预约演示

更新于：2026-01-10

Sacituzumab govitecan-hziy

戈沙妥组单抗

更新于：2026-01-10

概要

基本信息

药物类型

ADC

别名

hRS7-SN38 antibody drug conjugate、Isactuzumab govitecan、Sacituzumab Govitecan

+ [13]

靶点

Top I x Trop-2

作用方式

抑制剂

作用机制

TOP1抑制剂(DNA拓扑异构酶I抑制剂)、Trop-2抑制剂(肿瘤相关钙信号传感器2抑制剂)

治疗领域

肿瘤皮肤和肌肉骨骼疾病内分泌与代谢疾病+ [9]

在研适应症

转移性三阴性乳腺癌乳腺癌HR阳性/HER2阴性乳腺癌+ [90]

非在研适应症

多形性胶质母细胞瘤肝细胞癌肾细胞癌

原研机构

Immunomedics, Inc.

在研机构

Gilead Sciences, Inc.

Merck Sharp & Dohme Corp.

Pfizer Inc.

+ [13]

非在研机构

Everest Medicines II Ltd.

权益机构

Seagen, Inc.

BSP Pharmaceuticals SpA

Gilead Sciences, Inc.

+ [7]

最高研发阶段批准上市

首次获批日期

美国 (2020-04-22),

三阴性乳腺癌

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、快速通道 (美国)、加速批准 (美国)、孤儿药 (美国)、优先审评 (中国)、孤儿药 (韩国)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、快速通道 (韩国)、优先审评 (中国台湾)、优先审评 (美国)、附条件批准 (中国)

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结构/序列

使用我们的ADC技术数据为新药研发加速。

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Sequence Code 27958L

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Sequence Code 319372635H

来源: *****

关联

128

项与戈沙妥组单抗相关的临床试验

CTIS2025-521489-80-00

/ Not yet recruiting临床2期

A PHASE II TRIAL EVALUATING THE SAFETY AND EFFICACY OF THE COMBINATION OF ZIMBERELIMAB, DOMVANALIMAB, AND SACITUZUMAB GOVITECAN AS FIRST-LINE THERAPY FOR PD-L1 POSITIVE ADVANCED TRIPLE-NEGATIVE BREAST CANCER (The ADJUNCT Study)

开始日期2026-01-31

申办/合作机构-

NCT07178730

/ Not yet recruiting临床3期IIT

NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer

TNBC is a heterogeneous disease with distinct pathological, genetic, and clinical features among subtypes. Treatment results for high-risk primary TNBC remain poor compared to other breast cancer subtypes. Preoperative chemotherapy is the standard of care for patients with stage II or III primary TNBC. Multiple lines of clinical evidence demonstrate that TNBC patients who achieve a pCR to NACT, (ypT0/is ypN0), have an excellent long-term prognosis. A meta-analysis of individual patient data confirmed a strong association of pCR after NACT with improved long-term event-free survival (EFS, hazard ratio [HR] 0.24) and overall survival (OS, HR 0.16) benefit. Taxane- and anthracycline-based neoadjuvant regimens generally result in pCR rates between 25-50% [REFs], whereas the addition of platinum increases pCR rates to approximately 50-55%.
The KEYNOTE-522 trial has demonstrated that the addition of the immune-checkpoint inhibitor PEM to anthracycline- (AC), taxane- and platinum-based NACT resulted in a significant increase in pCR rates to nearly 65%, associated with a significant reduction of recurrences (EFS, HR 0.65 at 5 years) and improvement of OS (HR 0.66). Based on these results, the KEYNOTE-522 regimen has been approved by the FDA and EMA and has become the standard of care for patients with stage II or III TNBC.
Despite this significant progress, two major questions remain unresolved which will be investigated in the ADAPT-TN-IV trial:
1. Do all patients require the full 6 months of NACT as per KEYNOTE-522 or is there a subgroup of patients who are sufficiently treated with 12 weeks of NACT plus PEM?
2. Can incorporation of ADCs into the KEYNOTE-522 regimen improve response and outcomes in patients without an optimal early response? The outcome of patients with residual disease after 24 weeks of NACT and PEM remains suboptimal and there is an urgent need for more effective strategies. ADCs such as SG have demonstrated superior efficacy compared to standard chemotherapy in metastatic TNBC, resulting in substantially higher response rates and improved progression-free (PFS) and OS. Combination studies of ADCs and immunotherapy in metastatic TNBC have demonstrated significant activity, suggesting possible synergistic activity It is therefore a logical next step to investigate, whether the incorporation of SG in the NACT regimen can improve pCR rates and EFS results in patients who have residual clinical disease after 12 weeks of NACT with CARBO/PAC + PEM.

开始日期2026-01-31

申办/合作机构

Gilead Sciences, Inc.

