This is a Phase II, interventional, prospective, single-arm, multi-center study that will enroll patients with stage II/III triple negative breast cancer (TNBC) who have residual cancer burden (RCB) II/III after conventional neoadjuvant chemo-immunotherapy followed by surgery. Technological advances in ctDNA assays have improved both the sensitivity and reliability of molecular residual disease (MRD) detection to enable real-time measurement with clinical-grade assays.
The primary objective of this study will be to evaluate ctDNA-based MRD status in high-risk, early-stage TNBC patients by defining the proportion of TNBC patients with MRD-only recurrence (ctDNA positive without radiographically measurable recurrence) during post-surgery surveillance. The secondary objectives will evaluate the safety, preliminary efficacy, and survival outcomes of using Dato-DXd in participants with MRD-only TNBC.
Dato-DXd is an investigational antibody-drug conjugate (monoclonal antibody specific for TROP2 and a topoisomerase I (Topo-1) inhibitor) that has demonstrated promising efficacy in TNBC patients with a manageable safety profile.

开始日期2025-09-01

申办/合作机构

Lineberger Comprehensive Cancer Center

[+1]

NCT07098338

/ Not yet recruiting临床2期

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)

This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.

开始日期2025-08-08

申办/合作机构

AstraZeneca PLC

NCT06954480

/ Not yet recruiting临床2期

An Open-label Randomised, Phase II Trial of Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer

The DIAMOND study is being carried out to evaluate if Datopotamab deruxtecan (Dato-DX) in combination with Durvalumab is more effective than Dato-DXd alone in treating PDL1-negative advanced or metastatic triple negative breast cancer (TNBC). Globally, breast cancer is the most common malignancy in women and the second most common cancer overall. The term TNBC is used to define tumours that do not express oestrogen receptors, progesterone receptors and HER2 receptors. TNBC comprises 10 -15% of all breast cancers. It remains the subtype with poorest outcome and there is a significant need to develop new therapies for this group of patients especially. Moreover, the PDL1-negative tumour has demonstrated no benefit from standard 1st line treatment of chemotherapy plus immune checkpoint inhibitors.

开始日期2025-08-01

申办/合作机构

Queen Mary University of London

[+1]

100 项与德达博妥单抗相关的临床结果

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100 项与德达博妥单抗相关的转化医学

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100 项与德达博妥单抗相关的专利（医药）

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项与德达博妥单抗相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

作者: Kapoor, Vaishali ; Crescioli, Silvia ; Kaplon, Hélène ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

2025-12-01·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

作者: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

2025-09-01·SUPPORTIVE CARE IN CANCER

US expert Delphi consensus on the prevention and management of stomatitis in patients treated with datopotamab deruxtecan

Article

作者: Rugo, Hope ; Tolaney, Sara ; Sands, Jacob ; Bardia, Aditya ; Lisberg, Aaron ; Bruno, Debora S ; Levy, Benjamin ; Hamilton, Erika ; Treister, Nathaniel S ; Heist, Rebecca ; Jhaveri, Komal ; O'Shaughnessy, Joyce ; Johnson, Melissa ; Spira, Alexander ; Ernani, Vinicius ; Matthews, Cecile

Summary:

Background:

Datopotamab deruxtecan (Dato-DXd) is an investigational antibody–drug conjugate that has shown promising results in phase III clinical trials of lung and breast cancers. Stomatitis is a common adverse event associated with Dato-DXd in these trials, and there are currently no formalized guidelines for its prevention and management. An expert consensus was needed to establish these guidelines.

Methods:

Fifteen experts participated in a modified three-round Delphi to achieve consensus on the prevention and management of Dato-DXd-related stomatitis in lung and breast cancer patients. Fourteen experts had managed Dato-DXd-induced stomatitis and served as investigators in the TROPION-Lung01, TROPION-Lung05, and TROPION-Breast01 phase III clinical trials. The first two rounds consisted of anonymized surveys with a mixture of open- and closed-ended questions, and the third round consisted of a consensus group meeting and 1:1 follow-up meetings.

