Fam-trastuzumab deruxtecan-NXKI

BD机会来了! 【国内企业寻找抗体产品】CEACAM5抗体（CMC已经完成），或者HER2抗体（GMP ready），希望不要有Fc功能。 欢迎感兴趣的药企立即联系药时代BD团队！ BD@drugtimes.cn 2026年6月，ADC领域溃败接连而至：ADC Therapeutics因患者死亡被迫重组裁员，辉瑞430亿美元收购Seagen后首个新药III期折戟，吉利德Trodelvy在肺癌战场第三次倒下。 当狂奔十年的热门赛道突然接连踩下刹车，人们不禁要问：这究竟是偶发的颠簸，还是一个行业周期必然的换挡时刻？ ADC Therapeutics： 疗效达标，但27例患者死亡，公司裁员 6月24日，ADC Therapeutics宣布启动战略重组，计划裁员约17%，涉及约32个岗位。截至2025年底，公司全球员工总数为188人。这场裁员的直接导火索，指向了其核心产品Zynlonta在关键验证性试验中爆出的安全性危机。 时针拨回6月4日，ADC Therapeutics公布了核心产品Zynlonta的关键III期LOTIS-5数据。从疗效看，试验达到了无进展生存期主要终点：Zynlonta联合利妥昔单抗组中位PFS为6.1个月，优于对照组的4.7个月，完全缓解率39.5%也大幅高于对照组的26.7%。 然而，试验组却出现了27例（13.2%）死亡，是对照组9例（4.6%）的近三倍。多数死亡病例集中在75岁及以上高龄患者，死因以感染为主。严重不良事件发生率49%，因不良反应终止治疗比例高达25.5%。数据公布当天，ADCT股价单日暴跌近60%。 Zynlonta的困局，根源在于其技术路线的选择。当前主流ADC多采用MMAE、DM1等微管抑制剂或deruxtecan等拓扑异构酶抑制剂作为载荷，在杀伤力与安全性之间取得了相对成熟的平衡。 而Zynlonta使用的是PBD（吡咯并苯并二氮杂䓬）二聚体毒素，其机制与主流payload截然不同，不作用于微管或拓扑异构酶，而是直接与DNA小沟共价交联，阻断肿瘤细胞的DNA复制与修复。其杀伤效力远超传统ADC载荷，是目前已知活性最强的ADC毒素之一。 然而，PBD毒素的治疗窗口极为狭窄。效力过强导致脱靶毒性难以控制，在杀伤肿瘤的同时，全身性毒副作用同样显著，尤其在免疫功能随年龄衰退的高龄患者中，感染风险被急剧放大。 LOTIS-5本是为Zynlonta从加速批准转为完全批准的关键验证性试验，如今却暴露了其安全性硬伤。当毒性无法被精准驾驭时，即便疗效数字达标，患者也可能面临获益与风险的不平衡。PBD技术路线的临床价值，因此被打上了一个问号。 辉瑞：430亿美元收购后的首份答卷，不及格 6月22日，辉瑞公布了sigvotatug vedotin的III期SigVie-002试验结果。这是辉瑞以430亿美元收购Seagen后，首个读出关键数据的全新ADC药物，承载了市场的广泛期待。 然而结果令人失望。在既往经治的非鳞状非小细胞肺癌患者中，该药未能显著改善总生存期，未达到主要终点。 更值得关注的是，sigvotatug vedotin的设计靶点为整合素β6，约90%的NSCLC肿瘤表达该蛋白，但探索性分析显示，疗效与IB6表达水平之间并无明确关联，靶点与应答脱钩，动摇了该药的设计基础。 这并非辉瑞Seagen资产的首次受挫。自收购完成以来，辉瑞已陆续终止了B7-H4 ADC项目，以及PF-08046031、PF-08046037两项早期ADC试验。 接连受挫的背后，并非简单的临床运气不佳，而是Seagen技术路线与行业演进方向的结构性错位。Seagen的技术基石：MMAE抗微管载荷搭配可裂解连接子在2010年代曾是行业标杆。 但自2019年起，ADC领域的载荷重心已整体迁移至以DXd为代表的拓扑异构酶I抑制剂。决定性证据来自头对头试验：同靶向HER2，搭载DXd的Enhertu在临床研究中展现出优于搭载抗微管载荷DM1的Kadcyla的疗效，确立了TOPO1在实体瘤ADC中的优势：旁观者效应更强、可杀伤静息期细胞、治疗窗更宽。 辉瑞选择了另一条路：让Seagen的MMAE实体瘤资产直接闯入强者如林的赛道。而在ADC开发已是TOPO1主战场的今天，这些分子面临的不仅仅是同类竞争，更是技术代际的降维压制。 不过，辉瑞并未放弃这一资产。sigvotatug在仅接受过一线治疗的患者亚组中，OS和PFS均显示出优于化疗的趋势；MMAE可诱导免疫原性细胞死亡，为与免疫检查点抑制剂联合提供了机制依据。sigvotatug联合Keytruda的一线III期试验仍在进行中。同时，辉瑞已启动另一款以Topo1为载荷的IB6靶向ADC候选物，PD-L1靶向ADC fetrastobart vedotin也已进入III期阶段。 一个关键问题由此浮现：手握430亿美元收购而来的昔日标杆技术，能否在当前以TOPO1为主导的竞争格局中实现突围？答案尚待时间揭晓。 吉利德：Trodelvy肺癌三败 6月8日，吉利德宣布提前终止Trodelvy联合Keytruda一线治疗PD-L1高表达NSCLC的III期EVOKE-3试验。独立数据监测委员会基于最终PFS和期中OS数据建议终止，因联合治疗相比K药单药，PFS仅有数字性改善，无统计学意义，OS也不太可能达到显著差异。 这是Trodelvy在肺癌领域的第三次受挫。此前其用于二线NSCLC的III期试验已告失败；2024年又因疗效不佳撤回了膀胱癌适应症。吉利德2020年以210亿美元收购Immunomedics获得该药，如今其确证的适应症主要集中在三阴性乳腺癌领域。 Trodelvy的困境，可追溯至其作为早期TROP2 ADC的分子设计特征。该药所用SN38毒素：伊立替康的活性代谢物，水溶性较差、易被耐药泵排出、毒性窗口较窄。其DAR值高达7.6，虽可提升活性分子血药浓度，但脱靶毒性也随之增加。较为典型的是，Trodelvy因存在较明显的骨髓抑制等副作用，FDA在其说明书中加入了黑框警告。当疗效优势有限时，安全性负担进一步压缩了其临床应用空间。 此次失败后，TROP2 ADC在NSCLC领域的竞争焦点转向默沙东/科伦博泰的sac-TMT以及阿斯利康/第一三共的Datroway。分析师指出，sac-TMT在类似人群中展现出更优的PFS获益，治疗相关停药率不足10%，远低于Trodelvy的24%。疗效与耐受性的双重差距，使Trodelvy在这场竞争中处于被动位置。 小结 2026年6月，ADC赛道经历了近年少有的密集挫折。三起事件的失利逻辑各有不同：ADC Therapeutics受困于PBD载荷的安全性窗过窄，辉瑞面临MMAE技术在实体瘤中代际竞争力的疑问，吉利德则暴露了早期TROP2 ADC分子设计的局限。但它们共同指向一个基本命题：ADC的临床成功，需要靶点选择、连接子设计、载荷活性、适应症定位、患者筛选等多个环节的系统性配合。 当估值回归理性、临床数据持续读出，ADC赛道的竞争正从概念驱动转向产品力驱动。那些具备清晰差异化设计、可靠临床数据和明确患者获益的分子，才能在大浪淘沙中展现出持续的生命力。 参考资料： 1.ADC Therapeutics. ADC Therapeutics Announces Results From LOTIS-5 Phase 3 Confirmatory Clinical Trial of ZYNLONTA® in Combination with Rituximab in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. June 3, 2026. 2.ADC Therapeutics. ADC Therapeutics Announces Strategic Reorganization to Support ZYNLONTA® Growth Opportunities and Regulatory Priorities. June 24, 2026. 3.Pfizer. Pfizer Announces Topline Phase 3 Results for Sigvotatug Vedotin in Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer. June 22, 2026. 4.Gilead Sciences & Merck. Merck and Gilead Provide Update on Phase 3 KEYNOTE-D46/EVOKE-03 Study. June 8, 2026. 