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+ [62]

Inactive Indication

Meningeal Carcinomatosis

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.AstraZeneca AB

+ [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)

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Structure/Sequence

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Sequence Code 18481L

Source: *****

Sequence Code 44772H

Source: *****

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]

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 Dec 2025

Sponsor / Collaborator

National Cancer Institute

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.

985

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

12 Nov 2025

·www.prnewswire.com

EirGenix Signed The Commercial Licensing Agreement for Its Second HER2 Biosimilar Asset EG1206A

TAIPEI, Nov. 12, 2025 /PRNewswire/ -- EirGenix Inc.(TWSE: 6589) today announced that it has entered into a second global exclusive licensing agreement with international biosimilar leader Sandoz AG (SIX:SDZ/OTCQX:SDZNY) for the commercialization of its independently developed breast cancer biosimilar, EG1206A (Pertuzumab Biosimilar to Roche Perjeta®), covering all territories except Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, and Japan. The agreement further strengthens the two companies' collaborative development of the HER2 biosimilar product. Under the terms of the agreement, EirGenix will receive a total up to USD 152 million of upfront and milestone payments. In addition, EirGenix will also be entitled to a profit share once the product is launched in the licensed territory plus potential sales incentives based on market performance. EirGenix will be responsible for product development, manufacturing, and supply. EG1206A has completed its pharmacokinetic (PK) clinical study, and last month received positive feedback from both the U.S. FDA and the European Medicines Agency (EMA), confirming that the product qualifies for an abbreviated development pathway, allowing for the waiver of Phase III comparative efficacy trials. This agreement marks another major milestone and breakthrough in EirGenix's biosimilar development efforts. This partnership further strengthens the existing collaboration between Sandoz and EirGenix. The two companies previously signed a global commercialization agreement for EG12014 (Trastuzumab Biosimilar in both 150 mg and 420 mg formulations). EG12014 has already been approved by the European Commission and is currently under BLA review by the U.S. FDA. Globally, there are approximately 2.3 million breast cancer patients, of which about 20% are diagnosed with HER2-positive disease. The Trastuzumab and Pertuzumab combination therapy has become the current standard of care for these patients. Recent studies also suggest that Pertuzumab combined with Trastuzumab deruxtecan (Enhertu®) may become the new first-line treatment for HER2-positive metastatic breast cancer, indicating strong potential for future market expansion of EG1206A. In addition to its first-generation product EG12014 already on the market, the launch of second-generation EG1206A will further enhance treatment options for patients with HER2-positive breast cancer. According to Roche's 2024 annual report, global sales of Perjeta® reached CHF 3.62 billion (~ USD 4 billion). Sandoz is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world's first oral penicillin in 1951, and the world's first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. EirGenix has successfully utilized reverse engineering technologies to develop multiple biosimilar products. This new agreement underscores EirGenix's global competitiveness, technical excellence, and internationalization capabilities. With regulatory trends increasingly favorable, EirGenix is accelerating the development of four HER2-targeted antibody programs, expanding its in-house product pipeline as well as CDMO services for additional biosimilar projects. As global demand for biosimilar R&D and manufacturing continues to grow, EirGenix's technical expertise, production capacity, and large-scale facilities have attracted strong attention from international pharmaceutical companies. The increased utilization of EirGenix's two commercial production lines in Zhubei further demonstrates its rapid progress. EirGenix is poised to become a key development and manufacturing partner in the global biosimilar landscape and continue its strong growth trajectory. SOURCE EirGenix, Inc. 21% more press release views with Request a Demo

License out/inDrug ApprovalPhase 3Biosimilar

12 Nov 2025

·www.prnewswire.com

EirGenix Signed The Commercial Licensinse Agreement for It's Second HER2 Biosimilar Asset EG1206A

