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

Metastatic human epidermal growth factor 2 positive carcinoma of breastStomach CancerHER2 Positive Solid Tumors+ [76]

Inactive Indication

HER2 Positive Transitional Cell CarcinomaHER2-expressing Gastroesophageal Junction AdenocarcinomaMeningeal Carcinomatosis+ [1]

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Daiichi Sankyo Co., Ltd.

AstraZeneca PLC

AstraZeneca Investment (China) Co. Ltd.

+ [10]

Inactive Organization-

License Organization

Merck & Co., Inc.

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (20 Dec 2019),

HER2 Positive Breast Cancer

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

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: *****

203

Clinical Trials associated with Fam-trastuzumab deruxtecan-NXKI

NCT07578116

/ Not yet recruitingPhase 3IIT

Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.

Start Date09 Mar 2027

Sponsor / Collaborator

SWOG

[+1]

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

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

1,167

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

01 Oct 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

An intrinsically hydrophilic linker enables a stable, high-DAR exatecan-based HER2 ADC with potent antitumor activity

Article

Author: Feng, Chaoyang ; Ma, Jianglei ; Wu, Chenglong ; Huang, Jinkun ; Bao, Yiwen ; Heng, Xiaojie ; Zeng, Nan ; Yang, Tingting ; Ni, Dechun

Antibody-drug conjugates (ADCs) combine the targeting specificity of monoclonal antibodies with the potent cytotoxicity of small-molecule drugs. However, ADC development using Exatecan, a potent topoisomerase I inhibitor, has been challenged by its hydrophobicity, leading to aggregation, rapid clearance, and off-target toxicity. Herein, we report the design of an intrinsically hydrophilic drug-linker platform (SMP-70067-L) that enables the construction of a homogeneous Exatecan-based HER2-targeted ADC (SMP-70067-X) with a high drug-to-antibody ratio (DAR of 7.92). Similar to Trastuzumab deruxtecan (DS-8201a), which achieves high DAR without PEG or polysarcosine chains through a hydrophilic self-immolative spacer, SMP-70067-L integrates minimal hydrophilic elements, including a glutamic acid residue and a modified aromatic self-immolative spacer, to balance hydrophilicity, stability, and efficient payload release. The resulting ADC exhibits low aggregation (<1%), favorable plasma and thermal stability, and sustained exatecan release. SMP-70067-X demonstrates potent cytotoxicity in HER2-positive tumor cells (sub-nanomolar IC₅₀ values) and significantly enhanced antitumor efficacy compared to DS-8201a in HER2-moderate and HER2-low xenograft models. These results highlight the critical role of rational linker engineering in expanding the therapeutic window of hydrophobic topoisomerase I inhibitor-based ADCs.

01 Jul 2026·Respiratory Investigation

Response to trastuzumab deruxtecan in postoperative recurrent lung adenocarcinoma harboring concurrent EGFR and HER2 mutations after progression on adjuvant osimertinib

Article

Author: Muramoto, Kei ; Naito, Daiki ; Goebuchi, Kageaki ; Fukushima, Kazuaki ; Furukawa, Tsuguhiro ; Akaike, Kimitaka ; Tomita, Yusuke ; Sakagami, Takuro ; Saruwatari, Koichi ; Nishiyama, Taketaka ; Okabayashi, Hiroko

Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations are key molecular targets in non-small cell lung cancer (NSCLC). We report a rare case of postoperative recurrent lung adenocarcinoma in an 84-year-old woman harboring EGFR L858R and HER2 S310F mutations after progression on adjuvant osimertinib. After further progression on chemotherapy, she received trastuzumab deruxtecan (T-DXd), which induced metastatic regression and yielded disease control for approximately 6 months. This case highlights a therapeutic approach for NSCLC with multiple driver alterations and demonstrates the clinical activity of T-DXd in osimertinib-refractory EGFR-mutant disease with a concurrent HER2 alteration.

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.

