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Last update 06 Jun 2025

Patritumab Deruxtecan

Last update 06 Jun 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

HER3-DXd, Patritumab-DX-8951 conjugate, HER3-DXD

+ [6]

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

EGFR-mutated non-small Cell Lung CancerNon-squamous non-small cell lung cancerNon-Small Cell Lung Cancer+ [38]

Inactive Indication-

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Daiichi Sankyo Co., Ltd.Merck Sharp & Dohme LLC

Merck & Co., Inc.

+ [4]

Inactive Organization

Daiichi Sankyo (China) Holdings Co., Ltd.

License Organization

Institut Gustave Roussy EURL

Merck Sharp & Dohme Corp.

AstraZeneca PLC

+ [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

NCT05620914

/ RecruitingPhase 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]

NCT06941272

/ Not yet recruitingPhase 1/2

LIGHTBEAM-U01 Substudy 01C: A Phase 1/2 Substudy to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Researchers are looking for new ways to treat children with hepatoblastoma or rhabdomyosarcoma (RMS) that has relapsed or is refractory:
* Hepatoblastoma is a common liver cancer in babies and very young children
* RMS is a cancer that starts in muscle cells, often in a child's head and neck, bladder, arms, or legs
* Relapsed means the cancer came back after treatment
* Refractory means the cancer did not respond (get smaller or go away) to treatment
The study treatment HER3-DXd (also known as MK-1022 or patritumab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn:
* About the safety of HER3-DXd in children and if they tolerate it
* What happens to HER3-DXd in children's bodies over time
* If children who receive HER3-DXd have the cancer get smaller or go away

Start Date12 Jun 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

NCT06731907

/ RecruitingPhase 2

KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)

Researchers are investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. This study aims to determine the effectiveness of adding other treatments, including the human epidermal growth factor receptor 3-directed antibody-drug conjugate (HER3-DXd) patritumab deruxtecan, to pembrolizumab, with or without chemotherapy. The primary goals are to assess safety and efficacy of the treatments.

Start Date30 Mar 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+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

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

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

01 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 ; Kroemer, Guido ; Leduc, Marion

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.

01 Aug 2025·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Evolving treatment for advanced non-small cell lung cancer harbouring common EGFR activating mutations

Review

Author: Califano, Raffaele ; Bria, Emilio ; Monaca, Federico ; Gomez-Randulfe, Igor ; Planchard, David

A clinically important subgroup of non-small cell lung cancer (NSCLC) is driven by common mutations in the epidermal growth factor receptor (EGFR). Over the past decade, first-, second-, and third-generation EGFR tyrosine kinase inhibitors (TKIs) have substantially improved clinical outcomes, although acquired resistance inevitably emerges. In particular, the third-generation TKI osimertinib has demonstrated superior progression-free survival (PFS) and overall survival (OS) compared to earlier-generation TKIs in the frontline setting, yet median OS remains approximately three years in pivotal trials. Efforts to extend disease control have led to various upfront intensification strategies, including combining EGFR TKIs with antiangiogenics or chemotherapy (e.g., the FLAURA-2 trial), and pairing novel bispecific antibodies such as amivantamab with third-generation TKIs. Upon progression on third-generation EGFR TKIs, platinum-based chemotherapy remains the standard second-line treatment, albeit with modest response rates. Emerging therapies targeting MET amplification (e.g., savolitinib plus osimertinib), leveraging antibody-drug conjugates (e.g., patritumab deruxtecan), or adding immunotherapy and antiangiogenics have shown preliminary promise in overcoming resistance. Ongoing trials are assessing optimal treatment sequencing and the use of circulating tumor DNA (ctDNA) to guide therapy escalation or de-escalation. Ultimately, the evolving landscape of EGFR-mutant NSCLC underscores the need for refined biomarker-driven approaches and personalized regimens to achieve further gains in survival. In this review, we discuss these strategies in detail, highlighting current evidence and future directions for EGFR-mutant NSCLC treatment.

News (Medical) associated with Patritumab Deruxtecan

04 Jun 2025

·www.biopharmadive.com

Daiichi Sankyo struck gold with ‘ADC’ cancer drugs. Its new CEO has to figure out what’s next.

