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

HER2 Positive Solid TumorsHR-positive/HER2-low Breast CarcinomaHormone receptor positive HER2 positive breast cancer+ [60]

Inactive Indication

Meningeal Carcinomatosis

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

AstraZeneca PLC

Daiichi Sankyo Co., Ltd.

Daiichi Sankyo, Inc.

+ [8]

Inactive Organization

Daiichi Sankyo Taiwan Ltd.

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), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), SAKIGAKE (Japan), Priority Review (United States)

Structure/Sequence

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Sequence Code 18481L

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Sequence Code 44772H

Source: *****

149

Clinical Trials associated with Fam-trastuzumab deruxtecan-NXKI

NCT06899126

/ Not yet recruitingPhase 3

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)

This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS <50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

Start Date07 Sep 2025

Sponsor / Collaborator

Daiichi Sankyo Co., Ltd.

[+1]

NCT06585969

/ Not yet recruitingPhase 3IIT

A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer

The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative metastatic breast cancer

Start Date01 May 2025

Sponsor / Collaborator

Danish Breast Cancer Cooperative Group

ChiCTR2500099141

/ SuspendedNot ApplicableIIT

A Prospective Clinical Study Evaluating the Predictive Value of MRI Radiomics with Machine Learning Algorithms for Treatment Response to Trastuzumab Deruxtecan in Breast Cancer Patients with Brain Metastases

Start Date01 May 2025

Sponsor / Collaborator

Affiliated Hospital of Guangdong Medical University

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

801

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

31 Dec 2025·Human Vaccines & Immunotherapeutics

Cost-effectiveness of trastuzumab deruxtecan as a second-line treatment for HER2-mutant advanced non-small cell lung cancer

Article

Author: You, Shuhui ; Gong, Caifeng ; Cai, Qi ; Zhang, Wen ; Huang, Jinglong ; Zhou, Aiping

The study of DESTINY-Lung01 and DESTINY-Lung02 demonstrated the favorable efficacy and optimal dosage of trastuzumab deruxtecan (T-DXd) in managing the human epidermal growth factor receptor 2 (HER2)-mutant non-small cell lung cancer (NSCLC) patients who had received previous treatment. The study sought to assess the cost-effectiveness of T-DXd in both the United States (US) and Chinese healthcare systems. Markov models were developed to evaluate the overall cost, incremental cost-effectiveness ratio (ICER), quality-adjusted life years (QALYs), and life years (LYs) of treatment with T-DXd compared with docetaxel, nivolumab, and pyrotinib for patients in the US and China. The level of willingness-to-pay (WTP) in the US and China is 150,000/QALYs and 32,517/QALYs, respectively. Sensitivity analyses were carried out to ensure the precision of the model. T-DXd yielded additional QALYs of 0.63 and 0.06 with an ICER of $338997.84 and $1437258.33 per QALY, respectively, in the US compared to the docetaxel and nivolumab regimens. And T-DXd yielded additional QALYs of 0.63, 0.06, and 0.13 with an ICER of $137959.45, $623805.93, and $515447.12 per QALY, respectively, in China compared to the docetaxel, nivolumab, and pyrotinib regimens. Sensitivity analysis showed that the cost of drugs is the most influential factor. T-DXd provides substantial therapeutic benefit for NSCLC patients with HER2 mutations who have had previous treatment but is not deemed cost-effective in either the US or China when compared to docetaxel, nivolumab, and pyrotinib. Price reduction is perhaps the main way to make T-DXd cost-effective.

01 Jun 2025·American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Emerging Paradigms in Genitourinary Cancers: Integrating Molecular Imaging, Hypoxia-Inducible Factor–Targeted Therapies, and Antibody-Drug Conjugates in Renal Cell and Urothelial Carcinomas

Review

Author: Hofman, Michael S. ; Wulff-Burchfield, Elizabeth M. ; Eapen, Renu ; McKay, Rana R.

Novel approaches in molecular imaging and targeted therapeutics are transforming the management of renal cell carcinoma (RCC) and urothelial carcinoma (UC). This review focuses on three key areas of innovation: molecular imaging, hypoxia-inducible factor-2α (HIF-2α) inhibition, and antibody-drug conjugates (ADCs). In molecular imaging, prostate-specific membrane antigen positron emission tomography/computed tomography has shown promise in RCC, while novel tracers targeting carbonic anhydrase IX and nectin-4 are emerging for RCC and UC, respectively. These approaches may enable better characterization of disease and treatment response monitoring. HIF-2α inhibition represents a breakthrough in targeting the fundamental pathobiology of clear cell RCC, with belzutifan demonstrating significant clinical benefit in both von Hippel-Lindau disease and sporadic RCC. Next-generation HIF-2α inhibitors, including casdatifan, show promising early clinical results with distinct pharmacologic properties. ADCs have become a cornerstone of UC treatment, with enfortumab vedotin plus pembrolizumab now approved as first-line therapy. Multiple human epidermal growth factor receptor 2 (HER2)-directed ADCs have shown efficacy in HER2-expressing UC, including trastuzumab deruxtecan, which recently received tumor-agnostic approval. While ADC development in RCC faces unique challenges, novel approaches including immunostimulatory payloads and bispecific antibodies are being explored. The integration of these advances in molecular imaging and therapeutics offers opportunities for more personalized treatment approaches in RCC and UC.