1,164

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

14 Jul 2026

·www.astrazeneca.com

AstraZeneca enters exclusive global license agreement for novel oral EGFR inhibitor Zegfrovy for lung cancer with Dizal Pharmaceutical

AstraZeneca has entered into an exclusive license agreement with Dizal Pharmaceutical Co., Ltd for Zegfrovy (sunvozertinib), a novel oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy. Zegfrovy is approved in the US and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Approximately 80-85% of lung cancer patients globally have NSCLC. About 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR-mutated (EGFRm) NSCLC. Roughly one in four patients with EGFRm NSCLC has a tumour with an exon 20 insertion mutation or other atypical mutation for which targeted treatment options are limited. Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “AstraZeneca is a leader in treating EGFR-mutated lung cancer, and we are eager to add Zegfrovy to our world-class portfolio of innovative medicines for patients whose tumours carry exon 20 insertion mutations. With this agreement, we will bring a differentiated, oral targeted treatment to these patients with limited options across the globe.” Dr. Xiaolin Zhang, Chief Executive Officer of Dizal said: “As a leading global company with a strong lung cancer franchise, AstraZeneca will help ensure patients around the world can benefit from this innovation discovered by Dizal scientists in China. Zegfrovy is the only oral targeted therapy for EGFR exon 20 insertion non-small cell lung cancer approved in the US and China for patients following prior systemic therapy.” Dizal recently announced positive results from the global WU-KONG28 Phase III trial of Zegfrovy in 1st-line NSCLC with exon 20 insertion EGFR mutations. These data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine. Supported by these results, a Supplemental New Drug Application for approval in the 1st-line setting has been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting. Sunvozertinib (Zegfrovy) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC as a Category 2A recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines® for detailed recommendations.1 Financial considerations AstraZeneca will make an upfront payment to Dizal of $600m and additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy. The transaction is expected to close in the second half of 2026, subject to customary closing conditions and regulatory clearances. The transaction does not impact AstraZeneca’s financial guidance for 2026. Notes NSCLC Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.2 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.2-3 Approximately 75% of people are diagnosed with advanced NSCLC.4 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.5-7 Zegfrovy Zegfrovy is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. Zegfrovy is approved in the US and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. In addition, Zegfrovy also demonstrated encouraging anti-tumour activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon 20 insertions. Zegfrovy showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related treatment-emergent adverse events were Grade 1/2 in nature and clinically manageable. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating in innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan) in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. 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 Disease, 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 1. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. (Version 6.2026). https://www.nccn.org/login?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed July 2026. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed August 2025. 3. American Cancer Society. What Is Lung Cancer?. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2025. 4. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688. 5. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. 6. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-2812. 7. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89. Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

Phase 3Drug ApprovalLicense out/inASCOBreakthrough Therapy

09 Jul 2026

·www.fiercepharma.com

BioNTech plots right-sized HER2 ADC launch to ‘build the muscle’ for BMS-partnered bispecific

