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]

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

NCT06750484

/ Recruiting临床2期IIT

Open-label Single-arm Phase 2 Trial of Trastuzumab Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced Breast Cancer

The purpose of this study is to test the good and bad effects of a drug called trastuzumab deruxtecan (T-DXd) in adult patients with metastatic HER2-negative breast cancer and which patients might benefit the most from T-DXd.

开始日期2025-05-01

申办/合作机构

Yale University

[+2]

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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775

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.

2025-05-01·EUROPEAN UROLOGY

European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2025 Guidelines

Review

作者: Smith, Emma J ; Bruins, Harman Max ; Sæbjørnsen, Sæbjørn ; Mariappan, Param ; Martini, Alberto ; Cathomas, Richard ; van der Heijden, Antoine G ; Dimitropoulos, Konstantinos ; Neuzillet, Yann ; Panebianco, Valeria ; Efstathiou, Jason A ; Thalmann, George N ; Fietkau, Rainer ; Mertens, Laura S ; Lorch, Anja ; Kailavasan, Mithun ; Compérat, Eva ; Carrion, Albert ; Meijer, Richard P ; Milowsky, Matthew I ; Rink, Michael

BACKGROUND AND OBJECTIVE:

This publication represents a summary of the updated 2025 European Association of Urology (EAU) guidelines for muscle-invasive and metastatic bladder cancer (MMIBC). The aim is to provide practical recommendations on the clinical management of MMIBC with a focus on diagnosis, treatment, and follow-up.

METHODS:

For the 2025 guidelines, new and relevant evidence was identified, collated, and appraised via a structured assessment of the literature. Databases searched included Medline, EMBASE, and the Cochrane Libraries. Recommendations within the guidelines were developed by the panel to prioritise clinically important care decisions. The strength of each recommendation was determined according to a balance between desirable and undesirable consequences of alternative management strategies, the quality of the evidence (including the certainty of estimates), and the nature and variability of patient values and preferences.

KEY FINDINGS AND LIMITATIONS:

The key recommendations emphasise the importance of thorough diagnosis, treatment, and follow-up for patients with MMIBC. The guidelines stress the importance of a multidisciplinary approach to the treatment of MMIBC patients and the importance of shared decision-making with patients. The key changes in the 2025 muscle-invasive bladder cancer (MIBC) guidelines include the following: a new recommendation for the use of susceptible FGFR3 alterations to select patients with unresectable or metastatic urothelial carcinoma for treatment with erdafitinib; significant adaption and update of the recommendations for pre- and postoperative radiotherapy and sexual organ-preserving techniques in women; new recommendation related to radical cystectomy and extent of lymph node dissection based on the results of the SWOG trial; recommendation related to hospital volume; new recommendations for salvage cystectomy after trimodality therapy and for the management of all patients who are candidates for trimodality bladder-preserving treatment in a multidisciplinary team setting using a shared decision-making process; significant adaption and update to the recommendation for adjuvant nivolumab in selected patients with pT3/4 and/or pN+ disease not eligible for, or who declined, adjuvant cisplatin-based chemotherapy; and addition of a new recommendation for metastatic disease regarding the antibody-drug conjugate trastuzumab deruxtecan in case of HER2 overexpression; in addition, removal of the recommendations on sacituzumab govitecan as the manufacturer has withdrawn the US Food and Drug Administration approval for this product; update of the follow-up of MIBC; and full update of the management algorithms of MIBC.

CONCLUSIONS AND CLINICAL IMPLICATIONS:

This overview of the 2025 EAU guidelines offers valuable insights into risk factors, diagnosis, classification, treatment, and follow-up of MIBC patients and is designed for effective integration into clinical practice.

