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.

开始日期2025-09-07

申办/合作机构

Daiichi Sankyo Co., Ltd.

[+1]

NCT06486883

/ Not yet recruiting临床2期

A Randomized Phase II Study to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan Versus CDK4/6 Inhibitor-based Endocrine Therapy as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype According to Gene Expression Profiling.

This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET). The main purpose of the study is to analyze the efficacy of T-DXd in patients who have HR-positive and HER2-low/ultralow advanced breast cancer classified as non-luminal subtype.

开始日期2025-05-01

申办/合作机构

Medica Scientia Innovation Research SL

ChiCTR2500099141

/ SuspendedN/AIIT

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

开始日期2025-05-01

申办/合作机构

广东医科大学附属医院

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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812

项与德曲妥珠单抗相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

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

Article

作者: You, Shuhui ; Gong, Caifeng ; Cai, Qi ; Huang, Jinglong ; Zhang, Wen ; 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.

2025-06-01·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

作者: 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.

2025-06-01·PATHOLOGY

HER2-low across solid tumours: different incidences and definitions

Review

作者: von der Thüsen, Jan ; van Deurzen, Carolien H M ; Curigliano, Giuseppe ; Fusco, Nicola ; Groenendijk, Floris H ; 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.

2,866

项与德曲妥珠单抗相关的新闻（医药）

2025-05-27

·新药前沿

ASCO 2025 亮点聚焦：肿瘤学关键进展与中国崛起的全球影响力

2025年美国临床肿瘤学会（ASCO）年会于芝加哥拉开帷幕，会议将围绕乳腺癌与血液癌突破性进展、创新治疗模式及中国在肿瘤研发中的崛起展开。以下是核心亮点梳理：乳腺癌与血液癌：改变临床实践的数据乳腺癌领域SERENA-6试验（阿斯利康）：III期研究评估口服选择性雌激素受体降解剂（SERD）camizestrant联合CDK4/6抑制剂治疗HR阳性/HER2阴性晚期乳腺癌合并ESR1突变患者。该试验首次证明无需影像学进展即可显著延长无进展生存期（PFS），被MD Anderson专家称为“内分泌耐药管理的范式转变”。DESTINY-Breast09（阿斯利康/第一三共）：抗体偶联药物（ADC）Enhertu联合或不联合罗氏Perjeta作为HER2阳性转移性乳腺癌一线治疗的III期数据公布，为患者提供“去化疗化”高效选择。血液癌突破Rusfertide（武田/Protagonist）：治疗真性红细胞增多症的拟铁调素类似物在III期VERIFY试验中展现显著疗效——77%患者达主要终点（安慰剂组33%），减少放血需求并改善生活质量，获全体大会报告席位。微小残留病（MRD）检测：多发性骨髓瘤MRD动态监测技术或成新药开发“加速器”，推动临床策略革新。创新治疗模式：双/三特异性抗体与放射性药物双特异性抗体：针对“冷肿瘤”（如前列腺癌、胆囊癌）的VEGF/免疫双靶点抗体崭露头角，通过抑制血管生成同时激活免疫应答破解治疗困境。三特异性抗体：强生JNJ-5322与Ichnos GlenmarkISB-2001针对复发/难治多发性骨髓瘤的早期临床数据首次披露，开启靶向治疗新维度。放射性药物：新型同位素与生物标志物发现推动领域爆发，MD Anderson专家称“放射药物正从诊断工具向精准治疗武器进化”。中国力量：从“快速跟随”到全球创新引领者研发占比跃升：Truist证券报告指出，ASCO 2025近1/3报告涉及中国公司研发管线，印证中国从“仿制跟随”向“首创新药（FIC）”的战略转型。案例聚焦：康方生物/Summit的PD-1/VEGF双抗ivonescimab：临床数据或撼动Keytruda在免疫治疗霸主地位，引发默沙东、辉瑞等巨头争相布局同类管线。行业影响：专家指出，中美创新竞争将催生“激发彼此潜力”效应——倒逼药企聚焦差异化管线设计与生物学机制深度挖掘，最终惠及全球患者。ASCO 2025不仅是肿瘤治疗前沿的展示窗口，更成为全球研发格局变迁的缩影。从耐药破解到冷肿瘤攻坚，从中国创新崛起到治疗模式革新，这场盛会或将重塑未来十年癌症治疗版图。本文由「新药前沿」微信公众号根据公开资料整理编辑，欢迎个人转发至朋友圈。媒体或机构转载授权请在「新药前沿」微信公众号留言公众号名称，审核通过后开通白名单获取转载授权，转载请标识来源。免责声明：本文仅作信息交流之目的，非投资建议或者治疗方案推荐，「新药前沿」微信公众号不对任何主体因使用本文内容而导致的任何损失承担责任。限于作者水平和专业知识所限，如有谬误，欢迎指正！

