Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.

开始日期2027-03-09

申办/合作机构

SWOG

[+1]

NCT07126561

/ Not yet recruiting临床2期IIT

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

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100 项与德曲妥珠单抗相关的专利（医药）

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1,105

项与德曲妥珠单抗相关的文献（医药）

2026-07-01·Respiratory Investigation

Response to trastuzumab deruxtecan in postoperative recurrent lung adenocarcinoma harboring concurrent EGFR and HER2 mutations after progression on adjuvant osimertinib

Article

作者: Muramoto, Kei ; Naito, Daiki ; Fukushima, Kazuaki ; Goebuchi, Kageaki ; Akaike, Kimitaka ; Furukawa, Tsuguhiro ; Sakagami, Takuro ; Tomita, Yusuke ; Saruwatari, Koichi ; Nishiyama, Taketaka ; Okabayashi, Hiroko

Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations are key molecular targets in non-small cell lung cancer (NSCLC). We report a rare case of postoperative recurrent lung adenocarcinoma in an 84-year-old woman harboring EGFR L858R and HER2 S310F mutations after progression on adjuvant osimertinib. After further progression on chemotherapy, she received trastuzumab deruxtecan (T-DXd), which induced metastatic regression and yielded disease control for approximately 6 months. This case highlights a therapeutic approach for NSCLC with multiple driver alterations and demonstrates the clinical activity of T-DXd in osimertinib-refractory EGFR-mutant disease with a concurrent HER2 alteration.

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.

2026-06-01·BREAST

Antibody–drug conjugate sequencing in HER2-positive metastatic breast cancer: Real-world outcomes of trastuzumab deruxtecan with and without prior T-DM1 exposure

Article

作者: Bayram, Ertuğrul ; Deliktaş Onur, İlknur ; Yeşil Çınkır, Havva ; Majidova, Nargiz ; Gündüz, Şeyda ; Erdem, Dilek ; Karadurmuş, Nuri ; Er, Özlem ; Selçukbiricik, Fatih ; Başaran, Gül ; Güney, Bünyamin ; Gürsu, Rıza Umar ; Kalem, Ali ; Oruç, Ahmet ; Tünbekici, Salih ; Seyyar, Mustafa ; Güren, Ali Kaan ; Ateş, Öztürk ; Köylü, Bahadır ; Yazıcı, Melike ; Türker, Sema ; Güney, Gizem ; Akdoğan, Orhun ; Araz, Murat ; Göker, Erdem ; Kaban, Kerim ; Yılmaz, Mesut ; Demir, Nazan ; Aykan, Musa Barış ; Yıldız, İbrahim ; Molinas Mandel, Nil ; Kıkılı, Cevat İlteriş ; Biter, Sedat ; Korkmaz, Taner ; Tunalı, Didem ; Çabuk, Devrim ; Laçin, Şahin ; Bilici, Ahmet ; Sezer, Ahmet ; Altunok, Oğuz ; Şahin, Taha Koray ; Çelik, Emir ; Bayoğlu, İbrahim Vedat ; Aksoy, Sercan ; Açıkel Yüksel, Sakine Damla ; Ekinci, Ömer Burak ; Kemik, Fatih ; Özçelik, Hakan ; Güven, Deniz Can ; Yazıcı, Ozan ; Tural, Deniz

BACKGROUND:

Optimal sequencing of trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd) in HER2 positive metastatic breast cancer (mBC) remains uncertain, and real-world evidence on the impact of prior T-DM1 exposure on subsequent T-DXd outcomes is limited.

METHODS:

We conducted a multicenter, retrospective cohort study across 21 oncology centers in Türkiye including consecutive adults with HER2 positive mBC who received at least one cycle of T-DXd between 2020 and 2025. Patients were classified as T-DM1 pretreated or T-DM1 naive at T-DXd initiation. The primary endpoint was progression free survival (PFS); secondary endpoints included objective response rate (ORR), duration of response (DOR), and overall survival (OS). To address confounding by indication, we applied stabilized inverse probability of treatment weighting (IPTW) based on prespecified clinical covariates and assessed covariate balance using standardized mean differences.

RESULTS:

Among 218 patients treated with T-DXd, 137 (62.8%) had received prior T-DM1 and 81 (37.2%) were T-DM1 naive. The ORR was 71.9%, including 15.2% complete and 56.7% partial responses. Median DOR in the overall cohort was 20.96 months (95% CI, 15.71-26.22). In the IPTW-weighted analysis, prior T-DM1 exposure was associated with significantly shorter PFS: 12.1 months (95% CI, 10.3-20.5) versus 26.0 months (95% CI, 18.9 - not reached) in T-DM1 naive patients (IPTW-weighted log-rank p = 0.006). Prior T-DM1 remained independently associated with higher progression risk (HR 1.99, 95% CI 1.09 - 3.62; p = 0.02). Median OS was 18.9 months (95% CI, 17.2-not reached) in T-DM1 pretreated patients and not reached in T-DM1 naive patients; the IPTW-weighted OS hazard ratio did not reach statistical significance (HR 1.80, 95% CI 0.86-3.79; p = 0.12).

CONCLUSIONS:

Trastuzumab deruxtecan demonstrated substantial real-world activity after prior T-DM1 exposure, but PFS was significantly shorter compared with T-DM1 naive patients, even after rigorous adjustment for measured confounding. These findings highlight the clinical relevance of antibody drug conjugate sequencing and support prospective studies to define the optimal positioning of T-DXd in HER2 positive mBC treatment algorithms.