Unexpectedly catapulted into global fame as a COVID-19 vaccine maker, BioNTech is on the verge of returning to its oncology roots with potentially its first commercial cancer drug. Yet, to Chief Commercial Officer Annemarie Hanekamp, the upcoming launch is less of a standalone milestone than a strategic springboard for a far more critical pipeline product. Backed by positive phase 2 data and an ongoing confirmatory phase 3 trial, BioNTech is readying its Duality Biologics-partnered antibody-drug conjugate (ADC) trastuzumab pamirtecan (T-Pam) for submission with the FDA for previously treated HER2-expressing endometrial cancer. If approved, the drug will compete with AstraZeneca and Daiichi Sankyo’s blockbuster HER2 ADC, Enhertu, which boasts a pan-tumor indication. Challenging the market leader, however, is not BioNTech’s end goal for T-Pam. “This is not about competing head to head with Enhertu and overtaking them,” Hanekamp said in a recent interview with Fierce Pharma. “We’re very realistic, and we know in the oncology space, first-mover advantage matters. They’ve been in the market for a while, it’s an amazing drug, and we don’t claim to be all that differentiated versus Enhertu.” Instead, Hanekamp views T-Pam as a “strategic launch,” an exercise to “run water through the pipes” and test BioNTech’s commercial infrastructure in oncology. “We’ve never launched [in oncology] before, and launching is not just building a commercial organization,” she explained. “It’s a mindset. It’s building the muscle across all the functions to become commercial-ready.” For BioNTech, that operational reset involves right-sizing its manufacturing footprint. By cutting idle capacity in the vaccine space, the company can reallocate resources to its immediate priorities, putting advancing its late-stage pipeline front and center, Hanekamp noted. The evolution also involves the planned departure of its two researcher founders, CEO Uğur Şahin, M.D., and Chief Medical Officer Özlem Türeci, M.D. “You see this with all founder-led biotechs that grow into a certain stage that the founders ultimately transition,” Hanekamp observed. Ultimately, all the build-out is meant to help polish a crown jewel: pumitamig , a PD-L1xVEGF bispecific antibody partnered with Bristol Myers Squibb. Years ago, Şahin and Türeci had the foresight to tap into innovations from China before the broader industry caught on. BioNTech first licensed pumitamig from China’s Biotheus in 2023 before fully acquiring the firm the next year. Today, the drug is billed as a potential next-generation immuno-oncology backbone for its new owners, anchored by what is so far the most expansive global phase 3 program in the highly competitive PD-(L)1xVEGF class. Thanks to BMS’ experience in cancer immunotherapy and the deal's co-commercialization framework , Hanekamp said the alliance is ready to launch pumitamig in the U.S. right away if needed. “But as BioNTech, it’s our goal to also build that muscle,” she said. BioNTech and BMS maintain a very flexible partnership, allowing each party to explore combinations independently, Hanekamp noted. While novel combos are not part of the first wave of nine global pivotal trials currently underway for pumitamig, BioNTech is pursuing this strategy for the second wave, which will then require that commercial muscle of its own. “We’re still all about the novel combinations with the three platforms,” Hanekamp said, pointing to the firm’s targeted therapies like ADCs, immunomodulators and its signature mRNA platform. Beyond the U.S., BioNTech and BMS have already started commercial planning for pumitamig in Europe, and the partners are “going through the strategic evaluation” to define their blueprint in Japan, according to Hanekamp. Before pumitamig reaches the market, BioNTech could have a second oncology launch in the OncoC4-partnered CTLA-4 agent gotistobart . A pivotal readout from the phase 3 Preserve-003 trial in second-line squamous non-small cell lung cancer is expected this year. Unlike T-Pam, where the launch is “not about the revenues,” gotistobart, if successful, could address an unmet need and add substantial growth to BioNTech’s topline, Hanekamp said. Gotistobart is poised to bulk up BioNTech’s commercialization muscle, too, ahead of pumitamig’s arrival. Rosetta Lung-01, the first global phase 3 readout expected for pumitamig, is in small cell lung cancer. Meanwhile, the all-important Rosetta Lung-02 trial in first-line NSCLC and Rosetta Breast-01 in triple-negative breast cancer (TNBC) are on track to report results the following year in 2029. Hanekamp’s commercial team plans to leverage the market footprints of its earlier launches to establish clinical relationships for pumitamig. Specifically, the company sees a major overlap between prescribers who treat endometrial cancer—the planned initial indication for T-Pam—and those who treat TNBC. Similarly, the lung cancer specialists BioNTech will engage for gotistobart are the same ones it will need to target for pumitamig. “For me, there’s one priority, and that’s relationships,” Hanekamp said. “Once you’re launching out of the gate, you don’t want to have a sales rep needing to build those relationships,” she explained. “If it takes six months to get your first approved meeting with a physician, then you’re six months too late.” RELATED: ASCO: In next-gen IO race, BioNTech/BMS and Pfizer are divided on overall survival approach Of course, any marketing efforts behind pumitamig will have to be based on data. In a bid to accelerate the drug’s regulatory timeline in first-line NSCLC, BioNTech recently tweaked Rosetta Lung-02’s design to make progression-free survival its sole primary endpoint. That means, by the time pumitamig enters that market, it may lack statistically significant data on the key secondary endpoint of overall survival, potentially putting it at a commercial disadvantage. Hanekamp was involved in making that protocol adjustment, and she said the commercial team is “fully supportive of this approach.” “Lung cancer is one of the bigger indications. It is important to be part of the first wave,” she said. “We know the timelines for the competition , so we are constantly evaluating, is there an opportunity for us to speed up to bring these drugs to patients earlier, and therefore also be a little bit more competitive?” If OS is not mature enough to be included in pumitamig’s FDA label—which would bar sales reps from promoting it—Hanekamp argues that a more comprehensive data package will still be available in the public domain once it’s presented at medical meetings. Even as the commercial infrastructure is meant to lay the groundwork for a much bigger product, Hanekamp stressed that the inaugural team will be right-sized. “There’s a foundation that I need to build,” the commercial chief said. “Once I have built that capability, then I can scale. Scaling, it’s still effort, but scaling is less complex than to build the capability from scratch.”