2,686

项与德曲妥珠单抗相关的新闻（医药）

2025-04-17

·复宏汉霖

再拓乳腺癌创新治疗布局，复宏汉霖HLX22联合T-DXd完成HER2低表达HR阳性乳腺癌II期临床首例患者给药

2025年4月17日，复宏汉霖（2696.HK）宣布，公司创新型抗HER2单抗HLX22单抗注射液联合德曲妥珠单抗治疗HER2低表达HR阳性的局部晚期或转移性乳腺癌的II期临床研究（HLX22-BC201）于中国境内完成首例患者给药。继HER2阳性胃癌之后，HLX22的治疗领域再度拓宽至乳腺癌疾病领域，有望为更多肿瘤患者带来新的治疗选择。乳腺癌是全球和中国发病率第二高的癌症，据GLOBOCAN数据显示，2022年全球乳腺癌新发病例约230万，中国乳腺癌新发病例逾35.7万[1]。其中，HER2低表达乳腺癌是对IHC 1+或2+且ISH阴性的乳腺癌提出的一个新的临床分类，此类患者约占全部乳腺癌的45%-55%[2]。目前，由于缺乏针对性的靶向治疗药物，HER2低表达HR阳性乳腺癌主要依赖内分泌治疗或化疗等治疗[3]。尽管T-DXd等分子在HER2低表达HR阳性乳腺癌中展现出抗肿瘤活性[4]，但该类患者群体的治疗选择仍相对有限，亟待进一步探索更加安全有效的创新治疗方案。HLX22作为一款靶向HER2的创新型单克隆抗体，可结合在HER2的胞外亚结构域IV，但结合表位与曲妥珠单抗有所不同，使得该产品能够与曲妥珠单抗同时结合至HER2，促进HER2二聚体（HER2同源二聚体及HER2/EGFR异源二聚体）的内吞和降解，进而产生更强的HER2受体阻断效果。此前，HLX22联合曲妥珠单抗的HER2双靶疗法已在HER2阳性胃癌的治疗中展现出优异的疗效，一项HLX22联合汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）治疗HER2阳性胃癌的II期临床研究（HLX22-GC-201）结果显示，在汉曲优®联用化疗的基础上加入HLX22可提高HER2阳性G/GEJ癌患者一线治疗的生存期和抗肿瘤反应，且安全性可控[5-7]。目前，HLX22联合曲妥珠单抗及化疗一线治疗HER2阳性晚期胃癌的国际多中心III期临床研究（HLX22-GC-301）分别获得中国、美国、日本和澳大利亚等地药监机构的新药临床试验（IND）许可，并完成首例患者给药。此外，HLX22于2025年获得美国食品药品监督管理局（FDA）授予的孤儿药资格认定（Orphan Drug Designation, ODD），用于胃癌的治疗。基于HLX22在HER2阳性胃癌领域取得的优异成果，复宏汉霖积极探索HLX22在更广泛实体瘤中的疗效，持续拓宽惠及的患者群体。2024年，HLX22联合曲妥珠单抗和化疗或联合德曲妥珠单抗的II期临床试验申请获得中国国家药品监督管理局（NMPA）批准，拟用于治疗HER2表达实体瘤。HLX22联合德曲妥珠单抗的临床前动物试验显示，该抗HER2联合疗法展现出协同抗肿瘤作用和良好的安全性，有望为HER2表达肿瘤患者带来更多获益。未来，复宏汉霖也将持续探索新型抗HER2靶向疗法在肿瘤中的治疗潜力，高效推进HLX22的全球临床开发进展，为全球患者提供更多可负担、疗效更好的治疗方案。关于HLX22-BC201本研究是一项多中心的II期临床研究，旨在评估HLX22联合德曲妥珠单抗治疗经标准治疗后疾病进展或不可耐受毒性反应的，HER2低表达HR阳性的局部晚期或转移性乳腺癌患者的疗效和安全性。符合条件的受试者将接受HLX22联合德曲妥珠单抗治疗。该研究的主要终点为独立影像评估委员会（IRRC）基于RECIST v1.1评估的客观缓解率（ORR）和无进展生存期（PFS）；次要终点包括研究者评估的客观缓解率（ORR）和无进展生存期（PFS），总生存期（OS），独立影像评估委员会（IRRC）或研究者评估的缓解持续时间（DOR）、安全性、药代动力学、免疫原性和生物标志物。关于复宏汉霖复宏汉霖（2696.HK）是一家国际化的创新生物制药公司，致力于为全球患者提供可负担的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已有6款产品在中国获批上市，4款产品在国际获批上市，5个上市申请分别获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（GMP）标准进行生产和质量管控，不断夯实一体化综合生产平台，其中，公司商业化生产基地已相继获得中国、欧盟和美国GMP认证。复宏汉霖前瞻性布局了一个多元化、高质量的产品管线，涵盖约50个分子，并全面推进基于自有抗PD-1单抗H药汉斯状®的肿瘤免疫联合疗法。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19个产品在全球范围内开展30多项临床试验，对外授权全面覆盖欧美主流生物药市场和众多新兴市场。Henlius' Innovative Anti-HER2 mAb HLX22 in Combination with T-Dxd Advances to a Phase 2 Clinical Trial for the Treatment of HER2-low, HR-positive BC with First Patient DosedShanghai, China, April 17, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in China in HLX22-BC201, a phase 2 clinical trial of the company’s novel anti-HER2 monoclonal antibody (mAb), HLX22, in combination with trastuzumab deruxtecan (T-DXd) for the treatment of HER2-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer. Apart from its exploration in HER2-positive gastric cancer, the therapeutic scope of HLX22 has further expanded to the field of breast cancer, potentially providing new treatment options for broader tumour patients population.Breast cancer is the second most diagnosed cancer in the world, according to GLOBOCAN 2022. There were around 2.30 million new cases of breast cancer in 2022 globally, including more than 357,000 in China[1]. Among these, HER2-low breast cancer has been proposed as a novel clinical classification for breast cancers demonstrating IHC 1+ or 2+ with negative ISH results. This category accounts for approximately 45%-55% of all breast cancer cases[2]. Currently, due to the lack of targeted therapies, HER2-low,hormone receptor (HR)-positive breast cancer primarily relies on treatments such as endocrine therapy or chemotherapy[3]. Despite novel regimens like trastuzumab deruxtecan (T-DXd) has demonstrated anti-tumour activity in HER2-low, HR-positive breast cancer[4], therapeutic options for this patient population remain relatively limited, indicating an unmet medical need to explore more safe and effective innovative