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

+ [15]

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+ [75]

Inactive Indication

Adenocarcinoma of LungAdvanced HER2-Positive Breast CarcinomaHER2 Positive Transitional Cell Carcinoma+ [2]

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Daiichi Sankyo, Inc.

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.

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

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Structure/Sequence

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Sequence Code 18481L

Source: *****

Sequence Code 44772H

Source: *****

Purpose: This clinical trial is designed to evaluate the safety and effectiveness of Trastuzumab Deruxtecan for patients with HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer. The goal is to determine how well this treatment works and to identify any potential side effects.
Who Can Participate: We are looking for Participants with histologically confirmed HER2 positive locally advanced unresectable and/or metastatic esophageal, gastric or GEJ adenocarcinoma with an ECOG PS of 2 and measurable disease according to RECIST 1.1 within 42 days prior to registration. Participants will be carefully screened to ensure they meet the study requirements.
What to Expect: Participants will undergo 6.4mg/kg, IV infusion of Trastuzumab deruxtucan over the course of the study. They will receive detailed information about the study and will have the opportunity to ask questions before deciding to participate. Informed consent will be obtained to ensure that participants understand the study's purpose, procedures, risks, and benefits.
Safety Monitoring: The health and safety of participants are our top priority. An Independent Data and Safety Monitoring Committee (DSMC) will regularly review the study data to ensure participant safety and to monitor for any adverse events. Any serious side effects will be reported and addressed promptly.
Benefits and Risks: While the study aims to provide potential benefits, such as improved treatment options for HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer there may also be risks involved. Participants will be informed of all possible risks before enrolling in the study.
Confidentiality: All personal information will be kept confidential, and data will be used only for research purposes.
Contact Information: For more information about this study, please contact PhaseIICRA@medicine.bsd.uchicago.edu

Start Date01 Nov 2026

Sponsor / Collaborator

The University of Chicago

NCT07137416

/ 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 Date05 Oct 2026

Sponsor / Collaborator

National Cancer Institute

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

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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1,079

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

01 Jul 2026·Value in Health Regional Issues

Budget Impact Analysis of Fam-Trastuzumab-Deruxtecan as a Second Line in Patients With HER2-Positive Metastatic Breast Cancer in Oman

Article

Author: Aljaber, Rana ; Al Froukh, Rawan F ; Al Hashar, Amna

OBJECTIVES:

Despite advancements, breast cancer remains a major global health and financial challenge. Trastuzumab-based therapies, particularly Fam-Trastuzumab-Deruxtecan (T-DXd), have shown superior outcomes, leading to its recommendation as a preferred second-line treatment. However, its high cost necessitates a budget impact analysis (BIA) to evaluate financial feasibility. This study assesses the 1-year budget impact of replacing Trastuzumab Emtansine (TDM1) with T-DXd for HER2+ metastatic breast cancer in an Omani cancer center.

METHODS:

A static BIA model was built based on National Institute for Health and Care Excellence template with adaptation as required. The model time horizon was 1 year then projected over another 2 years, using 2022 as the baseline year, adopting Omani healthcare-payer perspective. The analysis considered 2 scenarios: (1) TDM1 as the current formulary drug and (2) T-DXd is introduced instead of TDM1, assuming that treatment share would be 100%. One-way sensitivity analysis is performed to assess the model's robustness.

RESULTS:

The BIA demonstrated that replacing TDM1 with T-DXd for the eligible patients would lead to increase in the budget expenditure. Over a 3-year period, considering the provided assumptions and input data, the cumulative excess amount to €5 909 481.67. The primary contributing factors are the drug acquisition cost and the median treatment duration. The sensitivity analysis results suggest the model is robust to changes in adverse drug reaction costs, unlike changes in treatment duration and drug cost.

CONCLUSIONS:

Although T-DXd improves clinical outcomes, its adoption as a second-line treatment in Oman poses a substantial financial burden, necessitating careful budget planning to ensure long-term affordability.

01 May 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Resistance mechanisms and post-trastuzumab deruxtecan (T-DXd) strategies in HER2+ and HER2-low breast cancer: From biology to clinical practice

Review

Author: Xue, Wenwu ; Chen, Minna ; Wen, Xiaofen ; Li, Xiaozhi ; Zeng, De ; Song, Junwei ; Lin, Danxia ; Wang, Wende ; Zhang, Weichun ; Shen, Jiaxin

Trastuzumab deruxtecan (T-DXd), a HER2-directed antibody-drug conjugate (ADC), has revolutionized the treatment landscape for HER2-positive and HER2-low breast cancer, offering unprecedented improvements in progression-free survival (PFS) and overall survival (OS). However, the emergence of resistance limits its long-term efficacy and highlights the need for rational post-progression strategies. This review summarizes current understanding of resistance mechanisms to T-DXd, including dynamic HER2 expression loss, dysregulation of DNA damage repair, tumor microenvironment remodeling, and immune evasion. Building upon these mechanistic insights, we explore therapeutic strategies following T-DXd resistance, including sequential ADCs with alternative targets or payloads, combinations with HER2-targeted tyrosine kinase inhibitors (TKIs), CDK4/6 or PARP inhibitors, endocrine therapy, and immunotherapy. Novel agents such as ARX788, patritumab deruxtecan, and Dato-DXd demonstrate promise in overcoming resistance through diversified mechanisms. Real-world data further support a "three-step strategy" involving ADC rechallenge after interim non-ADC therapies, offering a practical, mechanism-informed treatment model. This review provides a framework for precision-guided care in patients with advanced breast cancer and supports ongoing efforts to extend the therapeutic window beyond initial T-DXd benefit.

01 Apr 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Recent advances in systemic treatment for HER2-negative breast cancer with brain metastases

Review

Author: Zhu, Yuehong ; Hao, Chunfang ; Zhang, Jie

Human epidermal growth factor receptor 2 (HER2) -negative breast cancer brain metastases (BCBM) and leptomeningeal disease (LMD) pose significant clinical challenges due to limited treatment options and poor prognosis. Unlike HER2-positive BCBM, which has established therapeutic protocols, HER2-negative BCBM and LMD lacks standardized approaches. Recent advances have introduced novel systemic therapies targeting diverse pathways, including cell cycle regulation, DNA repair, immune modulation, vascular suppression, and leptomeningeal penetration, with emerging data supporting activity in LMD. Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors show promise in hormone receptor-positive subsets, particularly when combined with radiotherapy. Antibody-drug conjugates (ADCs), such as trastuzumab deruxtecan and sacituzumab govitecan, demonstrate enhanced central nervous system penetration and tumor-specific cytotoxicity, improving outcomes in both stable and active brain metastases. Immune checkpoint inhibitors (ICIs) and poly (ADP-ribose) polymerase (PARP) inhibitors also exhibit potential, though their efficacy varies by molecular subtype. Additionally, intrathecal therapies have become a cornerstone for LMD management, bypassing the blood-CSF barrier. Emerging therapies like selective estrogen receptor degraders (SERDs) and kinase inhibitors address resistance mechanisms, offering new avenues for personalized treatment. This review underscores the need for survival-prolonging, quality-of-life-preserving strategies with optimized safety profiles, highlighting the evolving landscape of HER2-negative BCBM and LMD management.

1,078

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

30 Mar 2026

·www.businesswire.com

Guardant Health’s InfinityAI Real-World Evidence Supports Approval of ENHERTU® for Previously Treated Patients with HER2-Positive Metastatic Solid Tumors in Japan

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that real-world evidence generated from Guardant’s InfinityAI contributed to the recent approval of ENHERTU® (trastuzumab deruxtecan), developed and commercialized by Daiichi Sankyo (TSE:4568) in Japan, for the treatment of patients with HER2-positive (HER2 [ERBB2] gene amplification or immunohistochemistry [IHC] 3+) advanced or recurrent solid cancers refractory or intolerant to standard treatments. This approval, granted by Japan’s Ministry of Health, Labour and Welfare (MHLW), was supported by data from the HERALD, DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01 clinical trials and supplemental real-world evidence (RWE) generated using the real-world data platform from InfinityAI, Guardant Health’s artificial intelligence platform. HER2 amplification is well characterized in breast cancer but patient identification and evidence continues to be challenging. In biomarker-defined populations with low prevalence, real-world data (RWD) can play a critical role in identifying patients at scale and characterizing unmet need. To support its MHLW application, Daiichi Sankyo incorporated real-world evidence generated from InfinityAI as supplemental data alongside clinical findings. Together, Guardant Health and Daiichi Sankyo analyzed outcomes from a large cohort of patients with HER2 amplifications detected via Guardant360®, demonstrating significant unmet need and real-world clinical relevance across multiple tumor types. The collaboration illustrates an innovative pathway that leverages high-quality RWE to complement clinical trial data, particularly in genomic subpopulations where traditional trial enrollment may be limited. “This approval highlights the growing role of real-world evidence in precision oncology and underscores the potential for new regulatory pathways in rare biomarker-defined populations,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “InfinityAI allows us to generate clinically meaningful evidence from large-scale, longitudinal data, helping to complement traditional trials and ultimately expand access to targeted therapies for patients who might otherwise be overlooked.” About InfinityAI InfinityAI is Guardant Health’s artificial intelligence and machine learning platform for generating real-world evidence and data-driven insights. It is built on a large, proprietary dataset derived from Guardant Health’s clinical testing portfolio, integrating longitudinal, multimodal molecular and clinical data, including genomic and epigenomic information, into a unified framework. InfinityAI supports biopharma and healthcare partners across research, development, and clinical applications, including biomarker discovery, patient identification, and clinical trial optimization. Through flexible data and analytics solutions, InfinityAI enables more informed decision-making to improve development efficiency and patient outcomes. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Guardant Health Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

Drug ApprovalClinical StudyImmunotherapy

26 Mar 2026

·allsci.com

Tempus AI and Daiichi Sankyo collaborate on AI-driven biomarker discovery for antibody drug conjugate

Tempus AI (NASDAQ: TEM) and Daiichi Sankyo have entered a strategic collaboration to apply artificial intelligence and real-world data analytics to the clinical development of an undisclosed antibody drug conjugate in oncology. Chicago-based Tempus will deploy its proprietary AI platform, including the PRISM2 foundation model, to support biomarker discovery and patient stratification for the ADC program. Tokyo-based Daiichi Sankyo, which maintains one of the industry’s largest ADC portfolios, will contribute clinical trial and preclinical research data. Financial terms of the collaboration were not disclosed. The collaboration centers on Tempus’s multimodal data and AI capabilities rather than a transfer of drug rights. Tempus operates one of the largest libraries of clinical and molecular data in healthcare, integrating electronic health records, genomic sequencing, and pathology imaging into a unified analytics platform. The company was founded in 2015 and provides AI-enabled precision medicine tools to both clinicians and pharmaceutical partners. Under the agreement, the two companies will develop proof-of-concept AI models designed to optimize patient selection for the ADC. Tempus’s PRISM2 model combines pathology images with clinical data to generate diagnostic and predictive outputs. These models will be deployed across Tempus’s oncology database to produce response maps intended to support patient stratification and benchmarking of potential control arms for future clinical trials. The specific ADC program was not identified. Daiichi Sankyo’s ADC portfolio includes trastuzumab deruxtecan, marketed as Enhertu in partnership with AstraZeneca, and datopotamab deruxtecan, which targets TROP2. The company has additional ADC candidates in clinical development across multiple tumor types. The press release refers to “a novel ADC” without disclosing the biological target, development stage, or indication. For Daiichi Sankyo, the collaboration reflects a broader industry trend of applying AI-driven analytics to ADC clinical development in oncology, where patient selection and biomarker-guided trial design are increasingly viewed as levers to improve probability of technical success. ADCs as a class face complex pharmacology involving antibody targeting, linker stability, and payload potency, making precise patient stratification a priority in late-stage development. Tempus has signed similar AI-driven collaborations with pharmaceutical companies including AstraZeneca, Takeda, and Merck, focused on applying real-world data and machine learning to drug development. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