Findings:

Experts recognized stomatitis as an important adverse event associated with several anticancer treatments and its impact on patients’ quality of life. Lung and breast cancer specialists noted similar manifestations of stomatitis with Dato-DXd, with breast cancer experts referencing similarities to everolimus-induced conditions and lung cancer experts reporting ulcerative lesions. There was consensus on the need for standardized guidelines to improve outcomes and reduce treatment disruptions. Agreed preventive measures emphasized patient education, oral hygiene, and prophylactic mouthwashes. Management strategies focused on patient-centered care, monitoring of symptoms, and timely interventions, such as the use of a steroid-containing mouthwash to maintain treatment schedules and quality of life.

Interpretation:

We used the expert consensus to provide guidelines for the prevention and management of stomatitis in patients treated with Dato-DXd.

Putting research into context:

Evidence before this study:

Dato-DXd has shown promising results in clinical trials for lung and breast cancers. However, many patients in these trials developed stomatitis, an adverse event that may impact quality of life and disrupt treatment regimens. The lack of standardized guidelines for dealing with stomatitis in this context necessitated the establishment of best practices via expert consensus.

Added value of this study:

This study provides peer-reviewed guidance for the prevention and management of stomatitis secondary to Dato-DXd. Most experts selected for this study had experience using this therapy and preventing and managing stomatitis associated with Dato-DXd and other anticancer treatments. Thus, the study has collected the perspectives of well-placed, expert clinicians and derived best practices pending the completion of clinical trials.

Implications of all the available evidence:

The development and implementation of this guidance and the education therein will lead to improved quality of life, greater treatment compliance, and better clinical outcomes.