TAIPEI, Nov. 12, 2025 /PRNewswire/ -- EirGenix Inc.(TWSE: 6589) today announced that it has entered into a second global exclusive licensing agreement with international biosimilar leader Sandoz AG (SIX:SDZ/OTCQX:SDZNY) for the commercialization of its independently developed breast cancer biosimilar, EG1206A (Pertuzumab Biosimilar to Roche Perjeta®), covering all territories except Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, and Japan. The agreement further strengthens the two companies' collaborative development of the HER2 biosimilar product. Under the terms of the agreement, EirGenix will receive a total up to USD 152 million of upfront and milestone payments. In addition, EirGenix will also be entitled to a profit share once the product is launched in the licensed territory plus potential sales incentives based on market performance. EirGenix will be responsible for product development, manufacturing, and supply. EG1206A has completed its pharmacokinetic (PK) clinical study, and last month received positive feedback from both the U.S. FDA and the European Medicines Agency (EMA), confirming that the product qualifies for an abbreviated development pathway, allowing for the waiver of Phase III comparative efficacy trials. This agreement marks another major milestone and breakthrough in EirGenix's biosimilar development efforts. This partnership further strengthens the existing collaboration between Sandoz and EirGenix. The two companies previously signed a global commercialization agreement for EG12014 (Trastuzumab Biosimilar in both 150 mg and 420 mg formulations). EG12014 has already been approved by the European Commission and is currently under BLA review by the U.S. FDA. Globally, there are approximately 2.3 million breast cancer patients, of which about 20% are diagnosed with HER2-positive disease. The Trastuzumab and Pertuzumab combination therapy has become the current standard of care for these patients. Recent studies also suggest that Pertuzumab combined with Trastuzumab deruxtecan (Enhertu®) may become the new first-line treatment for HER2-positive metastatic breast cancer, indicating strong potential for future market expansion of EG1206A. In addition to its first-generation product EG12014 already on the market, the launch of second-generation EG1206A will further enhance treatment options for patients with HER2-positive breast cancer. According to Roche's 2024 annual report, global sales of Perjeta® reached CHF 3.62 billion (~ USD 4 billion). Sandoz is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world's first oral penicillin in 1951, and the world's first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. EirGenix has successfully utilized reverse engineering technologies to develop multiple biosimilar products. This new agreement underscores EirGenix's global competitiveness, technical excellence, and internationalization capabilities. With regulatory trends increasingly favorable, EirGenix is accelerating the development of four HER2-targeted antibody programs, expanding its in-house product pipeline as well as CDMO services for additional biosimilar projects. As global demand for biosimilar R&D and manufacturing continues to grow, EirGenix's technical expertise, production capacity, and large-scale facilities have attracted strong attention from international pharmaceutical companies. The increased utilization of EirGenix's two commercial production lines in Zhubei further demonstrates its rapid progress. EirGenix is poised to become a key development and manufacturing partner in the global biosimilar landscape and continue its strong growth trajectory. 21% more press release views with Request a Demo

License out/inDrug ApprovalPhase 3Biosimilar

10 Nov 2025

·www.mobihealthnews.com

Iambic secures $100M for drug discovery platform

Iambic, a clinical-stage life sciences company, announced an oversubscribed $100 million funding round. Abingworth, Alexandria Venture Investments , Alumni Ventures, ARK , Ascenta, Catalio, Everbright Biofund, Freeflow Ventures, Illumina Ventures, Mubadala , Pegasus Tech Ventures, Qatar Investment Authority, Regeneron Ventures, Sequoia, Tao Capital Partners, Terra Magnum Capital Partners, Wilson Sonsini Goodrich and Rosati participated in the round. WHAT IT DOES Iambic integrates physics principles into its AI architectures, creating models aimed at going deeper into the chemical space. Iambic's platforms include Enchant, NeuralPLexar and OrbNet. Enchant is a state-of-the-art multimodal transformer model that supplements small amounts of clinical data with laboratory data to make predictions of human pharmacokinetics and other clinical drug properties from the earliest stages of discovery programs. NeuralPLexer predicts the structure of protein-ligand complexes and the conformational changes to these structures from the addition of drug molecules. OrbNet is an AI-accelerated quantum chemistryGraph neural network architecture based on quantum features. The company will use the funds to further promote its technology platform. MARKET SNAPSHOT The announcement of the oversubscribed round comes in the wake of Iambic’s presentation of clinical data for IAM1363, an investigational drug candidate, at the European Society for Medical Oncology Congress in Germany, where IAM1363 showed anti-tumor activity and a positive safety profile across HER2-wild-type and HER2-mutated cancers, and in multiple disease indications. In October, Iambic entered into a research collaboration and drug supply agreement with Jazz Pharmaceuticals. Jazz provided zanidatamab (Ziihera), a HER2-targeted bispecific antibody, at no cost to Iambic for evaluation in tandem with IAM1363, Iambic’s brain-penetrant HER2 small-molecule tyrosine kinase inhibitor. The combo will be analyzed in patients with HER2-positive breast cancer who have previously been treated with trastuzumab deruxtecan (T-DXd; Enhertu). In July, Iambic unveiled a technology and research collaboration with Revolution Medicines to pursue novel drug candidates using Iambic's AI models. Iambic will use structures and molecular libraries provided by Revolution Medicines to train bespoke versions of NeuralLexer. In return, Revolution Medicines will have access to Iambic's PropANE model, a pre-trained graph neural network deployed across lots of drug properties for lead selection and optimization. The HIMSS AI & Cybersecurity Virtual Forum is free to attend on Nov. 18. Learn more and register.