01 Jun 2025·PATHOLOGY

HER2-low across solid tumours: different incidences and definitions

Review

Author: von der Thüsen, Jan ; van Deurzen, Carolien H M ; Curigliano, Giuseppe ; Groenendijk, Floris H ; Fusco, Nicola ; Baez-Navarro, Ximena ; Oudijk, Lindsey

Antibody-drug conjugates, particularly trastuzumab deruxtecan (T-DXd), have emerged as effective therapies for various solid tumours. Clinical trials show that T-DXd improves survival in both HER2-positive and HER2-low breast cancer patients. Additionally, it improves survival in HER2-positive gastro-oesophageal cancer and elicits objective responses in HER2-low tumours. Responses have also been noted in lung and gynaecological cancers with HER2 expression, although subgroup analyses for HER2-low cases are lacking. This review assesses HER2 protein expression levels and gene amplification across solid tumours where T-DXd shows potential benefits. We focus on the accuracy and limitations of HER2 testing methods, particularly for identifying HER2-low cancer. A semi-systematic approach was employed, searching EMBASE, Medline, Cochrane, and PubMed databases. We calculated median incidences of HER2-positive, HER2-low, and HER2-0 by immunohistochemistry (IHC), and HER2 amplification by in situ hybridisation (ISH). A total of 144 studies were included, covering breast (n=57), gastro-oesophageal (n=33), lung (n=17), gynaecological (n=24), and various other carcinomas (n=13). The median incidences of HER2-low were 52%, 16%, 58%, and 17% in breast, gastro-oesophageal, endometrial, and ovarian cancers, respectively, with unknown incidences in lung and cervical cancers. Factors influencing HER2-low detection include tumour heterogeneity, antibody clones, observer variability, and lack of validated scoring criteria. Given the significant proportion of HER2-low cases, many patients could benefit from T-DXd, but limitations in detection accuracy necessitate further research and standardisation in diagnostic methods and criteria to advance the clinical utility of T-DXd for HER2-low tumours.

