Delving into the Latest Updates on Fam-trastuzumab deruxtecan-NXKI with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

Fam-trastuzumab deruxtecan, T-DXd, Trastuzumab deruxtecan

+ [14]

Target

HER2 x Top I

Action

antagonists, inhibitors

Mechanism

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

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.

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

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

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Structure/Sequence

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Sequence Code 18481L

Source: *****

Sequence Code 44772H

Source: *****

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

NCT07137416

/ Not yet recruitingPhase 1IIT

Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors

This phase I trial tests the safety, side effects, and best dose of Pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth. 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 Pidnarulex in combination with trastuzumab deruxtecan may be safe, tolerable and/or effective in treating patients with metastatic, unresectable, or locally advanced HER2-expressing breast cancer or other solid tumors.

Start Date09 Mar 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]

100 Clinical Results associated with Fam-trastuzumab deruxtecan-NXKI

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100 Translational Medicine associated with Fam-trastuzumab deruxtecan-NXKI

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

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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 ; Huang, Jinglong ; Zhang, Wen ; 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.

1,018

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

19 Dec 2025

·www.fiercepharma.com

Fierce Pharma Asia—Daiichi ADCs' 1st-line nod, trial deaths; Takeda's TYK2 trial win

Enhertu's first-line breast cancer approval, unexpected death cases in a Daiichi Sankyo antibody-drug conjugate trial and positive readouts from Takeda's Sotyktu challenger made our news this week. In the last Fierce Pharma Asia weekly news roundup of 2025, Daiichi Sankyo scored a key FDA approval for AstraZeneca-partnered Enhertu in first-line HER2-positive breast cancer but paused a phase 3 trial of its Merck & Co.-partnered antibody-drug conjugate due to unexpected patient deaths. Takeda plans to file its TYK2 inhibitor for an FDA approval following a pair of positive phase 3 trials in psoriasis. And more.1. AZ, Daiichi score with FDA nod for Enhertu combo in 1st-line breast cancerThe FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu in combination with Roche’s Perjeta as the first new first-line treatment of HER2-positive metastatic breast cancer in more than a decade. In the Destiny-Breast09 trial, the combo significantly lowered the risk of progression or death by 44% compared with the traditional THP regimen.2. Patient deaths prompt partial hold for Daiichi-Merck’s global phase 3 ADC programDaiichi has paused enrollment in a phase 3 trial of its Merck & Co.-partnered B7-H3 antibody-drug conjugate, ifinatamab deruxtecan, after an unexpected number of deaths from interstitial lung disease. The partial clinical hold comes as the pharma partners said they were aiming for an accelerated approval for the candidate for pretreated small cell lung cancer based on a phase 2 readout.3. Takeda looks to 2026 FDA filing for its Sotyktu rival zasocitinib after phase 3 successTakeda said its oral TYK2 inhibitor zasocitinib, a potential competitor to Bristol Myers Squibb’s Sotyktu, succeeded in two phase 3 trials in moderate to severe plaque psoriasis. The drug beat placebo on the trials’ co-primary endpoints of static Physician Global Assessment 0/1 and the Psoriasis Area and Severity Index 75 at Week 16. The company plans to file for an FDA approval. 4. Biosecure Act heads to Trump's desk with defense spending bill after Senate voteBoth the House of Representatives and the Senate have passed the annual defense bill that includes the revamped Biosecure Act. President Donald Trump is expected to sign the massive defense package into law. Once enacted, the updated Biosecure Act will raise hurdles for life sciences companies from China.5. Fosun signs up to take on China's Green Valley, revive controversial Alzheimer's medFosun Pharma is spending about $200 million to take a 53% stake in Green Valley Pharmaceuticals, aiming to revive the latter’s controversial Alzheimer’s disease med, sodium oligomannate (GV-971), after Chinese regulators opted not to renew the drug’s conditional approval. The Shanghai Stock Exchange sent Fosun a regulatory letter related to the proposed transaction. Such a letter typically reminds a public company of potential regulatory breaches.6. Harbour BioMed docks with BMS in antibody discovery, development deal worth up to $1.1BBristol Myers Squibb signed on China’s Harbour BioMed to discover multispecific antibodies. Harbour could receive payments totaling $90 million plus development and commercial milestones of up to $1.035 billion. Before BMS, Harbour had forged collaborations with Otsuka and AstraZeneca earlier this year.7. Sanofi signs $1B biobucks pact for Alzheimer's asset in 2nd biotech deal of the daySanofi has signed a licensing deal worth up to $1.04 billion with South Korean biotech Adel. The pact focuses on ADEL-Y01, a tau-targeting antibody for Alzheimer’s disease. Sanofi will pay $80 million upfront for the clinical-stage asset and related backup compounds. Rather than broadly targeting tau, the drug focuses on tau acetylated at lysine-280.Other News of Note: 8. AI drug designer Insilico Medicine aims to generate nearly $300M in Hong Kong IPO9. Keytruda, Padcev keep winning streak with another patient survival benefit in bladder cancer10. Yarrow blooms with $1.37B deal, landing autoimmune thyroid disease drug from China's GenSci11. Yarrow to go public in reverse merger with Vyne (release)12. Boehringer inks AI protein design pact with Korea’s Galux (release)13. Hansoh sells regional rights to EGFR inhibitor to Glenmark in potential $1B deal (release)14. Lilly to help Korea’s Medi&Gene advance an obesity asset (release)

