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

Stomach CancerHER2 Positive Solid TumorsHR-positive/HER2-low Breast Carcinoma+ [60]

Inactive Indication

HER2 Positive Transitional Cell CarcinomaMeningeal CarcinomatosisUrothelial Carcinoma of the Urinary Bladder

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Daiichi Sankyo Co., Ltd.

AstraZeneca PLC

Daiichi Sankyo, Inc.

+ [8]

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 (Australia), Priority Review (Australia), SAKIGAKE (Japan), Conditional marketing approval (China), Orphan Drug (Japan)

Structure/Sequence

Boost your research with our ADC technology data.

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Sequence Code 18481L

Source: *****

Sequence Code 44772H

Source: *****

177

Clinical Trials associated with Fam-trastuzumab deruxtecan-NXKI

NCT07012031

/ RecruitingPhase 1/2IIT

A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of Sotorasib Plus Trastuzumab Deruxtecan in Patients With Advanced Non-Small Cell Lung Cancer With a KRASG12C Mutation

This phase I/II trial tests the safety, side effects and best dose of sotorasib with trastuzumab deruxtecan and how well the combination works in treating patients with KRAS G12C mutated non-small cell lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sotorasib blocks a protein made by the mutated KRAS gene (KRAS p.G12C), which may help keep tumor cells from growing and may kill them. It is a type of targeted therapy. Trastuzumab deruxtecan 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 tumor cells in a targeted way and delivers deruxtecan to kill them. Giving sotorasib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or effective in treating patients with locally advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation.

Start Date07 Aug 2026

Sponsor / Collaborator

National Cancer Institute

NCT07198724

/ Not yet recruitingPhase 1/2IIT

ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer

The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast cancer that is resistant to prior CDK4/6 inhibitor and endocrine therapy.
The names of the study drugs involved in this study are:
* Elacestrant (a type of selective estrogen receptor degrader)
* Trastuzumab deruxtecan (a type of standard of care antibody drug conjugate)

Start Date01 Mar 2026

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

NCT07086768

/ Not yet recruitingPhase 1IIT

A Phase Ia/Ib, 2-Part, Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors

This is a study that will enroll patients with cancer who have tumors that may have spread. The patients will know what medication they are being given.
There will be 2 parts to the study. For the first part of the study only one medication will be taken, and the dose changed to a higher dose over time.
In the second part of the study tow medications will be taken and the dose of the medication may be changed to a higher dose.

Start Date01 Jan 2026

Sponsor / Collaborator

University of Texas Health Science Center At San Antonio

[+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

914

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

31 Dec 2025·OncoImmunology

Immunogenic cell death and bystander killing: expanding the therapeutic potential of modern antibody-drug conjugates

Article

Author: Kepp, Oliver ; Kroemer, Guido

HER3-DXd and T-DXd are antibody-drug conjugates (ADCs) that induce immunogenic cell death and bystander killing, enhancing antitumor immunity beyond target-specific cytotoxicity. These findings highlight novel mechanisms that can overcome antigen heterogeneity and suggest opportunities for improving ADC design and therapeutic synergy through informed combination with immunotherapies.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Cost-effectiveness of trastuzumab deruxtecan as a second-line treatment for HER2-mutant advanced non-small cell lung cancer

Article

Author: You, Shuhui ; Gong, Caifeng ; Cai, Qi ; Zhang, Wen ; Huang, Jinglong ; Zhou, Aiping