795

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

27 May 2025

·www.businesswire.com

ASCO 2025: REVEAL GENOMICS Unveils New HER2DX Data From 800+ Patients

BARCELONA, Spain--(BUSINESS WIRE)--REVEAL GENOMICS, S.L., a biotechnology company advancing precision oncology through biomarker innovation, today announced the presentation of four independent studies at the 2025 ASCO Annual Meeting. The studies, involving more than 800 patients, evaluated the clinical utility of its flagship test, HER2DX, in early-stage HER2-positive (HER2+) breast cancer. The studies presented at the 2025 ASCO Annual Meeting, involving more than 800 patients, evaluated the clinical utility of HER2DX, in early-stage HER2-positive (HER2+) breast cancer. The four studies, CompassHER2 pCR, BionHER, RESPECT and DFCI, validate HER2DX as a powerful genomic tool for predicting response to therapy and long-term prognosis, addressing critical questions. The findings, which provide valuable insights for optimizing treatment strategies in early-stage HER2+ breast cancer and metastatic breast cancer, will be shared in oral and poster sessions led by academic investigators from the U.S., Europe, and Japan. CompassHER2 pCR or EA1181 (U.S.): HER2DX determining response to THP-based de-escalated therapy This study is led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), a scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer, comprising nearly 1,400 member institutions in the U.S. and around the world. HER2DX was evaluated as a secondary aim as part of a pre-specified, prospectively planned analysis embedded in the CompassHER2 pCR trial, also known as EA1181 (NCT04266249). This large, prospective multicenter phase II trial is assessing neoadjuvant taxane, trastuzumab, and pertuzumab (THP) in more than 2,000 patients with stage II–III HER2+ breast cancer, without the use of anthracyclines, cyclophosphamide, and carboplatin. The HER2DX assay was defined as a key secondary endpoint, with profiling of all available baseline samples planned. Among 569 patients assessed to date for the HER2DX pathologic complete response (pCR) score, those with higher scores achieved significantly greater pCR rates, independent of estrogen receptor (ER) status. These findings confirm the ability of HER2DX to identify tumors more likely to respond to THP. Importantly, additional results are expected from this trial, as patients continue to be followed for the primary endpoints of 3-year survival outcomes, and the study team plans to profile many more baseline samples. “The ability to predict response to THP is extremely valuable,” said Dr. Nadine Tung, Director of Breast Medical Oncology at Beth Israel Deaconess Medical Center, Professor of Medicine at Harvard Medical School, and Principal Investigator of the CompassHER2 pCR (EA1181) trial. “HER2DX provides a biology-driven tool that contributes to the selection of patients who can safely reduce chemotherapy, something we’ve long needed in HER2-positive early breast cancer.” “It is encouraging to see the assay’s performance in both ER-positive and ER-negative subgroups,” added Dr. Tung. “The plan is to profile all available samples from the trial, and these early data already provide valuable insights for guiding treatment selection.” BionHER trial (Spain): Validation of HER2DX-guided de-escalation strategy The BionHER phase II trial (NCT05912062) evaluated HER2DX in 83 patients with stage I–III HER2+ breast cancer treated with neoadjuvant THP for up to 15 weeks at the Catalan Institute of Oncology (ICO L’Hospitalet, Barcelona, Spain). HER2DX was successfully performed in all baseline FFPE tumor samples. The HER2DX pCR score was significantly associated with pCR with a performance AUC of 0.835. Patients classified by HER2DX pCR score into low, medium, and high groups had increasing pCR rates of 13.3%, 51.6%, and 81.8%, respectively. HER2DX outperformed traditional biomarkers, such as ER, Ki-67, and tumor-infiltrating lymphocytes, in predicting pCR. “HER2DX is transforming the way we approach treatment selection in HER2-positive disease,” said Dr. Sònia Pernas, head of the breast cancer unit at ICO L’Hospitalet, and Principal Investigator of the BionHER study. “By identifying tumors more likely to respond to dual HER2 blockade with a single taxane, we are increasingly able to personalize treatment intensity without compromising efficacy.” RESPECT trial (Japan): a response for an unrepresented population Trans-RESPECT is a prespecified translational analysis within the Japanese RESPECT non-inferiority trial (NCT01104935), in which 266 patients aged 70–80 years with stage I-III HER2+ breast cancer were randomized to receive adjuvant trastuzumab with or without chemotherapy (Sawaki et al. J Clin Oncol 2020). HER2DX was assessed in 154 of these patients, with a median follow-up of 9.1 years. The HER2DX risk score effectively stratified patients by 10-year relapse-free survival (86.6% in the low-risk group vs. 68.4% in the high-risk group) and overall survival (94.5% vs.72.5%). Notably, chemotherapy conferred an overall survival benefit only in tumors classified as pCR-high by HER2DX, with a significant interaction p-value of 0.045. “HER2DX provided clear long-term prognostic information in this elderly population,” said Dr. Kazuki Nozawa, Lead Investigator of Trans-RESPECT, from the Department of Advanced Clinical Research and Development and the Department of Breast Surgery at Nagoya City University Graduate School of Medical Sciences. “Importantly, its ability to help identify which patients may benefit from adjuvant chemotherapy is highly relevant to clinical decision-making. Older patients with HER2DX low-risk scores, particularly those classified as pCR-low or -medium, appear to be ideal candidates for trastuzumab alone, without chemotherapy.” DFCI T-DXd study (U.S.): predicting survival outcome to T-DXd Dana-Farber Cancer Institute (DFCI) conducted a retrospective analysis of 41 patients with metastatic breast cancer (25 HER2-positive, 16 HER2-negative) treated with trastuzumab deruxtecan (T-DXd) monotherapy between 2017 and 2023. The HER2DX HER2 signature score was significantly associated with time to next treatment (p=0.001). When stratified into tertiles, patients in the highest tertile had a median time to next treatment of 12.03 months compared to 4.7 months in the lowest tertile (p=0.02). “Quantitative measurement of HER2 amplicon expression by HER2DX is a key determinant of T-DXd activity in metastatic breast cancer,” said Dr. Sara M. Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute. She added, “Further evaluation of this genomic test in ongoing T-DXd trials is warranted.” HER2DX makes a significant impact at ASCO 2025 “ASCO 2025 marks a pivotal milestone for HER2DX,” said Dr. Aleix Prat, Chief Scientific Officer and co-founder of REVEAL GENOMICS. “This test is demonstrating clinical value in real-world practice across continents and care settings, assisting in the tailoring of chemotherapy intensity in the neoadjuvant setting and supporting chemotherapy-free decisions in the adjuvant setting.” Patricia Villagrasa, CEO and co-founder, added, “HER2DX was developed with HER2+ disease at its core, and these four high-quality, independent studies reinforce its clinical value. As we continue to grow globally, this is a clear example of how REVEAL GENOMICS is turning cutting-edge science into meaningful solutions that advance personalized cancer care worldwide.” About HER2DX HER2DX is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, the HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer. HER2DX is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene. HER2DX®️predicts: Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer. pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery. ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer. About REVEAL GENOMICS REVEAL GENOMICS, S.L., together with its U.S. subsidiary REVEAL GENOMICS, Inc., is a biotechnology company dedicated to redefining the role of biomarkers in oncology. The company focuses on developing innovative diagnostic tools that optimize therapeutic decision-making for individuals with cancer. By leveraging advanced genomic technologies, sophisticated computational algorithms, and machine learning, REVEAL GENOMICS generates novel insights into cancer biology and treatment response. academic and clinical institutions to advance precision oncology. REVEAL GENOMICS, S.L. is a spin-off company of Hospital Clínic of Barcelona, IDIBAPS, the University of Barcelona (U.B.), and the Vall d’Hebron Institute of Oncology (VHIO). REVEAL GENOMICS® and HER2DX® are registered trademarks of REVEAL GENOMICS, S.L. For further information visit: http://www.reveal-genomics.com