6,440

项与德曲妥珠单抗相关的新闻（医药）

2026-06-23

·Biotech前瞻

更换CFO与三期折戟，辉瑞在免疫和ADC时代下的落寞

点击蓝字关注我们本期看点引言美国东部时间 6 月 18 日早上，辉瑞于官网发布了公司执行副总裁兼首席财务官戴夫·登顿（Dave Denton）将卸任现职的消息，最后工作日是 8 月 15 日，离开辉瑞后，其将接受一个制药行业之外、消费品领域的职业机会。目前，辉瑞已任命现任全球生物制药业务财务高级副总裁塞西尔·盖根（Cecile Guegan）为临时首席财务官，自 8 月 16 日起生效。在此期间，辉瑞将开展全面的内部和外部人选遴选，戴夫·登顿和塞西尔·盖根将共同努力，确保平稳交接。在后新冠时代红利迅速退去的背景下，全球制药巨头辉瑞（Pfizer）正处于其帝国历史上最艰难的战略重塑期。为了填补疫苗和口服药收入锐减留下的巨大业绩鸿沟，辉瑞不惜举巨债进行大举扩张，将肿瘤学——尤其是抗体偶联药物（ADC）与免疫检查点抑制剂（ICI）——确立为其后疫情时代增长策略的核心支柱。然而，近期公布的一项 late-stage 临床试验折戟，再次将这家制药巨头的转型阵痛毫无保留地推向了聚光灯下。来源：辉瑞官网由辉瑞斥资430亿美元收购Seagen后获得的核心ADC资产——靶向整合素 β6（IB6）的潜在首创（First-in-class）新药 Sigvotatug vedotin，在针对非小细胞肺癌（NSCLC）的随机、III期临床研究（SigVie-002）中未能达到总生存期（OS）的主要终点。这一沉重的临床挫折不仅令辉瑞的肿瘤管线蒙上阴影，更宛如一面镜子，映射出辉瑞在免疫治疗和ADC这两个黄金时代中，空有万亿资本却步步落后、频频受挫的战略窘境。 01 SigVie-002单药III期折戟深度解析作为辉瑞后新冠时代管线重建的“明日之星”，Sigvotatug vedotin（此前被称为 SGN-B6A）承载着辉瑞在肺癌ADC领域打破现有临床僵局的厚望。该药物靶向的整合素 β6（IB6）是一种在非小细胞肺癌等实体瘤中表达率超过90%的肿瘤相关膜蛋白，且与患者的不良预后密切相关。作用机制该药通过将靶向 IB6 的单抗与微管抑制剂单甲基奥瑞斯他汀E（MMAE）偶联，旨在通过直接细胞毒性及旁观者效应精准杀伤肿瘤。然而，近期公布的 SigVie-002 顶层数据却并未带来预期的战略破局。研究结果和设计作为一项旨在评估该药物疗效与安全性的随机、III期、开放性临床研究，该试验共纳入了703名既往接受过系统治疗的局部晚期、不可切除或转移性非鳞状NSCLC受试者，旨在直接挑战临床常用的标准化疗方案多西他赛。分析该研究的顶层数据可以发现，该资产在单药后线治疗中的临床推进呈现出极其复杂的局面：在总体受试人群中，与多西他赛相比，Sigvotatug vedotin 在主要终点总生存期（OS）上未能显示出统计学上的显著改善，这标志着该试验未能达到其主要终点。尽管如此，在仅接受过一线系统治疗的亚组患者中（该亚组约占总体研究人群的三分之二），Sigvotatug vedotin 相比多西他赛在 OS 和无进展生存期（PFS）上均展现出了更具临床意义的获益趋势。在安全性方面，该药表现出了良好的耐受性，未发现新的安全信号，这与早期的临床研究数据保持了一致。然而，最令行业担忧的是其探索性分析结果：研究未能观察到明显的 IB6 表达水平与治疗反应之间的相关性。这意味着该靶点在体内的抗原表达高低并不能作为精准筛选获益人群的可靠生物标志物，为后续的临床设计蒙上了一层迷雾。为了更清晰地对比该资产的后续开发脉络，下表展示了目前辉瑞针对 Sigvotatug vedotin 启动的两项关键III期临床试验的设计差异：尽管单药后线试验折戟，但辉瑞并未放弃该资产，而是将赌注全面转向了 Be6A Lung-02（SigVie-003）研究，试图通过联合免疫检查点抑制剂，利用 ADC 诱导的免疫原性细胞死亡（ICD）与 PD-1 抑制剂产生协同效应，以挽回其在肺癌领域的战略颓势。 02 免疫治疗时代下的落寞 SigVie-002单药试验的失败，不仅是一次孤立的临床受挫，更是辉瑞在免疫检查点抑制剂（ICI）时代步步落后这一历史宿命的延续。在以 PD-1/PD-L1 抑制剂为核心的肿瘤免疫黄金十年里，整个市场见证了默沙东（MSD）的帕博利珠单抗（Keytruda）凭借其在非小细胞肺癌一线治疗中的绝对统治力，在2024年全球销售额一举突破290亿美元，独占整个 PD-(L)1 市场超过50%的份额。相比之下，辉瑞在初代免疫时代交出的答卷则显得极其暗淡。2014年，辉瑞与德国默克雪兰诺（Merck KGaA）达成了一项高达28.5亿美元（包括8.5亿美元首付款及20亿美元里程碑付款）的战略联盟，共同开发 PD-L1 单抗 avelumab（商品名：Bavencio）。