The study of DESTINY-Lung01 and DESTINY-Lung02 demonstrated the favorable efficacy and optimal dosage of trastuzumab deruxtecan (T-DXd) in managing the human epidermal growth factor receptor 2 (HER2)-mutant non-small cell lung cancer (NSCLC) patients who had received previous treatment. The study sought to assess the cost-effectiveness of T-DXd in both the United States (US) and Chinese healthcare systems. Markov models were developed to evaluate the overall cost, incremental cost-effectiveness ratio (ICER), quality-adjusted life years (QALYs), and life years (LYs) of treatment with T-DXd compared with docetaxel, nivolumab, and pyrotinib for patients in the US and China. The level of willingness-to-pay (WTP) in the US and China is 150,000/QALYs and 32,517/QALYs, respectively. Sensitivity analyses were carried out to ensure the precision of the model. T-DXd yielded additional QALYs of 0.63 and 0.06 with an ICER of $338997.84 and $1437258.33 per QALY, respectively, in the US compared to the docetaxel and nivolumab regimens. And T-DXd yielded additional QALYs of 0.63, 0.06, and 0.13 with an ICER of $137959.45, $623805.93, and $515447.12 per QALY, respectively, in China compared to the docetaxel, nivolumab, and pyrotinib regimens. Sensitivity analysis showed that the cost of drugs is the most influential factor. T-DXd provides substantial therapeutic benefit for NSCLC patients with HER2 mutations who have had previous treatment but is not deemed cost-effective in either the US or China when compared to docetaxel, nivolumab, and pyrotinib. Price reduction is perhaps the main way to make T-DXd cost-effective.

12 Dec 2025·Deutsches Arzteblatt International

Gastric Carcinoma: Diagnosis, Staging, and Treatment.

Review

Author: Moehler, Markus ; Nothacker, Monika ; Huber, Yvonne ; Langer, Thomas ; Unverzagt, Susanne ; Lynen Jansen, Petra

BACKGROUND:

Gastric carcinoma ranks tenth in incidence among all cancers in men and women in Germany. 5565 women and 9027 men received a diagnosis of gastric carcinoma in Germany in 2022.

METHODS:

The German clinical practice guideline was comprehensively revised with the interdisciplinary participation of German specialty societies under the leadership of the German Society for Gastroenterology, Digestive and Metabolic Disorders, according to the methodological specifications of the Association of Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF).

RESULTS:

The new recommendations promote preventive measures in the presence of risk factors such as hereditary diseases or infection with Helicobacter pylori. Combinations of chemotherapy with immunotherapy, such as nivolumab, pembrolizumab, and tislelizumab, prolong median overall survival compared to chemotherapy alone (e.g., nivolumab plus chemotherapy, 14.4 vs. 11.1 months, HR 0.71) and markedly prolong 5-year survival to 16%. In patients with high claudin18.2 expression, the antibody zolbetuximab, combined with chemotherapy, prolongs median survival to 16.4 vs. 13.4 months (HR 0.77). For patients in good general health, further chemotherapy or biomarker-defined approved second-line (trastuzumab deruxtecan, pembolizumab) or third-line treatment (e.g., trifluridine tipirazole) and advanced molecular-pathological diagnostic testing should be offered at centers for personalized oncology in case of treatment failure. The biomarkers HER2, PD-L1, MSI, and claudin18.2 enable new targeted therapies in palliative situations with long-term improvement in outcome.

CONCLUSION:

The diagnostic evaluation of gastric carcinoma should include high-resolution video endoscopy, and its treatment should be stage-adapted and interdisciplinary. Monoclonal antibodies and immune checkpoint inhibitors are increasingly being used for palliative treatment. The new modifications to the clinical practice guideline will promote the use of uniform strategies for perioperative and palliative treatment and supportive measures.

997

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

16 hours ago

·www.businesswire.com

Daiichi Sankyo Showcases Strength of Industry-Leading ADC Portfolio with Latest Research Updates from Five Landmark Breast Cancer Trials at SABCS

