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+ [67]

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, Inc.

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)

Structure/Sequence

Boost your research with our ADC technology data.

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Sequence Code 18481L

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Sequence Code 44772H

Source: *****

185

Clinical Trials associated with Fam-trastuzumab deruxtecan-NXKI

NCT07126561

/ Not yet recruitingPhase 2IIT

Phase II Open Label Trial of Trastuzumab Deruxtecan (Enhertu, DS-8210) in HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer Patients With an ECOG Performance Status of 2

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

100 Translational Medicine associated with Fam-trastuzumab deruxtecan-NXKI

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

1,085

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.

03 Apr 2026·Expert Opinion On Drug Safety

Hematological toxicities in antibody–drug conjugates related with breast cancer: a pharmacovigilance study using FDA adverse event reporting system database

Article

Author: Mei, Qinghua ; Zhou, Hui ; Chen, Zhiru ; Wang, Shiqiao ; Huang, Jiayu ; Chen, Jiayi ; Pan, Heng ; Zou, Guosheng

OBJECTIVE:

The trastuzumab emtansine, trastuzumab deruxtecan, and sacituzumab govitecan are antibody-drug conjugates (ADCs) that have demonstrated efficacy in the treatment of breast cancer. Nonetheless, these ADCs can also induce severe toxicities in various organ systems, particularly the hematological system. Therefore, this study evaluated the hematological toxicities associated with ADCs in breast cancer based on real-world data.

METHODS:

Data were extracted from the FDA Adverse Event Reporting System (FAERS) database, spanning from 2014 Q1 to 2023 Q3. Further analysis was done on the hematological toxicities related with ADCs, including their features, onset time, and fatality proportion.

RESULTS:

Out of 10,976 adverse event reports, 1895 hematotoxicity reports (17.26%) were analyzed. All ADCs exhibited positive safety signals for hematological toxicities, as indicated by reporting odds ratios and the information component. Unexpected significant adverse events, including splenomegaly, immune thrombocytopenia, hemolytic anemia, and hemolytic anemia, that were discovered in the medication label transpired during our data mining. The median time-to-onset of these toxicities was 13 days (interquartile range [IQR] 7-54.75), and the fatality proportion associated with hematological toxicities and ADCs was 17.41%.

CONCLUSION:

The study indicated that hematological toxicities caused by ADCs preferentially emerge early and may have catastrophic consequences. Early detection and management of these hematological toxicities associated with ADC is essential.

1,081

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

08 Apr 2026

·www.pharmaceutical-technology.com

Sidewinder pockets $137m in Series B to take bispecific ADCs to clinic

Sidewinder will use the money to progress its pipeline of bispecific ADCs to the clinic. Credit: SauliusJan / Shutterstock.com. Sidewinder Therapeutics has secured $137m in a Series B financing round to progress its pipeline of bispecific antibody-drug conjugates (ADCs) – marking the continued growth in investor interest over the modality. Novartis Venture Fund and Frazier Life Sciences co-led this funding round, while life sciences investment giants like OrbiMed, Goldman Sachs and Astellas Venture Management also contributed – allowing Sidewinder to push forward the development of its three-strong bispecific ADC pipeline to the clinic. The company will advance two of these programmes internally, while exploring out-licensing opportunities for the others under its jurisdiction. According to Sidewinder, its ADC pipeline differs from other drugs within the modality as it targets two receptor co-complexes, potentially creating a more tumour-specific approach to treatment over first-generation ADCs. The company’s lead asset, SWT012, has already demonstrated the potential to achieve benefit in a preclinical bladder cancer model, as per a company presentation shared with Pharmaceutical Technology . In the study, the bispecific ADC significantly improved cell internalisation and efficacy over the corresponding bivalent, monospecific antibodies. Sidewinder plans to file an investigational new drug application (IND) for SWT012 at the end of 2026. Alongside its development efforts for SWT012, the San Diego-based biotech is looking to take its lung and colorectal cancer assets, SWT019 and SWT020, to the clinic. Both drugs have shown promise in preclinical studies, and Sidewinder hopes to submit an IND for SWT019 and a DC nomination for SWT020 in the first half of 2027. Founded in 2023, Sidewinder is focused on developing next-generation ADCs for cancers with larger patient populations that have been typically difficult to treat. This includes solid tumours like head and neck, squamous cell lung and gastrointestinal cancers. Bispecific ADCs turn heads Sidewinder’s Series B comes as investors and pharma companies alike take greater interest in bispecific ADCs, which GlobalData analysts tout as a potential game changer for enhanced ADC selectivity and diminished off-target toxicity. Commercial success for blockbuster modality pioneers like AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) continues to grow, with GlobalData forecasting that the drug’s total sales will reach $5.3bn in 2032. In October 2025, Takeda became one of several big pharma companies to ink a high-value deal around bispecific ADCs, signing a $11.4bn mega-deal with Innovent Biologics to secure the rights to several drugs – including bispecific ADC IBI3001 – outside of China. According to GlobalData, parent company of Pharmaceutical Technology , around 84% of bispecific ADCs were in the preclinical or discovery stages in August 2025 , though there are four candidates currently in Phase III. This includes Systimmune and Bristol Myers Squibb’s (BMS) izalontamab brengitecan (iza-bren), which recently met its dual primary endpoints in a Chinese Phase III study in triple-negative breast cancer (TNBC). While bispecific ADCs are more generally in the early stages of development, 52% of all Chinese licensing deals involving ADCs centred around drugs with two targets in 2024 – highlighting the strong interest in this next-generation format.

