HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [5]

Active Indication

Metastatic human epidermal growth factor 2 positive carcinoma of breastStomach CancerHER2 Positive Solid Tumors+ [80]

Inactive Indication

Bone metastasesEstrogen receptor positive breast cancerHER2 Positive Transitional Cell Carcinoma+ [5]

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Daiichi Sankyo Co., Ltd.

AstraZeneca PLC

Daiichi Sankyo, Inc.

+ [10]

Inactive Organization-

License Organization

Merck & Co., Inc.

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (20 Dec 2019),

HER2 Positive Breast Cancer

RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), SAKIGAKE (Japan), Conditional marketing approval (China)

Structure/Sequence

Boost your research with our ADC technology data.

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Sequence Code 18481L

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Sequence Code 44772H

Source: *****

215

Clinical Trials associated with Fam-trastuzumab deruxtecan-NXKI

NCT07619521

/ RecruitingPhase 1/2IIT

Phase I/II Study of the MEK Inhibitor Selumetinib Plus DS-8201a (Trastuzumab Deruxtecan) in KRAS-Mutant, HER2-Expressing Pancreatic Ductal Adenocarcinoma

This phase I/II trial tests the safety, side effects, best dose and how well giving selumetinib with trastuzumab deruxtecan (DS-8201a) works for the treatment of pancreatic ductal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. DS-8201a is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving selumetinib with DS-8201a may be safe, tolerable and/or effective in treating patients with advanced, unresectable or metastatic pancreatic ductal adenocarcinoma.

Start Date01 Jun 2027

Sponsor / Collaborator

National Cancer Institute

NCT07578116

/ RecruitingPhase 3IIT

Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.

Start Date09 Mar 2027

Sponsor / Collaborator

SWOG

[+1]

NCT07454668

/ Not yet recruitingPhase 1IIT

Phase 1 Trial of Trastuzumab Deruxtecan With Stereotactic Radiosurgery (SRS) in Participants With Brain Metastases From HER-2 Positive Breast Cancer

A phase I clinical trial (a type of research study) for people with human epidermal growth factor receptor 2 (HER-2) positive breast cancer with metastasis to the brain. This research study will evaluate how well brain metastases can be controlled using a type of radiation therapy known as stereotactic radiosurgery (SRS) when combined with the therapeutic agent Trastuzumab Deruxtecan (T-DXd). The combined use of SRS with T-DXd is considered investigational.

Start Date01 Jan 2027

Sponsor / Collaborator

Baptist Health South Florida, Inc.

[+1]

100 Clinical Results associated with Fam-trastuzumab deruxtecan-NXKI

100 Translational Medicine associated with Fam-trastuzumab deruxtecan-NXKI

100 Patents (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

1,284

Literatures (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

01 Feb 2027·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Construction of efficacy prediction model for T-DXd treatment of HER2-positive and HER2-low expression breast cancer based on hematological indicators: A real-world study

Article

Author: Feng, Huachao ; Yuan, Peng ; Li, Man ; Zhang, Yurong ; Fan, Shanmin ; He, Binsheng ; Zhang, Yanyan ; Sang, Die ; Liu, Haiyan ; Zhao, Meiqing ; Su, Yanfang ; Li, Shiyu ; Zhang, Jintao ; Zhao, Longmei ; Zhang, Guoyong

BACKGROUND:

This study explores hematological changes during trastuzumab deruxtecan (T-DXd) treatment in HER2-positive and HER2-low breast cancer patients, aiming to develop an efficacy prediction model for personalized clinical decisions.

MATERIALS:

A retrospective analysis of 114 patients treated with T-DXd at Beijing Chaoyang District Sanhuan Cancer Hospital (March 2023-December 2024) was conducted. Data included demographics, treatment history, and laboratory results. Efficacy was assessed via RECIST 1.1, with analyses using the Wilcoxon test and Kaplan-Meier method.