treatment approaches.HLX22, an innovative anti-HER2 mAb, can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, thereby promoting the internalization and HER2 dimer degradation. The phase 2 clinical data on the combination of HLX22 and HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) demonstrate that the addition of HLX22 to HANQUYOU plus chemotherapy significantly improves survival and anti-tumour efficacy in first-line treatment of HER2-positive gastric/gastroesophageal junction cancer (GC/GEJC) patients, with manageable safety profiles[5-7]. At present, the Investigational New Drug (IND) applications for HLX22-GC-301, a phase 3 clinical study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic GC/GEJC, have been approved by regulatory authorities in China, the U.S, Japan and Australia, etc., and this international study has been initiated in multiple countries and regions worldwide and has completed its first patient dosing globally. Furthermore, HLX22 has received orphan drug designation (ODD) in 2025 from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer. Based on the promising results showcased by HLX22 in the field of HER2-positive gastric cancer, Henlius is actively exploring the efficacy of HLX22 in a broader range of solid tumours, continuously expanding the patient groups who can benefit from it. In 2024, the phase 2 clinical trial of HLX22 in combination with trastuzumab and chemotherapy or combined with T-DXd was approved by the China National Medical Products Administration (NMPA) for the treatment of HER2-expressing solid tumours. Preclinical animal studies of HLX22 combined with T-DXd showed synergistic anti-tumour effect and good safety profiles, which may offer more benefits to patients with HER2-expressing tumours. Looking forward, Henlius will also continue to explore the therapeutic potential of its novel anti-HER2 targeted therapies in tumours and efficiently accelerate the global development of HLX22, offering more affordable and effective treatment options for patients worldwide.About HLX22-BC201This is a multicenter phase 2 study aimed to evaluate the efficacy and safety of HLX22 combined with trastuzumab deruxtecan for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer who have progressed on or are intolerant to standard therapy. Eligible subjects will receive HLX22 plus trastuzumab deruxtecan. The primary endpoints of this study are objective response rate (ORR) and progression-free survival (PFS) accessed by independent radiology review committee (IRRC) per RECIST 1.1; secondary endpoints include investigator-assessed objective response rate (ORR) and progression-free survival (PFS), overall survival (OS), IRRC or investigator-accessed duration of response (DOR), safety, pharmacokinetics, immunogenicity, and biomarkers.About HenliusHenlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 5 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.References[1] Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35.[2] Tarantino, P., et al. (2021). HER2-Low Breast Cancer: Pathological and Clinical Perspectives. Journal of Clinical Oncology, 39(15), 3205-3214.[3] Gennari, A., et al. (2022). HER2-Low Breast Cancer: A New Entity with Therapeutic Implications. Nature Reviews Clinical Oncology, 19(6), 325-336.[4] Modi, S., et al. (2022). Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. New England Journal of Medicine, 387(1), 9-20.[5] Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).[6] J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology, Annals of Oncology (2024) 35 (suppl_1): S162-S204.[7] Li N, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2.联系方式媒体：PR@Henlius.com投资者：IR@Henlius.com喜欢本文内容点击下方按钮·分享 ·收藏 ·点赞 ·在看