1,059

项与德达博妥单抗相关的新闻（医药）

2025-08-11

·Biotech前瞻

前沿透视｜Trop2靶点药物在乳腺癌中的治疗探索之路

点击蓝字关注我们本期看点【Trop2靶点丨乳腺癌】乳腺癌常被称为“粉红杀手”，发病率高居女性恶性肿瘤首位，且男性乳腺癌患者也存在(0.5%-1%)。目前乳腺癌全球新发病例数已经超过肺癌，成为全球第一大癌症。乳腺癌的治疗手段很多，包括：手术、化疗、放疗、内分泌治疗、靶向治疗和免疫治疗。而随着精准肿瘤治疗时代的到来，以Trop2靶点为代表的创新抗肿瘤产品逐步在临床上获得关注。本文就乳腺癌流行病学及治疗现状、Trop2靶点药物介绍及作用机制、较成熟Trop2靶点药物（戈沙妥珠单抗、SKB264、Dato-DXd）在乳腺癌中的重磅研究进展（部分研究更新至最近的2025ASCO）三部分进行详细阐述，以飨读者。研究整理示例如下，全为可编辑状态：本期内容 01 乳腺癌流行病学及治疗现状 02 Trop2靶点药物介绍及作用机制 03 较成熟TROP2靶点药物在乳腺癌中的重磅研究进展 04 如何索取幻灯及其他福利【01 乳腺癌流行病学及治疗现状】全球临床开发2022年新诊断女性乳腺癌230万，约占女性癌症病例的四分之一；其中，中国女性新发乳腺癌患者约35.72万，占世界乳腺癌患者新发病例的15.5%，死亡患者7.5万，占世界乳腺癌死亡人数的11.3%。 2011年，St.Gallen国际乳腺癌治疗专家共识的提出，基于对乳腺癌生物学亚型认识的深入，采用了按照乳腺癌分类来进行治疗决策的新方法，这也标志着乳腺癌个体化治疗时代的到来。一项大型回顾性队列研究结果显示: 1.LuminalA是最常见的，预后最好，5年生存率95.1% 2.TNBC的预后最差，5年OS率为78.5% 3.LuminalBHER2-的5年OS率为88.7% 4.HER2+的5年OS率为85.6% 虽然乳腺癌的治疗进展迅速，很多患者的总生存期持续延长。但在整个乳腺癌中，最为难治疗的是三阴性乳腺癌(Triple-Negative Breast Cancer, TNBC)，其特点是在免疫组化检测中，雌激素受体(ER)、孕激素受体(PR)以及人表皮生长因子受体2 (HER2)均为阴性，是临床上难治性癌种。根据2024年CSCO乳腺癌指南，对于早期TNBC、晚期TNBC的治疗推荐手工制作可编辑幻灯。 2024年V4版NCCN乳腺癌指南内容整理如下。近年来Trop2靶点被发现在多个瘤种中高表达且其相关药物BC中具有较好的抗肿瘤活性，尤其以ADC较为热门，虽然国内指南尚未更新，但最新版NCCN指南对于晚期TNBC二线治疗推荐使用戈沙妥珠单抗。根据2024年CSCO乳腺癌指南，对于HR+乳腺癌的治疗推荐手工制作可编辑幻灯。 02 Trop2靶点药物介绍及作用机制 TROP2（trophoblast cell surface antigen 2，跨膜糖蛋白滋养层细胞表面抗原-2）广泛表达于各种上皮性癌和特定的正常组织。 Trop2在多种恶性肿瘤中持续高表达，并参与多种致癌信号通路，导致肿瘤的发生、侵袭和转移。在宫颈癌中表达量最高（88.7%），其次是甲状腺癌（82.5%），在乳腺癌中表达占比62.4%，但在TNBC中表达排名第三，占比78.1%。 Trop2过表达与不良预后有关，TNBC中Trop2表达越高，预后越差。 Trop2靶点类型药物有ADC、双抗/三抗、双抗ADC、单抗或CAR-T等。其中以ADC药物最为成熟，2款ADC药物已进入III期临床阶段，1款(戈沙妥珠单抗)已在国内获批晚期TNBC三线及以上治疗适应症。其他类型药物尚在临床前研发或I/II期临床阶段。【03 较成熟TROP2靶点药物在乳腺癌中的重磅研究进展】本章节内容是关于Trop2靶点药物治疗在乳腺癌中模式探索，重磅研究介绍及难点分析。较成熟Trop2靶点药物（戈沙妥珠单抗、SKB264、Dato-DXd）在乳腺癌中的重磅研究进展整理如下。 2025ASCO上内容也整理了：呈现样式如下： 04 如何索取幻灯及其他福利在这个瞬息万变的医药时代，每一位专业人士都在追求卓越，力求在肿瘤治疗、研究设计、行业洞察等领域不断突破。作为聚焦医药行业的第三方专业医学服务商，我们始终致力于为每一位伙伴提供最前沿、最实用的医学知识与服务，助力您的职业成长与学术探索。过去，我们携手走过了一段段充实而精彩的旅程，从肿瘤基础类幻灯到研究进展类幻灯，从研究设计小课堂到行业研究类幻灯，每一份资料都凝聚着我们的专业与用心，也见证了您的成长与进步。如今，2025年已至7月，我们带着全新的会员福利计划，再次向您发出诚挚的邀请，开启一段新的赋能之旅。不定期还有会员福利惊喜赠送或享限时优惠价格哦！早购买，早获益，意愿者请联系如下。 ★