CHICAGO Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took over as the Japanese drugmakers new CEO two months ago and inherited a company whose cancer medicines have, over the past half-decade, won it three of the pharmaceutical industrys largest licensing deals.One of those medicines, the antibody-drug conjugate Enhertu, again took the spotlightat the American Society of Clinical Oncologys annual meeting here, showing potential to become part of standard therapy for the frontline treatment of advanced breast cancer. It did the same in 2022 and 2024.Okuzawa can point to Enhertu and four other antibody-drug conjugates Daiichi Sankyos developing with AstraZeneca and Merck & Co. as proof of the strength of its research laboratories. By 2030, the company plans to have these five ADCs approved across more than 30 tumor types, which would allow it to treat nearly 400,000 cancer patients each year.Wed like to become one of the most important players in oncology, said Okuzawa, noting aspirations to crack the top 10 companies by cancer drug sales. Our senior leaders are now talking about not only top 10, but maybe top 5. Were very much confident in our ADCs.But, current success notwithstanding, the task ahead of Okuzawa is among the most difficult in corporate management. Daiichi Sankyo has one hit drug platform; he must figure out what comes next.In the coming five years, our growth will be driven by these five programs, he said in an interview at ASCO. But at the same time, we would like to establish the next growth driver. Identifying that driver will be a big part of the companys next five-year plan, which it will launch for the fiscal year beginning next April.Daiichi Sankyos current ADCs are built around a technology known as DXd that the companys scientists have fine-tuned since inventing it 15 years ago. It is the backbone for Enhertu, as well as the recently approved breast cancer medicine Datroway and three other ADCs that remain experimental.ADCs like these contain three main components: a targeting antibody, a cancer-killing toxin and a linking molecule that can tightly hold onto the drugs payload while its transiting through the body, but then release it upon arriving at the tumor. The concept is simple, but the details make the difference in balancing efficacy with safety.Both AstraZeneca and Merck are convinced Daiichi Sankyo has struck the right balance. The former company gave Daiichi Sankyo $1.35 billion in 2019 to license rights to what became Enhertu and then one year later paid another $1 billion upfront for the drug the two companies now sell as Datroway. Then, in 2023, Merck bought rights to the three experimental ADCs for $5.5 billion in payments spread over two years.Daiichi Sankyos next big thing might end up being more ADCs. Okuzawa highlighted two as particularly promising. The first, dubbed DS-3939, combines an antibody licensed from Glycotope with the DXd backbone. It could be an opportunity for Daiichi Sankyo to take on independently, said Okuzawa. The other, DS-9606, uses a new payload technology Daiichi Sankyo hopes will yield other medicines in much the same way DXd has.Yet Okuzawa, who has been at Daiichi Sankyo since 1986 and previously held several senior leadership positions, noted that the companys research may take it in new directions, too. There are a lot of opportunities in the ADC space. On the other hand, [our scientists] are also pursuing discovery research outside of ADCs, he said. We have rich ideas for new modalities.In the meantime, Daiichi Sankyo needs to execute on the partnerships it already has in place with AstraZeneca and Merck. Combined, those deals promise up to $27 billion in conditional fees due upon Daiichi Sankyos medicines reaching certain regulatory and sales milestones. While some of those payments have already been made, the bulk remains unrealized.Enhertu, which earned some $3.7 billion in sales last year, is well on track to meeting expectations. However, the path forward for Datroway and the lead program being developed with Merck may be steeper. While Datroway won an important U.S. approval in January, AstraZeneca and Daiichi Sankyo have narrowed their development plans in lung cancer after obtaining mixed study results. And late last month, Merck and Daiichi Sankyo withdrew an approval application for another ADC in lung cancer after it failed to extend survival in a study they presented Sunday at ASCO.Further biomarker analyses of the [study] are being conducted to determine if certain patient populations might differentially benefit as we explore the path forward for patritumab deruxtecan in lung cancer, a spokesperson for Daiichi Sankyo confirmed by email, using the ADCs generic name.However, we remain confident in the broad clinical development program of patritumab deruxtecan, which includes multiple clinical trials across 15 types of cancer.Development setbacks may be partly to blame for Daiichi Sankyos stock price, which in U.S. over-the-counter trading has fallen by one-quarter over the past year. Shares now trade at just under $26 apiece, about what they were worth at the start of the current five-year planning cycle in 2021.Turning that around may require Okuzawa to navigate Daiichi Sankyo through broader economic challenges, too. The Trump administration is currently investigating whether U.S. importation of pharmaceuticals poses national security risks, a probe that is expected to result in tariffs levied against drugs shipped in from abroad. Its not clear, however, which countries may be targeted.Im concerned that the tariffs could disrupt the global supply chain and may cause drug shortages for U.S. patients, said Okuzawa. We would like to avoid such a situation.Daiichi Sankyo is responsible for supplying both Enhertu and Datroway, and does some of the drugs manufacturing outside of the U.S. The company plans to invest $350 million in building out a plant in Ohio that will be used in ADC production and is considering spending more, according to Okuzawa.We also started internally further discussion to expand the capacity of that New Albany plant to accelerate our ADC manufacturing, he said. '