作为全美第四款上市的 PD-(L)1 抑制剂，Bavencio 随后的商业轨迹却成了一部战略退守史：由于在非小细胞肺癌一线治疗的临床开发中步步慢于对手，Bavencio 错失了规模最大的肺癌市场。此后，该药在胃癌后线维持治疗以及头颈部鳞癌的临床试验中接连折戟。在肾细胞癌的一线治疗中，Bavencio 联合阿昔替尼（Inlyta）的方案在一项长达六年的随访中，未能显示出相比舒尼替尼（Sutent）的统计学显著 OS 获益，在市场竞争中被 Keytruda 与 Lenvima 等方案彻底碾压。最终，Bavencio 仅在罕见的 Merkel 细胞癌和铂类化疗后无进展的晚期尿路上皮癌一线维持治疗等极狭窄的细分领域艰难立足。截至2023年初，Bavencio 的销售规模与 Keytruda 相比已是云泥之别。2023年3月，随着并购 Seagen 的反垄断压力显现，辉瑞正式终止了与默克雪兰诺长达九年的 Bavencio 联合开发与商业化协定，将原本的利润分成转为了15%的销售特许权使用费。这一退步不仅宣告了辉瑞在初代免疫检查点单抗角逐中彻底出局，更导致其在过去十年的肺癌、胃癌等主流免疫治疗战场上几乎处于“失声”状态，为如今在 ADC 时代不得不采取激进且高风险的买断式并购埋下了伏笔。 03 巨资买单Seagen下的隐痛为了扭转在免疫治疗时代的战略被动，并寻找后疫情时代新的增长故事，辉瑞在2023年末完成了对知名ADC先驱Seagen高达430亿美元的史诗级收购。辉瑞试图通过将 Seagen 先进的ADC技术平台与自身全球制造和资本网络相结合，在2030年之前打造出至少8款具有重磅炸弹（Blockbuster）潜力的肿瘤药物，并实现100亿美元的肿瘤销售增量。然而，依靠高昂溢价并购换来的“捷径”，并未能让辉瑞立刻高枕无忧。相反，高昂的资产整合成本、同类管线的剧烈竞争，迫使辉瑞在2024至2026年期间启动了残酷的管线调整，并吞下了数十亿美元的资产减值苦果。下表详细梳理了近年来辉瑞对其肿瘤学及并购管线进行的重大调整与资金减值情况： Felmetatug vedotin（原计划作为8款重磅炸弹候选药之一）的腰斩，以及维迪西妥单抗在核心膀胱癌适应症上的撤退，都以极其高昂的资金减值为代价，直接拖累了辉瑞的财务表现。 04 与第一三共法律纠纷除了在研发与管线修剪上面临阵痛，辉瑞在试图依靠 Seagen 留存的专利库建立行业“技术税收壁垒”的法律战线上，也遭遇了毁灭性的溃败。多年来，Seagen 与日本第一三共（Daiichi Sankyo）就后者的超级重磅明星ADC药物——与阿斯利康（AstraZeneca）联手开发的 Enhertu 展开了漫长的专利战。Seagen 声称，第一三共利用了其在2008至2015年合作期间获知的ADC链接子及毒素肽段偶联技术，侵犯了其美国第 10,808,039 号专利（‘039专利）——该专利广泛保护了通过特定肽类链接子偶联的单甲基奥瑞斯他汀（auristatin）类ADC化合物。在德克萨斯州联邦地方法院的初审中，Seagen 曾赢得了一次历史性胜利：2022年，陪审团判定第一三共构成故意侵权，并需支付4180万美元的损害赔偿金，以及在全美范围内对 Enhertu 销售额计提8%的持续运行专利许可费，直至‘039专利于2024年11月到期。这笔特许权费用对于完成并购后的辉瑞而言，本是一笔稳赚不赔且具有高度战略杠杆作用的知识产权税。然而，2025年12月2日，美国联邦巡回抗诉法院（CAFC）的一纸判决彻底粉碎了辉瑞的幻想：抗诉法院推翻了德州地方法院的判决，裁定‘039专利因未能满足“书面描述”和“使能性”的法律要求而宣告无效。法院指出，Seagen 在2004年的原始优先权申请中，其保护的肽类说明书理论上涵盖了“超过4700万种不同的四肽单元”。这种极度泛化的描述未能提供足够的“路标”来清晰指向诉讼中主张的特定 Gly/Phe 四肽链接子。随着专利被判无效，地方法院判处的第一三共侵权裁决、4180万美元赔偿金及后续8%的销售分成义务被全数撤销。2026年3月2日，双方申请进一步司法复审的最后期限届满，意味着第一三共取得了全面且不可逆的最终胜利。这场被称为“专利滑铁卢”的诉讼终结，不仅剥离了辉瑞试图以专利诉讼掣肘第一三共/阿斯利康 DXd 平台扩张的筹码，更证明了辉瑞无法在法律和技术底层对当前最火热的非奥瑞斯他汀类（如 topoisomerase I 抑制剂）ADC市场施加有效控制。 05 三生制药双抗的引进与联合疗法布局在核心单药ADC面临重挫、首代免疫单抗彻底出局的腹背受敌境遇下，辉瑞不得不调转枪头，通过极其激进的外源性授权引进，直接押注下一代“PD-1 x VEGF”双特异性抗体领域，以此作为重夺免疫治疗发言权并拯救其ADC联合疗法版图的唯一出路。 