Phase 3VaccineImmunotherapyPhase 2

09 Jul 2026

·synapse.patsnap.com

B7-H3 Target Evaluation Report: Biology, Validation, Competition, IP, and R&D Strategy

B7-H3 Target Evaluation Report: Biology, Validation, Competition, IP, and R&D StrategyThis B7-H3 target evaluation report is generated based on structured data from PatSnap Target & Disease MCP and PatSnap Clinical Trials MCP. It turns target biology, disease context, clinical validation, competitive intensity, and IP strategy into a repeatable target evaluation workflow for life sciences AI agents. Explore PatSnap Life Sciences MCP Servers Target B7-H3 UniProt Q5ZPR3 Target-linked drugs 278 254 active development drugs NSCLC trials 29 B7-H3 + NSCLC MCP query Released results 5 Clinical result query Executive ViewB7-H3 / CD276 is an attractive solid-tumor target with strong translational interest and growing clinical competition in non-small cell lung cancer. The target is compelling because it sits at the intersection of tumor immune evasion and antibody-drug conjugate development, but differentiation depends on payload, therapeutic index, patient selection, and evidence in driver-negative or post-standard-care NSCLC. Biology: Target & Disease MCP identifies CD276, also known as B7-H3, as an immune-regulatory molecule that may inhibit NK-mediated tumor-cell lysis and modulate T-cell responses.Disease context: NSCLC is a large oncology development arena with high clinical activity and intense standard-of-care competition.Validation: Clinical Trials MCP returns 29 B7-H3 + Non-Small Cell Lung Cancer trials and 5 released result records.Strategy: Differentiate through ADC design, tumor-expression threshold, safety window, and combination with immunotherapy or chemotherapy.ScorecardBiology confidence: High translational rationale Clinical validation: Emerging-to-medium Competitive pressure: Rising White-space potential: ADC and biomarker-led Biology and Disease RationaleTarget & Disease MCP returns CD276 / B7-H3 with aliases including B7H3 and 4Ig-B7-H3, UniProt Q5ZPR3, and 278 target-linked drugs. The target profile points to immune-response regulation, protection of tumor cells through inhibition of NK-mediated lysis, and modulation of CD4 and cytotoxic T-cell activity. This biology supports both immuno-oncology positioning and B7-H3-directed ADC strategies. For non-small cell lung cancer, Target & Disease MCP shows a highly active disease record with 1,526 development drugs and 2,155 roll-up development drugs. That context means a B7-H3 program needs a clear clinical niche, such as driver-negative disease, post-checkpoint treatment, biomarker-enriched populations, or ADC sequencing after other targeted payload approaches. Explore PatSnap Life Sciences MCP Servers for AI agents Selected Trial and Result EvidenceHS-20093 + adebrelimab vs docetaxelClinical Trials MCP returned not-yet-recruiting Phase 3 studies in driver-gene-negative advanced or metastatic non-squamous NSCLC, showing late-stage competitive movement around B7-H3-directed therapy.IDE034 in locally advanced/metastatic solid tumorsRecruiting Phase 1 study, reflecting broader early clinical exploration of B7-H3-directed modalities across solid tumors.KEYMAKER-U01 substudies in stage IV NSCLCClinical trial result query returned a positive Phase 2 record involving ifinatamab deruxtecan, raludotatug deruxtecan, and docetaxel in stage IV NSCLC.YL-201 B7-H3-targeting ADCReleased Phase 1/1b positive result record in advanced solid tumors, supporting the ADC development thesis for B7-H3.IP and R&D RecommendationB7-H3 IP review should map antibody sequences, ADC linker-payload claims, epitope coverage, dosing and combination claims, NSCLC biomarker thresholds, and freedom-to-operate against established CD276-directed antibody and ADC portfolios. RecommendationB7-H3 is attractive for teams with a differentiated ADC platform or a strong biomarker strategy. In NSCLC, the strongest development story should connect expression-defined enrollment, post-standard-care positioning, payload tolerability, and comparative evidence versus docetaxel or checkpoint-based combinations. Start building target evaluation agents with PatSnap Life Sciences MCP Servers Data note: Target biology, disease profile, clinical trial counts, trial examples, and result evidence were generated from PatSnap Target & Disease MCP and PatSnap Clinical Trials MCP queries performed on July 9, 2026.

