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

Purpose: This clinical trial is designed to evaluate the safety and effectiveness of Trastuzumab Deruxtecan for patients with HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer. The goal is to determine how well this treatment works and to identify any potential side effects.
Who Can Participate: We are looking for Participants with histologically confirmed HER2 positive locally advanced unresectable and/or metastatic esophageal, gastric or GEJ adenocarcinoma with an ECOG PS of 2 and measurable disease according to RECIST 1.1 within 42 days prior to registration. Participants will be carefully screened to ensure they meet the study requirements.
What to Expect: Participants will undergo 6.4mg/kg, IV infusion of Trastuzumab deruxtucan over the course of the study. They will receive detailed information about the study and will have the opportunity to ask questions before deciding to participate. Informed consent will be obtained to ensure that participants understand the study's purpose, procedures, risks, and benefits.
Safety Monitoring: The health and safety of participants are our top priority. An Independent Data and Safety Monitoring Committee (DSMC) will regularly review the study data to ensure participant safety and to monitor for any adverse events. Any serious side effects will be reported and addressed promptly.
Benefits and Risks: While the study aims to provide potential benefits, such as improved treatment options for HER2 Positive Newly Diagnosed Metastatic Esophageal, Gastric, GEJ Cancer there may also be risks involved. Participants will be informed of all possible risks before enrolling in the study.
Confidentiality: All personal information will be kept confidential, and data will be used only for research purposes.
Contact Information: For more information about this study, please contact PhaseIICRA@medicine.bsd.uchicago.edu

开始日期2026-11-01

申办/合作机构

The University of Chicago

NCT07137416

/ Recruiting临床1期IIT

Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors

This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving pidnarulex in combination with trastuzumab deruxtecan may be safe, tolerable and/or effective in treating patients with metastatic, unresectable, or locally advanced HER2-expressing breast cancer or other solid tumors.

开始日期2026-10-05

申办/合作机构

National Cancer Institute

NCT07012031

/ Recruiting临床1/2期IIT

A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of Sotorasib Plus Trastuzumab Deruxtecan in Patients With Advanced Non-Small Cell Lung Cancer With a KRASG12C Mutation

This phase I/II trial tests the safety, side effects and best dose of sotorasib with trastuzumab deruxtecan and how well the combination works in treating patients with KRAS G12C mutated non-small cell lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sotorasib blocks a protein made by the mutated KRAS gene (KRAS p.G12C), which may help keep tumor cells from growing and may kill them. It is a type of targeted therapy. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving sotorasib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or effective in treating patients with locally advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation.

开始日期2026-08-07

申办/合作机构

National Cancer Institute

100 项与德曲妥珠单抗相关的临床结果

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100 项与德曲妥珠单抗相关的转化医学

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100 项与德曲妥珠单抗相关的专利（医药）

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1,005

项与德曲妥珠单抗相关的文献（医药）

2026-07-01·Value in Health Regional Issues

Budget Impact Analysis of Fam-Trastuzumab-Deruxtecan as a Second Line in Patients With HER2-Positive Metastatic Breast Cancer in Oman

Article

作者: Aljaber, Rana ; Al Froukh, Rawan F ; Al Hashar, Amna

OBJECTIVES:

Despite advancements, breast cancer remains a major global health and financial challenge. Trastuzumab-based therapies, particularly Fam-Trastuzumab-Deruxtecan (T-DXd), have shown superior outcomes, leading to its recommendation as a preferred second-line treatment. However, its high cost necessitates a budget impact analysis (BIA) to evaluate financial feasibility. This study assesses the 1-year budget impact of replacing Trastuzumab Emtansine (TDM1) with T-DXd for HER2+ metastatic breast cancer in an Omani cancer center.

METHODS:

A static BIA model was built based on National Institute for Health and Care Excellence template with adaptation as required. The model time horizon was 1 year then projected over another 2 years, using 2022 as the baseline year, adopting Omani healthcare-payer perspective. The analysis considered 2 scenarios: (1) TDM1 as the current formulary drug and (2) T-DXd is introduced instead of TDM1, assuming that treatment share would be 100%. One-way sensitivity analysis is performed to assess the model's robustness.

RESULTS:

The BIA demonstrated that replacing TDM1 with T-DXd for the eligible patients would lead to increase in the budget expenditure. Over a 3-year period, considering the provided assumptions and input data, the cumulative excess amount to €5 909 481.67. The primary contributing factors are the drug acquisition cost and the median treatment duration. The sensitivity analysis results suggest the model is robust to changes in adverse drug reaction costs, unlike changes in treatment duration and drug cost.

CONCLUSIONS:

Although T-DXd improves clinical outcomes, its adoption as a second-line treatment in Oman poses a substantial financial burden, necessitating careful budget planning to ensure long-term affordability.

2026-05-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Resistance mechanisms and post-trastuzumab deruxtecan (T-DXd) strategies in HER2+ and HER2-low breast cancer: From biology to clinical practice

Review

作者: Chen, Minna ; Xue, Wenwu ; Wen, Xiaofen ; Li, Xiaozhi ; Zeng, De ; Lin, Danxia ; Song, Junwei ; Wang, Wende ; Zhang, Weichun ; Shen, Jiaxin

Trastuzumab deruxtecan (T-DXd), a HER2-directed antibody-drug conjugate (ADC), has revolutionized the treatment landscape for HER2-positive and HER2-low breast cancer, offering unprecedented improvements in progression-free survival (PFS) and overall survival (OS). However, the emergence of resistance limits its long-term efficacy and highlights the need for rational post-progression strategies. This review summarizes current understanding of resistance mechanisms to T-DXd, including dynamic HER2 expression loss, dysregulation of DNA damage repair, tumor microenvironment remodeling, and immune evasion. Building upon these mechanistic insights, we explore therapeutic strategies following T-DXd resistance, including sequential ADCs with alternative targets or payloads, combinations with HER2-targeted tyrosine kinase inhibitors (TKIs), CDK4/6 or PARP inhibitors, endocrine therapy, and immunotherapy. Novel agents such as ARX788, patritumab deruxtecan, and Dato-DXd demonstrate promise in overcoming resistance through diversified mechanisms. Real-world data further support a "three-step strategy" involving ADC rechallenge after interim non-ADC therapies, offering a practical, mechanism-informed treatment model. This review provides a framework for precision-guided care in patients with advanced breast cancer and supports ongoing efforts to extend the therapeutic window beyond initial T-DXd benefit.

2026-04-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Recent advances in systemic treatment for HER2-negative breast cancer with brain metastases

Review

作者: Zhu, Yuehong ; Hao, Chunfang ; Zhang, Jie

Human epidermal growth factor receptor 2 (HER2) -negative breast cancer brain metastases (BCBM) and leptomeningeal disease (LMD) pose significant clinical challenges due to limited treatment options and poor prognosis. Unlike HER2-positive BCBM, which has established therapeutic protocols, HER2-negative BCBM and LMD lacks standardized approaches. Recent advances have introduced novel systemic therapies targeting diverse pathways, including cell cycle regulation, DNA repair, immune modulation, vascular suppression, and leptomeningeal penetration, with emerging data supporting activity in LMD. Cyclin-dependent kinase 4/6 (CDK4/6) inhibitors show promise in hormone receptor-positive subsets, particularly when combined with radiotherapy. Antibody-drug conjugates (ADCs), such as trastuzumab deruxtecan and sacituzumab govitecan, demonstrate enhanced central nervous system penetration and tumor-specific cytotoxicity, improving outcomes in both stable and active brain metastases. Immune checkpoint inhibitors (ICIs) and poly (ADP-ribose) polymerase (PARP) inhibitors also exhibit potential, though their efficacy varies by molecular subtype. Additionally, intrathecal therapies have become a cornerstone for LMD management, bypassing the blood-CSF barrier. Emerging therapies like selective estrogen receptor degraders (SERDs) and kinase inhibitors address resistance mechanisms, offering new avenues for personalized treatment. This review underscores the need for survival-prolonging, quality-of-life-preserving strategies with optimized safety profiles, highlighting the evolving landscape of HER2-negative BCBM and LMD management.

5,287

项与德曲妥珠单抗相关的新闻（医药）

20 小时之前

·生物药观察

IO2.0+ADC联合疗法进展盘点

随着IO2.0时代的到来，多款PD-(L)1/VEGF，PD-(L)1/CTLA4，PD-1/IL-2，PD-1/TIGIT等IO2.0产品逐步推进到临床后期或已获批上市，有望替代传统PD1/PD-L1成为肿瘤免疫治疗的基石药物。同时，ADC药物作为化疗的升级版本，已经成为多种恶性肿瘤的新型疗法，改变了肿瘤的治疗格局。探索IO2.0和ADC药物的联合疗法，已经成为新的临床趋势，2026 年或将成为 IO2.0+ADC 组合的关键数据读出年。 🎯小编整理了IO2.0代表性产品PD-(L)1/VEGF联用ADC的研究进展，分享如下 🥇BioNtech：在IO2.0+ADC联用的布局最早，战略也比较清晰，通过授权的资产组合最大化临床价值。2022年启动了首个BNT327联合BNT325的联用研究，并于2025年AACR公开的临床前和初步临床结果，2026年将会读出多项临床联用的研究结果。 🐭在临床前研究中，BNT327联合多个ADC在肿瘤缓解和肿瘤控制方面展现了显著更优的药效 👴截至2025年3月，67例患者接受了BNT325（TROP2）+BNT327的联用方案 💀安全性方面，观察期内未见DLT，3级以上TRAE 32.8%，3例TRAE导致终止给药，包括1例3级口腔炎，1例2级ILD，1例5级肺炎。联用并未显著增加TRAE。有少量的毒性叠加，38例患者（56.7%）出现了口腔炎，其中3级口腔炎12例（17.9%），口腔炎导致17.9%患者BTN325减量。 🐮有效性方面，在2L-4L PROC，13例可评估患者，7例PR，3例SD，10例患者治疗中。NSCLC和TNBC也观察到药效。 🥈荣昌生物：RC148是另外一款有联合ADC临床数据读出的产品，已经开展了和自身两款管线RC118（CLDN18.2）和RC48（维迪西妥单抗）的临床研究。ADC联合疗法已经成为公司临床开发的主要策略。 🐮2025ESMO会议上，荣昌首次公开了RC118联合RC148的初步了临床结果：RC118与RC148 的组合方案展现出全面优势，ORR达 57.1%，显著高于 RC118 联合特瑞普利单抗治疗组的 33.3%；DCR 高达 95.2%，远优于 RC118 联合特瑞普利单抗治疗组的 66.7%；中位无进展生存期 mPFS为平均 7.9 个月，是RC118+特瑞普利单抗治疗组 4.3 个月的近两倍，且疾病进展或死亡风险显著降低了 57%。 💀安全性方面：整体安全性可控，3级以上TEAE2.8%，ADC联合IO2.0与ADC联合特瑞普利相比未显著增加安全性风险。 🥉康方生物：手握两款已经上市的IO2.0产品卡度尼利和依沃西，将迎来“众药互联”时代，结合其自主开发的ADC2.0产品，IO2.0+ADC2.0已经成为其重要战略。目前依沃西已经启动和宜联YL201的联用临床研究，与康宁杰瑞JSKN016的联用1L非小细胞肺癌的临床研究也已经进入临床II期。此外，即将启动联合自研ADC AK146D1，AK158D1的临床研究。 🏅三生制药：SSGJ-707于2025年5月与辉瑞达成全球独家授权协议，总交易金额超60亿美元，目前已收到28亿元的授权许可首付款等相关款项。在临床开发策略上实施3Wave 战略，2025年已经启动7项临床试验，包括和Nectin-4 ADC EV，IB 6 ADC Sigvotatug Vedotin的临床。2026年计划开展10+联用研究，包括联合ADC药物，建立去化疗的标准治疗方案。 🏅君实生物：3月27日君实生物年度业绩说明会上，明确JS207是公司未来两到三年最为关键的核心品种，企业将优先选择自主掌控其全球研发与商业化进程，仅当出现条件极为优厚且能大幅加快全球推进节奏的合作方案时，才会考虑对外授权。在临床开发计划上JS207将与JS212（EGFR/HER3 ADC）开展多项双抗联合ADC的组合疗法，目前已经启动2项联合212的临床研究，包括3月新启动的针对多种实体瘤的临床II期研究，此外与9MW2821（Nectin-4 ADC）启动了一线TNBC的联用临床研究。 🏅明慧医药：明慧医药自主研发了PD‑1/VEGF 双特异性抗体MHB039A，核心开发策略是联合自家 Trop2‑ADC（MHB036C）、B7‑H3‑ADC（MHB088C），聚焦肺癌 / 乳腺癌 / 实体瘤一线 / 后线，2025年启动了3项临床联用ADC研究。 🏅甫康生物：甫康生物开发了PD-L1/VEGF CVL006，临床前结果发表于Antibody Therapeutics（与AK112对比），单药I期结果也已经公开。2025年9月启动了联合SKB264，DS-8201，Nectin4 ADC EV的临床研究，目前已经进入II期拓展研究。 📚总结： IO2.0联合 ADC 的方案，是实体瘤治疗中 “免疫 + 化疗” 的升级版本，以精准靶向杀伤的 ADC 替代广谱细胞毒化疗，规避化疗带来的全身性不良反应提升患者治疗耐受性，同时突破传统ICI单抗联用 ADC 的协同天花板：既能通过多通路同步调控重塑免疫抑制肿瘤微环境、打破肿瘤血管屏障以提升 ADC 的肿瘤富集与渗透效率，又能双向放大 ADC 诱导的免疫原性细胞死亡效应与免疫激活作用，有效逆转 ADC 单药耐药、免疫冷肿瘤应答不足的痛点，是当前实体瘤治疗领域最具临床转化价值与商业化前景的核心研发赛道，期待更多临床数据为这一赛道提供数据支撑。点关注，不迷路参考文献： BNTC 2025 AACR 联用临床前和临床.pdf ESMO2025 RC118+RC148.pdf BioNTech Fourth Quarter and Full Year 2025 Earnings Presentation https://investors.biontech.de/system/files-encrypted/nasdaq_kms/assets/2026/03/20/8-29-25/BNTX%204QFY%20%202025%20Presentation_FINAL_200326.pdf 荣昌生物2025年度业绩： https://www.remegen.cn/uploadfile/2026/03/30/08a840c35a823bfa35e2e77da6bfc8e469ca19c03328d.pdf 康方生物2025年度业绩： https://www.akesobio.com/media/2808/akeso%E8%B7%AF%E6%BC%94%E6%9D%90%E6%96%99-20260327-final-%E7%BD%91%E7%BB%9C%E7%89%88.pdf 三生制药2025年度业绩： https://www.3sbio.com/ImgUpload/files/202603/2026033110100266424.pdf 君实生物2025年度业绩： https://junshi-bioscience-v2-umb.azurewebsites.net/media/awqkjqkx/cn-%E5%90%9B%E5%AE%9E%E7%94%9F%E7%89%A92025%E5%B9%B4%E5%B9%B4%E5%BA%A6%E4%B8%9A%E7%BB%A9.pdf 明慧医药招股书： https://www1.hkexnews.hk/app/sehk/2025/107887/documents/sehk25112401193_c.pdf

抗体药物偶联物临床结果AACR会议临床1期申请上市

2026-03-30

·医药速览

适配酚类载荷：新 ADC 平台如何同时搞定“水解稳定”与“高效释放”

长期以来，ADC 载荷开发多聚焦于含胺基的细胞毒素，而另一类带酚羟基的强效抗肿瘤毒素，却始终难以实现临床转化。传统酚羟基偶联策略，始终无法破解“血液循环中提前水解”与“肿瘤位点释放迟缓”的两难困局，成为 ADC 研发的核心技术瓶颈。近日，华东师范大学与中国药科大学的研究团队合作在《Journal of Controlled Release》发表研究“β-glucuronidase-triggered ortho-hydroxyl-mediated cyclization strategy for the efficient delivery of phenolic payloads in antibody-drug conjugates”开发出基于邻羟基苯胺骨架的新型自降解连接子策略，完美适配酚羟基类载荷，不仅实现了肿瘤微环境下的高效特异性释放，更在体内外实验中全面超越 DS-8201 类似物的临床标杆 ADC，为酚羟基类 ADC 研发搭建了全新技术平台。行业困局：酚羟基载荷为何成 ADC 研发 “老大难”？在ADC抗体、连接子、载荷三大核心元件中，载荷是杀伤肿瘤细胞的核心 “弹药”。喜树碱类、多卡霉素类等众多强效毒素均带有酚羟基，体外抗肿瘤活性极强，却迟迟难以转化为有效ADC药物，问题核心正出在连接子技术上。传统酚羟基偶联方式，始终无法平衡两大核心需求：一是血液循环中的稳定性，酚羟基构建的连接键极易在血液中提前水解，游离毒素会引发骨髓抑制、肝肾损伤等严重脱靶毒性；二是肿瘤位点的释放效率，若为提升稳定性修饰结构，又会导致肿瘤内毒素释放迟缓，直接削弱 ADC 抗肿瘤疗效。与此同时，传统疏水型连接子还会导致高药物抗体比（DAR）的 ADC 极易聚集，影响药代动力学、增加免疫原性风险。尽管亲水型 β- 葡萄糖醛酸酶可切割连接子已在临床验证了优异的肿瘤特异性，但其与酚羟基载荷的适配，始终是药物化学领域亟待攻克的难题。破局核心：邻羟基苯胺骨架，打造酚羟基载荷专属连接子平台面对行业痛点，团队设计出基于邻羟基苯胺骨架的新型自降解连接子策略，专为酚羟基类载荷量身打造，从根源解决了稳定性与释放效率的平衡难题，其技术设计的精妙之处体现在三大维度。第一，肿瘤特异性触发，精准释放活性毒素。团队以肿瘤微环境与癌细胞溶酶体中高表达的 β- 葡萄糖醛酸酶为触发开关，连接子上的葡萄糖醛酸基团被水解后，会立刻启动自降解级联反应，通过分子内环化高效释放游离活性毒素，体外实验验证该系统可实现近乎完全的 payload 释放。第二，亲水基团加持，破解疏水聚集难题。区别于传统疏水肽段连接子，系统自带的葡萄糖醛酸基团可有效屏蔽毒素疏水性，降低高 DAR ADC 的聚集倾向。团队还在基础骨架 GLU572 上引入 PEG8 侧链，打造出升级版 GLU579，通过 “PEG 掩蔽” 策略进一步提升了 ADC 溶解度与体内治疗指数。第三，pH 依赖性释放，完美适配肿瘤生理环境。该系统在 pH 5.5 的溶酶体酸性环境下，释放速率显著快于 pH 6.5 的肿瘤微环境，完美契合 β- 葡萄糖醛酸酶的最适催化 pH，实现了肿瘤位点的精准快速释药。硬核验证：疗效、稳定性、安全性全面碾压临床标杆基于该平台，团队以 HER2 靶向抗体曲妥珠单抗为载体，构建了 Tras-GLU572 与 Tras-GLU579 两款新型 ADC，并以 DS-8201 类似物 Tras-GGFG-DXd 为对照开展全面验证。理化性质上，两款 ADC 均实现约 8 的目标 DAR，单体纯度超 98%，亲水性显著优于对照药物；40℃热胁迫 7 天单体纯度仍保持 98% 以上，热稳定性优异；人源血浆孵育 7 天，Tras-GLU572 毒素释放仅 0.12%，Tras-GLU579 更是未检测到释放，远低于对照药物 3.32% 的释放量，从根源降低了脱靶毒性风险。体外活性上，两款 ADC 在 HER2 阳性细胞中引发强烈 S 期阻滞，NCI-N87 细胞 S 期占比从 31.9% 飙升至 60% 以上，而对照药物仅为 32.1%；对 HER2 阳性细胞 IC50 均约 1nM，与对照药物效力相当，对 HER2 阴性细胞则无明显杀伤，靶点特异性极强。体内抑瘤效果上，3mg/kg 单剂量给药后第 20 天，对照药物 T/C 值为 18.58%，Tras-GLU572 为 5.50%，Tras-GLU579 仅 2.33%；第 40 天实验终点，对照药物组肿瘤体积仍达 782mm³，Tras-GLU579 组仅 51mm³，更有小鼠实现肿瘤完全消退，且所有给药组小鼠体重均持续增长，耐受性良好。安全性上，10 倍治疗剂量的 30mg/kg 给药后，新型 ADC 组小鼠血液学、肝肾功能、心肌损伤相关指标均与对照组无差异，重要器官无病理异常，小鼠体重持续正常增长，而对照药物组小鼠体重增长出现停滞，治疗窗口优势显著。行业意义：突破技术瓶颈，打开 ADC 载荷开发全新边界这项研究的价值，远不止于开发出两款疗效更优的 HER2 靶向 ADC，更在于搭建了一个普适性的酚羟基载荷 ADC 开发平台，彻底解决了长期以来制约酚羟基类细胞毒素应用的合成与动力学难题。一直以来，ADC 载荷的开发范围被连接子技术所限制，大量具备强效抗肿瘤活性的酚羟基毒素，无法被有效应用于 ADC 研发。而这个全新的邻羟基苯胺骨架自降解连接子平台，为这类载荷提供了完美的适配方案，让科研人员能够将更多酚羟基类毒素纳入 ADC 的载荷库，极大地拓展了 ADC 药物的研发边界。同时，该平台兼具的肿瘤特异性激活、高血液循环稳定性、优异亲水性与低聚集倾向等优势，也为下一代 ADC 药物的研发提供了全新的设计思路，有望进一步提升 ADC 药物的疗效与安全性，拓宽治疗窗口。我们已经建立了医药交流群，群里有各大著名企业和重点高校的研究人员。大家可以一起讨论医药热点，分享经验，共同进步。想加入的话，扫码或添加小编微信（VX：Moon20240816），拉您进群！推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。 ©2021 医药速览保留所有权利往期链接 “小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记 PROTAC技术| 抗体药物| 抗体药物偶联-ADC 核酸疫苗 | CAR技术| 化学生物学温馨提示医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群请扫描上方二维码，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。简单操作即可星标⭐️医药速览，第一时间收到我们的推送 ①点击标题下方“医药速览” ②至右上角“...” ③点击“设为星标

2026-03-30

·Business Wire

Guardant Health’s InfinityAI Real-World Evidence Supports Approval of ENHERTU® for Previously Treated Patients with HER2-Positive Metastatic Solid Tumors in Japan

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that real-world evidence generated from Guardant’s InfinityAI contributed to the recent approval of ENHERTU® (trastuzumab deruxtecan), developed and commercialized by Daiichi Sankyo (TSE:4568) in Japan, for the treatment of patients with HER2-positive (HER2 [ERBB2] gene amplification or immunohistochemistry [IHC] 3+) advanced or recurrent solid cancers refractory or intolerant to standard treatments. This approval, granted by Japan’s Ministry of Health, Labour and Welfare (MHLW), was supported by data from the HERALD, DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01 clinical trials and supplemental real-world evidence (RWE) generated using the real-world data platform from InfinityAI, Guardant Health’s artificial intelligence platform. HER2 amplification is well characterized in breast cancer but patient identification and evidence continues to be challenging. In biomarker-defined populations with low prevalence, real-world data (RWD) can play a critical role in identifying patients at scale and characterizing unmet need. To support its MHLW application, Daiichi Sankyo incorporated real-world evidence generated from InfinityAI as supplemental data alongside clinical findings. Together, Guardant Health and Daiichi Sankyo analyzed outcomes from a large cohort of patients with HER2 amplifications detected via Guardant360®, demonstrating significant unmet need and real-world clinical relevance across multiple tumor types. The collaboration illustrates an innovative pathway that leverages high-quality RWE to complement clinical trial data, particularly in genomic subpopulations where traditional trial enrollment may be limited. “This approval highlights the growing role of real-world evidence in precision oncology and underscores the potential for new regulatory pathways in rare biomarker-defined populations,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “InfinityAI allows us to generate clinically meaningful evidence from large-scale, longitudinal data, helping to complement traditional trials and ultimately expand access to targeted therapies for patients who might otherwise be overlooked.” About InfinityAI InfinityAI is Guardant Health’s artificial intelligence and machine learning platform for generating real-world evidence and data-driven insights. It is built on a large, proprietary dataset derived from Guardant Health’s clinical testing portfolio, integrating longitudinal, multimodal molecular and clinical data, including genomic and epigenomic information, into a unified framework. InfinityAI supports biopharma and healthcare partners across research, development, and clinical applications, including biomarker discovery, patient identification, and clinical trial optimization. Through flexible data and analytics solutions, InfinityAI enables more informed decision-making to improve development efficiency and patient outcomes. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Guardant Health Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

上市批准临床研究免疫疗法

100 项与德曲妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	德曲妥珠单抗	L01XC	DB14962

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
胃癌	印度	AstraZeneca PLC	2025-10-07
HER2阳性实体瘤	英国	Daiichi Sankyo UK Ltd.	2025-04-09
HR阳性/HER2低表达乳腺癌	美国	Daiichi Sankyo Co., Ltd.	2025-01-28
HR阳性/HER2阳性乳腺癌	韩国	Daiichi Sankyo Co., Ltd.	2022-09-19
HER2突变型非小细胞肺癌	美国	Daiichi Sankyo, Inc.	2022-08-11
HER2阳性胃腺癌	澳大利亚	AstraZeneca Pty Ltd.	2021-10-08
HER2低表达乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	2021-10-08
转移性乳腺癌	加拿大	AstraZeneca Canada, Inc.	2021-04-15
HER2阳性胃食管结合部腺癌	美国	Daiichi Sankyo, Inc.	2021-01-15
HER2阳性胃癌	日本	Daiichi Sankyo Co., Ltd.	2020-09-25
HER2阳性乳腺癌	美国	Daiichi Sankyo, Inc.	2019-12-20

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
HER2阳性子宫内膜癌	临床3期	美国	Daiichi Sankyo, Inc.	2026-03-12
HER2阳性子宫内膜癌	临床3期	中国	Daiichi Sankyo, Inc.	2026-03-12
HER2阳性子宫内膜癌	临床3期	日本	Daiichi Sankyo, Inc.	2026-03-12
HER2阳性子宫内膜癌	临床3期	阿根廷	Daiichi Sankyo, Inc.	2026-03-12
HER2阳性子宫内膜癌	临床3期	巴西	Daiichi Sankyo, Inc.	2026-03-12
HER2阳性子宫内膜癌	临床3期	加拿大	Daiichi Sankyo, Inc.	2026-03-12
HER2阳性子宫内膜癌	临床3期	智利	Daiichi Sankyo, Inc.	2026-03-12
HER2阳性子宫内膜癌	临床3期	法国	Daiichi Sankyo, Inc.	2026-03-12
HER2阳性子宫内膜癌	临床3期	德国	Daiichi Sankyo, Inc.	2026-03-12
HER2阳性子宫内膜癌	临床3期	希腊	Daiichi Sankyo, Inc.	2026-03-12

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AACR2026	N/A	HER2阳性卵巢癌 \| HER2表达子宫内膜癌 HER2 expressing	33	Trastuzumab deruxtecan	廠繭齋夢網選築窪艱獵(壓願鏇襯膚鏇築齋構蓋) = 鑰鹽構遞鬱網鹽窪簾獵鬱醖網鏇簾鏇鏇糧繭積 (齋夢願壓醖範鹹鏇範憲 ) 更多	积极	2026-04-20
				Trastuzumab deruxtecan (Ovarian cancer)	廠繭齋夢網選築窪艱獵(壓願鏇襯膚鏇築齋構蓋) = 齋鬱糧糧顧夢醖鏇製壓鬱醖網鏇簾鏇鏇糧繭積 (齋夢願壓醖範鹹鏇範憲 ) 更多
AACR2026	N/A	转移性结直肠癌二线 HER2-amplified \| MSS	3,734	trastuzumab deruxtecan	憲壓鏇衊網鹽築壓餘淵(膚糧繭網願選艱衊廠齋): HR = 1.14 (95.0% CI, 1.05 ~ 1.24), P-Value = 0.0024 更多	积极	2026-04-19
				Standard Chemotherapy
ESMO_TAT2026	N/A	HER2-positive \| ERBB2-mutated	61	Trastuzumab deruxtecan (ERBB2 mutations)	鏇製鬱觸鏇糧憲襯選蓋(鹽鹽艱醖廠願鏇願窪觸) = 蓋窪膚鬱夢範艱鑰顧構構艱膚構選夢鬱醖憲艱 (鏇鹽糧糧醖範選鏇網艱 ) 更多	积极	2026-03-16
				Trastuzumab deruxtecan (HER2 IHC 3+)	鏇製鬱觸鏇糧憲襯選蓋(鹽鹽艱醖廠願鏇願窪觸) = 糧鑰鏇膚構選遞製壓積構艱膚構選夢鬱醖憲艱 (鏇鹽糧糧醖範選鏇網艱 ) 更多
NCT05744375 (TRANSCENDER, CTgov)	临床2期	局部晚期乳腺癌 \| HER2阳性转移性乳腺癌	2	Trastuzumab deruxtecan	壓夢築艱糧衊觸積觸窪 = 齋鹹遞壓壓淵廠繭願膚製網簾鏇糧鹹鹽鹹積獵 (構簾願憲網簾獵積鏇網, 壓鏇醖蓋願鹹餘顧鏇窪 ~ 遞築製鏇願憲顧獵遞獵) 更多	-	2026-03-12
ESMO_SRC2026	N/A	实体瘤	9	Trastuzumab deruxtecan	獵壓糧糧積窪醖網顧願(選遞範簾簾製積艱繭糧) = 觸襯醖夢鑰遞獵鹽蓋糧艱遞鹹願鑰獵範淵構願 (鬱鹽繭齋鹹鏇願艱繭艱 )	积极	2026-03-09