孤儿药临床2期临床申请临床3期临床结果

2025-04-17

·ioncology

熊慧华教授：HER2阳性晚期乳腺癌治疗进展

点击上方蓝字关注我们编者按：乳腺癌是全球女性最常见的恶性肿瘤之一，严重威胁着女性的健康。HER2阳性乳腺癌是乳腺癌的主要分型之一，其疾病进展速度较快，恶性程度通常较高，预后也较差，而一旦进展到晚期，若患者未进行规范化治疗，患者的总生存期（OS）不足 5 年[1]。随着抗HER2 治疗药物的不断发展，HER2阳性晚期乳腺癌的治疗策略取得了显著进展。本文中，我们特邀华中科技大学同济医学院附属同济医院熊慧华教授梳理HER2阳性晚期乳腺癌的一线、二线及三线治疗策略，重点介绍 CLEOPATRA、PHILA、PHOEBE 、DB-03等关键研究和药物在HER2阳性晚期乳腺癌患者治疗中的进展，为临床医生提供治疗参考。乳腺癌作为全球女性最常见的恶性肿瘤之一，其发病率和死亡率一直居高不下。HER2 阳性乳腺癌是乳腺癌的一种特定亚型，占乳腺癌患者总数的20%～25%[2]，且其具有侵袭性强、恶性程度高、预后不良等特点，给临床治疗带来了巨大挑战。既往研究结果提示，HER2 阳性晚期乳腺癌患者的总生存期不足 5 年[1]，因此，为晚期患者选择合适的手段，延长生存期，改善患者生活质量是主要目标。近年来，随着医学研究的深入和新药的不断涌现，HER2阳性晚期乳腺癌的治疗策略不断更新和完善，下文将介绍HER2阳性晚期乳腺癌患者不同线序的治疗选择。HER2阳性晚期乳腺癌一线治疗曲妥珠单抗作为第一个上市的抗HER2靶向治疗药物，自1998年被美国FDA批准用于晚期乳腺癌的一线治疗以来，已显著改善了患者的预后，多项研究（如 H0648g[3]和 M77001[4]等）均证实了曲妥珠单抗联合化疗在HER2阳性转移性乳腺癌中的一线地位。帕妥珠单抗作为一种新型的HER2单克隆抗体，与曲妥珠单抗联合应用可进一步增强治疗疗效。CLEOPATRA是一项Ⅲ期、随机、双盲、安慰剂对照研究，对比了曲妥珠单抗联合多西他赛基础上，加用帕妥珠单抗（曲帕双靶）与单用曲妥珠单抗联合多西他赛的疗效[5]。研究结果表明，曲帕双靶联合多西他赛显著改善了患者的总生存期（OS）和无进展生存期（PFS），两组中位 PFS 为：18.5 个月 vs. 12.4 个月（HR 0.56），中位 OS 为：57.1 个月 vs. 40.8 个月（HR 0.69）。自此，曲帕双靶联合化疗成为了HER2阳性晚期乳腺癌一线治疗的标准方案。这一方案的广泛应用，极大地改变了HER2阳性晚期乳腺癌的一线治疗格局，显著延长了患者的生存时间，提高了患者的生活质量。吡咯替尼是我国自主研发的、靶向HER1 、HER2和HER4受体的小分子酪氨酸激酶抑制剂（TKI），其在HER2阳性晚期乳腺癌患者一线治疗中也显示了较好的疗效。PHILA是一项随机、双盲、多中心的III期临床试验，探索了吡咯替尼联合曲妥珠单抗和多西他赛在HER2阳性晚期乳腺癌一线治疗中的疗效与安全性。2023年PHILA研究结果荣登BMJ杂志[6]，展现了吡咯替尼联合曲妥珠单抗和多西他赛（吡咯替尼组）相较于安慰剂+曲妥珠单抗+多西他赛（安慰剂组）方案的治疗优势（中位 PFS：24.3 个月 vs. 10.4 个月；HR 0.41），为HER2阳性晚期乳腺癌患者的一线治疗提供了新的有效选择。2024年SABCS 大会上，徐兵河院士报告了PHILA 研究PFS的最终分析结果，研究结果显示，吡咯替尼组相较于安慰剂组的PFS改善效果持续显著：22.1 个月 vs. 10.5 个月（HR 0.44，95% CI：0.36～0.53；单侧P＜0.0001），OS 显示出获益优势（HR 0.64，95%CI：0.46～0.89；单侧 P=0.0038）。该研究将小分子靶向药物与大分子靶向药物及化疗药物相结合，进一步优化了一线治疗策略，为临床医生提供了更多元化的治疗思路。HER2阳性晚期乳腺癌患者二线治疗HER2阳性晚期乳腺癌患者在接受一线治疗后，往往会出现疾病进展。但HER2阳性晚期乳腺癌二线治疗预后仍然不佳，患者的mPFS仅约1 年[7]，此时，选择一种有效的二线治疗方案对于延长患者生存具有重要意义。T-DM1是首款获批上市的抗体偶联药物（ADC），基于III期EMILIA 研究结果[8]，T-DM1于2013年获批用于治疗已经接受过曲妥珠单抗和紫杉醇化疗失败的HER2阳性晚期乳腺癌患者，开启了ADC药物在HER2阳性晚期乳腺癌治疗领域的新时代。T-DXd作为一种新型的ADC药物，通过人源化单克隆抗体部分曲妥珠单抗将细胞毒化合物拓扑异构酶Ⅰ抑制剂定向携带到乳腺肿瘤细胞内，从而发挥抗肿瘤作用，并在HER2阳性晚期乳腺癌的治疗中表现出了巨大的潜力。既往DB-01 研究、DB-02研究已展现出T-DXd的治疗疗效，DB-03一项开放标签、多中心、随机、对照的III期临床试验，旨在评估T-DXd对比T-DM1在HER2 阳性不可切除或转移性乳腺癌患者中的疗效和安全性。该研究共纳入524例既往晚期阶段接受过曲妥珠单抗和紫杉醇治疗的不可切除或转移性HER2阳性乳腺癌患者，研究结果显示，T-DXd组的中位PFS获益显著优于T-DM1组，T-DXd组和T-DM1组由BICR确定的中位PFS分别为28.8个月（95%CI：22.4～37.9）和6.8个月（95%CI：5.6～8.2）（HR 0.33 ；95%CI：0.26～0.43；P＜0.000001）[9]；2024年ASCO大会上，DB-03研究OS结果公布[10] ，T-DXd组相较于T-DM1组的mOS延长近10个月（52.6 个月 vs 42.7 个月，HR 0.73）进一步巩固了T-DXd在HER2阳性晚期乳腺癌患者中的治疗地位，为更多患者带来了生存希望。