ADCDrug Approval

31 May 2025

·pipelinereview.com

HER3-DXd shows promising results in the phase II TUXEDO-3 study for patients with limited therapeutic options

CHICAGO, IL, USA I May 30, 2025 I Leading international medical research company, MEDSIR announced today the positive results of the TUXEDO-3 trial at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. This phase II study funded by Daiichi Sankyo and Merck, known as MSD outside of the United States and Canada, evaluates the efficacy and safety of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases and leptomeningeal disease, serious complications associated with advanced stages of the cancer. The study was carried out to evaluate HER3-DXd in patients with metastatic breast cancer (mBC) and advanced non-small cell lung cancer (aNSCLC) with active brain metastases, and patients with leptomeningeal disease from solid tumors. This is an antibody-drug conjugate to target HER3, a protein receptor found on the surface of cancer cells in brain metastases. HER3-DXd is an investigational agent consisting 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. The DXd ADC Technology payload causes tumor DNA damage, killing cancer cells within and surrounding the tumor microenvironment The study showed promising results, which were presented today in an oral session. Results from the leptomeningeal cohort have been simultaneously published in the renowned journal Nature Medicine due to its potential benefit in patients with a high unmet medical need. In patients with breast cancer and brain metastases, intracranial responses were observed across all breast cancer subtypes, including luminal, HER2-positive, and triple-negative. Furthermore, some patients with breast cancer who had previously received antibody-drug conjugates also responded to HER3-DXd, highlighting the potential of HER3-DXd to overcome resistance and expand treatment options in refractory disease. Intracranial activity was also observed in patients with aNSCLC and brain metastases, intracranial responses were observed in patients whose tumors contained no activating driver mutations as well as patients whose tumors contained an EGFR or KRAS mutation. Overall, the data suggest that HER3-DXd may offer a novel treatment option for patients with secondary CNS involvement. KEY HIGHLIGHTS OF THE TUXEDO-3 STUDY The TUXEDO-3 study aimed to assess whether HER3-DXd could be an effective treatment option for patients with mBC and aNSCLC with active brain metastases, and leptomeningeal disease from solid tumors. The study met its primary objectives, with 23.8% and 30% patients achieving intracranial responses in active brain metastases from patients with mBC and aNSCLC, respectively, and 65% patients with leptomeningeal disease alive after 3 months. Side effects were consistent with previous studies using HER3-DXd. Tests evaluating quality of life and neurocognitive functions showed that patients remained stable or improved during the treatment follow-up. The primary objectives consisted of assessing the intracranial objective response rate in patients with active brain metastases from mBC and aNSCLC, and determining the number of patients with leptomeningeal disease alive after 3 months of starting the treatment. A NEW HOPE FOR DIFFICULT-TO-TREAT METASTASES “This study represents a significant advancement in our understanding of how to treat brain metastases and leptomeningeal disease, and we are hopeful that our findings will pave the way for new, effective therapies for these patients,” stated Dr. Matthias Preusser, MD, Medical Oncologist and Head of the Clinical Division of Oncology, Medical University of Vienna and Principal Investigator of TUXEDO-3. Dr. Rupert Bartsch, MD, PhD, Consultant Hematology and Medical Oncology, Medical University of Vienna, added: “Brain metastases and leptomeningeal disease represent severe complications in cancer, leading to increased morbidity and mortality, and HER3-DXd could be a promising therapeutic alternative for these patients.” ABOUT UMMET CANCER NEEDS Unmet cancer needs refer to gaps in resources, support, and treatment options that exist for cancer patients. Addressing unmet cancer needs is crucial to improving quality of life and outcomes for cancer patients. Through the collaborative work of healthcare providers, policymakers, and patient advocacy groups unmet cancer needs can be identified to help provide patients with comprehensive and quality care. SHOWCASING PROMISING COLLABORATIVE TRIALS AT ASCO In addition to the oral presentation of TUXEDO-3, MEDSIR will present both ADELA and WIN-B studies in poster format. The ADELA clinical trial is an ongoing international phase III study in collaboration with The Menarini Group, a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc., a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients. The study is being conducted across multiple countries which combines elacestrant with everolimus to treat advanced ER+/HER2- breast cancer with ESR1 mutations, aiming to delay disease progression. Regarding WIN-B , is a phase Ib/II, multi-center investigator-initiated trial, evaluating the safety and preliminary efficacy of combining Debiopharm’s selective WEE1 inhibitor, Debio 0123 and Gilead’s antibodydrug conjugate Trodelvy ® (sacituzumab govitecan-hziy) in advanced HR+/HER2- and triple-negative breast cancers. MEDSIR active presence at the ASCO Annual Meeting 2025 reinforces its leadership in excellence-driven oncology research and highlights its focus on addressing unmet needs in cancer treatment, with the aim of not leaving any patient left behind. ABOUT MEDSIR Established in 2012, MEDSIR prides itself on working closely with its strategic partners to drive innovation in oncology research. Operating in Spain and the United States, the company provides end-to-end clinical trial management, from study design to publication, with an extensive global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that enables research partners to benefit from the best of both worlds: industry clinical research and investigator-driven trials. With the aim of promoting independent research worldwide, MEDSIR has formed a strategic alliance with Oncoclínicas, the leading oncology group in Brazil, which offers outstanding research potential in South America. For further information: www.medsir.org SOURCE: MEDSIR