License out/inPhase 3Drug ApprovalADC

19 Dec 2025

·www.biospace.com

Patient Deaths Put Merck, Daiichi Sankyo’s Antibody-Drug Conjugate on Hold

iStock, Suchat longthara The fatalities were attributed to interstitial lung disease, a known side effect of Daiichi Sankyo’s DXd-based antibody-drug conjugates. A spokesperson declined to say how many patients died. The FDA has placed a partial clinical hold on Merck and Daiichi Sankyo’s late-stage development program for their antibody-drug conjugate ifinatamab deruxtecan after “a higher than expected” number of deaths were detected, according to several media reports on Thursday. The companies were studying ifinatamab deruxtecan—more commonly known as I-DXd—in the Phase III IDeate-Lung02 trial , which has enrolled more than 500 patients with relapsed small cell lung cancer. Participants were treated with I-DXd or with an active chemotherapy comparator, including topotecan, amrubicin and lurbinectedin. In a joint statement to Fierce Biotech , a spokesperson for the companies said that they detected “a higher than anticipated incidence of grade 5 interstitial lung disease (ILD) events” in IDeate-Lung02, which prompted Daiichi Sankyo to voluntarily halt recruitment. The FDA has since also applied a partial freeze on the study. The spokesperson did not indicate how many patients died. “ILD is a potentially fatal side effect known to be associated with all of Daiichi’s DX ADCs [antibody-drug conjugates],” Jefferies analysts explained in a Thursday note to investors. “This has not stopped Enhertu and Datroway from being approved.” The spokesperson said that the hold “does not impact other studies in the I-DXd clinical development program.” The partners are working with the regulator and with an independent data board to best understand the mortalities and determine the next steps for the affected study. Merck and Daiichi Sankyo teamed up in October 2023 to collaborate on three DXd-based ADCs—anti-cancer constructs that consist of an antibody and an exatecan derivative, which is a topoisomerase I inhibitor that causes cancer cells to die. In June 2024, the partners ran into a regulatory roadblock when the FDA declined to approve patritumab deruxtecan for locally advanced or metastatic non-small cell lung cancer. The rejection hinged on third-party manufacturing problems; the FDA did not identify issues with the drug’s efficacy or safety. The companies rallied in September of this year when I-DXd showed a 48.2% confirmed objective response rate in IDeate-Lung02—the same study that is now under partial hold. Aside from Merck, AstraZeneca has also bought into the promise of Daiichi Sankyo’s DXd platform. The partners have secured two approvals: one in late 2019 for Enhertu and another in January this year for Datroway .

ADCDrug ApprovalPhase 3Clinical ResultAccelerated Approval

19 Dec 2025

·www.biopharmadive.com

Patient deaths put Merck, Daiichi’s ADC trial on partial hold

The Food and Drug Administration has put a partial clinical hold on one of Merck & Co. and Daiichi Sankyos antibody-drug conjugates following an unexpected number of deaths in a late-stage clinical trial.Daiichi initiated a voluntary pause recruiting and enrolling the trial, called IDeate-Lung02, after higher than anticipated incidence of grade 5 interstitial lung disease events, a spokesperson for Merck and Daiichi said in a statement to BioPharma Dive. Following the pause, the FDA verbally placed the trial on a partial clinical hold in October. The spokesperson did not say the number of deaths recorded.During the hold, Daiichi, along with the FDA and an independent committee will review the safety data and decide on any necessary further actions. Trial enrollees will be able to continue treatment, but no new participants will be recruited.The experimental drug, called ifinatamab deruxtecan, or I-DXd, is one of three ADCs Merck gained the rights to through a major licensing deal with Daiichi in 2023. ADCs, which link an antibody to a toxic payload, are meant to more effectively target and destroy cancer cells while sparing the surrounding healthy tissue.Though theyve been around for decades, ADCs became a major asset for drug developers relatively recently. AstraZeneca and Daiichi, for instance, found success with their medicines Enhertu and Datroway, which are approved to treat several cancers. However, interstitial lung disease is a known side effect of Daiichis antibody-drug conjugates, and is listed on the labeling of Datroway and Enhertu.The Phase 3 trial testing I-DXd enrolled over 500 participants with small cell lung cancer, who were treated with the drug or randomized to receive a chemotherapy regimen of either topotecan, lurbinectedin or amrubicin.Expectations for the drug rose after Phase 2 results demonstrated promising objective response rates in people with pretreated, extensive-stage small cell lung cancer. The FDA granted breakthrough therapy designation to I-DXd based on those results.The spokesperson said the companies are in discussions with global regulatory authorities over the latest trial data, but would not comment further on regulatory strategy.The clinical hold represents another blow to Mercks ADC program. Earlier this year, the company pulled its approval application for a therapy called patritumab deruxtecan, after finding it did not extend survival in people who have a certain kind of non-small cell lung cancer with mutations in the EGFR gene. The FDA also rejected patritumab deruxtecan last year due to third-party manufacturing problems.The spokesperson said the clinical hold does not impact other studies of I-DXd.Merck and Daiichi are evaluating the potential impact of the hold on trial readout data timing, which is currently expected in 2027. '