NCT06462092

/ Recruiting临床1/2期IIT

A Phase I/II Clinical Study of Sacituzumab Govitecan Combined With Intrathecal Chemotherapy for the Treatment of Leptomeningeal Metastases From Her2-negative Breast Cancer

Leptomeningeal metastases (LM) is a lethal complication of malignant tumors, characterized by tumor cell invasion and proliferation within the subarachnoid space. LM from HER2-negative breast cancer remains challenging to treat, with a median overall survival of only 3-6 months despite aggressive therapy. This open-label, uncontrolled Phase I/II clinical study aims to evaluate the safety, feasibility, and potential efficacy of Sacituzumab Govitecan in combination with intrathecal pemetrexed chemotherapy for LM from HER2-negative breast cancer, with the objective of identifying a more effective treatment strategy.

开始日期2026-01-01

申办/合作机构

广州医科大学

100 项与戈沙妥组单抗相关的临床结果

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100 项与戈沙妥组单抗相关的转化医学

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100 项与戈沙妥组单抗相关的专利（医药）

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1,918

项与戈沙妥组单抗相关的文献（医药）

2026-02-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Antibody-Drug Conjugates in urothelial, prostate, and renal cell cancers: A review of current and emerging therapies

Review

作者: Maniam, Akash ; Hettiarachchige Don, Anton ; Perera, Anne ; Banna, Giuseppe Luigi ; Atsumi, Naoko

This review explores the therapeutic potential of Antibody-Drug Conjugates (ADC) in urological malignancies, emphasizing treatment efficacy, safety, and future prospects. ADC selectively deliver cytotoxic agents to cancer cells, reducing off-target toxicity compared to conventional therapies. Comprising a monoclonal antibody (mAb) linked to a cytotoxic payload, ADC exert their effects through apoptosis, antibody-dependent cellular cytotoxicity (ADCC), and complement-dependent cytotoxicity (CDC). This review highlights ADC advancements in urothelial cancer (UC), prostate cancer (PC), and renal cell carcinoma (RCC). Recent trials demonstrate encouraging outcomes with ADC such as Enfortumab Vedotin (EV), Sacituzumab Govitecan (SG), Trastuzumab Deruxtecan (T-DXd), and Disitamab Vedotin (DV) in UC, improving response rates and Progression-Free Survival (PFS). The influence of antigen expression, particularly Nectin-4 and Trop-2, on ADC treatment outcomes is investigated. In addition, efficacy and safety of ADC combinations with anti-PD-(L)1 therapies and dual immune checkpoint inhibitors to further enhance therapeutic benefit are explored. In PC, ADC targeting prostate-specific membrane antigen (PSMA), Trop-2, and B7-H3 exhibit promising antitumor activity, with research optimizing safety, efficacy, and monitoring strategies. In RCC, ADC against ENPP3, CD70, and TIM-1 show durable responses in early trials, though challenges such as dose-limiting toxicities require further investigation. Overall, this review underscores ADC as a transformative approach in uro-oncology, highlighting ongoing advancements in combination strategies and biomarker-driven applications to refine therapeutic outcomes and expand treatment options for these challenging malignancies.

2026-02-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

TROP-2–directed antibody–drug conjugates in advanced NSCLC: A systematic review and meta-analysis of efficacy, safety, and reconstructed survival outcomes

Review

作者: Siddiqui, Hafiza Tooba ; Rath, Shree ; Alam, Umama ; Ansab, Muhammad ; Desai, Aakash ; Burhan, Muhammad

INTRODUCTION:

Non-small cell lung cancer (NSCLC) represents the majority of lung cancer cases worldwide, with most patients diagnosed at advanced stages and limited by resistance to existing therapies. TROP-2, an epithelial cell surface glycoprotein overexpressed in many NSCLCs, has emerged as a promising therapeutic target for antibody-drug conjugates (ADCs). This study aims to systematically evaluate the efficacy and safety of TROP-2-directed ADCs in patients with advanced or metastatic NSCLC.

METHODS:

Electronic databases (PubMed, Embase, Clinical Trials and Cochrane Central) were searched up to November 2025 for studies reporting outcomes in advanced NSCLC patients treated with TROP-2-directed ADCs. Eligible studies included adult populations with advanced NSCLC that were treated with datopotamab deruxtecan, sacituzumab govitecan, or sacituzumab tirumotecan, and reported efficacy or safety outcomes. Pseudo-individual patient-level data for survival analyses were reconstructed from published Kaplan-Meier curves. Pooled effect sizes were estimated using random-effects meta-analytic models.

RESULTS:

Seven studies encompassing 1365 patients with advanced or metastatic NSCLC were included. The pooled median overall survival (OS) was 16.38 months (95 % CI: 11.17-22.96), and the median progression-free survival (PFS) was 6.08 months (95 % CI: 4.93-8.55). The objective response rate (ORR) across studies was 29 % (95 % CI: 19 %-39 %), with a disease control rate (DCR) of 79 % (95 % CI: 74 %-84 %). Subgroup analysis revealed patients with EGFR-mutated tumors had a significantly higher likelihood of response (risk ratio 1.70, 95 % CI: 1.11-2.61). Safety analysis showed treatment-emergent adverse events (TEAEs) in 98 % (95 % CI: 94 %-100 %), grade ≥ 3 TEAEs in 52 % (95 % CI: 38 %-67 %), and interstitial lung disease (ILD) in 9 % (95 % CI: 3 %-16 %).