Clinical ResultPhase 2ASCO

27 May 2025

·www.biospace.com

Practice-Changing Data, Innovative Modalities and China in Focus at #ASCO25

iStock, Sean Pavone Beginning this week in Chicago, the American Association for Cancer Research’s annual conference will feature presentations that could have far-reaching implications for breast and blood cancers and more. Kicking off Friday and running through June 3 at McCormick Place Convention Center in Chicago, the 2025 annual meeting of the American Association for Cancer Research will include some of the most cutting-edge developments in cancer, which experts believe could have far-reaching implications across the industry and for medical practice. “As we head into the 2025 ASCO Annual Meeting, there are several key breast cancer trials that reflect major advancements in how we approach treatment,” Jason Mouabbi, assistant professor of Breast Medical Oncology at The University of Texas MD Anderson Cancer Center, told BioSpace in an email. Meanwhile, Lore Gruenbaum, chief scientific officer of The Leukemia & Lymphoma Society, is looking forward to a host of blood cancer-related presentations, including those that explore minimal residual disease (MRD) testing in multiple myeloma—a development she called “exciting.” MRD testing, Gruenbaum added, “will likely change clinical development strategies for novel agents and may provide significant time savings” for drugmakers. Besides breast and blood cancers, many of the late-breakers at ASCO 2025 are focused on melanoma, gastric, prostate and lung cancers. Breast and Blood Cancers Amid the variety of presentations at ASCO 2025, the buzz around breast and blood cancers stands out. One such attention-grabber is Takeda and Protagonist Therapeutics’ investigational hepcidin mimetic rusfertide, which the partners are developing for polycythemia vera, a rare but potentially deadly blood malignancy. “Rusfertide is a promising emerging treatment option,” Gruenbaum told BioSpace, noting that the molecule could provide an effective alternative for patients who do not adequately respond to standard therapies. In March, Takeda and Protagonist released topline data from their Phase III VERIFY study, which showed that rusfertide met its primary efficacy endpoint, eliciting treatment responses in 77% of patients versus 33% of placebo counterparts. Rusfertide likewise aced key secondary endpoints, including reducing phlebotomies, boosting hematocrit control and improving patient-reported outcomes. While Gruenbaum had not yet seen the ASCO abstract , “the data available so far indicate the potential for Rusfertide to significantly reduce the need for phlebotomies and improve hematocrit control in patients with polycythemia vera,” she said, adding that an improvement in quality of life data “could be very meaningful to patients.” VERIFY has been granted a plenary spot at the conference. In breast cancer, several presentations have drummed up considerable pre-conference interest. One of these is AstraZeneca’s Phase III SERENA-6 trial, which MD Anderson’s Mouabbi said is “one of the most anticipated studies at ASCO.” SERENA-6 combines the pharma’s oral SERD camizestrant with a CDK4/6 blocker to treat patients with HR-positive, HER2-negative advanced breast cancer with emergent ESR1 mutations. High-level outcomes posted in February showed the camizestrant regimen significantly improved progression-free survival in these patients versus standard-of-care aromatase inhibitors. AstraZeneca did not reveal specific data at the time—but will do so now at ASCO. “This trial is especially compelling because it’s the first to show a statistically significant improvement in progression-free survival in this setting, without requiring radiographic progression,” Mouabbi told BioSpace . “It’s a potential paradigm shift in how we manage endocrine resistance.” Like VERIFY, SERENA-6 is also a plenary presentation . AstraZeneca will also have additional Phase III data from DESTINY-Breast09, which will be “another standout” presentation, according to Mouabbi. The trial centers on the antibody-drug conjugate Enhertu—which AstraZeneca is developing in partnership with Daiichi Sankyo—testing it with or without Roche’s Perjeta as a first-line option in patients with HER2-positive metastatic breast cancer. Last month, the partners announced that Enhertu significantly improved progression-free survival in Destiny-Breast09, though again without providing specific data. “This is a significant development for HER2+ patients, offering a less chemotherapy-intensive option with robust efficacy,” Mouabbi said. Other notable breast cancer presentations, according to Mouabbi, include Merck and Gilead’s ASCENT-04/KEYNOTE-D19 , which combines the anti-TROP2 ADC Trodelvy with the mega-blockbuster