2025年7月下旬，辉瑞以近乎疯狂的价码，完成了与中国本土药企三生制药（3SBio）旗下三生国健的全球（除中国外）独家授权协议，拿下了其自主研发的 PD-1/VEGF 双特异性抗体 SSGJ-707（在辉瑞内部代号为 PF-08634404）的开发、生产和商业化权益。 1. 战略级交易背后的财务博弈这笔高达60亿美元潜在总对价的交易，创下了当时中国创新药单笔出海首付款的历史新高：巨额现金首付：辉瑞支付了12.5亿美元（部分中国官方财报披露为等值14亿美元，扣除相关税费折合）的非退还首付款。直接股权绑定：辉瑞向三生制药注入1亿美元的直接股权投资。递延里程碑与特许费：后续涵盖临床开发、监管审批和销售业绩的里程碑付款高达48亿美元，并伴有双位数比例的销售额阶梯特许权使用费。中国商业化选择权：协议还规定，辉瑞在2025年7月支付了1.5亿美元的期权费，以获得未来将该资产在中国本土商业化的排他性选择权。 2. PF-08634404（SSGJ-707）的分子设计优势 PF-08634404 绝非普通的双抗拷贝，其独特的 tetravalent（四价）分子结构使其在同类竞争中具备独特的生物学优势：该分子采用 2+2 的四价双特异性结构（结合了共轻链线性 Common Light Chain Linear Fab x2 平台），在经典的 IgG4 骨架上构建。在肿瘤微环境中，该抗体在结合二聚化的 VEGF-A 时会发生自发性的分子多聚化。这种多聚化产生的协同效应，使该药对 T 细胞表面 PD-1 的结合亲和力（Avidity）暴增超过100倍，进而驱动 T 细胞表面 PD-1 受体的快速内吞与降解，阻断 PD-1 信号通路的能力比市面常规单抗提高了10倍以上。通过强力中和 VEGF，该药不仅能抑制肿瘤血管新生，还能逆转 VEGF 介导的微环境免疫抑制状态，使杀伤性 T 细胞更易向瘤体内部浸润。 3. 亮眼的早期临床表现在2026年美国临床肿瘤学会（ASCO）年会上，PF-08634404 披露了极具竞争力的临床结果：在一项评估其作为单药治疗一线晚期 NSCLC（PD-L1 TPS ≥1% 且无驱动基因突变）的 Phase II 临床研究中，在 FDA 推荐的 10 mg/kg Q3W 剂量组中，确认的客观缓解率（ORR）达到了 67.6%。试验表现出的中位无进展生存期（PFS）长达 12.4 个月，且疗效在不同的肿瘤病理分型中均保持高度一致。此外，在针对一线晚期/复发性子宫内膜癌（EC）的联合化疗 Phase II 研究中，PF-08634404 联合卡铂+紫杉醇治疗，在错配修复完整（pMMR）和错配修复缺陷（dMMR）患者中分别斩获了超过 80% 和 75% 的客观缓解率（ORR）。 4. 辉瑞的联合疗法反布局手握这枚双抗底牌，辉瑞正在以惊人的速度推进临床，试图通过将 PF-08634404 与 Seagen 留存的明星ADC资产进行多维度联用，构建属于辉瑞自己的“ICI + ADC”全自研生态圈。不仅如此，辉瑞还积极向外延展其联合拼图。2025年中期，辉瑞与 Summit Therapeutics 达成了一项极具前瞻性的临床合作，旨在评估后者的 PD-1/VEGF 双特异性抗体依沃西单抗（Ivonescimab）与辉瑞旗下多种核心奥瑞斯他汀类（vedotin）ADC资产在多种实体瘤中的联合疗法潜力，从而为其庞大的奥瑞斯他汀 ADC 平台寻找新的增长点。 03 总结与展望希沃妥珠单抗（Sigvotatug vedotin）在单药III期肺癌临床中的折戟，以及早前数个 Seagen ADC 候选药的关停减值，客观上暴露了辉瑞在消化这笔430亿美元资产时所遭遇的严重技术排异与时间差惩罚。同时，早期与第一三共围绕‘039专利的长跑诉讼宣告终结并彻底流产，更打碎了辉瑞试图以专利壁垒扼杀竞争对手的幻想。这不仅是资本运作与科学不确定性之间的一次激烈碰撞，更展现了辉瑞自初代 PD-L1 宣告败北后，在肿瘤战略高地上那挥之不去的落寞背影。然而，这种落寞并未让这家老牌帝国一蹶不振。通过在2025年以破纪录的价码闪电切入 PD-1/VEGF 双抗赛道，并快速启动多达7项临床试验（包括多项III期关键研究），辉瑞表现出了极强的纠偏意愿与资本力量。这种将“全球最强双抗”与“Seagen 顶尖ADC”强行缝合的联合疗法构想，是辉瑞在2030年前实现其肿瘤学复兴的最后一颗子弹。在未来的医学大会上，当 SigVie-002 的详细亚组生存数据和 PF-08634404 与 ADC 联用的首批临床效能数据陆续揭晓时，市场将看清：辉瑞究竟能凭借这一剂价值百亿的“双抗+ADC”解药彻底打破落寞、重登王座，还是将在更加拥挤、激烈的精密医学混战中，继续扮演着高价买单却步步落后的“追赶者”。风险提示：本文仅用于行业观察与产业研究，不构成任何投资建议、个股推荐或用药建议。文中涉及政策变化、BD交易、临床开发和商业化前景的内容，均存在较大不确定性。创新药研发需以严格临床证据和监管审批为准，相关产业判断应审慎参考。 ★