NCT06989112 (DESTINY-Endometrial01, ESGO2026)	临床3期	复发性子宫内膜癌一线 HER2-expressing \| mismatch repair-proficient (pMMR)	600	trastuzumab deruxtecan + rilvegostomig	範鏇願憲壓廠醖艱鏇製(遞築醖艱蓋齋窪廠遞網) = 網鹹製餘壓鹽襯鹽廠襯獵顧構鬱鬱選廠選艱膚 (廠餘範顧觸齋積網鏇獵, 24.9 ~ NR) 更多	积极	2026-02-28
				trastuzumab deruxtecan + pembrolizumab	蓋夢鹹築蓋繭廠顧鏇齋(蓋繭積遞鬱餘醖夢鑰膚) = 廠夢願鏇觸製餘醖窪廠簾憲壓糧鹹衊廠願鑰願 (獵簾鏇鹹壓範繭廠願鬱, 8.3 ~ 16.5) 更多
NCT04622319 (DESTINY-Breast05, Pubmed \| N Engl J Med)	临床3期	HER2阳性乳腺癌新辅助 HER2-positive	1,635	Trastuzumab Deruxtecan	糧憲範範糧構鹹築獵構(構網獵築夢顧願顧鏇鬱) = 網廠鏇觸艱鏇窪築鹹襯餘齋鏇鑰選衊構襯鏇憲 (鬱繭製衊廠鹽鹽齋壓願 ) 更多	积极	2026-02-26
				Trastuzumab emtansine (T-DM1)	糧憲範範糧構鹹築獵構(構網獵築夢顧願顧鏇鬱) = 製顧遞艱構遞艱窪壓蓋餘齋鏇鑰選衊構襯鏇憲 (鬱繭製衊廠鹽鹽齋壓願 ) 更多
NCT04482309 (DESTINY-PanTumor02 (DP-02), ASCO_GU2026)	临床2期	膀胱癌 HER2-expressing	41	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W	鬱窪網餘構糧範範鑰鹹(襯襯顧鬱衊夢糧築範選) = 淵鬱製遞築構範選鏇遞構憲齋憲繭鹹鏇糧積鑰 (繭夢簾製鹽膚鏇衊蓋製, 26.3 ~ 57.9) 更多	积极	2026-02-26
				Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W (HER2 IHC 3+)	鬱窪網餘構糧範範鑰鹹(襯襯顧鬱衊夢糧築範選) = 簾網襯廠糧獵築顧構廠構憲齋憲繭鹹鏇糧積鑰 (繭夢簾製鹽膚鏇衊蓋製, 29.9 ~ 80.2) 更多
NCT06610825 (CARPET, ASCO_GU2026)	临床2期	转移性去势抵抗性前列腺癌 HER2-positive (IHC 1+, 2+, or 3+)	5	trastuzumab deruxtecan	範簾構淵製蓋繭積醖醖(壓鏇構鏇壓糧鑰襯願鹹) = 簾繭遞選淵範獵夢廠鹽糧窪築糧築蓋範廠鬱齋 (鬱夢窪廠構鏇壓餘衊繭 ) 更多	积极	2026-02-26
NCT06764875 (ARTEMIDE-Gastric01, ASCO_GI2026)	临床3期	转移性 HER2 阳性胃食管结合部癌一线 HER2-positive \| PD-L1 CPS ≥1	840	rilvegostomig + T-DXd + investigator’s choice of capecitabine or 5-fluorouracil (5-FU)	積鑰廠衊窪簾膚壓窪願(選遞構鏇襯蓋鹽衊糧顧) = 鹽構顧蓋廠蓋鑰齋窪獵築製鹹積願廠襯糧壓鏇 (觸遞鑰糧積顧範廠醖獵, 24.9 ~ NR)	积极	2026-01-08
				rilvegostomig + trastuzumab + investigator’s choice of FP or CAPOX	範膚繭廠夢遞衊構繭鏇(鬱艱壓餘淵艱繭夢築鹽) = 顧構淵構觸範觸築選淵蓋襯遞鹹築鏇醖繭觸餘 (淵選鏇鹽繭範艱顧製觸, 17.0 ~ NR) 更多