5.Fierce Pharma. ADC Therapeutics' shares plummet after patient deaths in trial of Zynlonta. June 4, 2026. 6.Fierce Pharma. Amid safety concerns, ADC Therapeutics plots 17% staff cuts to push resources behind Zynlonta. June 24, 2026. 7.Fierce Pharma. As Gilead's Trodelvy stumbles in first-line lung cancer, all eyes turn to Merck, AZ and Daiichi rivals. June 9, 2026. 8.27例患者死亡！ADC股价大跌57%，矛头指向…… 9.Seagen的诅咒 | 辉瑞为何在ADC领域持续失败 （公众号：Alpha Lab） 10.其他公开资料 封面图来源：即梦AI 摒弃铁拳教育！ADHD新药III期临床成功，上市在即 2026-06-26 专访周虹：诺和诺德告别单品神话，以组合战略穿越行业周期 2026-06-25 全球首款实体瘤CAR-T上市，科济药企为何连跌两日？ 2026-06-24 重磅！美国HHS启动「史无前例」大改革 2026-06-23 版权声明/免责声明 本文为原创文章。 本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。 文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。 如有任何问题，请与我们联系。 衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩内容！

Approval based on three phase 2 trials of Daiichi Sankyo and AstraZeneca’s Enhertu that demonstrated clinically meaningful responses across a broad range of tumors Enhertu now approved for six indications in the EU TOKYO--(BUSINESS WIRE)--Enhertu ® (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from subgroups of patients with HER2 positive (IHC 3+) tumors across three phase 2 trials, including DESTINY-PanTumor02 , DESTINY-Lung01 and DESTINY-CRC02 . In DESTINY-PanTumor02, Enhertu demonstrated a confirmed objective response rate (ORR) of 52.3% (95% confidence interval [CI]: 42.6-61.8) and median duration of response (DOR) of 21.1 months (95% CI: 10.6-25.0) in a subgroup of previously treated patients (n=111) with centrally or locally assessed HER2 positive solid tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors. In DESTINY-Lung01, Enhertu demonstrated a confirmed ORR of 52.9% (95% CI: 27.8-77.0) and median DOR of 6.9 months (95% CI: 4.0-9.8) in a subgroup of previously treated patients (n=17) with centrally confirmed HER2 positive non-small cell lung cancer (NSCLC). In DESTINY-CRC02, Enhertu demonstrated a confirmed ORR of 46.9% (95% CI: 34.3-59.8) and median DOR of 5.5 months (95% CI: 4.2-8.1) in a subgroup of previously treated patients (n=64) with centrally confirmed HER2 positive colorectal cancer. “HER2 overexpression occurs across multiple tumor types and is associated with aggressive disease and a poor prognosis. Until now, HER2 directed therapies were only available for specific tumor types," said Benedikt Westphalen, MD, Head of the Precision Oncology Program, Comprehensive Cancer Center of the University of Munich, Germany. “The approval of trastuzumab deruxtecan as a tumor agnostic therapy opens a new treatment option for patients with HER2 positive cancers regardless of where the tumor originated.” In DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02, the safety pro Enhertu was consistent with previous clinical trials with no new safety concerns identified. Grade 3 or grade 4 adverse reactions from a pooled safety analysis of patients treated with Enhertu (5.4 mg/kg) across multiple tumor types in clinical studies included neutropenia (18.5%), anemia (9.9%), fatigue (8.2%), leukopenia (5.8%), thrombocytopenia (5.2%), nausea (4.8%), lymphopenia (4.2%), hypokalemia (3.6%), increased transaminases (3.6%), diarrhea (2.5%), vomiting (2.4%), decreased appetite (1.6%), pneumonia (1.4%) and decreased ejection fraction (1.0%). Grade 5 adverse reactions occurred in 1.1% of patients, including interstitial lung disease/pneumonitis (1.0%). “This approval of Enhertu marks a significant milestone in the EU for patients with HER2 positive metastatic solid tumors and establishes the first tumor agnostic indication for a HER2 directed therapy and antibody drug conjugate in the region,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “Enhertu is now approved for