2026-06-23

·BioSpace

Can ADCs be kinder and gentler? Join

/ iStock, BackyardProduction While existing antibody-drug conjugates have been incredible advancements in cancer care, patients are ready for a better experience. At the BIO International Convention in San Diego on Thursday, BioSpace will lead a discussion on the next generation of ADCs. Nurse practitioner Archana Ajmera has seen firsthand what patients can face when they receive an antibody-drug conjugate for their cancer. Interstitial lung disease is a common side effect, causing scarring of the lung tissue that can make breathing difficult. Severe cases result in death. Patients are treated with high dose steroids and sometimes have to discontinue treatment with the antibody-drug conjugate (ADC). That’s the last thing many patients with complex cancers want to do if a drug is working. Daiichi Sankyo and AstraZeneca’s Enhertu was first approved in 2019, providing a new, more targeted cytotoxic drug for the treatment of breast cancer, lung cancer, gastric cancer and other solid tumors. The HER2-targeting ADC improved survival for patients and has since moved up in the line of treatment. Enhertu changed the treatment paradigm but became associated with side effects like interstitial lung disease (ILD). Both Daiichi and AstraZeneca are trying to improve on the model with new candidates. But so too are a lineup of biotechs. That’s where Zymeworks and Kivu Biosciences stand. They want the improvements in survival with a better experience for patients. So as new ADCs with better safety and tolerability advance in the clinic, what exactly does that mean for patients? That’s a question we will try to answer at the BIO International Convention in San Diego on Thursday, in a panel I’m hosting called The Next Generation of ADCs: Building Kinder, Gentler Cancer Therapeutics . NextGen Facing pressure from China, BioSpace ’s NextGen biotech leaders say: ‘Bring it on’ From Chinese innovation to AI, biotech CEOs are being hit with challenges at a breakneck pace. Three leaders from BioSpace ’s NextGen Class of 2026 told us about the issues keeping them up at night. June 3, 2026 · 6 min read · Annalee Armstrong Read more Ajmera, who practices at UC San Diego Health, will join me, providing insight into the patient experience from the bedside. Then we’ll cover the exciting science happening in the preclinical space with Merck’s Michael Seganish, a scientist in the oncology leader’s discovery chemistry group who has been focusing on ADCs for the past six years. Seganish will arrive straight from the lab to tell us about the new payloads, mechanisms and discovery work that will form the basis of the ADCs of the future. New research is showing how ADCs can be combined with immunotherapy, further boosting treatment efficacy. Seganish’s perspective comes from the company on the leading edge of immuno-oncology—the home of Keytruda. From there, the discussion will shift to the treatments that are moving closer to patients. Zymeworks Chief Medical Officer Sabeen Mekan and Kivu Biosciences’ Mohit Trikha will provide a snapshot of the clinical space and how their companies are trying to create safer ADCs. Succeeding in that endeavor could require breaking down the effects of ADCs’ different parts, said Jakob Dupont, executive partner at Sofinnova Investments and another member of the panel. TROP2-targeting agents can cause skin toxicity, for instance. So perhaps a different antigen would serve as a better target for patients with existing skin issues. The payload, meanwhile, is the bomb dropped on the cancer. It’s the agent of therapy but also the agent of toxicity, Dupont explained. “ADCs are one of the most complicated molecules we can build. If we don’t have to make an ADC, we won’t,” he told BioSpace ahead of the panel. Patient selection isn’t just for finding treatments that will work the best—it’s about avoiding toxicity, too, Dupont added. Investors like Dupont are constantly searching for new assets to put their money behind. A key question, he said, is how a new candidate can solve a problem. ADCs have seen big investment on the venture capital side as well as through mega-partnerships between Big Pharmas and smaller biopharmas. All these experts will come together to explain how the next generation of ADC therapies can improve the patient experience, with kinder, gentler options. Join BioSpace at BIO 2026 to find out more. Antibody-drug conjugate (ADC) ASCO: Merck overshadowed by upstart biotechs but TROP2 plans begin to pay off Merck may not have had the splashiest presentation at the American Society of Clinical Oncology meeting, but the data show why the Big Pharma remains king of oncology, analysts say. June 2, 2026 · 4 min read · Annalee Armstrong Read more