ASCO会议CSCO会议临床结果免疫疗法抗体药物偶联物

2025-08-05

·抗体圈

双载荷 ADC：癌症治疗的 “双保险”，如何让耐药肿瘤无处可逃？

摘要：抗体药物偶联物（ADCs）作为靶向癌症治疗的重要手段，已从第一代的随机偶联发展到第二代的定点偶联，显著提升了治疗窗口。本文综述了双载荷均相 ADC这一新兴技术，其通过在单一抗体上精准携带两种不同作用机制的药物，实现了对肿瘤细胞的协同攻击，尤其在克服耐药性和提升疗效方面展现出巨大潜力。文中系统解析了双载荷 ADC 的制备方法，包括分支多功能 linker 技术、正交活性氨基酸策略和酶介导偶联技术，并探讨了其在工艺复杂性、药物比例调控及临床转化中的关键挑战。通过整合临床数据与前沿研究，本文揭示了双载荷 ADC 如何通过协同机制突破传统治疗瓶颈，为下一代癌症靶向治疗提供了全新方向。一、引言：ADC 的进化与双载荷技术的崛起抗体药物偶联物（ADCs）被誉为 “魔法子弹”，其核心是通过抗体的靶向性将细胞毒素精准递送至肿瘤细胞，在减少全身毒性的同时提升疗效。第一代 ADC 依赖赖氨酸随机偶联，导致产物异质性（药物数量和位置不确定），疗效和安全性波动较大。例如，早期 ADC 因药物 - 抗体比率（DAR）不一致，可能引发免疫原性或代谢不稳定。第二代 ADC 通过定点偶联技术（如 THIOMAB™平台）实现了均一性，DAR 可控且 linker 稳定性提升，显著改善了治疗指数。然而，肿瘤的异质性和获得性耐药仍是临床难题 —— 低抗原表达肿瘤常对单载荷 ADC 不敏感，且单一机制药物易引发交叉耐药（如拓扑异构酶 I 抑制剂类 ADC 间的交叉耐药）。在此背景下，双载荷均相 ADC应运而生：通过在同一抗体上定点连接两种不同作用机制（MOA）的药物，既能同时攻击肿瘤细胞的多个靶点，又能避免两种单载荷 ADC 联合使用时的靶点竞争和药代动力学不匹配问题。如图 1 所示，与 “ADC + 化疗” 或 “ADC+ADC” 联合方案相比，双载荷 ADC 可将两种药物精准递送至同一肿瘤细胞，实现协同杀伤。图 1：三种不同的联合治疗策略。与 ADC 联合化疗或两种单载荷 ADC 联用相比，双载荷 ADC 可将两种不同作用机制的药物同时递送至同一肿瘤细胞二、双载荷 ADC 的临床潜力：突破耐药性与疗效瓶颈肿瘤耐药性是 ADC 治疗失败的主要原因，而双载荷技术通过多机制协同为解决这一问题提供了新思路。2.1 克服交叉耐药性的临床证据临床数据显示，肿瘤对单一机制 ADC 的耐药可能扩散至同类药物。例如，在 TROPION-PanTumor01 试验中，既往接受过拓扑异构酶 I 抑制剂（Topo1i）类 ADC（如 sacituzumab govitecan）治疗的患者，对另一款 Topo1i 类 ADC（datopotamab deruxtecan）的响应率仅为 15%，而未接受过 Topo1i 治疗的患者响应率达 40%。更严峻的是，sacituzumab govitecan 与 trastuzumab deruxtecan 的序贯使用会导致响应率骤降和无进展生存期（PFS）缩短（图 2a）。相比之下，切换不同作用机制的药物可显著改善疗效。DESTINY-Breast02 试验中，接受过微管抑制剂类 ADC（trastuzumab emtansine）治疗的患者，改用 Topo1i 类 ADC（trastuzumab deruxtecan）后，响应率达 70%，PFS 延长至 17.8 个月（图 2b）。这提示，双载荷 ADC 通过同时递送两种不同机制药物，可从源头避免交叉耐药。图 2：ADC 序贯治疗对疗效的影响。（a）同一机制 ADC 的交叉耐药导致疗效下降；（b）切换不同机制 ADC 可维持疗效2.2 双载荷 ADC 的协同机制双载荷 ADC 的优势源于两种药物的协同作用，主要包括以下三类策略：双细胞毒素联用：如微管抑制剂（如 MMAE）与拓扑异构酶抑制剂（如 SN-38）联用，前者阻断细胞分裂，后者破坏 DNA 复制，协同诱导肿瘤细胞凋亡。临床前研究显示，此类组合在多药耐药模型中疗效显著优于单药 ADC。细胞毒素与增敏剂联用：例如 Topo1i 与 DNA 损伤修复抑制剂（DDRis）联用，DDRis 可阻断肿瘤细胞对 Topo1i 诱导的 DNA 损伤的修复，形成 “合成致死” 效应。细胞毒素与免疫激动剂联用：如将细胞毒素与 STING 激动剂结合，既能直接杀伤肿瘤，又能激活肿瘤微环境的免疫反应，增强全身性抗肿瘤效应。三、双载荷均相 ADC 的制备技术：精准偶联的三大路径双载荷 ADC 的核心挑战是实现均一性（药物比例可控、连接位置固定）和正交性（两种药物互不干扰）。