RESULTS:

HER2-positive patients had a progression-free survival (PFS) of 12.2 months vs. 10.2 months for HER2-low. Common adverse events included Nausea, primarily grade 1 or 2. T-DXd caused significant reductions in red blood cell count, hemoglobin, hematocrit, creatine kinase, and homocysteine (p < 0.05), along with increased red cell distribution width. Responders (CR+PR+SD) and progressors (PD) differed in platelets, plateletcrit, and homocysteine (p < 0.05). Stratification by estrogen receptor (ER) and progesterone receptor (PR) expression and Ki67 revealed distinct PFS outcomes. We aimed to predict the efficacy of T-DXd using pre-treatment hematological parameters and various machine learning models, including Random Forest, SVM, XGBoost, and LightGBM. The performance of the optimal models, as evaluated by leave-one-out cross-validation, yielded AUC values of 0.748 (XGBoost), 0.881 (SVM), and 0.830 (SVM) for models based on Complete Blood Count (CBC) parameters, biochemical markers, and their combination, respectively.

CONCLUSION:

Hematological toxicity is a recognized concern with T-DXd therapy. Our predictive model demonstrates strong performance in identifying patients suitable for treatment, highlighting that rigorous monitoring of hematological indicators is critical for mitigating risk and upholding safety standards in clinical practice.

01 Jan 2027·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Design and synthesis of 5,11- and 5,12-disubstituted benzophenanthridinone analogues as DNA topoisomerase IB (TOP1) inhibitors and their anticancer activity

Article

Author: Pommier, Yves ; An, Lin-Kun ; Xiong, Xiao-Peng ; Cao, Ye ; Yang, Xi ; Agama, Keli ; Chen, Ao ; Li, Yue-Wen ; Zhang, Xiang

Based on our previous work and molecular modeling studies, dual-substituted benzophenanthridinone derivatives were designed as DNA topoisomerase IB (TOP1) inhibitors. Here we report nine analogues (A4, A15, A58, A63, B7, B8, B16, C6 and C7) showing TOP1 trapping potency (++++) at least equal to CPT. Cellular assays demonstrate that fifty-one analogues exhibit strong cytotoxicity at nanomolar concentration in MDA-MB-231 cells. Additionally, A47, A63, B8 and B16 demonstrated picomolar concentration cytotoxicity (GI₅₀ < 100 pM) and greater activity than both SN38 the active metabolite of irinotecan and payload of Trodelvy® and deruxtecan the payload of Enhertu® and Datroway® in several cancer cell lines. A63 also showed very strong cytotoxicity in MDA-MB-231, RKO, NCI-H82, NCI-H1048 and U251 cells with GI₅₀ values ranging from 0.071 to 6 nM and antitumor efficacy in the MDA-MB-231 xenograft model. The mechanism of antitumor, and the cryo-EM structure of A63 in TOP1-DNA cleavage complex were also studied.

01 Dec 2026·RADIOTHERAPY AND ONCOLOGY

Safety of combining radiation therapy and antibody-drug conjugates in patients with breast cancer: a systematic review and meta-analysis

Review

Author: Isacke, Clare M ; Harbeck, Nadia ; Alkner, Sara ; Marangoni, Elisabetta ; Paluch-Shimon, Shani ; Rugo, Hope ; Kaidar-Person, Orit ; Saura, Cristina ; Offersen, Birgitte ; Jackson, Stephen P ; Becherini, Carlotta ; Kubeczko, Marcin ; Jones, Christopher M ; Lambertini, Matteo ; Stobart, Hilary ; Coles, Charlotte E ; Starzer, Angelika M ; de Azambuja, Evandro ; Caini, Saverio ; Cortés, Javier ; Spanic, Tanja ; Meattini, Icro ; Boersma, Liesbeth J ; Poortmans, Philip ; Curigliano, Giuseppe ; Livi, Lorenzo ; Morandi, Andrea ; Visani, Luca

BACKGROUND AND PURPOSE:

The treatment landscape for breast cancer has undergone significant advancements in the recent years, with the introduction of several new anticancer agents, especially those belonging to the antibody-drug conjugates (ADCs) class. However, there exists a lack of comprehensive evidence regarding the safety profile of combining ADCs with radiation therapy (RT). Here we provide a summary of the available data on the safety of combining RT with ADCs in both early and metastatic breast cancer settings as part of updating European Society for Radiotherapy and Oncology (ESTRO) consensus.