CONCLUSION:

TROP-2-directed ADCs demonstrate meaningful efficacy in previously treated advanced NSCLC, especially among EGFR-mutant and non-squamous histology patients, with survival and response outcomes superior to traditional chemotherapy. However, high rates of adverse events, particularly ILD, necessitate close monitoring. Further randomized and biomarker-driven studies are warranted to refine patient selection and optimize the therapeutic potential of these agents.

2026-01-01·BREAST CANCER RESEARCH AND TREATMENT

Efficacy and safety of sacituzumab govitecan in patients with metastatic metaplastic triple-negative breast cancer: a multinational retrospective case series from CEBCC-102 study

Article

作者: Pieniążek, Małgorzata ; Żubrowska, Justyna ; Holánek, Miloš ; Püsküllüoğlu, Mirosława ; Danielewicz, Iwona ; Bielčiková, Zuzana ; Łacko, Aleksandra ; Malejčíková, Miroslava ; Polakiewicz-Gilowska, Anna ; Pacholczak-Madej, Renata ; Lisik-Habib, Maja ; Konieczna, Aleksandra ; Soumarová, Renáta ; Kubeczko, Marcin

Abstract:

Background:

Metastatic metaplastic triple-negative breast cancer (mMpTNBC) is a rare, aggressive subtype with poor responsiveness to standard therapies. Sacituzumab govitecan (SG) is effective in metastatic TNBC (mTNBC), but data in mMpTNBC are limited to case reports. Patients and methods: This multinational, multicenter, retrospective case series was conducted within the CEBCC-102 real-world evidence project across 18 cancer centers. Female patients with histologically confirmed mMpTNBC treated with ≥ 2L SG outside of clinical trials in Poland, the Czech Republic and Slovakia between August 2021 and June 2025 were included. Clinical data, treatment outcomes, and adverse events (AEs) were collected from medical records and analysed.

Results:

Among 303 patients with mTNBC treated with SG in second and later lines within the CEBCC-102 project, 13 women (4.3%) had mMpTNBC and were included in this analysis. Median age was 58 years. PD-L1 CPS ≥ 10 was found in 83% of tested cases. Overall response rate was 36.4%, clinical benefit rate 45.5%, median progression-free survival 3.2 months and median overall survival 8.9 months. Neutropenia (N = 9, 69%) was the most common AE; no febrile neutropenia or treatment discontinuations due to toxicity occurred.

Conclusions:

This first international real-world series of SG in mMpTNBC shows clinically relevant activity and manageable toxicity, addressing a critical evidence gap and supporting further prospective studies, particularly in PD-L1–positive disease.

1,639

项与戈沙妥组单抗相关的新闻（医药）

2026-01-09

·观生物

《Nature Reviews Drug Discovery》双载荷ADC药物首次进入肿瘤临床试验

作为下一代肿瘤治疗技术，已进入早期临床开发阶段（部分候选药物进入 I 期临床试验），多家企业（如中国成都康弘、Innovent、Callio Therapeutics 等）积极布局，且数十款候选药物处于临床前阶段；该技术以TOP1 抑制剂为核心锚定载荷，通过搭配化疗药物、DNA 损伤应答（DDR）抑制剂、免疫激动剂等不同作用机制的载荷，结合精准靶点选择（如 TROP2、HER2、CEACAM5 等）和优化的 linker 设计，旨在克服现有 ADC（如 Enhertu）的耐药性问题、提升疗效持久性，临床前数据显示其在耐药肿瘤模型中具有显著抗瘤活性，但目前行业核心关注其临床安全性（如载荷毒性叠加）、linker 稳定性及人体疗效验证，大型药企仍在等待技术去风险后进一步介入。一、核心背景与技术概念双载荷ADC是指在单个抗体分子上同时连接两种不同细胞毒性药物（弹头）的新型抗体偶联药物。与传统单载荷ADC（如Enhertu、Trodelvy）相比，这种"双弹头"策略旨在通过多机制协同作用克服肿瘤耐药性，实现更持久的疗效。目前已有两个候选药物进入临床阶段，数十个同类药物处于临床前开发。二、技术原理与潜在优势1. 克服耐药性的核心逻辑双重打击机制：肿瘤细胞需同时突变两种不同通路才能产生耐药，难度呈指数级增加协同致死效应：两种弹药配合可阻断肿瘤细胞的代偿性生存通路旁观者效应优化：不同弹药采用差异化释放策略（细胞内释放 vs 微环境释放），扩大杀伤范围2. 业界的核心期待制药行业普遍认为，如果安全性可控，双载荷ADC可能成为"本垒打"式产品，解决当前单载荷ADC响应率有限、快速耐药的痛点。三、主要技术路线与代表产品已进入临床试验阶段 KH815（成都康弘）靶点：TROP2 载荷组合：拓扑异构酶I抑制剂（exatecan）+ RNA聚合酶II抑制剂（triptolide，来源于中药雷公藤）特点：4个exatecan偶联于抗体臂，平均3.5个triptolide偶联于抗体茎部，DAR总值7.5 释放策略：exatecan在细胞内稳定释放，triptolide在肿瘤微环境提前释放增强旁观者效应 IBI3020（信达生物）靶点：CEACAM5 载荷：未公开状态：已启动临床试验部分正在开发的选定双载荷四、三大主流载荷组合策略1. 化疗+化疗组合 TOP1抑制剂 + MMAE：最常见组合，利用两类已验证的成功弹药。但存在毒性叠加和潜在拮抗风险双TOP1抑制剂：Araris采用不同渗透性的exatecan衍生物，精准调控细胞内/外分布2. 化疗+DNA损伤反应（DDR）抑制剂 TOP1抑制剂 + ATR抑制剂：针对肿瘤上调DDR通路产生耐药的机制。临床前数据显示可克服已耐药的肿瘤细胞，重新致敏理论依据：合成致死数据库显示DDR通路缺陷细胞对TOP1抑制剂高度敏感3. 化疗+免疫激动剂 iADC（免疫刺激型ADC）概念：通过ADC快速缩瘤后，免疫激动剂激活免疫系统清除残余病灶代表：Sutro/Astellas合作项目，TLR7/8激动剂在研五、关键技术挑战与考量1. 安全性风险毒性叠加：两种弹药若均引起中性粒细胞减少等血液学毒性，可能加剧不良反应治疗窗狭窄：ADC本身治疗窗就窄，双载荷可能进一步压缩安全空间业界共识：I期临床首先需验证"双载荷是否能在合理剂量下保持可接受的安全性"2. 连接子技术（Linker）的决胜作用主流技术路线：差异化连接子：如康弘采用不同稳定性的连接子实现序贯释放分支连接子：Callio和CrossBridge采用单点连接多个载荷，提高均一性亲水性连接子：Araris技术可掩载荷疏水性，减少脱靶毒性制造难度：双载荷ADC的CMC复杂性远高于单载荷，需要稳定可放大的工艺3. 载荷比例（DAR）的优化需要根据载荷效价精细调整比例（如6+2、8+2、8+4），以达到最大治疗指数低效力载荷与高效力载荷配对时，比例失衡可能导致优势载荷主导疗效六、临床前数据亮点康弘KH815：在Sacituzumab govitecan耐药的患者源异种移植模型中仍显示显著抗肿瘤活性，而单载荷ADC无效 Sutro研究：对连续诱导产生多药耐药的肿瘤模型，TOP1+MMAE双载荷ADC可使肿瘤完全消退，且持续120天以上 CrossBridge：在对比试验中，双载荷ADC实现100%响应率，而单载荷仅50%响应，Benchmark组无响应七、产业格局与投资动态投资者热情高涨：Callio Therapeutics年初获得1.87亿美元融资，凸显资本对该领域的信心大药企态度谨慎：目前以观望为主，等待临床数据进一步降低技术风险技术并购活跃：Taiho以4亿美元收购Araris，获其分支连接子技术平台八、未来展望与核心待答问题临床验证阶段：2025-2026年将迎来首批临床数据，重点观察：安全性是否可接受是否显示协同效应（非简单叠加）对耐药肿瘤的逆转能力技术成熟度：连接子技术、DAR优化和制造工艺将是决定成败的关键监管路径：FDA等机构将如何处理这类创新药物的审评，尚无先例商业化前景：若临床成功，双载荷ADC可能重塑肿瘤治疗格局，但需克服生产成本高、定价策略复杂等挑战结论：双载荷ADC代表肿瘤药物研发的重大技术跃迁，其“双弹头”设计理念科学逻辑清晰，临床前数据令人鼓舞，但最终成败取决于临床安全性、疗效验证和工艺可实现性。未来2-3年的临床数据将决定这一领域是成为下一个PD-1级革命，还是技术性概念验证。 https://doi.org/10.1038/d41573-025-00121-y