Phase 3ADCLicense out/inClinical Result

03 Apr 2026

·www.prnewswire.com

Next Generation Drug Conjugates (NDCs) Market worth $42.55 billion by 2035 | MarketsandMarkets™

DELRAY BEACH, Fla., April 3, 2026 /PRNewswire/ -- According to MarketsandMarkets™, the Next Generation Drug Conjugates Market is projected to grow from about USD 15.75 billion in 2026 to USD 42.55 billion by 2035, at a CAGR of 11.7%. Browse 260 market data Tables and 60 Figures spread through 270 Pages and in-depth TOC on "Next Generation Drug Conjugates Market - Global Forecast to 2035" Next Generation Drug Conjugates Market Size & Forecast: Market Size Available for Years: 2026–2035 2026 Market Size: USD 15.75 billion 2035 Projected Market Size: USD 42.55 billion CAGR (2026–2035): 11.7% Next Generation Drug Conjugates Market Trends & Insights: By type, the peptide-radionuclide conjugate is projected to witness the highest CAGR of 14.6% between 2026 and 2035. By indication, breast cancer is expected to dominate the global next generation drug conjugates market in 2025 with a share of 45.9%. North America is projected to be the fastest-growing regional segment at a CAGR of 13.2% during the forecast period. Download PDF Brochure @ The growing prevalence of hematologic malignancies and solid tumors is a major driver for the next generation drug conjugates market. Additionally, continuous advancements in conjugation technologies, including improvements in targeting ligands, linker chemistry, payload design, and manufacturing processes, are enhancing the efficacy, safety, and scalability of these therapies. By product, The Enhertu segment accounted for the largest share of the global next generation drug conjugates market in 2025. the next generation drug conjugates market is segmented into Enhertu, Amvuttra, Pluvicto, Trodelvy, Sacituzumab Tirumotecan (SAC-TMT), Zilebesiran, 225Ac-PSMA-617, other commercialized products, and other pipeline products. The Enhertu dominated the market share in 2025, driven by its superior clinical efficacy, strong global adoption, and expanding approvals across multiple HER2-targeted indications, particularly in breast cancer. Its growing use in HER2-low populations and ongoing clinical trials in lung and gastric cancers further support its market leadership. Additionally, the increasing prevalence of breast cancer and the rising demand for targeted therapies continue to boost the uptake of Enhertu, reinforcing its dominant position in the global NGDC market. Request Sample Pages@ By Targeting ligand, Amino sugar is estimated to be the fastest-growing target ligand segment. The global next generation drug conjugates market is segmented by target ligand into antibodies, amino sugars, peptides, and other targeting ligands. In 2025, the amino sugar segment is projected to be the fastest growing during the forecast period, driven by its emerging role in targeted delivery and improved cellular uptake. Amino sugar-based ligands offer enhanced biocompatibility and potential for selective binding, supporting their increasing adoption in novel drug conjugate development and expanding research applications in precision oncology. North America accounted for the largest regional share in the global next generation drug conjugates market in 2025. North America accounted for the largest share of regional revenues in the next generation drug conjugates (NGDC) market and remains the primary growth engine. The region's dominance is driven by a high concentration of leading biopharmaceutical companies, advanced research institutions, and specialized cancer centers, along with strong regulatory support from the FDA and rapid adoption of innovative targeted therapies such as antibody-drug conjugates. Robust oncology pipelines, significant NIH and private funding, and an active clinical trials landscape position the US as the key innovation hub for NGDCs, while Canada contributes steadily through expanding healthcare infrastructure, increasing cancer research initiatives, and growing adoption of advanced oncology treatments. Inquire Before Buying@ Top Companies in Next Generation Drug Conjugates Market: The Top Companies in Next Generation Drug Conjugates Market include Alnylam Pharmaceuticals, Inc (US), Gilead Sciences, Inc (Immunomedics) (US), Novartis AG (Switzerland), AstraZeneca (UK), Daiichi Sankyo, Company Limited (Japan), Ionis Pharmaceuticals, Inc. (US), Rakuten Group, Inc. (US), Novo Nordisk (Dicerna Pharmaceuticals) (Denmark), ADC Therapeutics SA (Switzerland), Sanofi (France), Arrowhead Pharmaceuticals (US), and AbbVie, Inc (US). Browse Adjacent Markets: Medical Devices Market Research Reports & Consulting Related Reports: Antibody Discovery Market - Global Forecast to 2030 Antibody Therapeutics Market - Global Forecast to 2028 Oligonucleotide Synthesis Market - Global Forecast to 2030 Peptide Synthesis Market - Global Forecast to 2029 Drug Discovery Services Market - Global Forecast to 2030 About MarketsandMarkets™ MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report. MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe. Today, 80% of Fortune 2000 companies rely on MarketsandMarkets, and 90 of the top 100 companies in each sector trust us to accelerate their revenue growth. With a global clientele of over 13,000 organizations, we help businesses thrive in a disruptive ecosystem. The B2B economy is witnessing the emergence of $25 trillion in new revenue streams that are replacing existing ones within this decade. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing. Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts. MarketsandMarkets™ SalesPlay is an AI-driven Revenue Intelligence Co-Pilot designed to help revenue teams prioritize the right accounts, identify critical changes early, and surface opportunities ahead of demand, so pipeline builds naturally and deals close with greater consistency. To find out more, visit ™.com or follow us on Twitter , LinkedIn and Facebook . Contact: Mr. Rohan Salgarkar MarketsandMarkets™ INC. 1615 South Congress Ave. Suite 103, Delray Beach, FL 33445 USA: +1-888-600-6441 Email: [email protected] Visit Our Website: Logo - SOURCE MarketsandMarkets 21% more press release views with Request a Demo

02 Apr 2026

·www.astrazeneca.com

Imfinzi plus Imjudo combined with lenvatinib and TACE demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in embolisation-eligible unresectable liver cancer in EMERALD-3 Phase III trial

Positive high-level results from the EMERALD-3 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), lenvatinib and transarterial chemoembolisation (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone for patients with unresectable hepatocellular carcinoma (HCC) eligible for embolisation. At this interim analysis for overall survival (OS), a key secondary endpoint, this combination also demonstrated a trend toward OS improvement versus TACE alone. Patients in the investigational arms were treated with the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), with or without lenvatinib, before TACE, and then alongside TACE. Although not formally tested at this time, data for the treatment arm evaluating the STRIDE regimen plus TACE versus TACE alone showed strong trends toward improved PFS and OS. The trial will continue to follow OS and other key secondary endpoints in both investigational arms. HCC is the most common type of liver cancer.1 In 2026, more than 200,000 patients with HCC will be eligible for embolisation, a standard-of-care procedure that blocks the blood supply to the tumour and can also deliver chemotherapy directly to the liver.2-4 However, most patients who receive embolisation experience disease progression or recurrence within six to ten months.5 Ghassan Abou-Alfa, MD, JD, MBA, PhD(hc), Attending Physician, Professor of Medicine at Memorial Sloan Kettering Cancer Center, and principal investigator in the trial said, “Dual immunotherapy with durvalumab and tremelimumab in the STRIDE regimen represents a meaningful advance for patients with embolisation-eligible liver cancer, who currently lack systemic treatment options to keep their cancer from progressing or recurring, with a trend of improving survival. EMERALD‑3 shows we can now significantly reduce the risk of disease progression with STRIDE as the immunotherapy backbone alongside lenvatinib and TACE.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “EMERALD‑3 now shows that bringing the dual immunotherapy STRIDE regimen earlier, alongside TACE and lenvatinib, can further improve outcomes in earlier‑stage liver cancer. This builds on the HIMALAYA Phase III trial data in patients with advanced, unresectable disease, where the STRIDE regimen has already demonstrated durable overall survival benefit. We are discussing these positive data with global regulatory authorities while awaiting the final results from the key secondary endpoints.” The safety profile for each combination was consistent with the known profiles of each medicine, and there were no new safety findings. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. +++ Notes Liver cancer Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death.1,6 In 2026, more than 200,000 patients will be diagnosed with embolisation-eligible HCC.2 Embolisation is a standard-of-care procedure that blocks the blood supply to the tumour and can also deliver chemotherapy directly to the liver.3-4 Immunotherapy is a proven treatment modality in HCC with approved options available for patients in later-line settings.7 EMERALD-3 EMERALD-3 is a randomised, open-label, sponsor-blinded, multicentre, global Phase III trial of a single priming dose of Imjudo 300mg added to Imfinzi 1500mg followed by Imfinzi every four weeks (STRIDE regimen) plus TACE with or without lenvatinib versus TACE alone in a total of 760 patients with unresectable HCC eligible for embolisation. Participants were randomised in a 1:1:1 ratio to Arm A (TACE, Imfinzi, Imjudo, lenvatinib), Arm B (TACE, Imfinzi, Imjudo) and Arm C (TACE) until each arm reached 175 participants. Randomisation was then continued in a 1:1 ratio to treatment Arms A and C until each reached approximately 275 participants. Patients received Imfinzi with Imjudo, plus TACE as needed, with or without lenvatinib concurrently, followed by Imfinzi with or without lenvatinib until progression. The trial was conducted in 171 centres across 22 countries, including in North America, Europe, South America and Asia. The primary endpoint is PFS for Imfinzi plus Imjudo, lenvatinib and TACE versus TACE alone. Secondary endpoints include OS for Imfinzi plus Imjudo, lenvatinib and TACE, and PFS and OS for Imfinzi plus Imjudo and TACE versus TACE alone. Imfinzi Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. In gastrointestinal (GI) cancer, Imfinzi is approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo in unresectable HCC. Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. In addition to its indications in GI cancers, Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy (CRT). Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC, and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage small cell lung cancer (SCLC) in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy for the treatment of extensive-stage SCLC. Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved in the US, EU, Japan and other countries for patients with muscle-invasive bladder cancer based on results from the NIAGARA Phase III trial. Additionally, in May 2025, Imfinzi added to Bacillus Calmette-Guérin induction and maintenance therapy met the primary endpoint of disease-free survival for patients with high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial. Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in the US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in the EU and Japan. Since the first approval in May 2017, more than 414,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several GI cancers. Imjudo Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. In addition to its approved indications in liver and lung cancers, Imjudo is being tested in combination with Imfinzi across multiple tumour types including in SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE). AstraZeneca in GI cancers AstraZeneca has a broad development programme for the treatment of GI cancers across several medicines and a variety of tumour types and stages of disease. In 2022, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.8 Within this programme, the Company is committed to improving outcomes in gastric, liver, biliary tract, oesophageal, pancreatic and colorectal cancers. In addition to its indications in BTC and HCC, Imfinzi is being assessed in combinations, including with Imjudo, in oesophageal and gastric cancers in an extensive development programme spanning early to late-stage disease across settings. Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC), is approved in the US and several other countries for HER2-positive advanced gastric cancer. Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. Lynparza, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. inside the US and Canada). The Company is also assessing rilvegostomig, a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, in combination with bevacizumab with or without Imjudo as a 1st-line treatment in patients with advanced HCC, and as a 1st-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastric and gastroesophageal junction cancers. Rilvegostomig is also being evaluated in combination with Enhertu in previously untreated, HER2-expressing, locally advanced or metastatic BTC. AstraZeneca is advancing multiple modalities that provide complementary mechanisms for targeting Claudin 18.2, a promising therapeutic target in gastric cancer. These include sonesitatug vedotin, a potential first-in-class ADC licensed from KYM Biosciences Inc., currently in Phase III development; AZD5863, a novel Claudin 18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development; and AZD4360, an ADC, currently being evaluated in a Phase I/II trial in patients with advanced solid tumours. In early development, AstraZeneca is developing AZD7003, a Glypican 3 (GPC3) armoured CAR T, in HCC. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Dr. Abou-Alfa provides consulting and advisory services to AstraZeneca. Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

ImmunotherapyClinical ResultPhase 3Drug ApprovalPhase 2

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
Solid tumor	Phase 3	United States	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	China	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Japan	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Australia	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Brazil	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	France	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Israel	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Italy	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	South Korea	Daiichi Sankyo, Inc.	23 Dec 2025
Solid tumor	Phase 3	Spain	Daiichi Sankyo, Inc.	23 Dec 2025

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	ryyrtwnkad(pyzoocvkix) = laoahawiex gfvwkkzytp (mhqlfcfzbp ) View more	Positive	20 Apr 2026
				Trastuzumab deruxtecan (Ovarian cancer)	ryyrtwnkad(pyzoocvkix) = xwwdjbmfoa gfvwkkzytp (mhqlfcfzbp ) View more
AACR2026	Not Applicable	Metastatic Colorectal Carcinoma Second line HER2-amplified \| MSS	3,734	trastuzumab deruxtecan	fthqiiodai(kkpghvqplv): 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)	vqqszgqttb(lkvaugzzzg) = xebgcphgcj dkyhyhusmq (wpoyshifez ) View more	Positive	16 Mar 2026
				Trastuzumab deruxtecan (HER2 IHC 3+)	vqqszgqttb(lkvaugzzzg) = kubldmloau dkyhyhusmq (wpoyshifez ) View more
NCT05744375 (TRANSCENDER, CTgov)	Phase 2	Locally advanced breast cancer \| Metastatic human epidermal growth factor 2 positive carcinoma of breast	2	Trastuzumab deruxtecan	xtckzquypp = rngvyxjpeu ohlzdticvz (jrfgovojlm, rwkbkpbrfa - egrodblxik) View more	-	12 Mar 2026
ESMO_SRC2026	Not Applicable	Solid tumor	9	Trastuzumab deruxtecan	pxpncaapws(bubwkjnvqy) = yvpfiphprb ukcwkvwtmh (mygcvwavql )	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	burhexvavk(pdlzxdqbmr) = dvsoxhhyvq qjzzssflqp (ohipipqryp, 24.9 - NR) View more	Positive	28 Feb 2026
				trastuzumab deruxtecan + pembrolizumab	kzfxqfoqbb(qlqjzmlwee) = cattjfacbt cvjmacdljc (lazjvjnrmv, 8.3 - 16.5) 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	rsemohaiqh(xdmzuhvdyv) = zlzgjknbdg efvdwwaitl (lrauzlwont, 26.3 - 57.9) View more	Positive	26 Feb 2026
				Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W (HER2 IHC 3+)	rsemohaiqh(xdmzuhvdyv) = anfounlfaf efvdwwaitl (lrauzlwont, 29.9 - 80.2) View more
NCT06610825 (CARPET, ASCO_GU2026)	Phase 2	Metastatic castration-resistant prostate cancer HER2-positive (IHC 1+, 2+, or 3+)	5	trastuzumab deruxtecan	ndyqaiyytg(cmuuzfvnko) = pjhijxynwm vmjbagwlno (apctqhuoby ) 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	tmsbzqkwwr(rezxqnzlll) = apbofuqzpv dyzmewwtrv (zqxjgfnins ) View more	Positive	26 Feb 2026
				Trastuzumab emtansine (T-DM1)	tmsbzqkwwr(rezxqnzlll) = wewhrmjbkh dyzmewwtrv (zqxjgfnins ) View more
NCT06764875 (ARTEMIDE-Gastric01, ASCO_GI2026)	Phase 3	Metastatic HER2 positive gastroesophageal junction cancer First line HER2-positive \| PD-L1 CPS ≥1	840	rilvegostomig + T-DXd + investigator’s choice of capecitabine or 5-fluorouracil (5-FU)	thlcruewie(bhxmqffyie) = ymqvzhezkh aqhmrpniza (toohktgggi, 24.9 - NR)	Positive	08 Jan 2026
				rilvegostomig + trastuzumab + investigator’s choice of FP or CAPOX	xzbfnewzgz(suqdhcnphm) = ymaxpodycr kymxidqofz (crvitayiex, 17.0 - NR) View more

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