目前主流技术可分为三类：3.1 分支多功能 linker 技术通过设计含多个反应位点的分支 linker，实现对两种药物的分步或同步偶联。其关键是 linker 需包含：一个与抗体结合的主反应基团，以及两个可正交反应的次级基团（如叠氮、炔基、酮基等）。选择性脱保护策略：SEAGEN 团队设计的 linker 含两个受不同条件保护的半胱氨酸，通过 TCEP 还原和解保护剂（如醋酸汞）分步激活，分别连接 MMAE 和 MMAF，最终形成 DAR 16（各 8 个）的双载荷 ADC，在耐药模型中疗效优于单药（图 3a）。正交点击化学：MedImmune 开发的异三功能 linker，通过马来酰亚胺与抗体的工程化半胱氨酸结合后，再通过叠氮 - 炔基点击反应和肟连接分别引入 PBD 二聚体和 MMAE，偶联效率超 90%（图 3b）。该技术的优势是兼容现有抗体表达系统，但需解决 linker 合成复杂性和药物比例调控难题。图 3：分支多功能 linker 的三种设计策略。（a）通过选择性脱保护实现分步偶联；（b）正交化学基团实现双药连接；（c）二硫键桥接结合点击化学3.2 正交活性氨基酸策略利用氨基酸的化学特异性，在抗体中引入两种正交反应位点（如天然氨基酸与非天然氨基酸组合），实现精准偶联。天然氨基酸组合：如工程化半胱氨酸（硫醇反应）与硒代半胱氨酸（碘乙酰胺反应）的组合，在 HER2 靶向抗体中分别连接 PNU 和 MMAE，两种药物的作用机制在细胞形态学中均得到验证。非天然氨基酸（ncAA）技术：通过密码子扩展在抗体中引入含酮基（如 pAcF）或叠氮基（如 pAMF）的 ncAA，再通过肟连接或点击反应分别偶联药物。例如，Sutro 公司利用细胞 - free 系统在轻链引入 pAcF、重链引入 pAMF，实现了 “一锅法” 双药偶联，效率超 90%（图 4）。该技术的核心是正交反应的高效性，ncAA 策略尤其适合调控药物比例，但需依赖特殊表达系统。图 4：通过 pAcF（轻链）和 pAMF（重链）的正交反应实现双药偶联，可灵活调控 DAR 比例3.3 酶介导偶联技术利用酶的底物特异性，在抗体上引入酶识别标签，实现位点专一性双药连接。转谷氨酰胺酶（mTG）与脂酸连接酶（LpIA）组合：在抗体重链 Q295 位点通过 mTG 连接含叠氮的 linker，轻链 C 端 LAP 标签通过 LpIA 连接含 TCO 的 linker，再分别偶联荧光染料，验证了细胞内外的分步释放（图 5a）。分选酶（Sortase A）与布替酶（Butelase 1）组合：通过分选酶识别 LPXTG 标签、布替酶识别 NHV 标签，在抗体轻重链分别偶联药物，反应效率近定量（图 5b）。酶法的优势是反应条件温和，但需解决酶去除和反应动力学问题。图 5：（a）mTG 与 LpIA 介导的双位点偶联；（b）分选酶与布替酶的正交反应四、工艺挑战与优化：从实验室到临床的关键考量双载荷 ADC 的开发需平衡工艺复杂性与产品均一性，核心参数包括：4.1 药物比例（DAR）与协同效应两种药物的比例直接影响疗效。例如，4:2（MMAE:MMAF）的双载荷 ADC 在异种移植模型中疗效优于 6:0 单药 ADC，因 MMAE 的 “旁观者效应” 可弥补 MMAF 的局限性。通过分支 linker 的臂长调整或 ncAA 的位点数量设计，可实现 2:2、4:2 等灵活比例。4.2 工艺复杂性与可制造性反应步骤：分支 linker 技术需 3-6 步反应，而 ncAA “一锅法” 可缩减至 1-2 步。纯化需求：酶法需去除残留酶（如分选酶），而化学偶联主要去除游离药物。表达系统：ncAA 依赖工程化细胞或细胞 - free 系统，而酶法兼容传统 CHO 细胞。4.3 临床转化的潜在障碍毒性管理：两种药物的毒性可能叠加，需通过前临床模型优化比例（如免疫激动剂与细胞毒素的比例需平衡疗效与全身炎症风险）。药代动力学（PK）：双载荷 ADC 需确保两种药物同步释放，避免因代谢差异导致疗效失衡。五、未来展望：双载荷 ADC 如何改写癌症治疗双载荷均相 ADC 的突破不仅在于技术创新，更在于其临床价值：克服难治性肿瘤：对低抗原表达或异质性肿瘤，双机制攻击可提高杀伤效率。简化治疗方案：相比 “ADC+ADC” 联合疗法，单一双载荷 ADC 可减少给药次数和靶点竞争。拓展适应症：如用于免疫 “冷肿瘤” 的免疫 - 细胞毒素双载荷 ADC，有望激活全身抗肿瘤免疫。目前，成都康弘生物的 KH815（Trop2 靶向，含 Topo1i 和 RNA 聚合酶抑制剂）已进入临床，标志着该技术向临床转化的重要一步。未来需解决的核心问题包括：如何通过 AI 辅助设计优化药物组合，以及如何建立标准化的临床前评估体系。识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