MATERIALS AND METHODS:

This systematic review and meta-analysis project is part of the Second International Consensus Recommendations by the ESTRO Guidelines Committee on integrating RT with targeted treatments for breast cancer. A thorough literature search was conducted using the PUBMED/MedLine, Embase, and Cochrane databases to identify original studies focusing on the safety profile of combining ADCs with RT.

RESULTS:

After applying eligibility criteria, a total of 29 studies published between 2014 and 2026 were included, representing 3,817 patients who received at least one RT course concurrently to an ADC. The pooled grade ≥ 3 radiation necrosis rate across all studies reporting this endpoint was 5% (95% CI: 1-12%; I² = 85.9%). In the intracranial RT setting, the pooled grade ≥ 3 treatment-related adverse event rate was 8% (95% CI: 3-15%; I² = 81.7%), with T-DM1 studies showing the highest sub-total estimate of 13% (95% CI: 1-34%). Grade ≥ 3 pneumonitis was rare across all settings (pooled 0%; 95% CI: 0-1%; 12 studies), as well as grade ≥ 3 skin side effects (pooled 0%; 95% CI: 0-1%; 13 studies) were rare across all settings.

CONCLUSION:

RT can be safely delivered alongside ADCs therapy in most clinical settings, with severe complications occurring infrequently. The available evidence supports the use of conventional extracranial RT during treatment with T-DM1, T-DXd, and SG, provided that routine safety monitoring is maintained. In contrast, intracranial stereotactic RT remains the setting in which caution is warranted, particularly in patients receiving T-DM1, for whom an increased risk of radiation necrosis has been consistently reported. Current data does not suggest a similar risk signal for T-DXd or SG. Radiation necrosis; Stereotactic radiotherapy.

1,247

News (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

27 Oct 2026

·www.astrazeneca.com

Enhertu approved in the EU as adjuvant treatment for patients with residual disease after neoadjuvant treatment for HER2-positive early breast cancer