抗体药物偶联物临床结果

2026-01-08

·肿瘤资讯

从“原石”到临床基石：肺癌ADC药物的靶点深化与治疗格局重塑

编译：肿瘤资讯来源：肿瘤资讯在非小细胞肺癌（NSCLC）进入精准治疗深水区的今天，抗体偶联药物（ADC）正成为继靶向和免疫治疗后的第三大支柱。从早期的概念验证到如今多款药物获批，ADC药物在肺癌领域的应用版图日益清晰。审慎中的希望——回望“原石”时代时间回拨至2024年4月，国际肺癌研究协会（IASLC）旗下媒体曾以《ADC：原石中的钻石？》（Antibody Drug Conjugates: Diamonds in the Rough?）为题，对当时ADC在NSCLC领域的图景进行了客观而审慎的描绘[1]。彼时，尽管德曲妥珠单抗（T-DXd）已在HER2突变领域崭露头角，但专家们——包括Matthew Lee博士、Benjamin Levy博士和Balazs Halmos博士——指出了该类药物在广泛应用前必须面对的“粗糙切面”：生物标志物的困境：除了HER2突变，对于TROP2、CEACAM5等靶点，单纯的蛋白高表达是否足以精准预测疗效尚存争议，部分药物（如针对CEACAM5的Tusamitamab ravtansine）的III期研究折戟也加剧了这种担忧；毒性管理的挑战：间质性肺病（ILD）、口腔黏膜炎及血液学毒性等不良反应的复杂性，使得临床对ADC的安全性管理提出了更高要求；定位的探索：在免疫联合化疗已是一线标准的背景下，ADC的最佳介入时机（前线还是后线）及其与免疫药物的联合策略仍需探索。时隔一年多，随着多项关键III期临床研究数据的公布及监管机构的批准，医学界对这些问题的回答已逐渐清晰。除了FDA批准的多个ADC适应症外，2024年至2025年间，NMPA相继批准了三种针对肺癌的ADC药物，这些药物正通过更精细的人群筛选和更优化的分子设计，逐步完成从“原石”到“临床基石”的蜕变。HER2靶点：精准定义的“驱动基因”治疗范式HER2突变（约占肺腺癌2%-4%）曾是NSCLC治疗中的难点，传统抗HER2单抗及TKI疗效有限。2024年至2025年间，ADC药物确立了其作为该靶点标准治疗的地位。循证医学证据的全球与中国验证德曲妥珠单抗（T-DXd）凭借全球多中心研究DESTINY-Lung02率先在国际上获得认可。随后，针对中国人群的II期桥接研究DESTINY-Lung05进一步验证了其疗效。数据显示，经独立中心审查（ICR）评估的客观缓解率（ORR）达到58.3%，疾病控制率（DCR）为91.7%[2]。基于此，NMPA于2024年10月批准其用于HER2突变晚期经治NSCLC，标志着该类药物正式进入中国临床实践。创新药物设计的差异化探索中国创新力量也在这一领域取得了实质性突破。2025年5月，瑞康曲妥珠单抗（SHR-A1811）获批上市。其HORIZON-Lung研究显示，在经治HER2突变患者中ORR达到74.5%[3]。值得注意的是，该药物在分子结构上进行了差异化设计，通过将药物抗体比（DAR）设定为6以及引入手性环丙基技术提升连接子稳定性，旨在优化安全性与疗效的平衡。数据显示其ILD发生率为8.5%（≥3级为1.1%），药物相关不良事件导致的停药率为2.1%。此外，对于基线伴脑转移的患者，其亚组分析显示ORR达到87.5%，进一步证实了ADC药物在中枢神经系统（CNS）控制上的临床潜力[3]。TROP2靶点：从“泛表达”到“精准人群”的突破不同于HER2的明确突变驱动，TROP2靶点因在NSCLC中广泛高表达，其精准获益人群的筛选一直更具挑战性。2024年时，专家曾担忧TROP2 ADC是否仅是“化疗的重新包装”。然而，随后的研究通过聚焦特定临床情境，找到了破局之道。攻克EGFR-TKI耐药后的“生存悬崖”EGFR突变患者在TKI耐药后，标准含铂化疗的获益往往面临瓶颈（PFS约4-5个月）。2025年，芦康沙妥珠单抗（Sac-TMT）在中国获批两项适应症，分别针对经EGFR-TKI和含铂化疗治疗失败，以及经EGFR-TKI治疗失败的人群。机制驱动的临床获益转化医学研究提示，EGFR突变的肿瘤细胞相较于野生型，对ADC的内吞活性更强，这为筛选TROP2 ADC的优势人群提供了生物学依据。OptiTROP-Lung03研究：在后线治疗中对比多西他赛，芦康沙妥珠单抗显示出显著的PFS和OS获益（PFS 6.9个月 vs 2.8个月；OS HR 0.49）[4]。