Keytruda, and Pfizer and Arvinas’ VERITAC-2 trial, which in March returned mixed results for their investigational PROTAC degrader vepdegestrant. Bi – and Trispecifics Aside from specific presentations, experts are also looking forward to advancements in various treatment modalities. Such developments could give rise to new treatment opportunities for what Scott Kopetz, professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center, called “cold tumors”—those that are unlikely to elicit an immune response and are, in turn, less susceptible to immunotherapies. In particular, Kopetz has his eye on bispecific antibodies, which he said could usher in “a new era in VEGF-targeted therapies.” These emerging therapies “not only inhibit angiogenesis [the formation of new blood vessels] but also enhance immune responses,” he continued, noting that such a mechanism could lead to “promising efficacy and safety in advanced solid tumors.” As a result, bispecific antibodies could yield “potential breakthroughs” in the treatment of immunologically cold tumors, such as castration-resistant prostate and gallbladder cancers, Kopetz said. According to Gruenbaum, bispecifics, and now also trispecific antibody platforms, could likewise open up new treatment avenues for blood cancers. ASCO, she continued, will witness initial clinical data for two trispecifics, including Johnson & Johnson’s JNJ-5322 and Ichnos Glenmark Innovation’s ISB-2001, both of which are being developed for relapsed/refractory multiple myeloma. There is also now a growing number of bispecific therapies for blood cancers, some of which are inching toward regulatory approval, which they could secure “in the near future,” Gruenbaum said. Drug developers are also starting to move these agents into earlier lines of therapy, she added. For David Piwnica-Worms, chair of Cancer Systems Imaging at MD Anderson, ASCO 2025 will be an opportunity to learn about some of the latest developments in radiopharmaceuticals. “We’re really seeing two trends,” he told BioSpace in an email. The first deals with identifying biomarkers for cancers earlier in the disease cycle, while the second is focused on identifying novel isotopes. Both of these trends, Piwnica-Worms said, underscore that “this is an exciting time” for the radiopharma space, since “the field is rapidly expanding with new isotopes and new molecular targets.” China in Focus In a May 21 note to investors, analysts at Truist Securities made an astute observation: nearly a third of presentations at ASCO involve assets that came from Chinese companies. The considerable presence of China at the conference reflects “the country’s increase in R&D efforts, as per the Truist note. “China’s biotech innovation footprint has clearly expanded on the global stage.” Christiana Bardon, co-managing partner at biotech investment firm MPM BioImpact, made a similar observation. In an email to BioSpace , she pointed out that whereas Chinese companies “historically have focused on making ‘fast-follower drugs,” they are now taking an active leadership role in innovation and are advancing “disruptive, first-in-class medicines.” Bardon pointed to Summit Therapeutics’ and its Chinese partner Akeso’s PD-1/VEGF bispecific ivonescimab, “which may displace Keytruda’s dominant position in cancer immunotherapy.” According to Bardon, many Big Pharma players have been playing catch-up to Summit and Akeso in this space: “Since Summit Therapeutics in-licensed ivonescimab from Akeso, we have seen BioNTech, Merck, and Pfizer reach for additional PD(L)1 x VEGF assets from China.” Bardon sees no real problem with this, however. “Increasing innovation will ultimately benefit patients, regardless of where it originates,” she said. Paul Moore, chief scientific officer at Zymeworks, agreed, noting that China’s ascent as a worldwide leader in cancer innovation creates a “more competitive environment” across the oncology space, in turn pushing U.S. companies to be more “innovative and efficient.” Drugmakers, Moore offered, should become more “intentional” about their pipelines, look for opportunities to differentiate themselves and “prioritize thoughtful trial design.” Studies should pay particular consideration to the underlying biological mechanisms of diseases, while also taking advantage of companies’ respective “unique areas of expertise,” he added. Such an approach, Moore explained, is likely to result in drug candidates “with novel biological mechanisms and strong clinical potential.” Development efficiency will no longer be enough, Moore added. “Real progress will come from therapies...that offer something new and impactful for patients.” In all, he said that healthy competition between global leaders in biopharma innovation could lead to a “steel-sharpens-steel phenomenon.”

Phase 3Clinical ResultASCOImmunotherapy

26 May 2025

·www.prnewswire.com

Lunit Highlights AI's Role in Advancing Precision Oncology at ASCO 2025 with 12 Studies

SEOUL, South Korea, May 26, 2025 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI for cancer diagnostics and therapeutics, today announced that 12 studies featuring its AI-powered digital pathology solution will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30–June 3 in Chicago, IL. Of these, 11 studies will be presented as posters and one as an online publication. One of the featured studies, conducted with Japan's National Cancer Center Hospital East (NCCE), evaluated HER2 expression in biliary tract cancer (BTC) patients using Lunit's AI-powered analyzer. The resulting AI scores showed strong agreement with pathologist-assigned IHC scores in a 288-patient screening cohort. Among 29 patients treated with trastuzumab deruxtecan (T-DXd), those with higher levels of HER2-intense tumor cells achieved a higher objective response rate (ORR) of 50%, along with significantly longer progression-free survival and overall survival. The study also found that AI-derived "membrane specificity" helped identify additional responders who achieved a 50% ORR and improved survival. This group included not only HER2-intense patients but also some traditionally classified as HER2-low, suggesting that the metric may expand the pool of patients who can benefit from T-DXd. These findings suggest that AI-powered HER2 analysis - especially when incorporating membrane specificity - could expand access to targeted treatment and enable more precise therapy selection in BTC. A separate prospective study conducted with NCCE evaluated the concordance between pathologist- and AI-assessed PD-L1 expression in lung cancer patients enrolled in LC-SCRUM, one of Japan's largest nationwide observational cohorts, using Lunit SCOPE PD-L1. The study included 847 non-small cell lung cancer (NSCLC) and 102 small cell lung cancer (SCLC) patients. The overall concordance between the AI model and three expert pathologists was 70%. Concordance was particularly high in key subgroups: 84% for TPS ≥50% and 94% for TPS 1–49%. Of the 416 patients initially classified as TPS <1% by pathologists, the AI identified 231 with higher PD-L1 expression. Since PD-L1 scoring is widely used to guide treatment eligibility, these results highlight the potential of AI-powered PD-L1 evaluation to uncover additional candidates for immunotherapy who may have been previously excluded based on low TPS. The high concordance with expert pathologists also reinforces the reliability of the AI model as a clinical decision-support tool. A third highlighted study introduced an AI model to predict CLDN18.2 expression in gastric cancer. CLDN18.2 is a therapeutic target for zolbetuximab. It is typically assessed using immunohistochemistry (IHC), which is often limited by tissue quantity, cost, and time. To address this, researchers trained the AI on H&E slides and validated it in the external cohort. The model achieved AUROCs over 0.751, suggesting the potential to efficiently pre-screen CLDN18.2-positive patients using only H&E slides. The study also analyzed immune phenotypes using AI-powered whole-slide image analysis to explore treatment implications. Among patients predicted to be CLDN18.2-negative, those with an "inflamed" phenotype—marked by high tumor-infiltrating lymphocyte (TIL) density—showed significantly better outcomes when treated with immune checkpoint inhibitor plus chemotherapy compared to chemotherapy alone. These findings suggest that combining AI-based CLDN18.2 prediction with immune phenotype analysis could guide first-line treatment decisions without additional IHC tests. "Our ASCO 2025 presentations build on years of work to turn AI into a clinically dependable tool—not just for reading pathology images, but for improving how we select the right treatments. From HER2 scoring in biliary tract cancer to PD-L1 evaluation in lung cancer, our models are helping uncover treatment opportunities for patients who might otherwise be overlooked. This level of precision and reproducibility is exactly what AI needs to deliver real clinical value," said Brandon Suh, CEO of Lunit. In addition to these three featured studies, Lunit will present 9 additional abstracts covering a wide range of research topics. These include AI-based subcellular profiling to assess the drug-targetability of 74 membrane proteins across 34 cancer types, and deep learning