License out/inADC

25 Mar 2026

·www.fiercepharma.com

Biogen pays $20M upfront to tap into Alteogen's subQ delivery tech

Biogen will hand Alteogen $20 million upfront for help developing subcutaneous formulations of two unnamed biologics using Alteogen’s Hybrozyme technology and its recombinant human hyaluronidase ALT-B4. After attracting GSK with its subcutaneous delivery tech at the top of the year, South Korea’s Alteogen has snared another Big Pharma partner in Biogen. Biogen will hand Alteogen $20 million upfront for help developing subcutaneous formulations of two unnamed biologics using Alteogen’s Hybrozyme technology and its recombinant human hyaluronidase ALT-B4.As part of the license agreement, Alteogen is in line to receive another $10 million should Biogen kick off development of the second product, and the company is further eligible to receive up to $549 million tied to potential development and regulatory milestones, plus sales targets on the two products combined. Alteogen would also be up for royalties on net sales of the prospective subQ medicines should they make it to market, the company said in a March 25 press release. As part of the arrangement, Biogen also has an option to leverage Alteogen’s technology to develop a third unnamed product. ALT-B4, which also goes by the name berahyaluronidase alfa, is a recombinant human hyaluronidase developed using Alteogen’s Hybrozyme platform. The company’s hyaluronidase enzyme permits the “rapid and efficient dispersion and absorption of co-administered therapeutics” and has been designed to help convert biologics typically administered via intravenous infusion into subcutaneous formulations, Alteogen explained in its release. “We are very pleased to enter into this partnership and look forward to advancing innovative therapies together for patients," Tae-Yon Chun, Alteogen’s CEO, said of the Biogen tie-up in Wednesday’s announcement. The partners did not clarify which Biogen drugs they will attempt to reformulate for subcutaneous delivery. Earlier this year, Alteogen pulled GSK into ALT-B4’s orbit, linking up under another $20 million upfront deal to specifically develop a subcutaneous formulation of the British pharma’s checkpoint inhibitor Jemperli (dostarlimab). Alteogen stands to gain up to $265 million more from the deal tied to development, regulatory and sales milestones and would once again be in line for royalties if the reformulated product goes commercial. Since 2024, Alteogen has also inked similar deals with the likes of Daiichi Sankyo on its AstraZeneca-partnered antibody-drug conjugate Enhertu as well as with AZ around potential subQ oncology products more broadly.

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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
HER2 Positive Endometrial Carcinoma	Phase 3	United States	Daiichi Sankyo, Inc.	12 Mar 2026
HER2 Positive Endometrial Carcinoma	Phase 3	China	Daiichi Sankyo, Inc.	12 Mar 2026
HER2 Positive Endometrial Carcinoma	Phase 3	Japan	Daiichi Sankyo, Inc.	12 Mar 2026
HER2 Positive Endometrial Carcinoma	Phase 3	Argentina	Daiichi Sankyo, Inc.	12 Mar 2026
HER2 Positive Endometrial Carcinoma	Phase 3	Brazil	Daiichi Sankyo, Inc.	12 Mar 2026
HER2 Positive Endometrial Carcinoma	Phase 3	Canada	Daiichi Sankyo, Inc.	12 Mar 2026
HER2 Positive Endometrial Carcinoma	Phase 3	Chile	Daiichi Sankyo, Inc.	12 Mar 2026
HER2 Positive Endometrial Carcinoma	Phase 3	France	Daiichi Sankyo, Inc.	12 Mar 2026
HER2 Positive Endometrial Carcinoma	Phase 3	Germany	Daiichi Sankyo, Inc.	12 Mar 2026
HER2 Positive Endometrial Carcinoma	Phase 3	Greece	Daiichi Sankyo, Inc.	12 Mar 2026