AstraZeneca and Daiichi Sankyo’s Enhertu(trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted treatment. The approval by the European Commission follows the positive opinionof the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from the DESTINY-Breast05 Phase III trial presented at the 2025 European Society for Medical Oncology Congress and subsequently published in The New England Journal of Medicine.1 Sibylle Loibl, MD, PhD, German Breast Group (GBG) and Goethe University Medicine Frankfurt, Frankfurt am Main and lead investigator of the DESTINY-Breast05 trial, said: “For patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant therapy, reducing the risk of disease recurrence is critical for sustained long-term outcomes. The EU approval of trastuzumab deruxtecan, which demonstrated a more than 50 per cent reduction in risk of recurrence compared to standard of care in DESTINY-Breast05, has the potential to change how we treat eligible patients in this setting.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “The goal of treatment in early breast cancer is to help as many patients as possible achieve cure. Unfortunately, despite treatment advances, some patients still face recurrence in the long term. The approval of Enhertu in the adjuvant setting for patients with residual disease after neoadjuvant treatment has the potential to establish a new benchmark in this curative-intent setting, with more than 92 per cent of patients alive and free of invasive disease at three years.” Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., said: “By bringing Enhertu into the adjuvant setting, we are advancing this treatment option earlier in the course of disease for patients with HER2-positive early breast cancer. This first approval of Enhertu in early breast cancer in the EU reflects our continued commitment to bringing innovative medicines into earlier treatment settings, where there is significant potential to improve long-term outcomes for patients.” In DESTINY-Breast05, Enhertu significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% (based on a hazard ratio [HR] of 0.47; 95% confidence interval [CI] 0.34-0.66; p<0.0001) compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer with residual invasive disease following neoadjuvant therapy. Enhertu demonstrated a three-year IDFS rate of 92.4% (95% CI 89.7-94.4) compared to 83.7% with T-DM1 (95% CI 80.2-86.7). The safety profile of Enhertu was consistent with the known profile with no new safety concerns identified. Enhertu is now approved in more than 35 countries for the adjuvant treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Financial considerations Following this approval in the EU, an amount of $75 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the adjuvant HER2-positive early breast cancer indication. Sales of Enhertu in most EU territories are recognised by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019. Notes HER2-positive early breast cancer Breast cancer is the most common cancer in women worldwide and the leading cause of cancer-related deaths among women.2 Approximately 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally.2 In Europe, approximately 540,000 cases of breast cancer were diagnosed in 2024, with more than 140,000 deaths.3 HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.4 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.4 Approximately one in five cases of breast cancer is considered HER2-positive.5 HER2-positive early breast cancer is generally treated across two phases: the neoadjuvant (pre-surgical) phase and the adjuvant or post-neoadjuvant (post-surgical) phase. For patients treated before surgery, achieving pathologic complete response (pCR) – defined as no evidence of invasive cancer cells in the removed breast tissue or lymph nodes following neoadjuvant treatment – is an early indicator of improved long-term survival.6 However, approximately half of patients (39-66%) treated before surgery do not achieve pCR, increasing their risk of recurrence.7-11 Post-surgery therapy offers a key opportunity to reduce this risk and prevent progression to metastatic disease.12-14 Yet approximately one in four patients with residual disease treated with the historic adjuvant standard of care still experience invasive disease or death.12-15 Once disease becomes metastatic, five-year survival falls from around 90% to approximately 30%.15 DESTINY-Breast05 DESTINY-Breast05 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/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 randomisation until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed DFS. 