analysis of endothelial cells to understand how the tumor vascular environment influences immunotherapy response. Lunit will be exhibiting at Booth #26149, where attendees can learn more about the studies and AI solutions featured at this year's ASCO. Lunit's featured presentations at ASCO 2025 include: [Poster #4047/337] Artificial intelligence-based prediction of claudin 18.2 expression and immune phenotype to guide treatment decisions in patients with gastric cancer, May 31, 9:00 AM – 12:00 PM CDT, Hall A - Posters and Exhibits [Poster #3084/399] Artificial intelligence (AI)-powered evaluation of protein drug-targetability through subcellular-level expression profiling from immunohistochemistry (IHC) images, June 2, 1:30 PM – 4:30 PM CDT, Hall A - Posters and Exhibits [Poster #4097/387] Membrane-specific HER2 expression by artificial intelligence-based quantitative scoring for prediction of efficacy of trastuzumab deruxtecan in biliary tract cancer (HERB trial): Exploratory analysis of a multicenter, single arm, phase II trial, May 31, 9:00 AM – 12:00 PM CDT, Hall A - Posters and Exhibits [e13628] Deep learning to predict treatment response of immune checkpoint inhibitors from pretreatment chest X-rays in non–small-cell lung cancer, Online [Poster #593/186] Use of artificial intelligence (AI)–powered spatial analysis to predict pathologic complete response (pCR) in HR+ HER2- breast cancer (BC) patients treated with neoadjuvant chemotherapy (NAC), June 2, 9:00 AM – 12:00 PM CDT, Hall A - Posters and Exhibits [Poster #2578/225] Deep learning–powered H&E whole-slide image analysis of endothelial cells to characterize tumor vascular environment and correlate treatment outcome to immunotherapy, June 2, 1:30 PM – 4:30 PM CDT, Hall A - Posters and Exhibits [Poster #8572/52] Artificial intelligence-powered spatial analysis of tumor infiltrating lymphocytes and tertiary lymphoid structures in non-small cell lung cancer patients treated with immune-checkpoint inhibitors±chemotherapy, May 31, 1:30 PM – 4:30 PM CDT, Hall A - Posters and Exhibits [Poster #8536/16] Artificial intelligence-powered spatial analysis of tumor microenvironment in non-small cell lung cancer patients who acquired resistance after EGFR tyrosine kinase inhibitors, May 31, 1:30 PM – 4:30 PM CDT, Hall A - Posters and Exhibits [Poster #8535/15] A large validation study of AI-powered PD-L1 analyzer compared to pathologists' assessment of PD-L1 expression in lung cancer, May 31, 1:30 PM – 4:30 PM CDT, Hall A - Posters and Exhibits [Poster #1110/89] Artificial Intelligence-based tumor microenvironment and PD-L1 analysis using digital pathology to predict pembrolizumab response in metastatic triple-negative breast cancer, June 2, 9:00 AM – 12:00 PM CDT, Hall A - Posters and Exhibits [Poster #4137/427] Use of artificial intelligence-powered spatial analysis of tumor microenvironment to predict the prognosis in resected gallbladder cancer, May 31, 9:00 AM – 12:00 PM CDT, Hall A - Posters and Exhibits ### About Lunit Founded in 2013, Lunit (KRX:328130.KQ) is a global leader in AI for cancer diagnostics and therapeutics. With a mission to conquer cancer through AI, Lunit develops AI-powered solutions for medical imaging and biomarker analysis to enable precise diagnosis and personalized treatment. Lunit's FDA-cleared Lunit INSIGHT suite supports cancer screening at over 4,800 medical institutions in more than 55 countries. Lunit clinical studies have been featured in top-tier journals—including The Lancet Digital Health and Journal of Clinical Oncology—and presented at major conferences such as ASCO and RSNA. Headquartered in Seoul with global offices, Lunit is driving the worldwide fight against cancer. Learn more at lunit.io. SOURCE Lunit WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyASCOClinical ResultPhase 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
HER2 Positive Solid Tumors	United Kingdom	Daiichi Sankyo UK Ltd.	09 Apr 2025
HR-positive/HER2-low Breast Carcinoma	United States	Daiichi Sankyo Co., Ltd.	28 Jan 2025
Hormone receptor positive HER2 positive breast cancer	South Korea	Daiichi Sankyo Co., Ltd.	19 Sep 2022
HER2 mutant non-small cell lung cancer	United States	Daiichi Sankyo, Inc.	11 Aug 2022
HER2 Positive Stomach Adenocarcinoma	Australia	AstraZeneca Pty Ltd.	08 Oct 2021
HER2-Low Breast Carcinoma	Australia	AstraZeneca Pty Ltd.	08 Oct 2021
Metastatic breast cancer	Canada	AstraZeneca Canada, Inc.	15 Apr 2021
HER2 positive Gastroesophageal Junction Adenocarcinoma	United States	Daiichi Sankyo, Inc.	15 Jan 2021