OptiTROP-Lung04研究：在经EGFR-TKI治疗失败的人群中，芦康沙妥珠单抗单药对比含铂双药化疗，不仅显著延长了无进展生存期（PFS），更实现了总生存期（OS）的统计学显著改善[5]。这使其成为全球首个在III期研究中单药优于含铂双药化疗的ADC药物。这一进展不仅是药物研发的成功，更重要的是它在临床策略上提供了一个新思路：在缺乏特异性突变靶点的情况下，结合疾病生物学行为（如EGFR突变背景下的内吞增强）可能成为预测ADC疗效的新维度。全球视野下的多元化格局必须指出的是，肺癌ADC的研发图景远不止于此。在全球范围内，FDA已授予靶向c-Met的Telisotuzumab vedotin（Teliso-V）突破性疗法认定，用于c-Met高表达人群；靶向HER3的Patritumab deruxtecan（HER3-DXd）也在EGFR突变耐药患者中显示了具有临床意义的疗效。此外，包括Sacituzumab Govitecan和Datopotamab Deruxtecan在内的其他TROP2 ADC也在持续探索中。未来的探索方向正逐步向“前线”推移。目前，包括OptiTROP-Lung07（芦康沙妥珠单抗联合奥希替尼）在内的多项III期研究正在探索ADC联合靶向或免疫治疗在一线治疗中的应用。小结回顾从2024年ILCN提出“原石之问”至今的历程，ADC药物在肺癌领域的进展并非一蹴而就。通过不断的临床试验修正、生物标志物探索和药物结构优化，临床医学界正逐步解决早期面临的诸多不确定性。无论是得益于全球多中心研究的德曲妥珠单抗，还是源自本土创新的瑞康曲妥珠单抗与芦康沙妥珠单抗，这些药物的获批与应用，共同丰富了临床医生的武器库。随着对耐药机制理解的深入和精准分层的细化，ADC药物有望在肺癌的全程管理中发挥更基石性的作用。参考文献1. https://www.ilcn.org/antibody-drug-conjugates-diamonds-in-the-rough/?utm_source=iaslc.org&utm_medium=association-website&utm_campaign=rss-feed&utm_content=link-headline2. Cheng,et al. Trastuzumab deruxtecan (T-DXd) in Chinese patients (pts) with previously treated HER2 mutant non-small cell lung cancer (NSCLC): primary analysis from the Phase 2 DESTINY-Lung05 (DL-05) trial.2024 AACR. CT248.3. Li Z, Wang Y, Sun Y, et al. Trastuzumab rezetecan, a HER2-directed antibody–drug conjugate, in patients with advanced HER2-mutant non-small-cell lung cancer (HORIZON-Lung): phase 2 results from a multicentre, single-arm study. Lancet Oncol. 2025;26(4):437-446. doi:10.1016/S1470-2045(25)00012-94. Fang W, Li X, Wang Q, et al. Sacituzumab tirumotecan versus docetaxel for previously treated EGFR-mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial. BMJ. 2025;389:e085680.5. Zhang L, et al. OptiTROP-Lung04: A phase III study of sacituzumab govitecan versus platinum-pemetrexed chemotherapy in EGFR-mutant NSCLC after TKI failure. ESMO Presidential Symposium 2025.责任编辑：肿瘤资讯-Nydia 排版编辑：肿瘤资讯-Nydia 版权声明本文专供医学专业人士参考，未经著作人许可，不可出版发行。同时，欢迎个人转发分享，其他任何媒体、网站如需转载或引用本网版权所有内容，须获得授权，且在醒目位置处注明"转自：良医汇-肿瘤医生APP"。