基于DB-03研究，国内外权威指南纷纷将T-DXd作为HER2阳性晚期乳腺癌患者二线治疗的优选推荐方案。2023 年，DB-03研究结果公布后，T-DXd先后被国际权威指南NCCN和ESMO一致推荐为HER2阳性晚期乳腺癌二线治疗优选方案[11,12]。基于DB-03研究成果的公布和T-DXd在中国可及性的提升，2025 版《CSCO 乳腺癌诊疗指南》中T-DXd被作为HER2阳性晚期乳腺癌二线治疗IA 级推荐[13]。《CBCS&CSOBO 乳腺癌诊治指南与规范精要本（2025 年版精要本）》（小红书）中指出[14]，无论HER2阳性晚期乳腺癌患者是否有脑转移，在二线治疗中都推荐使用T-DXd。吡咯替尼作为我国自主研发的小分子TKI，在HER2阳性晚期乳腺癌二线治疗中也展现出了良好的疗效。PHENIX 研究结果显示[15]，在紫杉类和曲妥珠单抗治疗失败的患者中，吡咯替尼联合卡培他滨较单用卡培他滨可提高ORR和PFS。同时PHOEBE研究结果也显示[7]，相较于拉帕替尼联合卡培他滨（拉帕替尼组），吡咯替尼联合卡培他滨（吡咯替尼组）治疗HER2阳性晚期乳腺癌患者，能够显著延长患者的中位PFS（12.5 个月 vs 6.8 个月；HR 0.39，P＜0.0001），且安全性可控。2023年ABC7大会上，PHOEBE研究中位OS结果更新，结果显示，吡咯替尼组相较于拉帕替尼组OS延长了相比拉帕替尼组延长了10.8个月（39.4 个月 vs 28.6 个月，HR 0.78）[16]，这一成果奠定了吡咯替尼联合卡培他滨在HER2阳性晚期乳腺癌的二线标准治疗地位。HER2阳性晚期乳腺癌三线治疗对于HER2阳性晚期乳腺癌患者来说，三线及三线以后的治疗的选择相对较少，但仍有一些有效的治疗方案可供选择。奈拉替尼是一种口服的小分子TKI，能够不可逆地抑制HER1 、HER2和HER4受体的酪氨酸激酶活性。NALA 研究证实[17] ，奈拉替尼联合卡培他滨对比拉帕替尼联合卡培他滨治疗既往经过二线及以上抗HER2治疗的晚期患者，可以显著延长PFS ，提高临床获益率。尽管总生存并无显著获益，但奈拉替尼联合卡培他滨方案仍不失为一种有效的三线治疗方案。此外，一些新型的抗HER2 ADC药物在三线治疗中也有一定的探索。不过，总体而言，三线治疗的疗效相对有限，患者的生存获益相对较小。2024 版《CSCO 乳腺癌诊疗指南》中推荐，对于体力状态评分较好的患者，可以选择既往未使用过的方案；对于无法耐受进一步治疗的患者，考虑姑息治疗或参加临床研究。结语HER2阳性晚期乳腺癌的治疗在近年来取得了令人瞩目的进展，从一线到三线治疗均有了更多有效的方案。一线治疗中，PHILA研究带来的新联合方案以及CLEOPATRA研究确立的曲帕双靶标准方案，为患者争取了更多的生存时间；二线治疗中，T-DXd凭借DB-03研究的优异结果成为优选方案，吡咯替尼也为我国患者提供了重要的治疗选择；三线治疗虽然选择有限，但现有方案以及正在探索的新方向，也为患者带来了治疗希望。未来，随着医学研究的持续推进，相信会有更多更有效的治疗手段问世，进一步改善HER2阳性晚期乳腺癌患者的预后，提高患者的生活质量。熊慧华教授华中科技大学同济医学院附属同济医院华中科技大学同济医学院附属同济医院乳腺妇瘤及淋巴系统肿瘤科主任中国抗癌协会乳腺癌专业委员会委员长江学术带乳腺联盟副主任委员中国生物医学工程学会肿瘤靶向专业委员会委员湖北省抗癌协会肿瘤内科治疗专业委员会常委审批编号：CN-157682 *本材料由阿斯利康提供，仅供医疗卫生专业人士参考参考文献上下滑动查看更多内容[1] 、Grinda, T et al. “Evolution of overall survival and receipt of new therapies by subtype among 20 446 metastatic breast cancer patients in the 2008-2017 ESME cohort.” ESMO open vol. 6,3 (2021): 100114. doi:10.1016/j.esmoop.2021.100114[2] 、Schlam I, Swain SM, HER2-positive breast cancer and tyrosine kinaseinhibitors: the time is now[J]. NPJ Breast Cancer,2021 ,7(1):56[3] 、Slamon, D J et al. “Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.” The New England journal of medicine vol.344,11 (2001): 783-92. doi:10.1056/NEJM200103153441101[4] 、Marty, Michel et al. “Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group.” Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 23,19 (2005):4265-74. doi:10.1200/JCO.2005.04.173[5] 、Swain, Sandra M et al. “Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo- controlled, phase 3 study.” The Lancet. Oncology vol. 21,4 (2020): 519-530. doi:10.1016/S1470- 2045(19)30863-0[6] 、Ma, Fei et al. “Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial.” BMJ (Clinical research ed.) vol. 383 e076065. 31 Oct. 2023, doi:10.1136/bmj-2023-076065[7] 、Xu, Binghe et al. “Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial.” The Lancet. Oncology vol. 22,3 (2021): 351-360. doi:10.1016/S1470-2045(20)30702-6[8] 、Verma, Sunil et al. “Trastuzumab emtansine for HER2-positive advanced breast cancer.” The New England journal of medicine vol. 367,19 (2012): 1783-91. doi:10.1056/NEJMoa1209124[9] 、Hurvitz Sara A,Hegg Roberto,Chung Wei-Pang,et al.Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer:updated results from DESTINY-Breast03,a randomised,open-label,phase 3 trial.[J].Lancet,2023,401:105-117.[10] 、Cortés, Javier et al. “Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer: long-term survival analysis of the DESTINY-Breast03 trial.” Nature medicine vol. 30,8 (2024): 2208-2215. doi:10.1038/s41591-024-03021-7[11] 、National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Breast Cancer (2023 Version 4)[internet]; 2023[12] 、Im, S-A et al. “Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer.” ESMO open vol. 8,3 (2023): 101541. doi:10.1016/j.esmoop.2023.101541[13] 、中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会（CSCO）乳腺癌诊疗指南 2025.人民卫生出版社[14] 、CBCS&CSOBO 乳腺癌诊治指南与规范精要本（2025 年版精要本）》[15] 、Min Yan, Li Bian, Xichun Hu, et al. Pyrotinib plus capecitabine for human epidermal factor receptor 2-positive metastatic breast cancer after trastuzumab and taxanes (PHENIX): a randomized, double-blind, placebo-controlled phase 3study. Transl Breast Cancer Res.2020;1:13.[16] 、Xu B, Ma F, Yan M, et al. Updated overall survival (OS) outcomes from the phase 3 PHOEBE trial of pyrotinib plus capecitabine versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer. 2023 ABC7 . OR98.[17] 、Saura, Cristina et al. “Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2- Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial.” Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 38,27 (2020): 3138-3149. doi:10.1200/JCO.20.00147（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床3期临床成功