抗体药物偶联物

2025-08-05

·Firstwordpharma

AstraZeneca taps SOPHiA GENETICS' AI to advance breast cancer research

SOPHiA GENETICS is deepening its long-standing alliance with AstraZeneca. Under the new collaboration, SOPHiA's multimodal AI Factories will be used to study the therapeutic efficacy, real-world performance and value of treatments for specific types of breast cancer. The multi-year initiative will also further support development of a tailored, AI-powered predictive model aimed at optimising outcomes for patients undergoing breast cancer treatment. "Our platform is purpose-built to manage complex healthcare data environments, and this collaboration reinforces our shared commitment to driving better patient outcomes through trusted, federated analytics powered by data and AI," Ross Muken, president of SOPHiA GENETICS, said in a release Tuesday. The company's AI Factories are proprietary analytical engines embedded in the SOPHiA DDM Platform that integrate and analyse multiple data types — including genomics, imaging and clinical data — to train predictive AI models for precision medicine. AstraZeneca will use the platform to uncover insights that could help improve treatment strategies for patients with breast cancer receiving its therapies. The partners will also work on gathering real-world evidence across Europe and North America to identify key drivers of treatment response, address knowledge gaps and support more informed clinical decision-making. "A core component of our AI strategy has been rooted in the deployment of frontier AI solutions across oncology clinical development," said Jorge Reis-Filho, chief AI and data scientist at AstraZeneca. "Fine tuning and augmenting our models with multimodal data — including our own data and the data that will be generated as part of this collaboration — is helping us to generate a more holistic understanding of disease biology and biomarkers to tailor the most effective treatment to patients living with cancer." AstraZeneca's breast cancer portfolio spans multiple subtypes. For HR+/HER2- breast cancer, approved treatments include oestrogen receptor antagonist Faslodex (fulvestrant) and PARP inhibitor Lynparza (olaparib), for patients with BRCA mutations. The company recently introduced capivasertib, an AKT inhibitor, and is developing camizestrant, an oral selective estrogen receptor degrader (SERD). In HER2+ and HER2-low disease, AstraZeneca co-develops the HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) with Daiichi Sankyo. Another ADC, Datroway (datopotamab) deruxtecan, was recently approved for HR+/HER2- breast cancer following endocrine therapy. In triple-negative breast cancer, the PD-L1 inhibitor Imfinzi (durvalumab) is being studied in combination regimens. The partnership between SOPHiA and AstraZeneca began in 2023 to accelerate oncology drug development and support more targeted treatment strategies using SOPHiA's multimodal AI capabilities. The collaboration broadened in scope in late 2023 with the inclusion of Memorial Sloan Kettering Cancer Center, aiming to scale access to MSK's MSK‑ACCESS and MSK‑IMPACT genomic assays via the SOPHiA DDM cloud platform. AstraZeneca provided support to broaden deployment globally. During 2024, the partners rolled out MSK‑ACCESS powered by SOPHiA DDM across multiple institutions. By April 2025, the collaboration further expanded to reach 30 clinical institutions worldwide.