Clinical ResultPhase 2ASCOPhase 3Phase 1

30 May 2025

·pipelinereview.com

Patritumab Deruxtecan Biologics License Application for Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer Voluntarily Withdrawn

BASKING RIDGE, NJ & RAHWAY, NJ. USA I May 29, 2025 I The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, patritumab deruxtecan (HER3-DXd) based on the HERTHENA-Lung01 phase 2 trial for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies has been voluntarily withdrawn. The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 phase 3 trial where OS did not meet statistical significance as well as discussions with the U.S. Food and Drug Administration. The decision is unrelated to the Complete Response Letter that was received in June 2024 and outlined findings pertaining to an inspection of a third-party manufacturing facility. Patritumab deruxtecan is a specifically engineered HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck. Results from the HERTHENA-Lung02 phase 3 trial, including previously reported statistically significant progression-free survival (PFS) along with topline OS results, will be presented during an oral presentation (# 8506 ) at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting on Sunday, June 1, 2025. HERTHENA-Lung02 is evaluating patritumab deruxtecan monotherapy versus doublet chemotherapy, consisting of platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy, in patients with EGFR-mutated (exon 19 deletion or L858R mutated) advanced NSCLC after disease progression with a third generation EGFR tyrosine kinase inhibitor (TKI) treatment. Patients achieving tumor response will continue to receive patritumab deruxtecan or chemotherapy until disease progression, per investigator assessment. “EGFR-mutated non-small cell lung cancer has proven to be difficult-to-treat in the second-line metastatic setting and beyond,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “While we are disappointed with the overall survival results of HERTHENA-Lung02, we are conducting further biomarker analyses to better identify patients that may benefit from patritumab deruxtecan to guide our continued development in lung cancer. We remain confident in the broad development program of this HER3 directed antibody drug conjugate, which currently includes multiple clinical trials across 15 types of cancer.” “Lung cancer is one of the leading causes of cancer-related deaths worldwide and these results are a reminder of how challenging it can be to treat patients with EGFR-mutated non-small cell lung cancer in the second and later line settings,” said Eliav Barr, MD, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. “We would like to thank the patients, their families and investigators for their participation in this study.” The safety profile seen in HERTHENA-Lung02 was consistent with that observed for patritumab deruxtecan in previous lung cancer clinical trials with no new safety signals identified. About HERTHENA-Lung01 HERTHENA-Lung01 is a global, multicenter, open-label, two-arm phase 2 trial evaluating the safety and efficacy of patritumab deruxtecan in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression with an EGFR TKI and platinum-based chemotherapy. Patients were randomized 1:1 to receive 5.6 mg/kg (n=225) or an uptitration regimen (n=50). The uptitration arm was discontinued as the dose of 5.6 mg/kg of patritumab deruxtecan was selected following a risk-benefit analysis conducted from a separate phase 1 trial