ASCO会议抗体药物偶联物临床3期临床结果

2025-05-27

·氨基观察

吉利德走出水逆？

氨基观察-创新药组原创出品作者 | 武月2024年，吉利德堪称水逆王者。重金收购的Trodelvy，在非小细胞肺癌和尿路上皮癌的三期临床试验中接连失利，并撤回尿路上皮癌适应症的加速批准，一度被贴上“水逆”标签。戏剧性的是，在2025年，这款Trop2 ADC却在三阴性乳腺癌（TNBC）领域接连取胜：2025年4月21日，Trodelvy联合K药一线治疗转移性TNBC的ASCENT-04试验成功；5月23日，单药一线治疗PD-L1阴性TNBC的ASCENT-03试验再传捷报。这两项关键3期临床的胜利，有可能让Trodelvy成为一线mTNBC所有患者的骨干疗法，巩固其在首发适应症三阴乳腺癌的优势，更让吉利德的肿瘤管线重燃希望。但这并非终点。在ADC赛道“内卷”加剧的当下，Trodelvy既要面对同靶点竞品的围剿，又要警惕HER2 ADC的“跨界打击”。更紧迫的是，吉利德必须尽快突破乳腺癌的“舒适区”。Trodelvy在肺癌领域的失利阴影尚未消散，而小细胞肺癌、子宫内膜癌等新战场的开拓能否成功，将决定其能否真正走出水逆。当然，这不只决定Trodelvy处境，可能决定了Trop2 ADC的命运。/ 01 /一线突破三阴性乳腺癌因缺乏治疗靶点、预后极差，号称“乳腺癌之王”，给年轻女性的健康造成极大威胁。过去20年，化疗始终是标准疗法，但中位生存期仅1-2年。Trodelvy的崛起，始于2021年ASCENT试验中二线治疗的突破，而2025年的两项三期临床胜利，则将其推向了更前线的战场。4月21日，吉利德宣布，Trodelvy+K药联合一线治疗转移性三阴乳腺癌的ASCENT-04试验获得成功。该研究针对既往未接受过治疗的PD-L1高表达（CPS≥10）不可切除局部晚期或转移性三阴性乳腺癌（mTNBC）患者，结果显示，相较于K药联合化疗，Trodelvy+K药的方案在无进展生存期（PFS）方面展现出统计学及临床意义的显著改善，OS作为关键次要终点其数据尚未成熟，但呈现早期积极趋势。安全性方面，联合疗法未出现新的安全信号，与单药已知特性一致，具体数据将在即将举行的ASCO会议上披露。这也是mTNBC首个达到PFS终点的PD-1+Trop2 ADC联合治疗的三期临床试验。5月23日，吉利德再次宣布，Trodelvy单药一线治疗PD-L1阴性TNBC的ASCENT-03试验成功，与化疗相比，在不适合PD-1/PD-1的mTNBC患者中，经过Trodelvy治疗的患者PFS具有高度统计学意义和临床意义的改善。安全性方面也与之前的试验表现相同。传统化疗一直是mTNBC早期治疗的标准护理，但是化疗的效果亟待改善，并且吉利德表示，在mTNBC中，大约50%的患者没有接受超过1线的治疗，这表明需要额外的有效早线治疗选择。吉利德首席医疗官Dietmar Berger表示：“与化疗相比，ASCENT-03结果代表了20多年来这一患者群体的首次临床上有意义的进步。通过更早地解决这种侵袭性和难以治疗的疾病，我们有可能改善转移性三阴性乳腺癌患者面临的高未满足需求的治疗方案。”更重要的是，这两项关键三期临床的成功，使Trodelvy有望覆盖所有一线TNBC患者，成为新的“骨干疗法”。2024年，Trodelvy的销售额为13.15亿美元，若成功拓展至一线三阴乳腺癌，对吉利德显然是一大步。花旗分析师甚至预测，2030年Trodelvy的峰值销售额或达32亿美元。/ 02 /TNBC攻防战2025年一季度，Trodelvy的销售额出现了下滑，尽管吉利德表示这是库存调整所导致的，但市场竞争的压力不言而喻。能否借临床胜利保持增势，将是吉利德的下一个考验。毕竟，TROP2这个靶点在乳腺癌中的前景并不是十分明朗，不仅要面对同靶点药物的竞争，还要担心HER2 ADC的“背刺”，后来者的超车。即使是在Trodelvy已经建立先发优势的TNBC领域，HER2 ADC、后来者的攻势已箭在弦上。首先是双抗药物的进击。康方生物的PD-1/VEGF双抗AK112，普米斯/BioNTech的PD-L1/VEGF双抗PM8002以及康宁杰瑞的PD-1/CTLA-4双抗KN046，也正在加速探索TNBC适应症，AK112、PM8002已在2期试验中展现出对PD-L1高/低表达TNBC的强势疗效，并启动三期临床。在去年底召开的圣安东尼奥乳腺癌研讨会(SABCS)会上，AK112、PM8002更新了其一线治疗三阴乳腺癌的数据，前者的mPFS为9.3个月，后者为13.5个月。由于研发进度更快，PM8002已经读出部分OS数据，12个月和15个月的OS率分别为80.8%和78.1%。如果能够延续这样的临床表现，双抗无疑将为TNBC患者带来新的选择。除此之外，BioNtech还在全速推进PD-L1/VEGF+ADC策略，这无疑也会对吉利德的PD-1+TROP-2 ADC联用造成冲击。其次是HER2 ADC的“背刺”。虽然TNBC不适用于传统HER2靶向药，但有着旁观者效应的HER2 ADC，能对其中占比约30%的HER2低表达TNBC患者发挥作用。DS-8201率先在HER2低表达中取得突破。在一项3期临床DESTINY-Breast04中，纳入既往接受过1-2线化疗的低表达HER2的不可切除性或转移性乳腺癌患者，结果表明相比化疗组，DS-8201组ORR达50%，接受化疗的患者仅为16%，PFS更是增长了近3倍，OS也获益翻倍。尽管该研究样本数有限，但虑到目前TNBC治疗选择的有限性，以及DS-8201在低水平表达HER2的TNBC患者中的显著疗效，这也为TNBC提供了新方向。作为首发阵地，吉利德围绕三阴乳腺癌进行了全方位布局，除了前述的两项3期临床，还在开展PD-1+Trop2 ADC用于三阴乳腺癌术后辅助治疗的3期临床试验。除此之外，吉利德表示，正在对Trodelvy开展的一系列Trop-2高表达的肿瘤3期试验进行评估，包括单药及与K药的联用，涉及TNBC和HR+/HER2-乳腺癌的早期治疗。但是，在强手林立的世界，真正的护城河不在于数量，而是临床数据的深度，能否在OS/PFS最终分析中保持优势，并证明其在真实世界中的成本效益，将决定Trodelvy的长期竞争力。/ 03 /不能止于乳腺癌作为自己重金收购而来的ADC，吉利德没有理由、也不能放弃对它的潜力挖掘。换句话说，Trodelvy不能止于乳腺癌，倘若能在肺癌领域取得突破，必将开拓更大的市场。只不过，在非小细胞肺癌（NSCLC）领域，Trodelvy已经有了一次重大失利。2024年1月22日，名为EVOKE-01的研究没有达到OS的主要终点。在与对照组化疗相比，Trodelvy并未为晚期NSCLC患者带来OS改善，这也导致市场对Trodelvy预期的走低。目前其进度大为落后对手，科伦博泰的SKB264已经获批用于三线EGFR突变NSCLC，成功突围肺癌；第一三共的Dato-DXd也在失败之后，从广泛探索到“锚定”EGFR突变的NSCLC，并重新提交了新的上市申请，也获得了FDA的突破性疗法认定。对于Trodelvy来说，EVOKE-01研究也并非一无所获。通过该研究，吉利德发现患者此前接受PD-(L)1抑制剂治疗时的应答状态，会对Trodelvy治疗效果产生影响。简单来说，对于PD-(L)1抑制剂无应答的患者，相比经过PD-(L)1抑制剂治疗达成完全缓解或部分缓解的患者，或许能够在Trodelvy的治疗中获益更多。这也为TROP2 ADC在肺癌领域的应用提供了新的思路和方向。默沙东则在开展Trodelvy联合K药对比K药单药一线治疗PD-L1≥50%的NSCLC患者的3期临床。此前，联合治疗组在治疗PD-L1高表达患者的ORR达到69%，疾病控制率达到86%。Trodelvy能否在细分人群中扳回一城，仍是未知数。与此同时，吉利德也在推进Trodelvy在肺癌领域的其他研究。2024年国际肺癌研究协会世界肺癌大会上，吉利德公布了2期临床试验TROPiCS-03中广泛期小细胞肺癌（ES-SCLC）队列的结果。结果显示，43例小细胞肺癌患者，均为一线化疗联合免疫治疗耐药，该临床经确认的缓解率为41.9%，即43例患者中有18例达到PR，mPFS为4.4个月，中位OS为13.6个月。2024年底，FDA授予Trodelvy突破性疗法认定，用于治疗接受铂类化疗后疾病进展的ES-SCLC患者；今年2月份，Trodelvy已经登记了二线小细胞肺癌3期临床。小细胞肺癌约占肺癌病例的15%，其中约70%的患者在确诊时处于广泛期。对于ES-SCLC患者来说，当疾病对当前一线标准治疗（铂类化疗或免疫疗法）无应答时，预后通常较差且治疗选择有限。这意味着，若最终临床成功，吉利德无疑会开辟一片新市场，也能让市场重拾对Trodelvy的预期。/ 04 /总结肺癌领域足够宽广，但也已经足够内卷。去年7月，吉利德还启动了Trodelvy在子宫内膜癌患者中的三期临床，此外，其在胃癌、膀胱癌的早期探索也在进行中，只不过前路漫漫。总体来看，Trodelvy的三阴乳腺癌连续胜利，为吉利德赢得了喘息之机，但远非终局。在ADC赛道，既有DS-8201这样的超级明星，也有SKB264等本土黑马。若不能尽快在肺癌、妇科肿瘤等领域复制成功，Trodelvy恐难逃被替代的宿命。这就是ADC江湖的生存法则，不进则退。PS：欢迎扫描下方二维码，添加氨基君微信号交流。

临床3期ASCO会议抗体药物偶联物临床结果引进/卖出

2025-05-27

·Business Wire

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

临床结果临床2期ASCO会议

100 项与德曲妥珠单抗相关的药物交易

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

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
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

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适应症	最高研发状态	国家/地区	公司	日期
非鳞状非小细胞肺癌	临床3期	-	Daiichi Sankyo Co., Ltd.	2025-09-07
HER2阳性卵巢癌	临床3期	美国	Daiichi Sankyo, Inc.	2025-05-14
HER2阳性卵巢癌	临床3期	中国	Daiichi Sankyo, Inc.	2025-05-14
HER2阳性卵巢癌	临床3期	日本	Daiichi Sankyo, Inc.	2025-05-14
HER2阳性卵巢癌	临床3期	澳大利亚	Daiichi Sankyo, Inc.	2025-05-14
HER2阳性卵巢癌	临床3期	奥地利	Daiichi Sankyo, Inc.	2025-05-14
HER2阳性卵巢癌	临床3期	比利时	Daiichi Sankyo, Inc.	2025-05-14
HER2阳性卵巢癌	临床3期	巴西	Daiichi Sankyo, Inc.	2025-05-14
HER2阳性卵巢癌	临床3期	保加利亚	Daiichi Sankyo, Inc.	2025-05-14
HER2阳性卵巢癌	临床3期	捷克	Daiichi Sankyo, Inc.	2025-05-14

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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