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.	07 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	China	Daiichi Sankyo Co., Ltd.	07 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	Japan	Daiichi Sankyo Co., Ltd.	07 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	South Korea	Daiichi Sankyo Co., Ltd.	07 Oct 2025
Non-squamous non-small cell lung cancer	Phase 3	Taiwan Province	Daiichi Sankyo Co., Ltd.	07 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
HER2-positive Non-squamous non-small cell lung cancer	Phase 3	Argentina	Daiichi Sankyo, Inc.	02 Sep 2025
HER2-positive Non-squamous non-small cell lung cancer	Phase 3	Belgium	Daiichi Sankyo, Inc.	02 Sep 2025
HER2-positive Non-squamous non-small cell lung cancer	Phase 3	Brazil	Daiichi Sankyo, Inc.	02 Sep 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04622319 (DESTINY-Breast05, Company_Website \| ESMO2025) Manual	Phase 3	HER2 Positive Breast Cancer HER2 Positive	1,635	ENHERTU (5.4 mg/kg)	zsawrglbnq(hxryqmmjyl) = lnbsszkifc xnnaqagrrm (yadfqmcgcz ) View more	Positive	18 Oct 2025
				T-DM1	zsawrglbnq(hxryqmmjyl) = xiqdnvurii xnnaqagrrm (yadfqmcgcz ) 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)	imatcueopd(hjgjbeokpk) = nzpujvkjdj uhaztateex (gtgqinfvbc ) View more	Positive	18 Oct 2025
				ddAC (doxorubicin + cyclophosphamide) →  THP (paclitaxel + trastuzumab + pertuzumab)	imatcueopd(hjgjbeokpk) = yrnqknulzk uhaztateex (gtgqinfvbc ) View more
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	yififdchmy(lswblhqfaj) = rhlxgnmujq ivnjfrxivj (ymhqcpmqvf ) View more	Positive	17 Oct 2025
				Ramucirumab + Paclitaxel	yififdchmy(lswblhqfaj) = clnebiqpmv ivnjfrxivj (ymhqcpmqvf ) View more
ESMO2025	Not Applicable	Advanced breast cancer Second line \| First line HER2-positive \| HER2-low	112	Trastuzumab Deruxtecan (HER2-positive)	puwbnooqfn(fqhhyvqzra) = dfnsokambz ttgxspqywa (wnpvaapift, 0.8 - 13.1) View more	Positive	17 Oct 2025
				Trastuzumab Deruxtecan (HER2-low)	puwbnooqfn(fqhhyvqzra) = qlcnhpnoof ttgxspqywa (wnpvaapift, 6.1 - 23.2) 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)	tngcborrra(srkwzddxva) = czvibnryws vfrxtfjoza (wlegblonww )	Positive	17 Oct 2025
NCT04482309 (DP-02, ESMO2025)	Phase 2	HER2 Positive Cancer HER2-expressing	267	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W	xznfeejjul(xqsdopocxa) = ecuruzskgp rmaikdsczv (kitokjgulk, 11.9 - 15.3) View more	Positive	17 Oct 2025
				Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W (IHC 3+ tumors by local or central test used for enrollment)	xznfeejjul(xqsdopocxa) = ikumeoizcb rmaikdsczv (kitokjgulk, 12.8 - 23.4) View more
ESMO2025	Not Applicable	HER2 mutant non-small cell lung cancer HER2-mutant	35	Trastuzumab deruxtecan	jrrlbjnhgu(llbgmoiytd) = imvyqrormz namxksaxaq (hknwyqbllf ) 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	lergtydkub(kznypzbzjb) = No HBVr ± hepatic flare occurred during the study treatment or follow-up periods. noekncamoc (gbvxfgldpq )	Positive	17 Oct 2025
NCT04704661 (DASH, ESMO2025)	Phase 1	HER2 Positive Solid Tumors HER2 expression	24	trastuzumab deruxtecan (T-DXd) + AZD6738	glxcfzdivl(fyhfupugwa) = dnuhhlcxbw onulnqvoeu (mnwnumznba ) View more	Positive	17 Oct 2025
NCT03734029 (DESTINY-Breast04, Pubmed) Manual	Phase 3	HER2-Low Breast Carcinoma HER2-low	-	Trastuzumab deruxtecanTrastuzumab deruxtecan (T-DXd)	smahpgocqr(unrlgjhvof) = qclxxmfben ydshueqlvl (xqwsntdqhq )	Positive	08 Oct 2025
				Treatment of physician's choice of chemotherapy (TPC)	smahpgocqr(unrlgjhvof) = rqwtxzkejk ydshueqlvl (xqwsntdqhq )

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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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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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Related

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Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation