RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Orphan Drug (Taiwan Province), Orphan Drug (Japan)

Structure/Sequence

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Sequence Code 631427139H

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Sequence Code 631427141L

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Clinical Trials associated with Ifinatamab deruxtecan

NCT07630974

/ RecruitingPhase 1/2

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Researchers are looking for new ways to treat children with relapsed or refractory solid tumors:
* Relapsed means the cancer came back after treatment
* Refractory means the cancer did not respond (get smaller or go away) to treatment
* Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids
The study treatment I-DXd (also known as MK-2400 or ifinatamab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn:
* About the safety of I-DXd and if children younger than 12 years old tolerate it
* How many children who receive I-DXd have the cancer get smaller or go away

Start Date06 Jul 2026

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

CTR20261651

/ RecruitingPhase 2

一项在2L/3L局部晚期不可切除或转移性食管癌受试者中评价试验药物的II期、开放性、伞式平台研究：KEYMAKER-U06子研究06F

[Translation] A phase II, open-label, umbrella platform study evaluating the investigational drug in patients with 2L/3L locally advanced unresectable or metastatic esophageal cancer: KEYMAKER-U06 sub-study 06F

主要目的：基于BICR根据RECIST 1.1的评估评价ORR。次要目的：1、基于BICR根据RECIST 1.1的评估评价DOR，PFS，以及评价OS；2、评价I-DXd的安全性和耐受性。

[Translation]

Primary objective: To evaluate ORR based on BICR according to RECIST 1.1. Secondary objectives: 1. To evaluate DOR, PFS, and OS based on BICR according to RECIST 1.1; 2. To evaluate the safety and tolerability of I-DXd.

Start Date15 Jun 2026

Sponsor / Collaborator

MSD R&D (China) Co. Ltd.

[+2]

NCT07405151

/ RecruitingPhase 1/2

A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F

The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.

Start Date27 Mar 2026

Sponsor / Collaborator

Merck Sharp & Dohme LLC

[+1]

100 Clinical Results associated with Ifinatamab deruxtecan

100 Translational Medicine associated with Ifinatamab deruxtecan

100 Patents (Medical) associated with Ifinatamab deruxtecan

Literatures (Medical) associated with Ifinatamab deruxtecan

31 Dec 2026·mAbs

Antibodies to watch in 2026

Review

Author: Pinto, Kieran ; Kapoor, Vaishali ; Crescioli, Silvia ; Kaplon, Hélène ; Reichert, Janice M. ; Chenoweth, Alicia ; Hsu, Yu-Shin

The Antibodies to Watch article series provides annual updates on commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. Since the first article was published in 2010, the late-stage pipeline has grown from 26 antibody therapeutics to over 200, while during the same time numerous molecules in late-stage studies either transitioned to regulatory review and were approved or were terminated. In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab. As antibody therapeutics development is a global enterprise, we also discuss trends in annual first approvals granted to antibody therapeutics in any country since 2010, stratified by the antibody's country of origin, documenting the notable increases in the total number of first approvals and those approved first in China. Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by their therapeutic area, mechanism of action, format, and country of origin. Our data show that the development and approval period were typically ~6 years, but on average this period was shorter for China-originated products.

31 Dec 2026·mAbs

Preclinical development of ABL206, a novel bispecific antibody-drug conjugate targeting B7-H3 and ROR1

Article

Author: Ahn, Jinhyung ; Seo, Arim ; Sung, Byungje ; Lee, Suyoun ; You, Weon-Kyoo ; Ko, Min Ji ; Ryu, Ilhwan ; Son, Yong-Gyu ; Yoo, Myeonghan ; Lee, Sang Hoon ; Yoo, Jiseon ; Park, Hyeon Ji ; Park, Jin Young ; Yeom, Donghoon ; Eom, JaeHyun ; Jung, Jinwon ; Kim, Junyoung ; Kwon, Jung A. ; Yoo, Byeong Min ; Kim, Juhee

Bispecific antibody-drug conjugates (BsADCs) represent a promising strategy to enhance tumor selectivity and overcome the limitations of monospecific ADCs. Here, we report the preclinical development of ABL206 (NEOK001), a novel BsADC targeting B7-H3 and ROR1, which are frequently co-expressed in various solid tumors. ABL206 was engineered in a 2 + 2 format and site-specifically conjugated with tavatecan, an exatecan-based linker-payload, utilizing GlycoConnect® technology to yield a highly homogeneous molecule with a drug-to-antibody ratio (DAR) of 4. In vitro, ABL206 demonstrated specific dual antigen binding, internalization, potent target-dependent cytotoxicity and a bystander killing effect. In vivo, ABL206 induced superior tumor regression, outperforming exact-matched monospecific ADCs at equimolar doses. Across 38 patient-derived xenograft (PDX) models spanning nine tumor types, ABL206 demonstrated broad translational potential with strong tumor regression. ABL206 consistently outperformed clinical-stage benchmark monospecific ADCs, ifinatamab deruxtecan (I-DXd) and zilovertamab vedotin, and effectively induced regression in I-DXd-pretreated regrowing tumors. Furthermore, ABL206 exhibited excellent in vitro plasma stability, a robust pharmacokinetic profile in rodents and non-human primates, and a favorable safety profile with the highest non-severely toxic dose (HNSTD) of 60 mg/kg in cynomolgus monkeys. Collectively, these data provide a comprehensive preclinical proof-of-concept for ABL206, supporting its advancement into a Phase 1 clinical trial for patients with advanced solid tumors (NCT07612176).

22 Sep 2026·ONCOGENE

Enhancing the efficacy of B7-H3-targeting antibody-drug conjugate DS-7300a in TP53-deficient tumors by inducing ferroptosis

Article

Author: Gu, Qianlin ; Zhao, Di ; Leo, Javier ; Albittar, Yaman ; Fan, Zhen ; Goswami, Sangeeta ; Frigo, Daniel E ; Shi, Wei ; Chen, Feiyu ; Zhang, Jie ; Carmon, Kendra S ; Gan, Boyi ; Liang, Xin ; Meng, Chenling ; Aparicio, Ana

Abstract:

Immune checkpoint B7-H3 is an emerging target for immunotherapy. DS-7300a is an advanced B7-H3-targeting antibody-drug conjugate (ADC) warheaded with the topoisomerase I inhibitor DXd. DS-7300a has demonstrated clinical activity, but molecular biomarkers to predict its therapeutic response remain elusive. TP53 is one of the most mutated tumor suppressor genes across cancers, and effective therapies are urgently needed for TP53 -deficient cancers. Using prostate cancer (PCa) as a model system, we reported that DS-7300a’s anti-tumor efficacy is highly dependent on functional p53 in cancer cells, and TP53 defects confer resistance to DS-7300a. Mechanistically, we found that DS-7300a and its payload, DXd, induce DNA damage and activate the ATM/ATR/CHK signaling cascade, thereby stabilizing p53 and inducing a pro-apoptotic and senescence-associated transcriptome. In contrast, TP53 -deficient cells fail to sense DXd-induced DNA damage, maintain a high proliferation rate, and exhibit low levels of apoptosis and senescence, thereby conferring resistance to DS-7300a. Ferroptosis is an iron-dependent form of regulated cell death triggered by lipid peroxidation, which is mechanistically and morphologically distinct from apoptosis. Interestingly, DS-7300a treatment elevates lipid peroxidation in TP53-deficient cancer cells and upregulates glutathione peroxidase 4 (GPX4), an antioxidant enzyme that mitigates lipid peroxidation. Using isogeneic xenograft models and a newly developed humanized B7-H3 PCa model, we demonstrated that inducing ferroptosis by pharmacological inhibition of GPX4 enhances DS-7300a’s efficacy in TP53 -deficient tumors. Our studies demonstrate that TP53 status dictates anti-tumor responses to DS-7300a, and ferroptosis induction represents a promising therapeutic approach to overcome resistance to DS-7300a in malignancies harboring TP53 defects.

210

News (Medical) associated with Ifinatamab deruxtecan

30 Oct 2026

·www.biospace.com

Daiichi Sankyo Reports Second Quarter Fiscal Year 2026 Financial Results

Revenue increased 19.7% to 1.167 trillion yen year-over-year driven by Enhertu ® and Datroway ® Fiscal year 2026 guidance for revenue and operating profit remains unchanged Earnings call to take place on Friday, October 30 at 5:30 pm Japan Standard Time TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) reported financial results for the second quarter of fiscal year 2026, ending September 30, 2026. “Strong revenue growth continues in the second quarter of fiscal year 2026, driven by Enhertu and Datroway. These medicines have received nine new approvals across multiple indications since last quarter, including same day breast cancer approvals in Japan and China, which will allow us to bring these medicines to more patients,” said Hiroyuki Okuzawa, President and CEO of Daiichi Sankyo. “We also continue to explore novel combination strategies to deliver greater benefits to more patients through our DXd antibody drug conjugates as demonstrated by our new clinical trial collaboration to evaluate Datroway with ivonescimab.” Q2 FY2026 Results Global revenue increased 19.7% year-over-year to 1.167 trillion yen, driven by the company’s global oncology medicines. Operating profit increased 34.4% year-over-year to 193.8 billion yen. Global revenue was driven by Enhertu ® and Datroway ® , the company's two lead antibody drug conjugates (ADCs). Enhertu revenue, including milestone payments, was 500.0 billion yen, a 51.4% increase year-over-year. Datroway revenue, including milestone payments, was 54.4 billion yen, a 161.6% increase year-over-year. Revenue from the Oncology Business in the U.S., Europe and Canada was 422.6 billion yen, a year-over-year increase of 54.8%, with revenue driven by Enhertu and Datroway. Japan Business was 232.7 billion yen, a year-over-year decrease of 6.9%, with revenue driven by Lixiana ® , Tarlige ® , Enhertu and Pralia ® . ASCA (Asia, South and Central America) Business revenue was 142.5 billion yen, a 20.9% year-over-year increase, driven by Enhertu. European Union (EU) Specialty Business revenue was 149.2 billion yen, a 9.1% year-over-year increase, driven by Lixiana and Nilemdo ® /Nustendi ® . Full fiscal year 2026 guidance remains unchanged. Global revenue is anticipated to reach 2.34 trillion yen with an operating profit of 320.0 billion yen. Further details on financial performance can be found in the Financial Results Presentation Material . Daiichi Sankyo will host an investor and media conference call and webcast to discuss Q2 FY2026 results on Friday, October 30 at 5:30 pm Japan Standard Time. Q2 FY2026 and Recent Portfolio / Pipeline Highlights Daiichi Sankyo continued to advance its portfolio and pipeline with several milestones across its oncology portfolio, demonstrating momentum towards its goal of launching 20 new indications across five medicines by 2030. Eight additional breast cancer approvals for Enhertu and Datroway were received in China, the EU and Japan since Q1 FY2026. These approvals included Enhertu in combination with pertuzumab for the first-line treatment of patients with HER2 positive metastatic breast cancer based on DESTINY-Breast09 and Datroway for the first-line treatment of patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy based on TROPION-Breast02 . Additional approvals of Enhertu in the adjuvant setting of HER2 positive early breast cancer based on DESTINY-Breast05 were received in China and the EU. Enhertu also was approved for a tumor agnostic indication in China based on four phase 2 trials, including DESTINY-PanTumor02 , DESTINY-Lung01 , DESTINY-CRC02 and DESTINY-PanTumor03 . Data from DESTINY-Lung04 were presented during Presidential Symposium 2 at the IASLC 2026 World Conference on Lung Cancer, which showed Enhertu demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as a first-line treatment of patients with unresectable, locally advanced or metastatic HER2 mutant non-squamous non-small cell lung cancer (NSCLC). The results will be shared with global regulatory authorities for a potential new indication for Enhertu in this lung cancer setting. The Biologics License Application seeking accelerated approval in the U.S. for ifinatamab deruxtecan (I-DXd) for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) was voluntarily withdrawn. Patient enrollment is near completion in the IDeate-Lung02 phase 3 trial, where these results may support the potential global submissions of ifinatamab deruxtecan for relapsed ES-SCLC. Daiichi Sankyo and AstraZeneca entered into a clinical trial collaboration agreement with Summit Therapeutics Inc. to evaluate Datroway in combination with ivonescimab across multiple tumor types including lung and breast cancers. The companies intend to begin the collaboration with a phase 3 trial in first-line TNBC. Separately, the TROPION-Urothelial04 phase 3 trial evaluating Datroway as an adjuvant combination treatment in patients with muscle invasive urothelial cancer was initiated. Medicine Indication Q2 FY2026 and Recent Portfolio Updates Enhertu Breast Enhertu Approved in the EU as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer ( October 2026 ) Enhertu Approved in China as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer ( October 2026 ) Enhertu and Datroway Approved in Japan for Two New First-Line Indications for Patients with Metastatic Breast Cancer ( September 2026 ) Enhertu Plus Pertuzumab Approved in the EU as First New Regimen in More than a Decade for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer ( September 2026 ) Enhertu Plus Pertuzumab Approved in China as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer ( August 2026 ) Lung Enhertu Demonstrated a Median Progression-Free Survival of 14.3 Months as First-Line Therapy in Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer in DESTINY-Lung04 Phase 3 Trial ( September 2026 ) Tumor Agnostic Enhertu Approved in China as First and Only Tumor Agnostic HER2 Directed Medicine and Antibody Drug Conjugate for Previously Treated Patients with HER2 Positive Metastatic Solid Tumors ( October 2026 ) Datroway Breast and Lung Daiichi Sankyo and AstraZeneca Enter into Clinical Trial Collaboration with Summit Therapeutics to Evaluate Datroway in Combination with Ivonescimab Across Multiple Tumor Types ( October 2026 ) Breast Datroway Approved in China as First and Only TROP2 Directed Antibody Drug Conjugate with Overall Survival Benefit for Treatment of Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for PD 1/PD-L1 Inhibitor Therapy ( October 2026 ) Enhertu and Datroway Approved in Japan for Two New First-Line Indications for Patients with Metastatic Breast Cancer ( September 2026 ) Datroway Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy ( July 2026 ) Datroway Urothelial TROPION-Urothelial04 Phase 3 Trial of Datroway Initiated as Adjuvant Therapy in Patients with High-Risk Muscle Invasive Urothelial Cancer ( August 2026 ) I-DXd Lung Ifinatamab Deruxtecan Biologics License Application for Certain Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer Voluntarily Withdrawn ( September 2026 ) Corporate Highlights Daiichi Sankyo appointed Ken Keller to the newly created role of Chief Commercialization Officer effective April 1, 2027, where he will be responsible for accelerating further growth of the company’s oncology and specialty medicine business through a new globally integrated Commercialization Unit. Daiichi Sankyo received a favorable judgment from the Tokyo District Court dismissing all damage claims filed by Northern TK Venture (NTK). About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to being a trusted healthcare innovator, contributing to the enrichment of quality of life around the world through its strengths in science and technology. At Daiichi Sankyo, we believe progress depends on asking more of science, challenging assumptions and pursuing better answers. Progress like this is built by people who never stop learning, questioning and pushing what's possible. Together, we work to bring new breakthrough medicines within reach for patients and help shape what comes next in oncology and beyond. For more information, please visit and connect with us on LinkedIn . Forward-Looking Statements Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo’s future prospects. These forward-looking statements, including words such as “advance,” “anticipate,” “favorable,” “goal,” “momentum,” and “progress” were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are various inherent risks as well as uncertainties involved. As such, please note that actual results of Daiichi Sankyo may diverge materially from the outlook of Daiichi Sankyo or the content of this material. Furthermore, there is no assurance that any forward-looking statements in this material will be realized. Regardless of the actual results or facts, Daiichi Sankyo is not obliged and does not have in its policy the duty to update the content of this material from the date of this material onward. Some of the compounds under discussion are investigational agents and are not approved by the FDA or any other regulatory agency worldwide as a treatment for indications under investigation. Efficacy and safety have not been established in areas under investigation. There are no guarantees that these compounds will become commercially available in indications under investigation. Daiichi Sankyo takes reasonable care to ensure the accuracy of the content of this material but shall not be obliged to guarantee the absolute accuracy, appropriateness, completeness and feasibility, etc. of the information described in this material. Furthermore, any information regarding companies, organizations or any other matters outside the Daiichi Sankyo Group that is described within this material has been compiled or cited using publicly available information or other information, and Daiichi Sankyo has not performed in-house inspection of the accuracy, appropriateness, completeness and feasibility, etc. of such information, and does not guarantee the accuracy thereof. The information described in this material may be changed hereafter without notice. Accordingly, this material or the information described herein should be used at your own judgment, together with any other information you may otherwise obtain. This material does not constitute a solicitation of application to acquire or an offer to sell any security in the United States, Japan or elsewhere. This material disclosed here is for reference purposes only. Final investment decisions should be made at your own discretion. Daiichi Sankyo assumes no responsibility for any damages resulting from the use of this material or its content, including without limitation damages related to the use of erroneous information. Contacts MEDIA CONTACTS: Global: Jennifer Brennan jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com Japan: DS-PR_jp@daiichisankyo.com

Drug ApprovalPhase 3ImmunotherapyFinancial StatementExecutive Change

29 Oct 2026

·www.biospace.com

Daiichi Sankyo Highlights Ongoing Progress Across Industry-Leading ADC Portfolio with New Research Updates at ESMO

New data from six landmark trials reinforce practice-changing results of Enhertu and Datroway across a broad spectrum of patients in breast and lung cancer Additional analyses from two trials of raludotatug deruxtecan in ovarian cancer demonstrate emerging potential in gynecological cancers TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 30 abstracts, including four late breaking presentations, in multiple cancers at the 2026 European Society for Medical Oncology (#ESMO26) Congress. New data from six landmark trials demonstrate the company’s progress toward advancing new standards of care for patients in breast and lung cancer, including the DESTINY-Breast05 ( 539RO ), DESTINY-Breast06 ( 4279P ), DESTINY-Breast09 ( LBA49 ), DESTINY-Breast11 ( 543RO ) and DESTINY-Lung04 ( LBA74 ) phase 3 trials of Enhertu ® (trastuzumab deruxtecan) and the TROPION-Breast02 ( LBA96 ) phase 3 trial of Datroway ® (datopotamab deruxtecan). Additional data at ESMO also will spotlight the company’s commitment to advancing research for patients with advanced ovarian cancer across lines of therapy. An updated analysis, including progression-free survival and duration of response, will be presented from the REJOICE-Ovarian01 ( 1331P ) phase 2/3 trial evaluating raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. A mini oral presentation will highlight preliminary findings from the REJOICE-Ovarian02 ( 1247RO ) phase 1b/2 trial evaluating raludotatug deruxtecan in combination with bevacizumab in patients with platinum-resistant ovarian cancer. “The promising data for raludotatug deruxtecan in ovarian cancer and the robust scientific innovation demonstrated across our pipeline reflects our progress in advancing research for patients across multiple types of cancer,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Daiichi Sankyo continues to draw from its scientific and technological expertise to turn science into new medicines that can change the standard of care.” Data Demonstrate Benefit of DXd ADCs in Patients with Brain Metastases Research updates highlighting the impact of DXd ADCs in patients with brain metastases include late-breaking rapid oral and proffered paper presentations from the DESTINY-Breast09 ( LBA49 ) phase 3 trial evaluating Enhertu in combination with pertuzumab as a first-line treatment for patients with HER2 positive metastatic breast cancer and the TROPION-Breast02 ( LBA96 ) phase 3 trial evaluating Datroway as a first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option. Final overall survival results of the TUXEDO-3 ( 690O ) phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with active brain metastases from metastatic breast cancer, advanced non-small cell lung cancer (NSCLC) or leptomeningeal disease from any solid tumor will be presented as a proffered paper. New Data and Trials-in-Progress Presentations Across DXd ADC Portfolio Additional data highlighting new research across the DXd ADC portfolio include oral and poster presentations, including final results of the TALENT ( LBA23 ) phase 2 trial of Enhertu alone or in combination with anastrozole, or in sequence with chemotherapy, as neoadjuvant treatment for patients with HR positive, HER2 low early stage breast cancer. New data in NSCLC include the NeoCOAST-2 ( 4244RO ) phase 2 trial reporting event-free survival results, as well as findings on the association of ctDNA clearance with clinical outcomes in patients with resectable, early stage NSCLC treated with a combination of Datroway plus durvalumab and chemotherapy, and a retrospective analysis evaluating mechanisms of insensitivity to the Datroway payload in subgroups of patients with advanced NSCLC in the TROPION-Lung01 ( 4451P ) phase 3 trial. Updated findings from the EPOC2003 ( 2888P ) phase 2 trial evaluating neoadjuvant chemotherapy in combination with Enhertu in patients with HER2 positive gastric cancer: results from ESPERANZA ( 1014P ), an external comparator study evaluating Enhertu versus real-world standard of care as a second line or later treatment for patients with HER2 IHC 3+ solid tumors; and, the primary analysis evaluating patritumab deruxtecan monotherapy in patients with melanoma in the HERTHENA-PanTumor01 ( 2073RO ) phase 2 trial also will be presented. Trials-in-progress poster presentations include the DESTINY-Breast Guide ( 1795TiP ) prospective and interventional trial evaluating first-line treatment with Enhertu plus pertuzumab followed by palbociclib, endocrine therapy and dual HER2 blockade (trastuzumab plus pertuzumab), as well as retreatment with Enhertu following progression on maintenance therapy (palbociclib, endocrine therapy and trastuzumab plus pertuzumab) in previously untreated patients with HER2 positive advanced or metastatic breast cancer and the TROY ( 1335TiP ) phase 2 trial evaluating Enhertu in patients with recurrent ovarian cancer with disease progression on prior PARP inhibitor therapy. An overview of late-breaking, clinical data and trials-in-progress presentations from the ADC portfolio of Daiichi Sankyo includes: Presentation Title Author Abstract Presentation (CEST) LBAs Final results of TALENT: a neoadjuvant trial of T-DXd with or without anastrozole, or in sequence with chemotherapy for HER2-low, HR+ early-stage breast cancer S. Hurvitz LBA23 Proffered Paper Presentation Friday, October 23 1:30 pm – 3:00 pm First-line datopotamab deruxtecan (Dato-DXd) vs. chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: exploratory analysis of patients with brain metastases in TROPION-Breast02 R. Dent LBA96 Proffered Paper Presentation Saturday, October 24 8:30 am – 10:00 am First-line trastuzumab deruxtecan (T-DXd) in patients with HER2-mutant NSCLC: patient-reported outcomes from DESTINY-Lung04 S. Novello LBA74 Rapid Oral Presentation Saturday, October 24 8:30 am – 10:00 am DESTINY-Breast09 analysis of trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab for patients with HER2+ advanced/metastatic breast cancer and baseline brain metastases C. Saura LBA49 Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Breast DESTINY-Breast11: MRI-assessed objective responses during neoadjuvant treatment with trastuzumab deruxtecan (T-DXd) followed by paclitaxel + trastuzumab + pertuzumab vs. dose-dense doxorubicin + cyclophosphamide followed by THP in HER2+ early breast cancer J.F. Boileau 543RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Patient-reported outcomes from DESTINY-Breast05: health-related quality of life with trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with high-risk HER2 positive early breast cancer C. Barrios 539RO Rapid Oral Presentation Friday, October 23 4:15 pm – 5:45 pm Paired-biopsy multi-omic analysis reveals target-independent mechanisms of antibody-drug conjugate resistance in metastatic breast cancer P. Tarantino 4449RO Rapid Oral Presentation Monday, October 26 10:15 am – 11:45 am Trastuzumab deruxtecan (T-DXd) vs. physician’s choice of chemotherapy in HR+, HER2 low metastatic breast cancer: a DESTINY-Breast06 ctDNA molecular response analysis G. Curigliano 4279P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Trastuzumab deruxtecan (T-DXd) + pembrolizumab in previously treated human epidermal growth factor receptor 2-expressing advanced or metastatic breast cancer: primary analyses of the breast cohorts from the open-label, multicenter, phase 1b study DS8201-A-U106 H. Rugo 1771P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm DESTINY-Breast Respond HER2 low Europe non-interventional study of trastuzumab deruxtecan (T-DXd) in HER2 low metastatic breast cancer: update on baseline characteristics and anti-emetic treatment J.Y. Pierga 12P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Improving accuracy in HER2 ultralow identification: multi-site validation of an AI-decision support tool B. Van der Vegt 1784P Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Comparative evaluation of 7 artificial intelligence tools for HER2-low and ultralow scoring in breast cancer J.S. Frenel 287P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm A global, interventional, open-label trial of trastuzumab deruxtecan (T-DXd)-based therapy followed by palbociclib, endocrine therapy, and dual HER2 blockade in first-line human epidermal growth factor receptor positive, hormone receptor-positive advanced or metastatic breast cancer and retreatment with T-DXd (DESTINY-Breast Guide) S. Sammons 1795TiP Poster Presentation Saturday, October 24 12:00 pm – 12:45 pm Lung NeoCOAST-2: association of ctDNA clearance with clinical outcomes in a global platform phase 2 perioperative trial T. Cascone 4244RO Rapid Oral Presentation Sunday, October 25 8:30 am – 10:00 am Mechanisms of insensitivity to the datopotamab deruxtecan (Dato-DXd) payload in subgroups of patients with advanced non-small cell lung cancer in TROPION Lung01 N. Girard 4451P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: IDeate-Lung01 updated results M. Ahn 3842P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Ovarian Raludotatug deruxtecan (R-DXd) + bevacizumab in participants with platinum-resistant recurrent ovarian cancer: results for cohort B-1 of the phase 1b/2 REJOICE-Ovarian02 study A. Oaknin 1247RO Rapid Oral Presentation Saturday, October 24 08:30 am – 10:00 am Raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer: an updated analysis of efficacy and tolerability from the phase 2 part of REJOICE-Ovarian01 K. Hasegawa 1331P Poster Presentation Monday, October 26 12:00 pm – 12:45 pm A randomized phase 2, open-label, multicenter, study of trastuzumab deruxtecan versus investigator’s choice chemotherapy in recurrent ovarian cancer that progressed on prior PARP inhibitor therapy: TROY (APGOT-OV14) J.Y. Lee 1335TiP Poster Presentation Monday, October 26 12:00 pm – 12:45 pm Gastric Quality-adjusted time without symptoms or toxicity (Q-TWiST) of trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with HER2+ unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma from DESTINY-Gastric04 M. Gumus 2925P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm Perioperative trastuzumab deruxtecan plus capecitabine and durvalumab in HER2 positive gastric or gastroesophageal junction cancer: a phase II study (EPOC2003) D. Takahari 2888P Poster Presentation Sunday, October 25 12:00 pm – 12:45 pm PanTumor Final results of the TUXEDO-3 phase II trial of patritumab deruxtecan (HER3-DXd) in active brain metastases and leptomeningeal disease M. Preusser 690O Proffered Paper Presentation Sunday, October 25 10:15 am – 11:45 am Patritumab deruxtecan (HER3-DXd) in melanoma after anti-PD-(L)1 therapy: primary analysis from HERTHENA-PanTumor01 M. McKean 2073RO Rapid Oral Presentation Sunday, October 25 10:15 am – 11:45 am ESPERANZA: Results from an external comparator study of trastuzumab deruxtecan in HER2 IHC3+ solid tumors F. Meric-Bernstam 1014P Poster Presentation Friday, October 23 3:15 pm – 4:00 pm About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of nine ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. Additional ADCs being developed by Daiichi Sankyo include DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING, and DS1025, which consists of a CD25 directed antibody attached to an immuno-oncology optimized cytotoxic payload. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610, DS3790 and DS1025 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . Contacts MEDIA CONTACTS: Global: Jennifer Brennan Jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com

Phase 2Phase 3Clinical ResultADCImmunotherapy

27 Oct 2026

·www.fiercebiotech.com

GSK’s B7-H3 ADC drives 67% cancer risk reduction in Hansoh's phase 3 China trial

A phase 3 trial has linked GSK’s risvutatug rezetecan (ris-rez) to a 67% reduction in the risk of disease progression or death, providing evidence that B7-H3-directed antibody-drug conjugates (ADCs) work in relapsed osteosarcoma. Hansoh Pharma, GSK’s Shanghai-based partner on the therapy, ran the phase 3 clinical trial in China. The study, Artemis-011, enrolled 122 patients aged 12 years and older who were failed by second-line treatments. Hansoh randomized participants to receive ris-rez or the chemotherapy combination of gemcitabine and docetaxel. Median progression-free survival (PFS) was 5.5 months on ris-rez, compared to 1.5 months on chemotherapy. The difference amounted to a 67% risk reduction after a median follow-up of 7.1 months. Hansoh revealed the trial met its primary PFS endpoint in July without disclosing data. GSK reported grade 3 or higher treatment-related adverse events (TRAEs) in 93% of patients receiving ris-rez at the 12 mg/kg dose and in 83% of those receiving chemotherapy. Hematologic events were the most common grade 3 or higher TRAEs in both arms. TRAEs led to discontinuation in 4% of patients on ris-rez and 2% of patients receiving chemotherapy. The results were consistent with earlier trials. The data suggest B7-H3 ADCs improve outcomes in a setting that lacks approved drugs or a standard of care. Artemis-011 will extend randomized evidence on B7-H3 ADCs into osteosarcoma, H.C. Wainwright analysts said in a note to investors last month. The readout offers encouragement that B7-H3 ADCs work in the setting, while also setting the bar for other companies aiming to treat relapsed osteosarcoma. Daiichi Sankyo and Merck & Co.’s ifinatamab deruxtecan (I-DXd) has led the way for B7-H3 ADCs in small cell lung cancer (SCLC), although regulatory setbacks, including the recent withdrawal of a filing for FDA approval, have closed the gap. Osteosarcoma is on Daiichi and Merck’s roadmap, but I-DXd is trailing ris-rez in the setting. The partners started a global phase 1/2 clinical trial of I-DXd in July that, in its second part, will enroll patients with osteosarcoma and several other tumor types. GSK began a global phase 1/2 study of ris-rez in osteosarcoma and soft tissue sarcoma in June. The rivals are running osteosarcoma trials alongside studies in other indications. As well as SCLC, B7-H3 ADC developers are targeting tumor types including esophageal cancer, non-small cell lung cancer and prostate cancer. At the European Society for Medical Oncology Conference last week, GSK unveiled fresh data from its other Hansoh-partnered ADC. The presentation showed that among 45 patients with platinum-resistant ovarian cancer who received the B7-H4-directed mo-rez, there was a confirmed objective response rate of 62%, with a median duration of response of 12.2 months. Where Big Pharma is placing its bets is one of the hot topics being discussed at Fierce Biotech's high-impact event in London next month. Find out more information and register by clicking on the banner below:

Phase 3Clinical ResultASCOADC

100 Deals associated with Ifinatamab deruxtecan

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Indication	Highest Phase	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	NDA/BLA	United States	Daiichi Sankyo Co., Ltd.	13 Apr 2026
Metastatic castration-resistant prostate cancer	Phase 3	United States	Merck Sharp & Dohme LLC	13 May 2025
Metastatic castration-resistant prostate cancer	Phase 3	China	Merck Sharp & Dohme LLC	13 May 2025
Metastatic castration-resistant prostate cancer	Phase 3	Japan	Merck Sharp & Dohme LLC	13 May 2025
Metastatic castration-resistant prostate cancer	Phase 3	Argentina	Merck Sharp & Dohme LLC	13 May 2025
Metastatic castration-resistant prostate cancer	Phase 3	Australia	Merck Sharp & Dohme LLC	13 May 2025
Metastatic castration-resistant prostate cancer	Phase 3	Austria	Merck Sharp & Dohme LLC	13 May 2025
Metastatic castration-resistant prostate cancer	Phase 3	Brazil	Merck Sharp & Dohme LLC	13 May 2025
Metastatic castration-resistant prostate cancer	Phase 3	Chile	Merck Sharp & Dohme LLC	13 May 2025
Metastatic castration-resistant prostate cancer	Phase 3	Colombia	Merck Sharp & Dohme LLC	13 May 2025

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06780137 (6070-002, CSCO2026)	Phase 1/2	Extensive stage Small Cell Lung Cancer Second line	120	Gocatamig + Ifinatamab deruxtecan	vawaeqtvko(ymekvwvlpi) = tfdcfdsuqq phtjtgppqu (nchcjxeazt )	Positive	11 Sep 2026
NCT04145622 (IDeate-PanTumor01, Pubmed \| Lancet Oncol)	Phase 1/2	Advanced Malignant Solid Neoplasm	97	Ifinatamab deruxtecan	uiwmkayipa(bvbotbraui) = juzrhvfhtu upcpcxljln (gojbpgsjkx ) View more	Positive	01 Apr 2026
NCT06644781 (IDeate-Esophageal01, ESMO_ASIA2025)	Phase 3	Metastatic Esophageal Squamous Cell Carcinoma Second line B7 homolog 3 (B7-H3)	474	Ifinatamab deruxtecan (I-DXd) 12 mg/kg	vsxtacspoj(hwqrzknkzb) = jnlyzvovuy yohcwltpux (xmyglqykfv ) View more	Positive	05 Dec 2025
NCT06644781 (IDeate-Esophageal01, ESMO_ASIA2025)	Phase 3		474	Investigator’s choice of chemotherapy (paclitaxel, docetaxel, or irinotecan)	vsxtacspoj(hwqrzknkzb) = rivclicofs yohcwltpux (xmyglqykfv )	Positive	05 Dec 2025
NCT05280470 (IDeate-Lung01, ESMO2025) Manual	Phase 2	Extensive stage Small Cell Lung Cancer	137	I-DXd 12 mg/kg (with BL BM)	lvtwglxdyc(dtnplquqcf) = ckidlmyzcw evzqidvasi (gbdqgpwzmj, 33.7 - 59.0) View more	Positive	18 Oct 2025
NCT05280470 (IDeate-Lung01, ESMO2025) Manual	Phase 2	Extensive stage Small Cell Lung Cancer	137	I-DXd 12 mg/kg (No prior brain RT for BL BM)	lvtwglxdyc(dtnplquqcf) = vfntzjfzzq evzqidvasi (gbdqgpwzmj, 37 - 77) View more	Positive	18 Oct 2025
NCT06780085 (KEYMAKER-U01, ESMO2025)	Phase 2	metastatic non-small cell lung cancer	240	R-DXd 5.6 mg/kg Q3W	foezjatbjc(sbjmqobfvq) = osbzavozoc zpvdarhrth (usakbcfgec )	Positive	17 Oct 2025
NCT06780085 (KEYMAKER-U01, ESMO2025)	Phase 2	metastatic non-small cell lung cancer	240	I-DXd 12 mg/kg Q3W	foezjatbjc(wgworukrvp) = jtqfrmcqzk ppyoihgtzb (aahsmuxnpw ) View more	Positive	17 Oct 2025
NCT05280470 (IDeate-Lung01, WCLC2025)	Phase 2	Extensive stage Small Cell Lung Cancer Second line \| Third line \| Last line B7-H3	137	Ifinatamab Deruxtecan (I-DXd) 12 mg/kg (second-line (23.4%) + third-line (54.7%) + fourth-line (21.9%))	vdboaiuyke(tdgnhgsxym) = tcjedwtrdo stebypvubc (ejdgpmeuoh, 39.6 - 56.9) View more	Positive	09 Sep 2025

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