2026-01-08

·癌度

死亡风险直降40%！《新英格兰医学杂志》：EGFR靶向药耐药后，TROP2-ADC药物让生存期翻倍！

临床试验资讯研究交流群（点击）在肺腺癌这个肺癌亚型里，EGFR基因突变的概率达到了50%，这部分患者有很高的概率使用靶向药治疗。但是靶向药治疗会有耐药的问题。而靶向药耐药之后怎么办？2025年7月，一项名为OptiTROP-Lung04的III期临床研究带来了令人振奋的消息，芦康沙妥珠单抗（Sacituzumab Tirumotecan，sac-TMT）在EGFR突变非小细胞肺癌靶向治疗失败后，展现出显著的生存优势。研究结果发布在国际著名学术期刊新英格兰医学杂志。本文参考文献刊例示意图一、EGFR阳性肺腺癌靶向药耐药后的选择如果没有靶向药耐药的问题就好了，不过由于肿瘤这个疾病的异质性和进化的特点，靶向药还是会存在耐药的问题。EGFR基因突变在亚洲非小细胞肺腺癌患者中的比例高达40-50%，这个突变概率远高于欧美人群。对于这部分患者第三代EGFR基因靶向药已成为一线治疗标准，但是患者最终会出现耐药的问题。当靶向药治疗不能让患者获益了，患者就需要进入二线治疗。二线治疗有传统的铂类双药化疗，但目前的数据显示二线化疗后的中位无进展生存期仅有4到5个月，肿瘤的客观缓解率通常低于50%，这意味着大多数患者的病情会在短时间内再次进展。近年来，研究者们尝试将化疗与免疫治疗、抗血管生成药物等联合使用，虽然这种联合用药取得了一定的进展，但是总生存期的改善并不明确，且联合治疗往往伴随着更高的不良反应风险。二、靶向TROP2的芦康沙妥珠单抗今天这个文章给大家介绍的是芦康沙妥珠单抗，这是一款靶向TROP2的抗体偶联药（ADC），该药的治疗效果在国际多中心III期临床试验中得到了充分验证。这项研究纳入了376名EGFR基因突变且经EGFR靶向药治疗后进展的局部晚期或转移性非小细胞肺癌患者。患者被随机分配为两组，试验组患者使用芦康沙妥珠单抗，对照组则使用临床上的标准二线铂类化疗。芦康沙妥珠单抗改善无进展生存期如上面的图示，芦康沙妥珠单抗治疗组的中位无进展生存期达到了8.3个月，是化疗组（4.3个月）的近两倍。这意味着疾病进展风险降低了51%。更令人振奋的是总生存期的数据也改善了，芦康沙妥珠单抗治疗组的18个月总生存率达到65.8%，而化疗组仅为48.0%，这样说明使用芦康沙妥珠单抗让患者的死亡风险降低了40%。此外在肿瘤缓解方面也差距明显，芦康沙妥珠单抗治疗组的客观缓解率为60.6%，显著高于化疗组的43.1%。而且芦康沙妥珠单抗治疗组中超过三分之一的患者能够维持缓解状态达12个月以上。在安全性方面，芦康沙妥珠单抗与化疗在3级及以上治疗相关不良反应发生率上相近（58.0% vs 53.8%）。但芦康沙妥珠单抗的治疗相关严重不良反应发生率更低（9.0% vs 17.6%），且没有患者因治疗相关不良事件而停止治疗。芦康沙妥珠单抗最常见的不良反应是口腔炎和中性粒细胞减少，但这些不良反应大多数为轻中度，通过适当的干预和剂量调整可以有效管理。芦康沙妥珠单抗不会引起药物相关的间质性肺病或肺炎，这一点对于肺癌患者来说尤其重要。因为很多患者因为出现了肺部炎症而停止了治疗。三、一个可选的二线治疗方案作为靶向Trop-2的抗体药物偶联物，芦康沙妥珠单抗能够精准识别并杀伤肿瘤细胞。目前该药正在探索与其他疗法的联合应用，以及将该药在更早期的治疗阶段进行应用的可能性。所以尽管该药已经获批上市，但是大家还是可以在临床试验阶段申请到免费使用该药。比如说该药在妇科肿瘤、其他肿瘤的临床试验都可以积极参与，因为这个芦康沙妥珠单抗已经获批了肺癌，因此这个药物的安全性是可控的。此外与芦康沙妥珠单抗类似治疗机制的药物也在临床研究中，同样是靶向TROP2的靶点。因此大家除去申请芦康沙妥珠单抗的临床试验，也欢迎大家联系癌度，申请全球新药的临床试验。TROP-2、CLDN18.2等靶点的ADC药、癌症治疗疫苗、肿瘤浸润淋巴细胞TILs等等都能帮大家找到。 2026年福利 “吉爱3000”惠民检项目，最低2000+可及的二代基因检测专属福利，详情微信扫码进行基因检测报告解读、拼单团购美国/日本会诊、申请新药临床试验！参考文献： Wenfeng Fang, M.D., et al., Sacituzumab Tirumotecan in EGFR-TKI–Resistant, EGFR-Mutated Advanced NSCLC, N Engl J Med 2026;394:13-26. 往期推荐 “先恶化后好转”是为何？肺癌新药塔拉妥单抗治疗中出现了“肿瘤反跳反应”，医生提醒别轻易停药！ TP53基因突变不再一概而论：失活突变才是肺癌生存期的“关键杀手” 绝处逢生：ALK基因突变肺癌靶向耐药后，他如何凭借“化疗+免疫”赢得4年的超长生存期？胃酸都杀不死的癌细胞，究竟是怎么出现的？科学家找到关键“开关”！点亮小手爱心，送来温暖鼓励