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. Enhertu Enhertu is a HER2-directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme 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 (5.4mg/kg) followed by THP is approved in more than five countries as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or Stage III breast cancer based on the results from the DESTINY-Breast11 trial. Enhertu (5.4mg/kg) is approved in more than 35 countries worldwide for the adjuvant treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Enhertu (5.4mg/kg) in combination with pertuzumab is approved in more than 40 countries worldwide as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial. Enhertu (5.4mg/kg) is approved in more than 100 countries 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 (5.4mg/kg) is approved in more than 75 countries 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 has progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. Enhertu (5.4mg/kg) is approved in more than 100 countries 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 (5.4mg/kg) is approved in more than 80 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours 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 US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4mg/kg) is approved in more than 90 countries 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 (5.4mg/kg) is approved in more than 50 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02, DESTINY-PanTumor03 and/or HERALD trials. Continued approval in the US and China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu clinical development programme A comprehensive global clinical development programme 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. Daiichi Sankyo collaboration AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and Datroway (datopotamab deruxtecan) 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. AstraZeneca in breast cancer AstraZeneca is advancing a leading breast cancer portfolio across subtypes and stages, with five approved medicines across 12 indications and seven ongoing Phase III trials. In HER2-positive breast cancer, AstraZeneca is aiming to establish new standards of care across the disease continuum with Enhertu, with a focus on improving outcomes as early as possible. In HR-positive metastatic breast cancer, AstraZeneca is focused on extending the benefit of endocrine-based therapies by tackling key resistance mechanisms with Etcamah (camizestrant), a next-generation oral SERD, and Truqap (capivasertib), a first-in-class AKT inhibitor, while expanding the role of the antibody drug conjugates Enhertu and Datroway for patients no longer suitable for endocrine-based therapy. Etcamah is also being evaluated in early-stage disease. In triple-negative breast cancer (TNBC), AstraZeneca is advancing the treatment landscape by developing tailored approaches that move more patients beyond conventional chemotherapy. This includes Datroway, which is evolving the standard of care in metastatic TNBC and is also being evaluated in earlier settings and in combination with immunotherapy Imfinzi (durvalumab) and bispecific antibody ivonescimab. In germline BRCA-mutated (gBRCAm) breast cancer, AstraZeneca has redefined treatment with the PARP inhibitor Lynparza (olaparib) and is now building on this foundation with saruparib, a PARP1-selective inhibitor being evaluated in combination with Etcamah for patients with gBRCAm or PALB2m, HR-positive, HER2-negative metastatic breast cancer. Together, these efforts support AstraZeneca's ambition to cure more patients with early breast cancer, improve survival in metastatic disease, and ultimately eliminate breast cancer as a cause of death. AstraZeneca is collaborating with Daiichi Sankyo to develop and commercialise Enhertu and Datroway, with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza and with Summit Therapeutics on the clinical development of ivonescimab in combination with Datroway. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