上市批准ASCO会议抗体药物偶联物免疫疗法

2026-06-22

·丁香园 Insight 数据库

百利天恒的成人礼

6 月 22 日，百利天恒迎来一项重要里程碑进展： BL-B01D1（iza-bren）正式获得 NMPA 批准上市，用于治疗复发或转移性鼻咽癌，这不仅是全球首个获批上市的 EGFR×HER3 双抗 ADC，也是百利天恒首个获批上市的 1 类新药。至此，百利天恒历时十多年的创新药转型攻坚战终于迎来首个胜利成果。从仿制药起家到手握全球首创双抗 ADC，百利天恒缔造了中国创新药又一个闪亮时刻。老钱养新药百利天恒的前身是百利药业，其于 1996 年在四川温江注册建厂。早期，公司长期依靠化学仿制药和中成药建立基本盘，丙泊酚、右美托咪定、黄芪颗粒等品种撑起了最初收入，也为其提供了从供给到终端的产业化经验。 2010 年起，百利天恒开启战略转型，正式进军创新药业务，研发重点转向小分子创新药，并用化药及中成药现金流反哺创新药研发。 2014 年，百利天恒在美国西雅图成立全资子公司 Systlmmune，将早期发现、抗体工程和创新管线的 0 到 1 研发放到海外创新生态中推进。彼时国内创新药生态尚未成熟，ADC 远未成为热门赛道，这一选择是百利天恒一次高风险转身。 2023 年 1 月，百利天恒在科创板挂牌上市。同年 12 月，百利天恒与 BMS 就一款靶向 EGFR×HER3 的双抗 ADC iza-bren 达成合作，潜在交易总额高达 84 亿美元。双方采用 Co-Co 合作模式，在美国共同开发、共同商业化，百利天恒保留中国大陆权益。这笔交易把百利天恒推到了中国创新药出海的中心位置。 A 股市场反应迅速，交易披露后，公司开盘 20% 涨停，股价创历史新高。彼时 iza-bren 仍在临床早期，BMS 愿意出这样的价格，买的是一个双抗 ADC 跨瘤种开发的窗口期，也是中国 ADC 资产在全球药企管线里的新位置。两年多过去，84 亿美元仍然是百利天恒最醒目的标签。但百利天恒的业绩走势堪比过山车。2023 年，公司营收同比下滑 20.11%，归母净利润亏损 7.80 亿元；2024 年，受 BMS 合作首付款确认等因素影响，公司营收同比大增 936.31%，实现归母净利润 37.08 亿元，同比扭亏。进入 2025 年，百利天恒再度转亏。全年公司实现营收 25.20 亿元，同比下滑 56.72%；归母净利润亏损 10.54 亿元。上市后的价值叙事，第一次被业绩表现拉回现实。2026 年一季度，公司实现营业收入 9458.68 万元，同比增长 40.25%；归属于上市公司股东的净利润亏损 7.75 亿元，亏损额同比扩大 45.75%。二级市场上，业绩承压的百利天恒也迎来上市以来最剧烈的回调。从历史高点 414.02 元算起，连续调整后，公司股价已被「腰斩」。业绩大起大落背后，百利天恒与 BMS 围绕核心产品 iza-bren 的合作节奏是重要影响因素之一。iza-bren 商业化兑现仍是下一阶段核心压力。一药定成败 ADC 药物市场天花板高、增长确定性强，一直是行业重点看好的黄金赛道。据弗若斯特沙利文数据，2025 年全球 ADC 市场规模约为 187 亿美元，到 2032 年预计将进一步扩大至约 940 亿美元，年复合增率约 26%。相比之下，中国 ADC 市场起步较晚但增长更快。自 2020 年首款 ADC 实现商业化以来，中国 ADC 市场在 2025 年已达到约 10 亿美元，预计 2032 年将增至约 141 亿美元，年复合增率约 46%，明显高于全球市场（图 1）。图 1. 全球及中国 ADC 市场规模及预测图片来源：弗若斯特沙利文数据 iza-bren 作为一款 EGFR×HER3 双抗 ADC，一方面可阻断 EGFR 和 HER3 介导的肿瘤增殖与存活信号，另一方面可通过抗体介导的内吞作用，将有效载荷递送至肿瘤细胞内，引发基因毒性应激，最终导致肿瘤细胞死亡。随着鼻咽癌适应症获批，iza-bren 正式进入商业化阶段，也成为人类药史上首个实现商业化的双抗 ADC，而百利天恒也将开创双抗 ADC 新时代。目前，iza-bren 正在国内外开展 40 余项临床试验，覆盖鼻咽癌、食管鳞癌、非小细胞肺癌、小细胞肺癌、三阴性乳腺癌、HR+HER2-乳腺癌、尿路上皮癌、胆道癌等多个高发瘤种。其中，产品已推进至多项注册性和关键临床阶段，包括全球关键注册研究、中国上市申请受理、III 期、II/III 期、II 期及 Ib 期临床试验。更重要的是，iza-bren 的关键临床数据正在持续兑现。不到一年内，该产品已有 3 项确证性注册 III 期临床达到主要终点，商业化进程明显提速。 2025 年 7 月，iza-bren 鼻咽癌 III 期研究期中分析达到主要终点。同年 11 月，其首个新药上市申请获 CDE 受理，用于治疗既往经 PD-1/PD-L1 单抗治疗且经至少两线化疗（至少一线含铂）治疗失败的复发性或转移性鼻咽癌患者，该申请于近日通过优先审评通道获批上市。 2025 年 11 月，iza-bren 在食管鳞癌 III 期研究中同时达到 PFS 和 OS 双主要终点。2026 年 1 月，iza-bren 的食管鳞癌适应症上市申请获 CDE 受理并纳入优先审评。ASCO 上公布的数据显示，iza-bren 组 mPFS 为 4.17 个月，较化疗组 1.97 个月翻倍；ORR 为 35.3%，接近化疗组 13.1% 的 3 倍。