Additional data from DESTINY-Breast11, DESTINY-Breast05, DESTINY-Breast09, DESTINY-Breast03 and TROPION-Breast02 reinforce practice-changing results of ENHERTU ® and DATROWAY ® across a broad spectrum of patients with breast cancer Trials-in-progress across breast cancer portfolio of Daiichi Sankyo demonstrate company’s commitment to creating new standards of care Science & Technology Day to be held following SABCS to discuss R&D and oncology business updates TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new breast cancer clinical research across its DXd antibody drug conjugate (ADC) portfolio from more than 30 abstracts at the 2025 San Antonio Breast Cancer Symposium (#SABCS25), which include four rapid fire mini-oral sessions and other presentations from five landmark trials of ENHERTU® (trastuzumab deruxtecan) and DATROWAY® (datopotamab deruxtecan) across a broad spectrum of breast cancer. Four rapid fire mini-oral sessions will feature ENHERTU data in the curative-intent and metastatic settings of HER2 positive breast cancer, including two presentations from the DESTINY-Breast11 phase 3 trial highlighting patient reported outcomes (RF6-06) and further safety analyses (RF6-02) of ENHERTU followed by paclitaxel, trastuzumab and pertuzumab (THP) compared to dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2 positive early-stage breast cancer. Additional efficacy and safety data (RF6-01) from the DESTINY-Breast05 phase 3 trial comparing ENHERTU to trastuzumab emtansine (T-DM1) as a post-neoadjuvant (after surgery) therapy in patients with high-risk HER2 positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes also will be highlighted. The fourth rapid fire presentation will feature patient reported outcomes (RF6-07) from the ENHERTU plus pertuzumab arm of the DESTINY-Breast09 phase 3 trial as a first-line treatment of HER2 positive metastatic breast cancer. Interim results from DESTINY-Breast09 were recently published in The New England Journal of Medicine, marking the eighth pivotal trial of ENHERTU to be published in the prestigious journal. Additional updates from two other landmark breast cancer trials include poster presentations featuring the final analysis and five-year follow-up of efficacy and safety data (PS5-01-30) from the DESTINY-Breast03 phase 3 trial comparing ENHERTU versus T-DM1 as a second-line treatment of HER2 positive metastatic breast cancer, and further safety analysis (PS5-03-05) from the TROPION-Breast02 phase 3 trial of DATROWAY, the first trial ever to demonstrate a significant improvement in overall survival compared to chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy is not an option. “Our latest research across these five landmark trials demonstrate how the DXd antibody drug conjugate portfolio of Daiichi Sankyo continues to potentially transform standards of care for patients with breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “We remain committed to following the science and collaborating with the breast cancer community to create innovative medicines that advance the treatment of breast cancer.” Additional data from the DESTINY clinical trial program to be highlighted in poster presentations at SABCS include an exploratory post-hoc subgroup analysis by hormone receptor status from the DESTINY-Breast12 phase 3b/4 trial (PS5-01-27) of ENHERTU in patients with HER2 positive metastatic breast cancer and brain metastases; the final results from the ENHERTU monotherapy and ENHERTU plus pertuzumab arms of the DESTINY-Breast07 phase 1b/2 trial (PS5-01-14) in patients with previously untreated HER2 positive metastatic breast cancer; and, initial characteristics of first enrolled patients from the DESTINY Breast Respond HER2 Low Europe non-interventional study (PS5-08-14) of ENHERTU in HER2 low metastatic breast cancer. Collaborations Supporting Innovation in Breast Cancer Research Additional data presented at SABCS include results from four externally sponsored trials across the DXd ADC pipeline of Daiichi Sankyo. Two spotlight poster presentations will report interim results from the HALLOW prospective observational trial (PD13-11) evaluating the efficacy and safety of ENHERTU in patients with HER2 low (IHC 1+ or 2+/ISH-) metastatic breast cancer with and without active brain metastases in Japan, and a post-hoc pooled efficacy analysis (PD13-10) from