Drug ApprovalPhase 3License out/inImmunotherapyClinical Result

27 Oct 2026

·www.biospace.com

Enhertu® Approved in the EU as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer

Approval based on DESTINY-Breast05 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 First EU approval of Enhertu in the curative-intent early breast cancer setting Third approval for Enhertu in the EU in four months TOKYO--(BUSINESS WIRE)--Enhertu ® (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have residual invasive disease after neoadjuvant taxane-based and 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 approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results 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 DESTINY-Breast05, Enhertu significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% (hazard ratio [HR]=0.47; 95% confidence interval [CI]: 0.34-0.66; p<0.0001) compared to trastuzumab emtansine (T-DM1) in patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy. Enhertu demonstrated a three-year IDFS rate of 92.4% (95% CI: 89.7-94.4) and 83.7% with T-DM1 (95% CI: 80.2-86.7). Data also showed that Enhertu significantly reduced the risk of disease recurrence or death (disease-free survival [DFS]) by 53% (HR=0.47; 95% CI: 0.34-0.66; p<0.0001) compared to T-DM1. Results showed a three-year DFS rate of 92.3% (95% CI: 89.5-94.3) in the Enhertu arm and 83.5% with T-DM1 (95% CI: 79.9-86.4). “For patients with HER2 positive early breast cancer and residual invasive disease after neoadjuvant therapy, reducing the risk of disease recurrence is critical for sustained long-term outcomes,” said Sibylle Loibl, MD, PhD, GBG (German Breast Group) and Goethe University Medicine Frankfurt, Frankfurt am Main and lead investigator of the DESTINY-Breast05 trial. “The EU approval of trastuzumab deruxtecan, which demonstrated a more than 50% reduction in risk of recurrence compared to standard of care in DESTINY-Breast05, has the potential to change how we treat eligible patients in this setting.” In DESTINY-Breast05, the safety pro Enhertu was consistent with the known pro no new safety concerns identified. Grade 3 or grade 4 adverse reactions from a pooled safety analysis of 4,146 patients who received at least one dose of Enhertu (5.4 mg/kg) in clinical studies across multiple tumor types included neutropenia (18.7%), anemia (8.2%), fatigue (7.4%), leukopenia (6.6%), thrombocytopenia (5.4%), lymphopenia (5.0%), nausea (4.5%), increased transaminases (3.3%), hypokalemia (3.1%), pancytopenia (2.8%), diarrhea (2.1%), vomiting (2.0%), decreased appetite (1.4%) and pneumonia (1.2%). Grade 5 adverse reactions occurred in 0.9% of patients, including interstitial lung disease (ILD)/pneumonitis (0.8%). “By bringing Enhertu into the adjuvant setting, we are advancing this treatment option earlier in the course of disease for patients with HER2 positive early breast cancer,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “This first approval of Enhertu in early breast cancer in the EU reflects our continued commitment to bringing innovative medicines into earlier treatment settings, where there is significant potential to improve long-term outcomes for patients.” “The goal of treatment in early breast cancer is to help as many patients as possible achieve cure. Unfortunately, despite treatment advances, some patients still face recurrence in the long-term,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “The approval of Enhertu in the adjuvant setting for patients with residual disease after neoadjuvant treatment has the potential to establish a new benchmark in this curative-intent setting, with more than 92% of patients alive and free of invasive disease at three years.” Enhertu (5.4 mg/kg) is now approved in more than 35 countries/regions worldwide for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Financial Considerations Following this approval in the EU, an amount of $75 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the adjuvant HER2 positive early breast cancer indication. Sales of Enhertu in most EU territories are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019 . 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 DFS. 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 HER2 Positive Early Breast Cancer Breast cancer is the most common cancer in women worldwide and the leading cause of cancer-related deaths among women. 1 Approximately 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally. 1 In Europe, approximately 540,000 cases of breast cancer were diagnosed in 2024, with more than 140,000 deaths. 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 and is often associated with aggressive disease and poor prognosis in breast cancer. 3 Approximately one in five cases of breast cancer is considered HER2 positive. 4 Approximately one in three patients with HER2 positive early-stage breast cancer is considered high-risk, meaning they are more likely to experience disease recurrence and have a poor prognosis. 5 Despite receiving additional treatment with current standard of care for residual disease, some patients still experience invasive disease or death. 6 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 100% to approximately 34%. 7 Adjuvant therapy represents a key opportunity to minimize the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. 8,9,10 Prior to the approval of Enhertu in the HER2 positive adjuvant (after surgery) setting for patients with residual invasive disease, the standard of care was T-DM1. 11 About Enhertu Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, 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) followed by THP is approved in more than five countries/regions worldwide as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial. Enhertu (5.4 mg/kg) is approved in more than 35 countries/regions worldwide for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in more than 40 countries/regions worldwide as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial. Enhertu (5.4 mg/kg) is approved in more than 100 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 75 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 100 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 80 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 90 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 50 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02 , DESTINY-Lung01 , DESTINY-CRC02, DESTINY-PanTumor03 and/or HERALD 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. 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 nine 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. Additional ADCs being developed by Daiichi Sankyo include DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING, and DS1025, which consists of a CD25 directed antibody attached to an immuno-oncology optimized cytotoxic payload. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610, DS3790 and DS1025 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 (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . REFERENCES 1 World Health Organization. Global Status Report On Cancer 2026: The Future We Choose Together . Accessed October 2026. 2 World Health Organization. Breast Fact Sheet . Accessed October 2026. 3 Cheng X. Genes . 2024;15(7):903. 4 Tarantino P, et al. Ann Oncol . 2023;34(8):645-659. 5 Mahtani R, et al. Cancers (Basel). 2025;17(11):1848. 6 Geyer CE, et al. N Engl J Med . 2025;392(3):249-257. 7 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes . Accessed October 2026. 8 von Minckwitz G, et al. N Engl J Med . 2019;380(7):617-628. 9 Zaborowski AM and Wong SM. BJS . 2023;110(7):765-772. 10 Loibl S, et al. N Engl J Med . 2026;394(9):845-857. 11 Loibl S, et al. ESMO Clinical Practice Guidelines . 2024. Contacts MEDIA CONTACTS: Global: Jennifer Brennan jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) EU: Simone Jendsch-Dowé simone.jendsch-dowe@daiichisankyo.com +49 (89) 78080 (office) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com