NCT04739761 (DESTINYBreast-12 \| DESTINY-B12 \| DESTINY-Breast12, CTgov)	临床3期	HER2阳性转移性乳腺癌 \| 脑转移瘤	506	Trastuzumab Deruxtecan (T-DXd (Cohort 1: Trastuzumab Deruxtecan (T-DXd))	構網築鏇憲蓋糧糧簾獵 = 艱淵餘鏇積構窪獵衊獵簾糧衊鹹獵餘夢膚淵鑰 (艱積繭醖鑰夢遞齋網鹽, 願遞醖鏇顧餘選醖鏇鹽 ~ 網膚窪憲範範積獵窪壓) 更多	-	2025-05-16
				Trastuzumab Deruxtecan (T-DXd (Cohort 2: Trastuzumab Deruxtecan (T-DXd))	鬱鹹構醖選網齋廠糧鏇 = 遞鹽膚選築廠選襯觸觸願廠鏇糧鹽繭壓顧鹹鏇 (夢齋壓積廠鑰鏇襯鑰窪, 餘糧觸蓋鹽餘積簾窪襯 ~ 廠繭網醖艱醖鏇夢築鬱) 更多
NCT04494425 (DESTINY-Breast06, ESMO_BC 12025 \| ESMO_BC 22025) 人工标引	临床3期	转移性乳腺癌 Hormone Receptor Positive	866	Trastuzumab deruxtecan (T-DXd) (subgroups 1)	齋鹹構鹽襯壓願糧鑰網(顧簾夢窪構餘壓願糧艱) = 蓋蓋鹽簾鬱觸網蓋鏇鏇鑰壓繭蓋廠窪願蓋餘獵 (糧願淵鹹膚醖壓構顧範, 11.4 ~ 15.4) 更多	积极	2025-05-15
				Chemotherapy (CAPE) (subgroups 1)	齋鹹構鹽襯壓願糧鑰網(顧簾夢窪構餘壓願糧艱) = 鑰遞醖鏇範顧網鑰製鏇鑰壓繭蓋廠窪願蓋餘獵 (糧願淵鹹膚醖壓構顧範, 7.0 ~ 11.3) 更多
NCT03523585 \| NCT03529110 (DESTINY-Breast03, ESMO_BC 12025 \| ESMO_BC 22025) 人工标引	临床3期	转移性乳腺癌 HER2 Positive	-	Trastuzumab monotherapy (DESTINY-Breast02)	鬱鹽顧齋獵觸壓壓願獵(獵夢願獵構顧觸網夢憲) = 製壓鬱網願壓窪糧鏇夢醖餘選鏇獵壓鹽夢醖繭 (憲齋鑰淵願製糧廠夢廠, 0.0 ~ 25.4)	积极	2025-05-15
				Trastuzumab-based combinations (DESTINY-Breast02)	鬱鹽顧齋獵觸壓壓願獵(獵夢願獵構顧觸網夢憲) = 襯顧繭願膚齋築齋築鏇醖餘選鏇獵壓鹽夢醖繭 (憲齋鑰淵願製糧廠夢廠, 0.0 ~ 40.9)
ESMO_BC2025	N/A	HER2阳性转移性乳腺癌 HR+	145	Trastuzumab tucatinib capecitabine (TTC)	選願積齋壓壓範鑰膚網(繭鑰製糧選網遞願鬱簾) = 範獵襯鹹鬱淵築窪鬱積壓餘衊餘遞繭衊艱齋願 (壓網窪齋範憲選鑰繭鹽, 3.3 ~ 5.6)	-	2025-05-14
				Trastuzumab (T) + chemotherapy (CT)	選願積齋壓壓範鑰膚網(繭鑰製糧選網遞願鬱簾) = 鹹壓糧鏇憲憲獵鹽顧蓋壓餘衊餘遞繭衊艱齋願 (壓網窪齋範憲選鑰繭鹽, 1.6 ~ 5)