the TUXEDO-3 phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with HER2 positive metastatic breast cancer and active brain metastases or leptomeningeal disease previously treated with ENHERTU. Results from cohorts 1 and cohorts 2 of the TUXEDO-3 trial were recently published in The Lancet Oncology and results from cohort 3 were published in Nature Medicine. Two poster presentations will report on the intracranial and/or extracranial activity of ENHERTU and DATROWAY. A translational ctDNA analysis of intracranial and extracranial activity (PS2-08-20) of ENHERTU from the DEBBRAH phase 2 trial in patients with HER2 positive and HER2 low breast cancer with leptomeningeal disease will be highlighted, as well as results of intracranial activity (PS1-09-02) of DATROWAY from the DATO-BASE phase 2 trial in patients with HER2 negative breast cancer with leptomeningeal disease. Trials-in-Progress Across Breast Cancer Portfolio of Daiichi Sankyo Several trials-in-progress poster presentations at SABCS further highlight research underway to address a broad spectrum of unmet needs for patients with breast cancer. Additional externally sponsored trials for ENHERTU and DATROWAY include the PONTIAC phase 2 trial (PS5-07-15) evaluating ENHERTU versus CDK4/6 inhibitor-based endocrine therapy as a first-line treatment of non-luminal HR positive, HER2 low and HER2 ultralow advanced breast cancer; a phase 1b trial (PS5-09-22) evaluating ENHERTU in combination with valemetostat, an EZH1/2 inhibitor, in patients with HER2 low, HER2 ultralow and HER2 null metastatic breast cancer; and the TROPION-Breast06 phase 3b trial (PS5-07-21) of DATROWAY in patients with HR positive, HER2 IHC 0 inoperable or metastatic breast cancer refractory to endocrine therapy. Three additional trials-in-progress from the HERTHENA clinical development program of patritumab deruxtecan (HER3-DXd) also will be highlighted. These include the HERTHENA-Breast04 phase 3 trial (PS5-07-22) evaluating patritumab deruxtecan versus physician’s choice of treatment in patients with HR positive, HER2 negative unresectable locally advanced or metastatic breast cancer; the HERTHENA-Breast03 phase 2 trial (PS5-12-21) evaluating neoadjuvant patritumab deruxtecan plus pembrolizumab before or after pembrolizumab plus chemotherapy in patients with high-risk early-stage TNBC or HR low positive/HER2 negative breast cancer; and, the HERTHENA-Breast01 phase 1b/2 trial (PS5-12-23) evaluating patritumab deruxtecan in combination with HER2 targeted agents in patients with HER2 positive unresectable locally advanced or metastatic breast cancer. Science & Technology Day Daiichi Sankyo will hold its annual Science & Technology Day for investors on Monday, December 15, 2025, from 5:30 to 7:30 pm ET / Tuesday, December 16, 2025, from 7:30 – 9:30 am JST. Executives from Daiichi Sankyo will provide an update on R&D, business and manufacturing developments across the portfolio. Daiichi Sankyo Presentation Highlights at SABCS Presentation Title Author Abstract Presentation (CST) ENHERTU (trastuzumab deruxtecan; T-DXd) Patient-reported outcomes in DESTINY-Breast11: neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk, HER2+ early-stage breast cancer S. Modi RF6-06 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm DESTINY-Breast11 safety: neoadjuvant trastuzumab deruxtecan (T-DXd) alone or followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in high-risk, HER2+ early-stage breast cancer G. Curigliano RF6-02 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm Additional efficacy and safety from the DESTINY-Breast05 study of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T‑DM1) in patients with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary early breast cancer with residual invasive disease after neoadjuvant therapy S. Loibl RF6-01 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for first-line treatment of patients with HER2 positive (HER2+) advanced/metastatic breast cancer: patient-reported outcomes from the DESTINY-Breast09 study M. Rimawi RF6-07 Rapid Fire 6 Mini-Oral Session Wednesday, December 10 1:00 – 2:00 pm Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer: final analysis from DESTINY-Breast03 S. Im PS5-01-30 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Trastuzumab deruxtecan (T-DXd) monotherapy and T-DXd + pertuzumab