Phase 3Drug ApprovalClinical ResultLicense out/inADC

26 Oct 2026

·www.fiercebiotech.com

BioNTech sees ‘limited’ benefit to ADC after phase 3 reveals modest efficacy, ILD cases

BioNTech has reported modest efficacy and unexpected safety findings in a phase 3 breast cancer trial, leading the company to conclude its HER2-directed candidate may offer “limited” benefits in the current treatment landscape. The study, DYNASTY-Breast02, enrolled patients with HR-positive, HER2-low metastatic breast cancer. AstraZeneca and Daiichi Sankyo defined the HER2-low category with their antibody-drug conjugate (ADC) Enhertu. BioNTech’s trastuzumab pamirtecan (t-pam) uses the same anti-HER2 antibody as Enhertu but is differentiated by its linker technology and cytotoxic payload. DYNASTY-Breast02 raises doubts about whether those differences improve clinical outcomes. Working with its partner DualityBiologics, BioNTech reported a statistically significant but modest improvement in progression-free survival (PFS) in the phase 3 trial. A statistically significant PFS benefit versus chemotherapy “was largely expected,” BMO Capital Markets analysts said in a note to investors. With BioNTech’s press release lacking data on the magnitude of the PFS improvement, the analysts interpreted the efficacy readout as “an incremental negative.” BioNTech reported the modest PFS improvement alongside a higher rate of interstitial lung disease (ILD) than it saw in earlier trials of the ADC. Most ILD cases were grade 1 or 2. A “small proportion of patients” had severe or fatal events, the company acknowledged. The biopharma declined to provide more details of the data or their potential implications for the company’s other ADCs. “Given increasing physician sensitivity to pulmonary toxicity for HER2-directed ADCs, these findings are likely to weigh on competitive positioning,” the analysts said. “Taken together, DYNASTY-Breast02 data lowers our confidence in the overall competitive positioning of t-pam in HR+/HER2-low mBC.” BioNTech echoed the doubts, stating that the results suggest t-pam’s potential benefit to patients would be limited in the context of the current treatment landscape. BMO analysts interpreted the line as a sign that t-pam is less likely to be developed for the indication. BioNTech and DualityBio will discuss the data and decide the next steps. Overall survival data were immature as of the interim analysis. BMO analysts picked up on signs of growing uncertainty about the ADC’s future on BioNTech’s earnings call in August. Noting that BioNTech executives saw the ADC’s path forward as less certain in an evolving treatment landscape, the analysts said they “view potential downside associated with discontinuation as more limited given relatively smaller patient opportunities.” BioNTech already has data from a registrational cohort of endometrial carcinoma (EC) patients. In a note to investors last week, TD Cowen analysts said that a filing for approval in EC “technically remains on track for 2026.” However, the analysts suspected that BioNTech wouldn't file for approval in EC alone, given the small market size, and would instead wait to include breast cancer data in the filing package. The DYNASTY-Breast02 readout comes two weeks after BioNTech's mRNA cancer vaccine BNT113 missed one of its dual primary endpoints in a phase 2/3 clinical trial. The back-to-back setbacks leave the company looking to readouts on its anti-CTLA-4 antibody gotistobart for a near-term boost to its pipeline. In the longer term, the PD-L1xVEGF-A bispecific pumitamig is central to BioNTech’s prospects. The drug developer presented data on pumitamig, including in combination with its B7-H3-directed ADC, at the European Society for Medical Oncology conference over the weekend. The initial ADC combination results showed encouraging early activity, with “deep tumor shrinkage and responses that deepened beyond initial disease stabilization,” BioNTech said in its ESMO presentation. The results added to a growing body of evidence supporting the potential use of pumitamig with ADCs, the company added.

Clinical ResultVaccinePhase 3ADCmRNA

100 Deals associated with Fam-trastuzumab deruxtecan-NXKI

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KEGG	Wiki	ATC	Drug Bank
D11529	Fam-trastuzumab deruxtecan-NXKI	L04AG L01XC	DB14962

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic human epidermal growth factor 2 positive carcinoma of breast	United States	Daiichi Sankyo, Inc.	15 May 2026
Stomach Cancer	India	AstraZeneca PLC	07 Oct 2025
HER2 Positive Solid Tumors	United Kingdom	Daiichi Sankyo UK Ltd.	09 Apr 2025
HR-positive/HER2-low Breast Carcinoma	United States	Daiichi Sankyo Co., Ltd.	28 Jan 2025
Hormone receptor positive HER2 positive breast cancer	South Korea	Daiichi Sankyo Co., Ltd.	19 Sep 2022
HER2 mutant non-small cell lung cancer	United States	Daiichi Sankyo, Inc.	11 Aug 2022
HER2 Positive Stomach Adenocarcinoma	Australia	AstraZeneca Pty Ltd.	08 Oct 2021
HER2-Low Breast Carcinoma	Australia	AstraZeneca Pty Ltd.	08 Oct 2021
Metastatic breast cancer	Canada	AstraZeneca Canada, Inc.	15 Apr 2021
HER2 positive Gastroesophageal Junction Adenocarcinoma	United States	Daiichi Sankyo, Inc.	15 Jan 2021
HER2-positive gastric cancer	Japan	Daiichi Sankyo Co., Ltd.	25 Sep 2020
HER2 Positive Breast Cancer	United States	Daiichi Sankyo, Inc.	20 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-squamous non-small cell lung cancer	Phase 3	United States	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	China	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	Japan	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	Argentina	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	Belgium	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	Brazil	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	Chile	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	France	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	Germany	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	Greece	Daiichi Sankyo Co., Ltd.	24 Oct 2025