HER2-positive gastric cancer	Japan	Daiichi Sankyo Co., Ltd.	25 Sep 2020
HER2 Positive Breast Cancer	United States	Daiichi Sankyo, Inc.	20 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-squamous non-small cell lung cancer	Phase 3	-	Daiichi Sankyo Co., Ltd.	07 Sep 2025
HER2 Positive Ovarian Cancer	Phase 3	United States	Daiichi Sankyo, Inc.	14 May 2025
HER2 Positive Ovarian Cancer	Phase 3	China	Daiichi Sankyo, Inc.	14 May 2025
HER2 Positive Ovarian Cancer	Phase 3	Japan	Daiichi Sankyo, Inc.	14 May 2025
HER2 Positive Ovarian Cancer	Phase 3	Australia	Daiichi Sankyo, Inc.	14 May 2025
HER2 Positive Ovarian Cancer	Phase 3	Austria	Daiichi Sankyo, Inc.	14 May 2025
HER2 Positive Ovarian Cancer	Phase 3	Belgium	Daiichi Sankyo, Inc.	14 May 2025
HER2 Positive Ovarian Cancer	Phase 3	Brazil	Daiichi Sankyo, Inc.	14 May 2025
HER2 Positive Ovarian Cancer	Phase 3	Bulgaria	Daiichi Sankyo, Inc.	14 May 2025
HER2 Positive Ovarian Cancer	Phase 3	Czechia	Daiichi Sankyo, Inc.	14 May 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04739761 (DESTINYBreast-12 \| DESTINY-B12 \| DESTINY-Breast12, CTgov)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast \| Brain metastases	506	Trastuzumab Deruxtecan (T-DXd (Cohort 1: Trastuzumab Deruxtecan (T-DXd))	rypfjjxggn = nrgxgficso iqmkrohdrl (uaolfyycwv, kfyhwlqvhq - covxedmkgo) View more	-	16 May 2025
				Trastuzumab Deruxtecan (T-DXd (Cohort 2: Trastuzumab Deruxtecan (T-DXd))	doloonpvmg = vltfhdrucu vohmvvfsgx (qnkgotnzeh, wmqeuhqvxp - tktulmtohd) View more
NCT04494425 (DESTINY-Breast06, ESMO_BC 12025 \| ESMO_BC 22025) Manual	Phase 3	Metastatic breast cancer Hormone Receptor Positive	866	Trastuzumab deruxtecan (T-DXd) (subgroups 1)	rackjjemlr(cixjsfjpsk) = gslehtmchh yhpgpzjzrz (qsqhkyvwsk, 11.4 - 15.4) View more	Positive	15 May 2025
				Chemotherapy (CAPE) (subgroups 1)	rackjjemlr(cixjsfjpsk) = qoufhhvwco yhpgpzjzrz (qsqhkyvwsk, 7.0 - 11.3) View more
NCT03523585 \| NCT03529110 (DESTINY-Breast03, ESMO_BC 12025 \| ESMO_BC 22025) Manual	Phase 3	Metastatic breast cancer HER2 Positive	-	Trastuzumab monotherapy (DESTINY-Breast02)	lzntiqioqf(qjaakihvnp) = xmwidgenzo ablilbiujq (zitwytxkfv, 0.0 - 25.4)	Positive	15 May 2025
				Trastuzumab-based combinations (DESTINY-Breast02)	lzntiqioqf(qjaakihvnp) = bnedznmfxk ablilbiujq (zitwytxkfv, 0.0 - 40.9)
ESMO_BC2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HR+	145	Trastuzumab tucatinib capecitabine (TTC)	dfcrepoakt(qlznjxetev) = owfeoekgdz ucymuimutr (zbsfjvkknm, 3.3 - 5.6)	-	14 May 2025
				Trastuzumab (T) + chemotherapy (CT)	dfcrepoakt(qlznjxetev) = cpaqfnbgyn ucymuimutr (zbsfjvkknm, 1.6 - 5)
ESMO_BC2025	Not Applicable	Metastatic Breast Lobular Carcinoma HER2wt \| HER2m	43	trastuzumab deruxtecan (T-DXd) (HER2wt)	slatyibreb(rdxfwspnzz) = tewlikawlj chjxxbtzkz (hblxmigslv ) View more	Positive	14 May 2025
				trastuzumab deruxtecan (T-DXd) (HER2m)	slatyibreb(rdxfwspnzz) = oxbxsjtkwx chjxxbtzkz (hblxmigslv ) View more
ESMO_BC2025	Not Applicable	Metastatic breast cancer BRCA mutations \| PD-L1 status	1,098	trastuzumab deruxtecan (T-DXd) (BRCA mutations)	bunxgxllzk(whgaaayhgi) = The 5-year OS rates were not significantly different between group B and group A ndnibjckfh (zuvknqpuey )	-	14 May 2025
				trastuzumab deruxtecan (T-DXd) (PD-L1 positive)
DeReal-REST (ESMO_BC2025)	Not Applicable	Advanced HER2-Positive Breast Carcinoma Second line	69	trastuzumab-deruxtecan (Good-responder group (PFS≥12 mo))	qjcvvxkudb(kbvfewsklc) = osnmqqmkpc aqjjrxnngt (luasqlfhgv, 8.9 - 20.3)	Positive	14 May 2025
ESMO_BC2025	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-positive	1,689	Trastuzumab Deruxtecan	xwrhtoimhn(clzemflqyp): HR = 0.42 (95% CI, 0.3 - 0.6), P-Value = < 0.001 View more	Positive	14 May 2025
				Control
NCT05113251 (DESTINY-Breast11, PipelineReview) Manual	Phase 3	HER2 Positive Breast Cancer HER2 Positive	-	ENHERTU + paclitaxel, trastuzumab and pertuzumab (THP)	sgokzovsuf(rfeumzpgje) = demonstrated a statistically significant and clinically meaningful improvement. wwfahfjcgf (rlvblssjyw ) View more	Positive	07 May 2025
				dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]
AACR2025	Not Applicable	Breast Cancer HER2 expression	375	Trastuzumab deruxtecan (T-DXd)	qchwrmprwm(dzmyciburo) = one patient with a somatic ERBB2 mutation (V597M) in the trastuzumab binding region who showed no response to T-DXd despite being HER2 IHC 2+ ctiuqpwsmp (pyutruciyf ) View more	Positive	29 Apr 2025

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