in patients with previously untreated HER2+ unresectable/metastatic breast cancer: final results from DESTINY-Breast07 F. Andre PS5-01-14 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Outcomes by hormone receptor status in patients with HER2+ advanced/metastatic breast cancer with brain metastases treated with trastuzumab deruxtecan (T-DXd): a post-hoc subgroup analysis of DESTINY-Breast12 H. Wildiers PS5-01-27 Poster Session 5 Friday, December 12 12:30 – 2:00 pm DESTINY-Breast Respond HER2 low Europe: description of first enrolled patients in the non-interventional study of T-DXd in HER2 low metastatic breast cancer V. Guarneri PS5-08-14 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Interim analysis results for the effectiveness and safety of trastuzumab deruxtecan in patients with HER2 low breast cancer and brain metastases: the HALLOW study N. Niikura PD13-11 Poster Spotlight 13 Friday, December 12 7:00 – 8:30 am Translational analysis of cerebrospinal fluid and plasma circulating tumor DNA from breast cancer patients with leptomeningeal disease treated with trastuzumab deruxtecan (T-DXd) in the DEBBRAH trial A. Fitzpatrick PS2-08-20 Poster Session 2 Wednesday, December 10 5:00 – 6:30 pm Trials-in-Progress A randomized phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) versus CDK4/6 inhibitor-based endocrine therapy as first-line therapy of hormone receptor-positive and HER2 low/ultralow advanced breast cancer patients classified as non-luminal subtype according to gene expression profiling: the PONTIAC study J. Cortes PS5-07-15 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Phase 1b study of EZH1/2 inhibitor valemetostat in combination with trastuzumab deruxtecan in subjects with HER2 low/ultralow/null metastatic breast cancer S. Damodaran PS5-09-22 Poster Session 5 Friday, December 12 12:30 – 2:00 pm DATROWAY (datopotamab deruxtecan; Dato-DXd) First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy was not an option: additional safety analyses from the TROPION-Breast02 study T. Traina PS5-03-05 Poster Session 5 Friday, December 12 12:30 – 2:00 pm Intracranial activity of datopotamab deruxtecan (Dato-DXd) for patients with HER2 negative breast cancer and leptomeningeal disease: results from cohort C of the DATO-Base phase 2 trial P. Tarantino PS1-09-02 Poster Session 1 Wednesday, December 10 12:30 – 2:00 pm Trials-in-Progress TROPION-Breast06: multicenter, multinational, open-label, single-arm, phase 3b study of datopotamab deruxtecan (Dato-DXd) in patients with locally advanced inoperable or metastatic HR+/HER2 IHC 0 breast cancer refractory to endocrine therapy K. Jhaveri PS5-07-21 Poster Session 5 Friday, December 12 12:30 – 2:30 pm Patritumab Deruxtecan (HER3-DXd) Outcome of patritumab deruxtecan (HER3-DXd) in patients with HER2 positive metastatic breast cancer and CNS involvement previously treated with T-DXd: a subanalysis of TUXEDO-3 R. Bartsch PD13-10 Poster Spotlight 13 Friday, December 12 7:00 – 8:30 am Trials-in-Progress HERTHENA-Breast04: a phase 3, randomized, open-label study evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus treatment of physician’s choice in hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) unresectable locally advanced or metastatic breast cancer B. Pistilli PS5-07-22 Poster Session 5 Friday, December 12 12:30 – 2:00 pm HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2− breast cancer J. O’Shaughnessy PS5-12-21 Poster Session 5 Friday, December 12 12:30 – 2:00 pm HERTHENA-Breast01: a phase 1b/2, multicenter, open-label, dose-finding study to evaluate the safety and antitumor activity of patritumab deruxtecan (HER3-DXd) in HER2+ unresectable locally advanced or metastatic breast cancer S. Tolaney PS5-12-23 Poster Session 5 Friday, December 12 12:30 – 2:00 pm About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of six ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU® and DATROWAY®, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 is being developed by Daiichi Sankyo. Additional ADCs being developed by Daiichi Sankyo include DS-9606, which consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload and DS3610, which consists of an antibody attached to a novel immunomodulatory payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS-9606 and DS3610 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.