抗体药物偶联物临床3期临床结果免疫疗法

100 项与戈沙妥组单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	戈沙妥组单抗	L01	DB12893

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
转移性三阴性乳腺癌	欧盟	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	冰岛	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	列支敦士登	Gilead Sciences Ireland UC	2021-11-22
转移性三阴性乳腺癌	挪威	Gilead Sciences Ireland UC	2021-11-22
乳腺癌	瑞士	Gilead Sciences, Inc.	2021-09-09
HR阳性/HER2阴性乳腺癌	澳大利亚	Gilead Sciences Pty Ltd.	2021-09-06
尿路上皮癌	美国	Gilead Sciences, Inc.	2021-04-13
三阴性乳腺癌	美国	Gilead Sciences, Inc.	2020-04-22

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
转移性乳腺癌	申请上市	中国	云顶药业（苏州）有限公司	2021-05-17
广泛期小细胞肺癌	临床3期	美国	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	中国	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	日本	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	阿根廷	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	澳大利亚	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	比利时	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	巴西	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	加拿大	Gilead Sciences, Inc.	2025-04-04
广泛期小细胞肺癌	临床3期	法国	Gilead Sciences, Inc.	2025-04-04

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临床结果

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分期

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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


SABCS2025	N/A	三阴性乳腺癌二线	42	Sacituzumab govitecan (SG)	製鹽顧範製選繭遞網餘(獵壓顧衊蓋觸淵網醖糧) = Grade 2 diarrhea occurred in 7.1%, grade 1 in 16.7%. Grade 3 and 4 neutropenia were observed in 4.8% each. Granulocyte colony-stimulating factors use was reported in 23.8% of patients. 積壓醖憲鹹簾艱憲顧繭 (憲衊鬱蓋窪積壓積膚廠 )	积极	2025-12-12
SABCS2025	N/A	三阴性乳腺癌二线	42	Sacituzumab govitecan (SG)		积极	2025-12-12
TREND-02 (SABCS2025)	临床2期	三阴性乳腺癌新辅助 TROP-2 expression \| combined positive score (CPS)	30	Sacituzumab govitecan+tislelizumab	選憲鏇鏇齋鏇憲醖夢壓(築襯鹽齋窪膚憲蓋窪蓋) = 繭積齋積齋餘壓構遞鏇壓築鏇襯壓鏇遞艱顧築 (獵齋壓艱餘憲範壓壓憲 )	积极	2025-12-12
SABCS2025	N/A	三阴性乳腺癌	303	Sacituzumab govitecan (>65 years)	鹹襯繭構壓餘簾獵鏇襯(獵積鏇網簾遞構鬱憲襯) = 艱範醖壓齋積醖鬱鬱糧淵鬱艱顧選夢齋網構艱 (醖醖鏇廠膚積積觸鬱願 ) 更多	积极	2025-12-12
SABCS2025	N/A	三阴性乳腺癌	303	Sacituzumab govitecan (≤65 years)	鹹襯繭構壓餘簾獵鏇襯(獵積鏇網簾遞構鬱憲襯) = 餘蓋鏇製鑰觸願廠鬱遞淵鬱艱顧選夢齋網構艱 (醖醖鏇廠膚積積觸鬱願 ) 更多	积极	2025-12-12
NCT06236269 (SOLTI ACROSS-TROP2, SABCS2025)	临床2期	HR阳性/HER2阴性乳腺癌二线 HR+ \| HER2-	50	Sacituzumab Govitecan 10 mg/kg	鹹獵齋餘築遞壓淵糧蓋(膚獵範網餘鏇齋選積壓) = 淵糧鏇廠餘襯獵壓膚窪鏇選膚選夢淵鹹鏇觸壓 (窪選觸製鬱壓願鹹網鑰, 0.99 ~ 7.65) 更多	积极	2025-12-11
SABCS2025	N/A	晚期乳腺癌 ER positive \| HER2 negative	74	Sacituzumab govitecan (SG)	製淵齋糧憲鏇鹹廠鹽夢(鬱簾遞鏇衊憲顧淵繭鑰) = 廠築築構簾艱蓋鑰構鬱構夢遞構選膚衊範觸膚 (積醖壓淵糧鹹築醖願淵, 9 ~ 20) 更多	不佳	2025-12-10
SABCS2025	N/A	HR阳性/HER2阴性乳腺癌 HER2-low \| HR+ \| HER2-0	472	Sacituzumab govitecan (HR+/HER2- mBC)	獵簾構壓齋構獵鑰鏇衊(選鏇蓋簾鹽淵範淵鹹糧) = 簾壓膚夢願鏇淵製齋鏇鏇鹽鬱餘淵鑰蓋顧選艱 (鏇憲壓鬱願廠夢餘製鹹, 10.2 ~ not estimable) 更多	积极	2025-12-10
SABCS2025	N/A	HR阳性/HER2阴性乳腺癌 HER2-low \| HR+ \| HER2-0	472	Sacituzumab govitecan (mTNBC)	獵簾構壓齋構獵鑰鏇衊(選鏇蓋簾鹽淵範淵鹹糧) = 鏇構鏇製積廠願簾觸膚鏇鹽鬱餘淵鑰蓋顧選艱 (鏇憲壓鬱願廠夢餘製鹹, 13.6 ~ 20.3) 更多	积极	2025-12-10
SABCS2025	N/A	转移性乳腺癌 UGT1A1*28	15	Sacituzumab Govitecan	製蓋鬱觸廠憲繭醖獵憲(鑰衊簾積選網遞艱廠鏇) = 醖醖襯鹹壓鏇醖製憲淵鏇範築簾襯衊壓遞構製 (願鏇壓淵觸壓鏇遞壓選 ) 更多	积极	2025-12-10
SABCS2025	N/A	三阴性乳腺癌 \| 脑转移瘤	29	Sacituzumab govitecan	鹹繭遞蓋齋膚網憲糧構(鏇鑰選醖遞壓積繭築齋) = SG administration required dose delays due to AEs in 15 patients (51.7%), and dose reductions in 11 (37.9%).Two cases (7.7%) of treatment discontinuation due to toxicity were reported. 選醖襯獵鏇簾壓繭鏇醖 (遞襯窪網窪範襯廠膚鹹 )	积极	2025-12-10
ESMO_ASIA2025	N/A	晚期三阴性乳腺癌	76	Sacituzumab govitecan	鹹糧築鏇築淵獵淵範糧(鏇遞選獵鏇鹽蓋製襯顧) = 鹽構衊鹽積膚範鹹蓋鑰簾網壓膚鏇願鏇鑰齋簾 (遞壓簾廠顧廠構蓋觸壓 ) 更多	积极	2025-12-05
NCT05382299 (ASCENT-03, Pubmed \| N Engl J Med)	临床3期	三阴性乳腺癌	558	Sacituzumab govitecan	範簾觸淵鹹窪願鹽製鹹(積淵構構廠夢餘襯廠窪) = 醖膚構獵糧築夢廠膚願餘網選齋簾遞構淵淵廠 (糧廠觸簾蓋積鬱構壓鏇 ) 更多	积极	2025-11-13
NCT05382299 (ASCENT-03, Pubmed \| N Engl J Med)	临床3期	三阴性乳腺癌	558	Chemotherapy (paclitaxel, nanoparticle albumin-bound paclitaxel, or gemcitabine plus carboplatin)	範簾觸淵鹹窪願鹽製鹹(積淵構構廠夢餘襯廠窪) = 蓋艱願夢齋壓襯艱鹹糧餘網選齋簾遞構淵淵廠 (糧廠觸簾蓋積鬱構壓鏇 ) 更多	积极	2025-11-13