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
Metastatic human epidermal growth factor 2 positive carcinoma of breast	United States	Daiichi Sankyo, Inc.	15 May 2026
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


ASCO2026	Early Phase 1	Advanced Colorectal Adenocarcinoma	289	ADCs (indusatumab vedotin, labetuzumab govitecan, trastuzumab deruxtecan, precemtabart tocentecan)	sxvurwxunw(tjhmhevuxx) = tbrceggccn sujrqrznda (bbhaxvovtw, 3.7 - 16.4) View more	Positive	29 May 2026
NCT04784715 (DESTINY-Breast09, ASCO2026)	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2+	377	trastuzumab deruxtecan (T-DXd) + pertuzumab (P)	mjcbpbpdha(rwevjoqqgv) = pdtdrcuozv jthplvnylx (wcmqixiecd ) View more	Positive	29 May 2026
				trastuzumab deruxtecan (T-DXd) + pertuzumab (P) (CR)	mjcbpbpdha(rwevjoqqgv) = aeuqmvbqaq jthplvnylx (wcmqixiecd ) View more
NCT04622319 (DESTINY-Breast05, ASCO2026)	Phase 3	HER2 Positive Breast Cancer Adjuvant HER2+	1,619	trastuzumab deruxtecan (T-DXd) 5.4 mg/kg	hlbideaght(nvieufdcds) = upoogwetmk rltmuzcutr (qqykwtlcki ) View more	Positive	29 May 2026
				trastuzumab emtansine (T-DM1) 3.6 mg/kg	hlbideaght(nvieufdcds) = rcvcvcjmke rltmuzcutr (qqykwtlcki ) View more
NCT06819007 (DESTINY-Ovarian01, ASCO2026)	Phase 3	First line \| Maintenance HER2-expressing	21	T-DXd + BEV	xhuuflwlti(lczihqpjwk) = rcpljygrdw cuqmakjjqe (savaltdlxk ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Biliary Tract Neoplasms ERBB2 amplification \| single nucleotide variants (SNV) \| concurrent amplification and SNVs	21	HER2 directed therapy	hhhtplixam(enwmbrwbcx) = At baseline, ERBB2 alteration patterns included ERBB2 amplification in 15 patients (71.4%), single nucleotide variants (SNV) in 2 patients (9.5%), and concurrent amplification and SNVs in 3 patients (14.3%). iqogtplybx (ifazcdgpqe )	Positive	29 May 2026
ASCO2026	Not Applicable	HER2 Positive Breast Cancer HER2-positive \| HER2-low	63	Dose-adapted trastuzumab deruxtecan	zgfgofnfsn(apxlwwgwvy) = vsywxlxsdy ngoihcjoko (uyexuenefr, 46 - 71) View more	Positive	29 May 2026
				Dose-adapted trastuzumab deruxtecan (Evaluable cohort)	zgfgofnfsn(apxlwwgwvy) = bqccadkbae ngoihcjoko (uyexuenefr, 53 - 79) View more
ASCO2026	Not Applicable	Neoplasms \| Breast Cancer	30	Low-dose 2.7mg/kg	lpwgyulqjb(tjkzzajchk) = only one patient had grade 1 lung toxicity. She received SBRT to two lesions prior to TDxD. One patient experienced grade 4 diarrhea. bvbwmctmcy (gslncdcjrq ) View more	Positive	29 May 2026
				Standard-dose 5.4mg/kg
ASCO2026	Not Applicable	Metastatic Malignant Neoplasm to the Leptomeninges HER2 positive \| ER positive \| PR positive	16	Trastuzumab-deruxtecan	dncqzektyw(jcabufuric) = kauhyuqrdf ocgnfsdqvw (mnlarbxumh, 2.7 - 12.0) View more	Positive	29 May 2026
LC-SCRUM-Asia (ASCO2026)	Not Applicable	HER2-positive Non-squamous non-small cell lung cancer HER2 exon 20 insertion-positive	77	HER2-TKI-naïve patients	mnizaauzjw(lntadskukt) = hffodkpaag nzocrlndzc (jedkdzbnvv ) View more	Positive	29 May 2026
				those treated with selective HER2-TKIs (zongertinib or severtinib)	mnizaauzjw(lntadskukt) = mwiujdgczs nzocrlndzc (jedkdzbnvv ) View more
ASCO2026	Not Applicable	Non-Small Cell Lung Cancer First line HER2-exon 20 insertion mutations \| HER2 mutations \| HER2 amplification	404	Trastuzumab deruxtecan (T-DXd) monotherapy	eodpabaybm(ibqrgzlief) = dtodjlacuw gqurwxcplt (wxvbiewrgn )	Positive	29 May 2026
				Chemotherapy	eodpabaybm(ibqrgzlief) = pelurphqbr gqurwxcplt (wxvbiewrgn )

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