2025-04-17

·PRNewswire

Greater Precision of HER2-Expressing Breast Cancer Treatment with 3D Pathology: New JelloX Research Collaboration

In the preliminary findings of a study conducted with the National Taiwan University Hospital, over 50% of sample cases were reclassified as HER2-expressing when 3D pathology was applied. HSINCHU, April 16, 2025 /PRNewswire/ -- JelloX Biotech Inc., a Taiwan-based startup at the forefront of cancer pathology, announced the preliminary results of a research collaboration with the National Taiwan University Hospital (NTUH) on breast cancer patients. The study found that JelloX's 3D pathology technology identified a significantly increased proportion of tumors with HER2-low and HER2-ultralow expression compared to conventional methods, demonstrating this technology's increased sensitivity and potential as a superior diagnostic tool for HER2 detection in breast cancers. Continue Reading This is a 3D fluorescent-stained image of mammary ducts from a breast cancer patient. Green areas indicate drug-targeted receptors. Unlike traditional 2D pathology, this reveals the spatial distribution of receptors, reducing the risk of misjudging treatment decisions. Contact JelloX at [email protected] to explore partnerships and learn more about the company's cutting-edge 3D pathology technology. According to the US National Cancer Institute, breast cancer is the most prevalent form of cancer. However, the difficulty of precisely determining treatment has made the identification of HER2 expression essential. In HER2-low and HER2-ultralow metastatic breast cancer, the novel antibody-drug conjugate (ADC) Trastuzumab deruxtecan (T-DXd) has demonstrated robust efficacy over conventional chemotherapy. Yet considering HER2 spatial heterogeneity, traditional diagnostic methods have shown to be less precise than 3D pathology in detecting the presence of the HER2 protein. "For the specific challenges posed by metastatic breast cancer and the need to identify predictive biomarkers accurately, the high sampling capacity of 3D pathology holds particular potential," commented Dr. Yen-Yin Lin, CEO of JelloX. "JelloX Biotech's Comprehensive HER2 Diagnostic Solution is poised to revolutionize HER2 diagnostics. With a more comprehensive data set on tumor samples, healthcare providers can be empowered to make more precise diagnoses, ensuring that the right patients receive the right treatment at the right time." New findings with NTUH on HER2 breast cancer In JelloX's research collaboration with NTUH, preliminary findings indicate that more than half of the analyzed cases exhibited diagnostic discrepancies when re-evaluated using the company's advanced 3D pathology methods. Notably, among patients initially classified as HER2-null by traditional methods, more than 66.7% were reclassified as HER2-expressing (HER2-low or HER2-ultralow) using 3D technology, thereby becoming potentially eligible for T-DXd treatment. These findings echo the company's recent results using samples from colorectal and esophageal cancers, demonstrating that 3D pathology may have broader potential across various cancer types. The full findings will be shared at the Global Breast Cancer Conference in South Korea on April 17. Implications for breast cancer treatment and drug guidelines T-DXd has demonstrated significant efficacy in tumors with HER2 expression. However, tumors classified as HER2-null under conventional pathological testing are ineligible for T-DXd treatment. By detecting HER2 more precisely using 3D pathology methods, we can identify more patients eligible for T-DXd therapy. In addition to cancer patients, JelloX's 3D pathology technology has the potential to expand possibilities across healthcare stakeholders: For physicians: This advanced diagnostic tool offers a more comprehensive patient data set and, when integrated with AI, helps reduce physician workloads. For pharmaceutical companies and research institutions: The technology enhances companion diagnostics (CDx) for drug usage and is a valuable tool for new drug development. For healthcare systems: 3D pathology optimizes medical resource allocation and minimizes unnecessary financial and healthcare burdens. About JelloX Biotech Inc. Based in Hsinchu, Taiwan, JelloX Biotech Inc. is a startup that focuses on advancing cancer pathology through 3D digital imaging and AI technology. For more information, please visit: SOURCE JelloX Biotech Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果诊断试剂