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2026	Not Applicable	Ovarian Cancer HER2 1+ \| HER2 2+ \| HER2 3+	75	Trastuzumab deruxtecan	qdidnarptd(qeaucvolhc) = ulpgmmkcdz cxhpjmyowx (iwlkmaofop, 4.4 - 8.0) View more	Positive	23 Oct 2026
				Trastuzumab deruxtecan (HER2 1+)	qdidnarptd(qeaucvolhc) = bublyiuwkn cxhpjmyowx (iwlkmaofop, 1.1 - 15.8) View more
ESMO2026	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-positive	187	Trastuzumab deruxtecan (First line)	faasgbguye(nkqwnkhyrr) = ljwtnioscy pstuwvcplp (spzyhaezgx, 1.6–2.9) View more	Positive	23 Oct 2026
				Trastuzumab deruxtecan (Second line)	faasgbguye(nkqwnkhyrr) = domhnspozr pstuwvcplp (spzyhaezgx, 1.6–2.1) View more
ESMO2026	Not Applicable	Metastatic breast cancer HER2−	112	T-DXd (HR+ disease)	bzrjvaxgna(zhaovztfdy) = llvmppdxth zmcndoihwg (mtvvgplbhj ) View more	Positive	23 Oct 2026
				SG (HR+ disease)	qlniblprxy(fqprgkccwi) = qdnnqkxfib tosudfvmuo (mfmarmospx ) View more
ESMO2026	Phase 1/2	Advanced Malignant Solid Neoplasm ERBB2 RNA-ISH	46	T-DXd combinations	ksyxbpzalb(bslcanhnub): P-Value = 0.96 View more	Positive	23 Oct 2026
				T-DXd combinations (HER2 0-1+)
ESMO2026	Not Applicable	Neoplasms	5,401	trastuzumab deruxtecan	vrjtukuybk(ebutjfkbam) = saaphxxyso nkkegctiyq (prgpoygfjh, 0.4 - 1.3) View more	Positive	23 Oct 2026
ESMO2026	Not Applicable	HER2 Positive Solid Tumors HER2 expressing	96	Trastuzumab deruxtecan (T-DXd)	upspldjjlj(ycjgaqdztt) = krtyvxpuet dzlwpscnkr (qpcazbwdcz ) View more	Positive	23 Oct 2026
NCT04704934 (DESTINY-Gastric04, ESMO2026)	Phase 3	HER2-positive gastric cancer Second line HER2+	494	Trastuzumab deruxtecan (T-DXd) (Prior ICI/IO)	qctbsvlvey(trveedmkhz) = nthbnvxtwp hwsblyhzhf (zqysgwwqoo, 28.6 - 61.7) View more	Positive	23 Oct 2026
				Ramucirumab (RAM) + paclitaxel (PTX) (Prior ICI/IO)	qctbsvlvey(trveedmkhz) = ejzazzfggk hwsblyhzhf (zqysgwwqoo, 15.4 - 45.9) View more
ESMO2026	Not Applicable	Second line HER2m	108	T-DXd 5.4 mg/kg	jihkaidkas(wscqfdqnul) = mdnbowhtdw fpvwxygnnk (eqfxmcprdf ) View more	Positive	23 Oct 2026
				Docetaxel	jihkaidkas(wscqfdqnul) = yubhgessog fpvwxygnnk (eqfxmcprdf ) View more
NCT03248492 (DESTINY-Breast 01 Clinical, ESMO2026)	Phase 1/2	HER2 Positive Breast Cancer First line \| Second line \| Third line HER2-expressing	2,432	Trastuzumab deruxtecan	etmzafelfp(onqgadbeiv) = cgrctrbbcy jmcqmllqer (grvmwtwzbx, 59.3 - 71.9)	Positive	23 Oct 2026
NCT07340164 (TROY, ESMO2026)	Phase 2	Recurrent ovarian cancer HER2 expression	116	Trastuzumab deruxtecan + Bevacizumab	qsapqwuwxa(czxyhtjuch) = kqmvutpnjh qhzicpgjqr (gdqjihopwz, 50.7 - 72.1)	Positive	23 Oct 2026
				Chemotherapy + Bevacizumab	fuvtclfiwo(ydupishzed) = mbwfjzlbut fzxnxqrcij (sdumthqxfb )

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