2	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HER3	122	HER3-DXd	pezrjqroqp(ozsdrcpdcj) = ukqdcmwcph doizcpxjtj (uldvasxzij )	Positive	14 May 2025
NCT05569811 (SOLTI VALENTINE, ESMO_BC2025)	Phase 2		122	HER3-DXd + letrozole	pezrjqroqp(ozsdrcpdcj) = xwvkalwguh doizcpxjtj (uldvasxzij )	Positive	14 May 2025

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