assessing the doses in a similar patient population. The primary endpoint of HERTHENA-Lung01 was objective response rate (ORR) as assessed by blinded independent central review (BICR). Secondary endpoints included duration of response, PFS, disease control rate, and time to response – all assessed by both BICR and investigator assessment – as well as investigator-assessed ORR, OS, safety and tolerability. The ORR data and additional results for key secondary endpoints of HERTHENA-Lung01 were published in the Journal of Clinical Oncology in September 2023. HERTHENA-Lung01 enrolled 277 patients in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov . About HERTHENA-Lung02 HERTHENA-Lung02 is a global, multicenter, open-label, phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (5.6 mg/kg every three weeks) monotherapy versus four cycles of doublet chemotherapy (pemetrexed and platinum chemotherapy) in patients with metastatic or locally advanced NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) after failure of third-generation (e.g., osimertinib, lazertinib, aumolertinib, alflutinib) EGFR TKI therapy. Patients in the chemotherapy arm without disease progression after four cycles of pemetrexed and platinum chemotherapy are able to continue treatment with maintenance pemetrexed with no restriction on the number of cycles. The primary endpoint of HERTHENA-Lung02 is PFS as assessed by BICR. Secondary endpoints included OS, ORR, duration of response, clinical benefit rate, time to response, disease control rate, and safety. Patients enrolled in the study underwent brain imaging to allow for assessment of intracranial endpoints, including intracranial PFS as assessed by BICR. HERTHENA-Lung02 enrolled 586 patients in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov . About EGFR-Mutated Non-Small Cell Lung Cancer Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. Lung cancer is the most common cancer and the leading cause of cancer-related deaths worldwide. 1 NSCLC accounts for about 87% of all lung cancers. 2 Approximately 10% to 15% of patients with NSCLC in the U.S. and Europe, and 30% to 40% of patients in Asia have an EGFR mutation. 3,4 NSCLC is diagnosed at an advanced stage in up to 70% of patients. 5 For patients with tumors that have an EGFR mutation, the established first-line treatment in the metastatic setting includes EGFR-directed therapy with or without platinum-based chemotherapy. 6 While these therapies have improved outcomes, most patients eventually experience disease progression and receive subsequent therapies. 7-10 About HER3 HER3 is a member of the HER family of receptor tyrosine kinases. 11 It is estimated that about 83% of primary NSCLC tumors and 90% of advanced EGFR-mutated tumors express HER3 after prior EGFR TKI treatment. 12 HER3 is associated with poor treatment outcomes, including shorter relapse-free survival and significantly reduced survival. 13,14 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 treatments also are underway. About the Daiichi Sankyo and Merck Collaboration Daiichi Sankyo and Merck 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 will maintain exclusive rights. Merck 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. 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 https://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 . SOURCE: Daiichi Sankyo

ASCOClinical ResultPhase 3Phase 2License out/in

100 Deals associated with Patritumab Deruxtecan

R&D Status

10 top R&D records.