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

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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阳性胃食管交界处癌	临床3期	美国	Daiichi Sankyo, Inc.	2025-03-21
HER2阳性胃食管交界处癌	临床3期	中国	Daiichi Sankyo, Inc.	2025-03-21
HER2阳性胃食管交界处癌	临床3期	日本	Daiichi Sankyo, Inc.	2025-03-21
HER2阳性胃食管交界处癌	临床3期	阿根廷	Daiichi Sankyo, Inc.	2025-03-21
HER2阳性胃食管交界处癌	临床3期	澳大利亚	Daiichi Sankyo, Inc.	2025-03-21
HER2阳性胃食管交界处癌	临床3期	奥地利	Daiichi Sankyo, Inc.	2025-03-21
HER2阳性胃食管交界处癌	临床3期	比利时	Daiichi Sankyo, Inc.	2025-03-21
HER2阳性胃食管交界处癌	临床3期	巴西	Daiichi Sankyo, Inc.	2025-03-21
HER2阳性胃食管交界处癌	临床3期	加拿大	Daiichi Sankyo, Inc.	2025-03-21

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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


NCT04494425 (DB-06 \| DESTINY-Breast06, CTgov)	临床3期	HER2阳性转移性乳腺癌 \| HR阳性/HER2阳性乳腺癌 \| 晚期乳腺癌	866	T-DXd (T-DXd)	憲鏇積齋壓餘淵鏇簾廠(觸願糧網窪範鹽廠選糧) = 鹹廠製餘積觸餘淵獵鑰壓顧鏇窪憲獵構窪鏇糧 (襯繭製築憲簾構製衊鹹, 獵餘淵網窪淵繭襯餘蓋 ~ 顧鑰憲網網鹹鬱膚蓋觸) 更多	-	2025-04-02
				nab-paclitaxel+paclitaxel+capecitabine (Chemotherapy)	憲鏇積齋壓餘淵鏇簾廠(觸願糧網窪範鹽廠選糧) = 觸積鬱艱襯觸窪壓醖壓壓顧鏇窪憲獵構窪鏇糧 (襯繭製築憲簾構製衊鹹, 獵夢艱顧繭製窪淵蓋窪 ~ 遞觸獵鹽積膚艱構齋鏇) 更多
NCT04686305 (DL-03, ESMO_ELCC2025)	临床1期	转移性非小细胞肺癌 \| 转移性非鳞状非小细胞肺癌 \| 局部晚期非小细胞肺癌一线 HER2 overexpression	34	Trastuzumab deruxtecan (T-DXd)	襯齋窪窪繭艱憲製淵膚(選獵廠積壓範選蓋壓獵) = 蓋糧築觸製鏇窪觸醖網糧築鹹齋製觸窪選蓋廠 (齋蓋糧獵鏇繭遞壓鬱選 ) 更多	积极	2025-03-26
DESTINY-Gastric04 (NEWS) 人工标引	临床3期	HER2阳性胃癌二线 HER2 Positive	-	ENHERTU	構艱餘鏇範繭夢鹽艱簾(鹹淵願夢壓餘鏇構憲襯) = 鏇範範壓築觸網餘廠壓衊築壓積鹽淵觸獵壓構 (蓋觸襯壓窪鬱簾齋築製, 9.6 ~ 14.3) 更多	积极	2025-03-03
				irinotecan or paclitaxel	構艱餘鏇範繭夢鹽艱簾(鹹淵願夢壓餘鏇構憲襯) = 網糧壓鑰顧鹽製願艱窪衊築壓積鹽淵觸獵壓構 (蓋觸襯壓窪鬱簾齋築製, 6.9 ~ 10.7) 更多
ESMO_TAT2025	N/A	-	48	trastuzumab deruxtecan (High SAT density (HU))	網齋選廠遞艱鬱鹽艱顧(選醖簾獵齋構積鏇願窪) = 襯鹽夢窪積網觸構鹽選築淵憲選積獵積艱選蓋 (網蓋製遞憲獵鑰淵選範 )	积极	2025-03-03
				trastuzumab deruxtecan (High VAT density (HU))	製積鏇膚願鬱膚範製觸(範餘壓鏇壓憲顧糧醖鹹) = 選鏇鹹蓋夢鹹願鹽醖艱衊壓製製齋壓艱艱構願 (繭艱範獵膚觸壓遞觸鏇 )
NCT04379596 (DESTINY-Gastric03, ASCO_GI2025) 人工标引	临床1/2期	HER2阳性胃癌 \| HER2阳性食管癌 \| HER2阳性胃食管结合部腺癌一线 HER2 Positive	75	T-DXd 6.4 mg/kg + FP + Pembrolizumab	夢繭構衊壓糧鹹艱願鑰(窪衊鑰築窪繭築鹽衊襯) = 鏇襯膚簾壓製窪製製蓋衊齋觸構願顧襯鏇鏇簾 (製蓋觸廠壓願夢艱餘艱 ) 更多	积极	2025-01-23
				T-DXd 5.4 mg/kg + FP + Pembrolizumab	夢繭構衊壓糧鹹艱願鑰(窪衊鑰築窪繭築鹽衊襯) = 壓鹽範餘鏇製顧艱淵顧衊齋觸構願顧襯鏇鏇簾 (製蓋觸廠壓願夢艱餘艱 ) 更多
NCT04042701 (DS8201-A-U106, ESMO_IO2024) 人工标引	临床1期	非小细胞肺癌 HER2 Expression \| ERBB2 Mutation (Activating)	55	Trastuzumab deruxtecan (T-DXd) + Pembrolizumab (cohort 3 (HER2E; immunohistochemistry 1+, 2+, or 3+))	選鑰襯糧遞顧窪艱壓觸(遞膚艱醖廠繭築餘築鏇) = 蓋餘鏇範獵構窪膚餘築窪網衊鑰積鬱壓積艱觸 (顧壓鏇繭淵鏇壓衊範廠, 32.2 ~ 75.6) 更多	积极	2024-12-12
				Trastuzumab deruxtecan (T-DXd) + Pembrolizumab (cohort 4 (HER2m))	選鑰襯糧遞顧窪艱壓觸(遞膚艱醖廠繭築餘築鏇) = 餘壓範簾築醖餘蓋網衊窪網衊鑰積鬱壓積艱觸 (顧壓鏇繭淵鏇壓衊範廠, 48.2 ~ 82.0) 更多
NCT04989816 (DESTINY-Gastric06, ESMO_ASIA2024) 人工标引	临床2期	HER2阳性胃癌 \| HER2阳性胃食管结合部腺癌 HER2 Positive	95	Trastuzumab deruxtecan 6.4 mg/kg	構願膚積憲餘顧遞蓋願(艱齋選繭網積願廠夢願) = 膚網獵壓積鑰夢衊醖膚淵範鹹夢觸積願願選觸 (艱襯壓遞鏇襯窪鬱繭網 ) 更多	积极	2024-12-07
NCT04482309 (DP-02, ESMO_ASIA2024)	临床2期	HER2阳性癌症 HER2 IHC 3+ \| HER2 IHC 2+ \| in situ hybridization-positive ... 更多	-	Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg	憲鹽獵繭壓顧範壓鏇齋(襯憲淵鬱鬱獵餘艱餘艱) = 觸構遞選壓壓餘鏇廠選糧糧憲蓋廠衊壓憲鬱製 (鹹簾襯鏇築醖醖夢醖齋, 5.6 ~ 8.0) 更多	积极	2024-12-07
ESMO_ASIA2024	N/A	HER2低表达乳腺癌 HER2-low \| IHC 1+ \| IHC 2+	70	≥ 3 lines of chemotherapy	廠齋夢獵鑰糧簾膚壓願(廠簾遞鏇鹽構窪艱衊憲) = grade 3-4 AEs were neutropenia, anemia, and leukopenia (each 7.1%) 範範齋構構顧製鑰襯襯 (觸獵積鹹製壓繭壓鏇艱 ) 更多	积极	2024-12-07
				≤ 2 lines of chemotherapy
NCT05246514 (DL-05 \| DESTINY-Lung05 \| DESTINY-Lung05 (DL-05), CTgov)	临床2期	HER2突变型非小细胞肺癌	72	Trastuzumab deruxtecan	築齋選襯壓鏇範顧積遞 = 觸簾淵醖網繭觸構鹹窪糧獵醖窪窪鑰選窪廠築 (顧顧網淵齋積艱築襯網, 蓋壓網夢夢壓艱網廠膚 ~ 繭壓淵遞範糧願淵憲鹽) 更多	-	2024-12-04