Phase 3Breakthrough TherapyADCLicense out/inPhase 2

100 Deals associated with Fam-trastuzumab deruxtecan-NXKI

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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

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Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04784715 (DESTINY-Breast09, ESMO_ASIA2025) Manual	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast \| Advanced HER2-Positive Breast Carcinoma First line HER2 Positive	346	Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) (Asian Subgroup)	cvtqzsqwou(hrvxqpnriu) = livfyppxnc vfyfufmlua (mluzovwjyp, 36.5 - NC) View more	Positive	06 Dec 2025
				taxane + trastuzumab + pertuzumab (THP) (Asian Subgroup)	cvtqzsqwou(hrvxqpnriu) = miitkemuok vfyfufmlua (mluzovwjyp, 21.5 - NC) View more
ESMO_ASIA2025	Not Applicable	Advanced HER2-Positive Breast Carcinoma HER2-positive	56	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg	euyzbxxiar(dyoqiaghuc) = bglfgcxldi tvgcxozljx (qbombnaxnx ) View more	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	Metastatic breast cancer	54	Trastuzumab deruxtecan (HER2-positive)	cxqkiiqlni(pvocnzziua) = Cardiotoxicity (asymptomatic LVEF/GLS decline) occurred in 2 patients (3.7%), both recovered after temporary interruption and safe rechallenge. pwvxgjghwk (wgortlcwqe ) View more	Positive	05 Dec 2025
				Trastuzumab deruxtecan (HER2-low)
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	xuonuuqlxa(zqukntpmhb) = nnybyunyrd gntavbyyqd (tvyxnffywa, 39.9 - 60.1) View more	Positive	01 Dec 2025
				Trastuzumab Deruxtecan 6.4 mg/kg	xuonuuqlxa(zqukntpmhb) = vvoummqpcr gntavbyyqd (tvyxnffywa, 41.3 - 70.0) View more
NPJ Breast Cancer Manual	Not Applicable	HR-negative/HER2-low Breast Carcinoma HR Negative	64	Trastuzumab deruxtecan	xquaxjjokk(broeflqjim) = bzifltrzrm fibnlzxwzc (qocyphwizs ) 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)	uxwqlalolb(gmwxefscgo) = sehwzlfqex pfijrcwsed (ufboqvqopr ) View more	Positive	18 Oct 2025
				T-DM1	uxwqlalolb(gmwxefscgo) = qvsmypvten pfijrcwsed (ufboqvqopr ) 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)	tlfkunewrt(mvlqxyfytt) = rnezmzpfhd rcmglyngjl (deqwdsmhcm ) View more	Positive	18 Oct 2025
				ddAC (doxorubicin + cyclophosphamide) →  THP (paclitaxel + trastuzumab + pertuzumab)	tlfkunewrt(mvlqxyfytt) = hbxdvwbppg rcmglyngjl (deqwdsmhcm ) View more
ESMO2025	Not Applicable	HER2 mutant non-small cell lung cancer HER2-mutant	35	Trastuzumab deruxtecan	znswixpxlj(nrrxoclgkr) = itinioecsw qgicvovafx (imsjlezczq ) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable	Advanced breast cancer Second line \| First line HER2-positive \| HER2-low	112	Trastuzumab Deruxtecan (HER2-positive)	ijekddpjtx(yeehbwuxwq) = qhcdjnqlcp ayglzpsxds (tdzdomizab, 0.8 - 13.1) View more	Positive	17 Oct 2025
				Trastuzumab Deruxtecan (HER2-low)	ijekddpjtx(yeehbwuxwq) = bkgamfdtdv ayglzpsxds (tdzdomizab, 6.1 - 23.2) View more
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	rtpeupwpvl(bvrigghlye) = No HBVr ± hepatic flare occurred during the study treatment or follow-up periods. voujbuadwv (qpafzfdbfh )	Positive	17 Oct 2025

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Fam-trastuzumab deruxtecan-NXKI

Overview

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