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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
Non-squamous non-small cell lung cancer	Phase 3	United States	Daiichi Sankyo Co., Ltd.	08 Jul 2022
Non-squamous non-small cell lung cancer	Phase 3	China	Daiichi Sankyo Co., Ltd.	08 Jul 2022
Non-squamous non-small cell lung cancer	Phase 3	Japan	Daiichi Sankyo Co., Ltd.	08 Jul 2022
Non-squamous non-small cell lung cancer	Phase 3	Australia	Daiichi Sankyo Co., Ltd.	08 Jul 2022
Non-squamous non-small cell lung cancer	Phase 3	Austria	Daiichi Sankyo Co., Ltd.	08 Jul 2022
Non-squamous non-small cell lung cancer	Phase 3	Belgium	Daiichi Sankyo Co., Ltd.	08 Jul 2022
Non-squamous non-small cell lung cancer	Phase 3	Canada	Daiichi Sankyo Co., Ltd.	08 Jul 2022
Non-squamous non-small cell lung cancer	Phase 3	France	Daiichi Sankyo Co., Ltd.	08 Jul 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05338970 (HERTHENA-Lung02, ASCO2025)	Phase 3	Non-squamous non-small cell lung cancer \| EGFR-mutated non-small Cell Lung Cancer Ex19del \| L858R	586	Patritumab deruxtecan (HER3-DXd)	dnqosvitnp(rtmaptnclq) = njjhujmolz ylspmyncqo (heogyoqxei, 5.5 - 6.8) View more	Positive	30 May 2025
				Platinum-based chemotherapy (PBC)	dnqosvitnp(rtmaptnclq) = liqsctgdih ylspmyncqo (heogyoqxei, 5.0 - 5.6) View more
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	ifhfvcsohg(oxvpnfmpyo) = rcrwgmxiim mfopljnpqh (iniswkqthj )	Positive	30 May 2025
NCT04479436 (CTgov)	Phase 2	Metastatic Colorectal Carcinoma	40	Patritumab Deruxtecan (Cohort 1: HER3 High (IHC 3+, 2+))	dpydiudwgd = tnxwsgdxfb lqdpeonjvg (aekcpubyed, ybouhchowu - oirrinfdla) View more	-	18 May 2025
				Patritumab Deruxtecan (Cohort 2: HER3 Low/Negative (IHC 1+, 0))	dpydiudwgd = aovrezstrk lqdpeonjvg (aekcpubyed, kuasjrobez - ydvcqyqubz) View more
NCT05569811 (SOLTI VALENTINE, ESMO_BC2025)	Phase 2	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HER3	122	HER3-DXd	hulogztrro(wansjmclsi) = fpbozdvwlo aanaayzfgn (tkvgnlnikg )	Positive	14 May 2025
				HER3-DXd + letrozole	hulogztrro(wansjmclsi) = elieobqlck aanaayzfgn (tkvgnlnikg )
NCT05569811 (SOLTI VALENTINE, SABCS2024) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer Neoadjuvant	122	HER3-DXd	yvmhtjjjnd(yfhbgddjcv) = tnolkydriw aedpzeskmy (fpavbyfkfn, 0.5 - 13.7) View more	Positive	26 Nov 2024
				HER3-DXd + LET	yvmhtjjjnd(yfhbgddjcv) = mwqiysuguv aedpzeskmy (fpavbyfkfn, 0.1 - 11.1) View more
NCT04965766 (ICARUS-BREAST01, ESMO2024) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer Second line Hormone Receptor Positive \| HER2 Negative	99	Patritumab deruxtecan (HER3-DXd) 5.6 mg/kg IV	mgmtdyftes(ohqnkanxql) = xifdyryvqh fukbhihbrk (pfpdbyttyh, 43.2 - 63.6) View more	Positive	13 Sep 2024
NCT04619004 (HERTHENA-Lung01, ESMO_ELCC2024) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	225	HER3-DXd 5.6 mg/kg IV Q3W	wkraowbzdj(lkrqldyjqx) = kdkkhbamlp nmfvkisgyg (znprulfvhl ) View more	Positive	22 Mar 2024
NCT02980341 (U31402-A-J101, Pubmed \| J Clin Oncol)	Phase 1/2	Metastatic breast cancer HER3	-	Patritumab Deruxtecan (HER3-DXd) 1.6-8.0 mg/kg	utdgsdoqwy(cnhhgdqxcz) = GI and hematologic toxicities were the most common treatment-emergent adverse events (TEAEs) observed ezdtvdewlt (hqmkbfrrey ) View more	Positive	20 Dec 2023
NCT05338970 \| NCT04619004 (Pubmed \| J Clin Oncol)	Not Applicable	EGFR-mutated non-small Cell Lung Cancer	-	HER3-DXd 5.6 mg/kg	qvccuywoyc(zolajsfodx) = mxujfozsul dleitciphe (nooeaugtho, 17.3 - 52.8) View more	-	10 Dec 2023
NCT04619004 (HERTHENA-Lung01, ESMO 12023 \| ESMO 22023) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR mutation	95	HER3-DXd 5.6 mg/kg	gnqbazzptx(sqwnaslmti) = ammjbajlaa xruvcgmrxu (sauomwmcxc ) View more	Positive	22 Oct 2023
				HER3-DXd 5.6 mg/kg (Prior local CNS-directed radiotherapy <6 mo from start)	gnqbazzptx(sqwnaslmti) = sesggwmokb xruvcgmrxu (sauomwmcxc ) View more

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