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2026	Not Applicable	HER2 Positive Ovarian Cancer \| HER2-Expressing Endometrial Carcinoma HER2 expressing	33	Trastuzumab deruxtecan	pnmazvkojy(hzmrkioefe) = ngptzvguvk wmtmziezap (itnmwppcxj ) View more	Positive	20 Apr 2026
				Trastuzumab deruxtecan (Ovarian cancer)	pnmazvkojy(hzmrkioefe) = uskksqeisy wmtmziezap (itnmwppcxj ) View more
AACR2026	Not Applicable	Metastatic Colorectal Carcinoma Second line HER2-amplified \| MSS	3,734	trastuzumab deruxtecan	qvhbrmiyau(jzblcrgxnv): HR = 1.14 (95.0% CI, 1.05 - 1.24), P-Value = 0.0024 View more	Positive	19 Apr 2026
				Standard Chemotherapy
ESMO_TAT2026	Not Applicable	HER2-positive \| ERBB2-mutated	61	Trastuzumab deruxtecan (ERBB2 mutations)	gvtaxutiyr(grtrnxhlaf) = ietglhioee icijpjtjdp (pcoegfoonc ) View more	Positive	16 Mar 2026
				Trastuzumab deruxtecan (HER2 IHC 3+)	gvtaxutiyr(grtrnxhlaf) = cnfthgsbmd icijpjtjdp (pcoegfoonc ) View more
NCT05744375 (TRANSCENDER, CTgov)	Phase 2	Locally advanced breast cancer \| Metastatic human epidermal growth factor 2 positive carcinoma of breast	2	Trastuzumab deruxtecan	pwnlfocdze = qisnkkrjvo drtstqppoz (nzqvxdjuoy, ybuxbbvbzs - yqakjoxgtg) View more	-	12 Mar 2026
ESMO_SRC2026	Not Applicable	Solid tumor	9	Trastuzumab deruxtecan	itidyinhrc(pigeryovyt) = slzzmkwjhs ujyqbbwduy (hngsaunses )	Positive	09 Mar 2026
NCT06989112 (DESTINY-Endometrial01, ESGO2026)	Phase 3	Recurrent Endometrial Cancer First line HER2-expressing \| mismatch repair-proficient (pMMR)	600	trastuzumab deruxtecan + rilvegostomig	ymcktnqxoq(jkvmnwzegw) = aayrxcvclj grncksuxgo (zjntbspazs, 24.9 - NR) View more	Positive	28 Feb 2026
				trastuzumab deruxtecan + pembrolizumab	rkiacdxjvc(llwwsqcgug) = wkbjzuzveu vrdlddokhw (jvhewnqjiu, 8.3 - 16.5) View more
NCT06610825 (CARPET, ASCO_GU2026)	Phase 2	Metastatic castration-resistant prostate cancer HER2-positive (IHC 1+, 2+, or 3+)	5	trastuzumab deruxtecan	nofgxolgka(kcsxyqhvnv) = xmshirrqsj adqfdsiezy (lbvfuoqghd ) View more	Positive	26 Feb 2026
NCT04622319 (DESTINY-Breast05, Pubmed \| N Engl J Med)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	1,635	Trastuzumab Deruxtecan	smtdnxxxjf(wyntdntjdg) = wtgmmxfbwh puohdlqzaj (fsfwtewnwf ) View more	Positive	26 Feb 2026
				Trastuzumab emtansine (T-DM1)	smtdnxxxjf(wyntdntjdg) = rwzmncisse puohdlqzaj (fsfwtewnwf ) View more
NCT04482309 (DESTINY-PanTumor02 (DP-02), ASCO_GU2026)	Phase 2	Bladder Cancer HER2-expressing	41	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W	jefersuxgi(pjhuhwkyhp) = rbuvgcqrji ziahspvcgy (hstpeqzpnu, 26.3 - 57.9) View more	Positive	26 Feb 2026
				Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W (HER2 IHC 3+)	jefersuxgi(pjhuhwkyhp) = wmunisnclw ziahspvcgy (hstpeqzpnu, 29.9 - 80.2) View more
NCT06731478 (DESTINY-Gastric05, ASCO_GI2026)	Phase 3	Metastatic HER2 positive gastroesophageal junction cancer First line HER2+	726	T-DXd + 5-FU (or CAPE) + pembrolizumab	qmqwvrhhrq(rjdiwnaahx) = veuudzubey mwxjpewoef (inkdqhotxe )	Positive	08 Jan 2026
				Trastuzumab + platinum-based chemo + pembrolizumab	qmqwvrhhrq(rjdiwnaahx) = aflsntbonu mwxjpewoef (inkdqhotxe )

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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

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