安全性方面，不良反应主要为血液学毒性，TRAE 相关停药率为 2.0%。 2026 年 2 月，iza-bren 在局部晚期或转移性三阴性乳腺癌（TNBC）III 期研究中取得 PFS 和 OS 双阳性结果。ASCO 数据显示，iza-bren 组 mPFS 为 8.5 个月，化疗组为 3.1 个月；HER2 低表达人群 mPFS 为 9.7 个月，化疗组为 4.1 个月；mOS 为 15.9 个月，化疗组为 12.5 个月。安全性整体可控，TRAE 相关停药率为 1.9%。 6 月 11 日，iza-bren 用于三阴性乳腺癌的第 3 项适应症上市申请也获得了 CDE 的受理。鼻咽癌作为首个落地的适应症，竞争格局相对清晰，同类产品整体进度靠后，有利于产品完成市场导入。在此基础上，食管鳞癌将成为后续放量的重要增量市场。食管鳞癌患者基数更大，临床需求也更明确，二线治疗长期缺乏有效方案，传统化疗疗效和耐受性均存在不足。iza-bren 已在 III 期研究中取得 PFS 和 OS 双阳性结果，显示出较传统化疗更明确的临床获益，具备切入临床用药格局的基础。鼻咽癌和食管鳞癌之外，三阴性乳腺癌进一步打开了更大的实体瘤市场空间，加之后续多项适应症已被 NMPA 纳入突破性治疗品种名录，iza-bren 广谱覆盖瘤种适应症所形成的梯队效应，也将依次把 iza-bren 这一大药名号做实。与此同时，百利天恒也即将告别 BD 青春期，开始进入创新药销售兑现阶段。二梯队上桌百利天恒手里必然不止 iza-bren 这一副王炸。截至 2026 年一季度，公司共有 17 款创新药处于临床阶段。除 iza-bren 之外，后续管线也已经形成梯队。其中，HER2 ADC T-Bren（BL-M07D1）是百利天恒最受关注的创新资产之一，对标第一三共/阿斯利康旗下的 ADC 重磅产品 Enhertu（DS-8201），正在同步开展 8 项 III 期临床。从今年 ASCO 上已披露数据看，T-Bren 单药或联合帕妥珠单抗治疗初治不可切除局部晚期/转移性 HER2 阳性乳腺癌的 II 期研究中已经显露出冲击同类最佳的潜力：其单药组 ORR 达 88.4%，联用帕妥珠单抗组 ORR 为 87.5%，两组 DCR 分别达到 100% 和 97.5%；联用方案 12 个月 PFS 率为 90.8%。作为参照，DS-8201 此前披露的 ORR 为 85.1%，12 个月 PFS 率为 85.9%（非头对头）。这些数据已经足以让 T-Bren 进入 HER2 ADC 第一梯队，并成为 DS-8201 之后值得关注的追赶者之一。DS-8201 全球年销售额已接近 50 亿美元，且仍保持强劲增长。如果 T-Bren 后续 III 期数据能够延续这一表现，HER2 ADC 赛道或将迎来来自中国创新药的新变量。 T-bren 之外，DLL3 ADC BL-M14D1 是百利天恒的另一张王牌。DLL3 一直是小细胞肺癌领域的高价值靶点，但此前罗氏 Rova-T 因疗效和安全性问题折戟，使市场一度对这一方向趋于谨慎。 BL-M14D1 在 2026 年 ASCO 大会公布的数据，重新点燃了市场对 DLL3 靶点的信心。在二线小细胞肺癌中，其 mPFS 为 8.1 个月，ORR 为 78.6%，cORR 为 71.4%，生存获益与客观缓解均显著超过同类靶向 DLL3 抗体药物；在二线神经内分泌癌中，cORR 为 38.2%，DCR 为 94.1%，6 个月 PFS 率为 56.7%。安全性方面，停药率仅 2.4%，RP2D 剂量下未观察到停药事件。百利天恒依托 HIRE-ADC 平台，将 ADC 开发能力复制到多个靶点和瘤种中，形成 iza-bren（EGFR×HER3 双抗 ADC）、T-Bren（HER2 ADC）、BL-M14D1（DLL3 ADC）、BL-M05D1 （CLDN18.2 ADC）等丰富的 ADC 管线梯队。此外，百利天恒还在探索许多新型的分子类型，包括 SI-B001（EGFR×HER3 双抗）、GNC-077（多抗）、BL-ARC001（ARC 候选药物），以及三种处于 Ib 期的 GNC（制导、导航与控制）候选药物，即 GNC-038 (CD3×4-1BB×PD-L1×CD19)、GNC-035 (CD3×4-1BB×PD-L1×ROR1) 和GNC-039 (CD3×4-1BB×PD-L1×EGFRvIII)。这些管线将和 ADC 管线形成互补协同效应，支撑百利天恒向肿瘤领域全球化药企迈进。结语对于百利天恒而言，BL-B01D1 在中国的获批只是其创新药转型的起点。百利天恒 CEO 曾公开表示，公司的目标是在 2029 年底前成为一家入门级 MNC。要实现这一目标，企业需要具备四项核心能力：全球研发能力、全球临床开发能力、全球药物供应能力和全球商业化能力。目前，百利天恒已在 ADC、ARC 及多抗等领域建立起具有全球竞争力的研发和临床开发能力，并形成了与之相匹配的药物供应能力。全球商业化能力仍是百利天恒需要补齐的关键一环。随着 iza-bren 未来在海外市场陆续获批并推进商业化，百利天恒有望逐步构建全球商业化体系，向「入门级 MNC」的目标加速迈进。参考资料 [1] 百利天恒官网、官微 [2]Insight 数据库 [3] 弗若斯特沙利文官微编辑：耳又封面来源：站酷海洛Plus 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。