Phase 2Phase 3Clinical ResultADCPhase 1

17 hours ago

·www.globenewswire.com

Greenwich LifeSciences Announces Completion of Enrollment in the Open Label Arm of FLAMINGO-01

STAFFORD, Texas, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the completion of enrollment in the open label non-HLA-A*02 arm of FLAMINGO-01. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are currently planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types (non-HLA-A*02) are planned to be treated with GLSI-100 in a third open label arm. The non-HLA-A*02 patients do not have the HLA-A*02 allele from either parent and represent about 55% of the patient population in FLAMINGO-01. FLAMINGO-01 has achieved a major milestone by completing enrollment in the 250 patient open label non-HLA-A*02 arm of the Phase III trial, which is a result of the high screen rate and ensuing enrollment rate. The Company is continuing its review of the most recent data of this arm, including recurrence rates, which can be updated and/or published at any time.The Company stopped enrolling in this arm earlier this year and is now approaching regulatory agencies to seek approval to continue enrollment of new non-HLA-A*02 patients in a randomized manner with a control arm. The Company has continued to screen a large number of these patients so that rapid enrollment of these screened patients can commence if regulatory approval is received.The Company previously reported promising observations earlier this year showing that the immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the primary immunization series, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study, where breast cancer recurrences were reduced up to 80% or more and no metastatic breast cancer recurrences were reported. A preliminary analysis suggests that these promising trends are continuing. CEO Snehal Patel commented, "As we continue to analyze the immune response, safety, and recurrence rate data of the 250 patient non-HLA-A*02 data set, it is important to remember that all 250 patients received GLSI-100, which is 5 times more than the approximately 50 patients treated in the Phase IIb trial. We can compare the open label recurrence rate data of these 250 treated patients to the expected historical recurrence rate for this population, which is well known and recently reported, to the HLA-A*02 arms of FLAMINGO-01, and to the Phase IIb study. In addition, we may be able to compare the recurrence rate during the first 6 months of vaccination, also called the primary immunization series or PIS, to the recurrence rate after the PIS is completed and after peak immunity is achieved. We look forward to providing updates on this analysis at any time, including publications at conferences as we have previously done for the Phase IIb trial from 2020-2022." Mr. Patel added, "The use of GLSI-100 in the non-HLA-A*02 patient population is an invention by the Company, and the Company believes that any patent claims related to this invention are not subject to any license, royalties, or milestone payments. These patent claims should complement other patent claims that the Company has recently filed to potentially extend patent protection of GLSI-100 beyond 2040. The Company believes that this patient population could double the number of US and European patients eligible for GLSI-100 treatment to approximately 88,000 new patients per year with a market potential using the drug prices per year of Kadcyla or Enhertu in the range of $8-10 billion per year." Additional updates: The non-HLA-A*02 types that are most commonly being enrolled in FLAMINGO-01 continue to be HLA-A*03, HLA-A*24, HLA-A*01, HLA-A*11, HLA-A*68, HLA-A*29, HLA-A*30, HLA-A*23, and HLA-A*33.The enrollment of HLA-A*02 patients in the 500 patient randomized arms continues, unaffected by the end of enrollment in the non-HLA-A*02 arm, while the Company also seeks to increase the size of these HLA-A*02 arms such that enrollment is not stopped prior to any interim analyses.Enhertu (trastuzumab Deruxtecan [T-DXd]) treated patients continue to be eligible for enrollment in FLAMINGO-01. The Company believes that GLSI-100 will synergize with any trastuzumab based treatment in the neoadjuvant or adjuvant settings, including Enhertu. About FLAMINGO-01 and GLSI-100 FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com About Breast Cancer and HER2/neu Positivity One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. About Greenwich LifeSciences, Inc. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS. Forward-Looking Statement Disclaimer Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law. Company ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.com

Phase 2Phase 3ImmunotherapyClinical Result

05 Dec 2025

·www.fiercepharma.com

Fierce Pharma Asia—FDA safety probe of Takeda drug; Otsuka kidney disease nod; ADC patent fight