ESMO_BC2025	N/A	转移性乳腺小叶癌 HER2wt \| HER2m	43	trastuzumab deruxtecan (T-DXd) (HER2wt)	繭襯壓窪鹽膚壓觸齋鬱(簾築憲膚顧願蓋膚觸淵) = 繭範淵構襯壓積鏇鹹願顧願艱窪鏇顧鬱窪繭餘 (醖願壓壓簾網壓網膚願 ) 更多	积极	2025-05-14
				trastuzumab deruxtecan (T-DXd) (HER2m)	繭襯壓窪鹽膚壓觸齋鬱(簾築憲膚顧願蓋膚觸淵) = 衊鬱鬱鬱餘獵鑰鹽製齋顧願艱窪鏇顧鬱窪繭餘 (醖願壓壓簾網壓網膚願 ) 更多
DeReal-REST (ESMO_BC2025)	N/A	晚期 HER2 阳性乳腺癌二线	69	trastuzumab-deruxtecan (Good-responder group (PFS≥12 mo))	築繭繭積鏇製醖築簾餘(範壓鹹鏇築構構製顧憲) = 積遞夢憲鏇網蓋願膚夢鏇繭齋簾憲製網積選鹹 (製觸衊簾鏇觸積積願淵, 8.9 ~ 20.3)	积极	2025-05-14
ESMO_BC2025	N/A	HER2阳性转移性乳腺癌 HER2-positive	1,689	Trastuzumab Deruxtecan	蓋遞鹹糧繭憲積觸繭襯(願糧窪夢簾遞遞艱襯觸): HR = 0.42 (95% CI, 0.3 ~ 0.6), P-Value = < 0.001 更多	积极	2025-05-14
				Control
ESMO_BC2025	N/A	转移性乳腺癌 BRCA mutations \| PD-L1 status	1,098	trastuzumab deruxtecan (T-DXd) (BRCA mutations)	製觸鑰範艱鏇願夢願繭(獵顧鹽簾願鬱餘餘選憲) = The 5-year OS rates were not significantly different between group B and group A 顧築鬱鹽簾簾衊網構觸 (壓淵築鑰鏇築繭鬱淵繭 )	-	2025-05-14
				trastuzumab deruxtecan (T-DXd) (PD-L1 positive)
NCT05113251 (DESTINY-Breast11, PipelineReview) 人工标引	临床3期	HER2阳性乳腺癌 HER2 Positive	-	ENHERTU + paclitaxel, trastuzumab and pertuzumab (THP)	鹹淵鹽齋蓋鑰醖醖簾壓(遞鬱願餘鹹夢遞網餘艱) = demonstrated a statistically significant and clinically meaningful improvement. 襯選艱構繭獵糧衊範選 (簾積顧蓋憲鏇鏇築顧築 ) 更多	积极	2025-05-07
				dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]
AACR2025	N/A	乳腺癌 HER2 expression	375	Trastuzumab deruxtecan (T-DXd)	窪鏇窪憲遞蓋憲艱選鹽(鏇醖憲壓襯壓淵觸餘網) = 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+ 糧淵遞齋襯壓網願獵鏇 (淵鏇廠窪膚鹽獵鬱襯蓋 ) 更多	积极	2025-04-29