six indications in the EU, which demonstrates our commitment to advancing innovative medicines in areas of high unmet need to patients with cancer.” “Precision medicine is reshaping cancer care by helping inform treatment decisions based on the molecular and biological characteristics of a patient’s disease,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “Enhertu is already approved in breast, gastric and lung cancers, and with this approval, clinicians may now consider Enhertu for patients with HER2 positive status across multiple additional tumor types. This highlights the importance of biomarker testing to identify eligible patients and ensure that those with HER2 positive disease are considered for targeted treatment.” Enhertu (5.4 mg/kg) is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and/or have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Additional regulatory submissions for Enhertu also are underway in the EU, including in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer based on data from the DESTINY-Breast09 trial and for patients with HER2 positive breast cancer with residual invasive disease after neoadjuvant HER2 targeted treatment based on data from the DESTINY-Breast05 trial. Financial Considerations Following this approval in the EU, an amount of $25 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the HER2 positive metastatic solid tumor indication. Sales of Enhertu in most EU territories are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019 . About DESTINY-PanTumor02 DESTINY-PanTumor02 is a global, multicenter, multi-cohort, open-label, phase 2 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) for the treatment of previously treated HER2 expressing tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancer or other tumors. The primary endpoint of DESTINY-PanTumor02 is confirmed ORR as assessed by investigator. Secondary endpoints include DOR, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, tolerability and pharmacokinetics. Results from DESTINY-PanTumor02 were published in the Journal of Clinical Oncology . DESTINY-PanTumor02 enrolled 267 patients, including 111 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe, North America, South America and Oceania. For more information about the trial, visit ClinicalTrials.gov . About DESTINY-Lung01 DESTINY-Lung01 is a global, open-label, two-cohort, phase 2 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg or 6.4 mg/kg) in patients with HER2 mutant (Cohort 2, n=91) or HER2 overexpressing (defined as IHC 3+ or IHC 2+) (Cohort 1 and 1a, n=90) unresectable or metastatic NSCLC who had progressed after one or more systemic therapies. The primary endpoint of DESTINY-Lung01 is confirmed ORR by independent central review. Key secondary endpoints include DOR, DCR, PFS, OS and safety. Results from the HER2 mutant cohort were published in The New England Journal of Medicine and results from the HER2 overexpressing cohort were published in The Lancet Oncology . DESTINY-Lung01 enrolled 181 patients, including 17 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov . About DESTINY-CRC02 DESTINY-CRC02 is a global, randomized, two arm, parallel, multicenter, phase 2 trial evaluating the efficacy and safety of two doses (5.4 mg/kg or 6.4 mg/kg) of Enhertu in patients with locally advanced, unresectable or metastatic HER2 positive colorectal cancer of BRAF wild-type, RAS wild-type or RAS mutant tumor types previously treated with standard therapy. The trial was conducted in two stages. In the first stage, patients (n=80) were randomized 1:1 to receive either 5.4 mg/kg or 6.4 mg/kg of Enhertu. In the second stage, additional patients (n=42) were enrolled in the 5.4 mg/kg arm. The primary endpoint in DESTINY-CRC02 is confirmed ORR as assessed by blinded independent central review. Secondary endpoints include DOR, DCR, investigator-assessed confirmed ORR, clinical benefit ratio, PFS, OS and safety. Results from DESTINY-CRC02 were published in The Lancet Oncology. DESTINY-CRC02 enrolled 122 patients, including 64 HER2 positive (IHC 3+) adult patients at multiple sites in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov . About HER2 Expression in Solid Tumors HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of various tissue cells throughout the body and is involved in normal cell growth. 1 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in some cancers. 2 HER2 overexpression occurs in a range of solid tumors with the prevalence varying by tumor type. 3 HER2 directed therapies have been used to treat HER2 overexpression in breast, gastric and biliary tract cancers in the EU. 1,4,5,6 Although HER2 is overexpressed in additional solid tumor types including biliary tract, lung, bladder, cervical, colorectal, endometrial, ovarian, salivary gland and pancreatic cancers, HER2 testing is not routinely performed in these additional tumor types and prior to this approval there were no HER2 directed treatments approved in the EU to treat a broad range of solid tumors. 2,7,8 About Enhertu Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Enhertu (5.4 mg/kg) is approved in the U.S. for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial. Enhertu (5.4 mg/kg) followed by THP is approved in China and the U.S. as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in Brazil, India, Israel, Saudi Arabia, Switzerland, the United Arab Emirates and the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial. Enhertu (5.4 mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial. Enhertu (5.4 mg/kg) is approved in more than 95 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Enhertu (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial. Enhertu (5.4 mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 ( ERBB2 ) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu (6.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 , DESTINY-Gastric02 and/or DESTINY-Gastric04 trials. Enhertu (5.4 mg/kg) is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and/or have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02 , DESTINY-Lung01 , DESTINY-CRC02 and/or HERALD trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About the Enhertu Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of Enhertu as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu in March 2019 and Datroway ® in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and Datroway. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight 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. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 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 . ________________________________ REFERENCES: 1 Iqbal N, et al. Mol Biol Int. 2014;852748. 2 Cheng X. Genes (Basel ). 2024;15(7):903. 3 Yan M, et al. Cancer Metastasis Reviews. 2015;34(1):157-164. 4 Benli Y, et al. Clin Transl Oncol . 2025;27(9):3607-3624. 5 Uy NF, et al. Cancers (Basel) . 2022;14(17):4155. 6 Haigh JE, et al. Curr Oncol . 2024;31(9):5652-5661. 7 Omar N, et al. Pathogenesis . 2015;2(3):1-9. 8 Ismail A, et al. Oncologist . 2025;30(9):258. Contacts MEDIA CONTACTS: Global: Jennifer Brennan jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) EU: Simone Jendsch-Dowé simone.jendsch-dowe@daiichisankyo.com +49 (89) 78080 (office) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com