An FDA safety probe into Takeda's Adzynma, Otsuka's IgAN approval for Voyxact and Daiichi Sankyo's latest win against Pfizer made our news this week. The FDA is investigating a safety signal from Takeda’s rare disease med Adzynma. Otsuka won a first-in-class FDA approval to enter the crowded IgA nephropathy field. Daiichi Sankyo won reversal of an unfavorable ruling in its patent fight against Pfizer’s Seagen. And more.1. FDA launches investigation into Takeda's Adzynma following reported pediatric deathThe FDA is investigating Takeda’s Adzynma following a reported child's death. The drug, approved for the rare blood disorder congenital thrombotic thrombocytopenic purpura, is under scrutiny due to postmarketing reports of patients developing neutralizing antibodies against the drug’s ADAMTS13 protein ingredient. Takeda said it found no confirmed causal link.2. In crowded kidney disease space, Otsuka receives FDA approval for first-in-class VoyxactOtsuka received accelerated FDA approval for Voyxact (sibeprenlimab) to treat IgA nephropathy (IgAN). The monthly self-administered drug is the first biologic cleared for the kidney disease and the first to block the APRIL protein. Before entering a competitive market, Voyxact showed a placebo-adjusted 51% reduction in proteinuria at nine months in a phase 3 trial.3. Daiichi Sankyo prevails on appeal in long-running ADC patent battle with Seagen, flipping prior $41.8M verdictDaiichi Sankyo got a win in its long-running antibody-drug conjugate patent dispute with Pfizer’s Seagen. The U.S. Court of Appeals reversed a prior ruling that found Daiichi infringed a Seagen patent with Enhertu. The new decision nullifies a previous Texas court verdict, which said Daiichi owed Seagen royalties related to the popular ADC.4. Crescent waxes pipeline with $80M Kelun deal, bagging ADC to pair with PD-1xVEGF bispecificCrescent Biopharma struck a $80 million upfront deal for ex-China rights to Kelun-Biotech’s integrin beta-6-directed ADC candidate. Crescent plans to test the new ADC in combination with its own PD-1xVEGF bispecific antibody for solid tumors. In exchange, Kelun will pay $20 million upfront for Chinese right to Crescent’s bispecific. 5. Merck's partner Kelun touts phase 3 win for ADC-Keytruda combo in first-line lung cancerKelun also reported a phase 3 win for its Merck & Co.-partnered TROP2 ADC, sacituzumab tirumotecan (sac-TMT), combined with Keytruda. The combo significantly improved progression-free survival versus Keytruda alone in Chinese patients with first-line PD-L1-positive non-small cell lung cancer, according to Kelun.6. FDA grants game-changing perioperative approval to Padcev, Keytruda combo in bladder cancerA combination of Astellas and Pfizer’s Padcev and Keytruda won an FDA approval as a perioperative treatment for muscle-invasive bladder cancer patients ineligible for cisplatin chemotherapy. The regimen, used around surgery, is the first to significantly improve survival over surgery alone in this population, reducing the risk of death by 50% in a phase 3 trial.7. Daiichi Sankyo receives FDA untitled letter taking aim at Turalio patient ambassador videoSK Life Science Xcopri ad meets a roadblock with FDA untitled letterThe FDA issued separate untitled letters to Daiichi Sankyo and SK Life Science over “false or misleading” drug marketing. The letter to Daiichi cited a Turalio patient ambassador video that overstated treatment benefits, while the letter to SK Life Science took aim at a TV ad for the anti-seizure drug Xcopri for omitting major risk warnings and failing to present risk information concurrently in both audio and text.Other News of Note: 8. FDA floats user fee cuts for early-stage US trials, additional fees for overseas development9. After dodging Biosecure threat, WuXi AppTec faces new security scrutiny from Pentagon: Bloomberg10. Tanabe Pharma shifts gears for Bain-backed future, dropping Mitsubishi moniker after $3.3B deal11. Sun Pharma shines a light on diabetic retinopathy in #SeeBeyondSugar campaign12. Pfizer, GSK, Shionogi sponsor London run of musical about antimicrobial resistance13. Eisai finalizes FDA filing for subcutaneous Leqembi starter dose (Regulatory tracker)14. China launches national drug price registration system (Yicai)