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,

后查看更多信息

适应症	国家/地区	公司	日期
HER2阳性转移性乳腺癌	美国	Daiichi Sankyo, Inc.	2026-05-15
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
实体瘤	临床3期	美国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	中国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	日本	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	澳大利亚	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	巴西	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	法国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	以色列	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	意大利	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	韩国	Daiichi Sankyo, Inc.	2025-12-23
实体瘤	临床3期	西班牙	Daiichi Sankyo, Inc.	2025-12-23

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临床结果

适应症

分期

评价

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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


NCT04704934 (DESTINY-Gastric04, ASCO2026)	临床3期	HER2阳性胃癌 \| 胃食管交界处腺癌二线 HER2+	494	trastuzumab deruxtecan (T-DXd) 6.4 mg/kg	鏇齋衊鹽範襯構憲遞鏇(淵窪顧積糧淵齋鬱顧鑰) = 淵繭鹹壓範繭選鏇鹹網鹹網簾淵夢獵鹹積齋獵 (艱範繭膚簾齋壓鹹鹹遞, 2.7 ~ 5.0) 更多	积极	2026-05-29
				ramucirumab + paclitaxel	鏇齋衊鹽範襯構憲遞鏇(淵窪顧積糧淵齋鬱顧鑰) = 蓋鬱範遞繭壓廠鏇積齋鹹網簾淵夢獵鹹積齋獵 (艱範繭膚簾齋壓鹹鹹遞, 2.1 ~ 3.5) 更多
LC-SCRUM-Asia (ASCO2026)	N/A	HER2阳性非鳞状非小细胞肺癌 HER2 exon 20 insertion-positive	77	HER2-TKI-naïve patients	鹹醖衊簾觸窪網顧觸壓(網鹽鏇襯鹽遞鬱襯襯繭) = 顧範範蓋壓淵鹽遞鏇窪繭夢憲願鏇襯壓觸簾獵 (衊製製廠鹽鏇願觸鹹遞 ) 更多	积极	2026-05-29
				those treated with selective HER2-TKIs (zongertinib or severtinib)	鹹醖衊簾觸窪網顧觸壓(網鹽鏇襯鹽遞鬱襯襯繭) = 夢窪廠廠淵簾襯鹹鑰襯繭夢憲願鏇襯壓觸簾獵 (衊製製廠鹽鏇願觸鹹遞 ) 更多
ASCO2026	N/A	软脑膜转移性恶性肿瘤 HER2 positive \| ER positive \| PR positive	16	Trastuzumab-deruxtecan	顧齋廠範鬱鹽鬱鏇繭膚(築壓襯觸鹽鏇鏇網鑰顧) = 糧醖廠膚願簾鹹衊範衊構鑰廠窪遞餘憲壓蓋憲 (觸鏇築鹽觸顧襯繭鑰製, 2.7 ~ 12.0) 更多	积极	2026-05-29
ASCO2026	早期临床1期	晚期结直肠腺癌	289	ADCs (indusatumab vedotin, labetuzumab govitecan, trastuzumab deruxtecan, precemtabart tocentecan)	範壓窪糧醖憲艱廠願醖(繭遞製糧簾襯齋鹽鏇選) = 襯餘淵選顧鬱繭鑰顧醖繭廠願夢襯繭繭遞鑰鬱 (憲構鹹夢餘襯繭鹹鹽襯, 3.7 ~ 16.4) 更多	积极	2026-05-29
NCT04379596 (DESTINY-Gastric03 (DG-03), ASCO2026)	临床1/2期	食管腺癌 \| HER2表达胃腺癌 \| 胃食管交界处腺癌一线 HER2-expressing	137	T-DXd 6.4 mg/kg + pembrolizumab + fluoropyrimidine	膚醖壓獵繭衊齋鬱艱糧(壓遞襯簾觸鑰糧遞衊鏇) = 顧顧衊顧觸蓋願醖糧鬱願壓範顧範窪齋構獵選 (艱壓淵網範窪鹹糧鹹願 ) 更多	积极	2026-05-29
				T-DXd 5.4 mg/kg + pembrolizumab + fluoropyrimidine	膚醖壓獵繭衊齋鬱艱糧(壓遞襯簾觸鑰糧遞衊鏇) = 糧糧壓遞壓獵衊醖鏇網願壓範顧範窪齋構獵選 (艱壓淵網範窪鹹糧鹹願 ) 更多
JPRN-jRCT2011210017 (MYTHOS, ASCO2026)	临床2期	唾液腺癌复发 HER2-low	36	Trastuzumab deruxtecan 5.4 mg/kg	鹽顧獵觸積糧鏇鬱齋顧(憲鹹範顧網鹽襯選膚鑰) = 齋蓋築鏇鬱艱窪淵廠齋顧鑰獵簾鹽遞膚夢醖膚 (鬱繭醖鑰製壓觸選遞襯, 23.1 ~ 56.5) 更多	不佳	2026-05-29
				Trastuzumab deruxtecan 5.4 mg/kg (salivary duct carcinoma)	鹽顧獵觸積糧鏇鬱齋顧(憲鹹範顧網鹽襯選膚鑰) = 糧衊鑰遞繭範範築窪鹽顧鑰獵簾鹽遞膚夢醖膚 (鬱繭醖鑰製壓觸選遞襯, 28.3 ~ 65.7)
NCT06819007 (DESTINY-Ovarian01, ASCO2026)	临床3期	一线 \| 维持 HER2-expressing	21	T-DXd + BEV	簾淵蓋簾齋獵蓋構範窪(鹹選糧餘鬱餘遞鹽獵廠) = 範網蓋構願範襯簾獵憲夢網蓋壓鏇構窪製鬱繭 (觸築廠鑰餘蓋廠鬱製淵 ) 更多	积极	2026-05-29
ASCO2026	N/A	转移性乳腺癌 HER2-positive \| HER2-low	406	Trastuzumab deruxtecan	鬱築艱齋衊餘壓糧糧繭(齋構鏇製範廠鹽鬱獵蓋) = 鏇顧遞淵獵鏇淵鹹艱積遞夢遞範鹹餘鏇築廠選 (顧簾齋糧齋製衊壓窪餘 ) 更多	积极	2026-05-29
ASCO2026	N/A	胆道癌 ERBB2 amplification \| single nucleotide variants (SNV) \| concurrent amplification and SNVs	21	HER2 directed therapy	膚壓範壓積壓遞觸鹹願(網鏇鏇觸範選淵窪壓窪) = At baseline, ERBB2 alteration patterns included ERBB2 amplification in 15 patients (71.4%), single nucleotide variants (SNV) in 2 patients (9.5%), and concurrent amplification and SNVs in 3 patients (14.3%). 選鹹廠廠繭範簾膚鹽窪 (選繭廠鏇鏇構窪糧衊簾 )	积极	2026-05-29
ASCO2026	N/A	HER2阳性乳腺癌 HER2-positive \| HER2-low	63	Dose-adapted trastuzumab deruxtecan	選壓蓋鏇簾衊鹽衊窪鑰(製願餘遞鹹願鹹艱願糧) = 鬱壓觸鹽獵積襯鏇積鹽艱糧鏇窪鑰鬱壓網齋壓 (鏇鏇鏇製糧願鹹顧繭簾, 46 ~ 71) 更多	积极	2026-05-29
				Dose-adapted trastuzumab deruxtecan (Evaluable cohort)	選壓蓋鏇簾衊鹽衊窪鑰(製願餘遞鹹願鹹艱願糧) = 壓觸簾網齋繭遞積窪衊艱糧鏇窪鑰鬱壓網齋壓 (鏇鏇鏇製糧願鹹顧繭簾, 53 ~ 79) 更多