Drug ApprovalPhase 3Clinical Result

100 Deals associated with Fam-trastuzumab deruxtecan-NXKI

External Link

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

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
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	Brazil	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	Malaysia	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	South Korea	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	Taiwan Province	Daiichi Sankyo Co., Ltd.	24 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	United Kingdom	Daiichi Sankyo Co., Ltd.	24 Oct 2025
HER2-positive Non-squamous non-small cell lung cancer	Phase 3	United States	Daiichi Sankyo, Inc.	02 Sep 2025
HER2-positive Non-squamous non-small cell lung cancer	Phase 3	Japan	Daiichi Sankyo, Inc.	02 Sep 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04644237 (DESTINY-Lung02, Pubmed \| J Thorac Oncol)	Phase 2	HER2 mutant non-small cell lung cancer HER2-Mutant	152	Trastuzumab Deruxtecan 5.4 mg/kg	seoauweqwn(xojikmrtzt) = igyupaihyp ygxlhbylcc (dnfrkiqczk, 39.9 - 60.1) View more	Positive	01 Dec 2025
				Trastuzumab Deruxtecan 6.4 mg/kg	seoauweqwn(xojikmrtzt) = sklkzurfrk ygxlhbylcc (dnfrkiqczk, 41.3 - 70.0) View more
NPJ Breast Cancer Manual	Not Applicable	HR-negative/HER2-low Breast Carcinoma HR Negative	64	Trastuzumab deruxtecan	gfdvlhzmzu(ojqvudqcnl) = uewcpbpvqp cvvcpsdvhg (ekqeicbecx ) View more	Positive	07 Nov 2025
NCT04622319 (DESTINY-Breast05, Company_Website \| ESMO2025) Manual	Phase 3	HER2 Positive Breast Cancer HER2 Positive	1,635	ENHERTU (5.4 mg/kg)	shcprlddfk(shkjelugub) = gsbylegpan btkzltkdcn (jbkympcnyq ) View more	Positive	18 Oct 2025
				T-DM1	shcprlddfk(shkjelugub) = ldpxsilrxz btkzltkdcn (jbkympcnyq ) View more
NCT05113251 (DESTINY-Breast11, Company_Website \| ESMO2025) Manual	Phase 3	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	641	T-DXd → THP (paclitaxel + trastuzumab + pertuzumab)	hbizjuxlwk(enhxkzkgtl) = orvvxchzbo ropzwlbieq (ogcznmmtim ) View more	Positive	18 Oct 2025
				ddAC (doxorubicin + cyclophosphamide) →  THP (paclitaxel + trastuzumab + pertuzumab)	hbizjuxlwk(enhxkzkgtl) = gcedpcynnj ropzwlbieq (ogcznmmtim ) View more
NCT06643585 (SURVIVE HERoes, ESMO2025)	Phase 3	HER2 Positive Breast Cancer Adjuvant HER2 positive \| HER2 low \| HR+	180	Trastuzumab deruxtecan + Trastuzumab deruxtecan HR+ patients)	staivejkim(xnojppxbcy) = jrskuivhlm kuswbltscn (mgfhaoexsx )	Positive	17 Oct 2025
NCT04704934 (DESTINY-Gastric04, ESMO2025)	Phase 3	HER2-positive gastric cancer \| Gastroesophageal junction adenocarcinoma Second line HER2+	246	Trastuzumab deruxtecan (T-DXd) 6.4 mg/kg	uvmdcwkohg(htjykmzehm) = dflfmtqtqe ivyvtpugvq (mcdfukxxkn ) View more	Positive	17 Oct 2025
				Ramucirumab + Paclitaxel	uvmdcwkohg(htjykmzehm) = utcxbpxjtk ivyvtpugvq (mcdfukxxkn ) View more
ESMO2025	Not Applicable	Advanced breast cancer Second line \| First line HER2-positive \| HER2-low	112	Trastuzumab Deruxtecan (HER2-positive)	vsktbqzyur(ebaopofilr) = vehixvozcv nuhhsbubuc (njcwmyazfj, 0.8 - 13.1) View more	Positive	17 Oct 2025
				Trastuzumab Deruxtecan (HER2-low)	vsktbqzyur(ebaopofilr) = nifolkcrzo nuhhsbubuc (njcwmyazfj, 6.1 - 23.2) View more
ESMO2025	Not Applicable	HER2 mutant non-small cell lung cancer HER2-mutant	35	Trastuzumab deruxtecan	grgenducjy(xhxgfusjsp) = jsbbkstten tmpbpcwkhy (jtgwobsrjo ) View more	Positive	17 Oct 2025
NCT04989816 (DESTINY-Gastric06, ESMO2025)	Phase 2	HER2-positive gastric cancer \| HER2 positive Gastroesophageal Junction Adenocarcinoma Second line HER2+	95	Trastuzumab deruxtecan (T-DXd) 6.4 mg/kg IV Q3W	lpcikykajc(hmvidxyvtg) = No HBVr ± hepatic flare occurred during the study treatment or follow-up periods. cwcmoccola (fsjlwievww )	Positive	17 Oct 2025
NCT04704661 (DASH, ESMO2025)	Phase 1	HER2 Positive Solid Tumors HER2 expression	24	trastuzumab deruxtecan (T-DXd) + AZD6738	avdrgtnkpk(omhfwkhdso) = nwogfgrcbu bxxygiizwv (tdlimesbna ) View more	Positive	17 Oct 2025

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