上市批准抗体药物偶联物

100 项与德达博妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16410

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
EGFR阳性非小细胞肺癌	美国	Daiichi Sankyo, Inc.	2025-06-23
ER阳性/HER2阴性乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	2025-05-20
晚期非小细胞肺癌	加拿大	AstraZeneca Canada, Inc.	2025-03-01
HR阳性/HER2阴性乳腺癌	日本	Daiichi Sankyo Co., Ltd.	2024-12-27

未上市

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适应症	最高研发状态	国家/地区	公司	日期
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2024-11-12
EGFR突变的非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-11-12
局部晚期非鳞状非小细胞肺癌	申请上市	美国	Daiichi Sankyo, Inc.	2024-02-19
局部晚期非鳞状非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-02-19
转移性非鳞状非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-02-19
转移性非鳞状非小细胞肺癌	申请上市	美国	Daiichi Sankyo, Inc.	2024-02-19
肺腺癌	临床3期	美国	AstraZeneca PLC	2024-10-15
肺腺癌	临床3期	日本	AstraZeneca PLC	2024-10-15
肺腺癌	临床3期	比利时	AstraZeneca PLC	2024-10-15
肺腺癌	临床3期	巴西	AstraZeneca PLC	2024-10-15

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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


NCT04656652 (TROPION-Lung01, CTgov)	临床3期	转移性非小细胞肺癌	605	DS-1062a (DS-1062a 6.0 mg/kg)	繭憲醖窪夢築齋構憲構(窪窪餘簾鏇膚蓋壓憲繭) = 築憲願夢鏇鏇夢簾夢餘鑰糧窪艱積餘範獵鹽鑰 (艱艱淵艱築選膚醖積餘, 鹽築艱糧艱鏇鑰觸遞壓 ~ 選網鬱積繭廠糧壓簾憲) 更多	-	2025-07-23
				Docetaxel (Docetaxel 75 mg/m^2)	繭憲醖窪夢築齋構憲構(窪窪餘簾鏇膚蓋壓憲繭) = 衊獵糧窪鹽選襯壓廠膚鑰糧窪艱積餘範獵鹽鑰 (艱艱淵艱築選膚醖積餘, 鏇鹹壓獵鏇壓蓋鏇衊憲 ~ 膚襯製築構獵鬱鏇襯醖) 更多
NCT04484142 \| NCT04656652 (TROPION-Lung01, FDA_CDER) 人工标引	N/A	EGFR突变的非小细胞肺癌 EGFR Mutation	114	DATROWAY (DATROWAY TL05)	夢範鏇簾簾膚糧繭築獵(糧膚築窪窪鑰衊醖網餘) = 鹽醖壓鏇觸壓簾襯廠築壓襯顧願窪糧選觸膚顧 (繭鬱網壓壓齋蓋鬱選觸, 34 ~ 57) 更多	积极	2025-06-23
				DATROWAY (DATROWAY TL01)	夢範鏇簾簾膚糧繭築獵(糧膚築窪窪鑰衊醖網餘) = 壓鬱築顧獵繭齋糧鏇蓋壓襯顧願窪糧選觸膚顧 (繭鬱網壓壓齋蓋鬱選觸, 27 ~ 61) 更多
NCT04526691 (TROPION-Lung02, ASCO2025) 人工标引	临床1期	晚期非小细胞肺癌一线	96	Datopotamab deruxtecan + pembrolizumab	願襯繭鹽鏇網餘憲網襯(網餘糧膚積鏇選糧襯膚) = 廠網蓋衊艱鑰醖觸餘壓鹹衊餘淵憲鬱膚襯蓋襯 (壓選蓋繭壓憲選觸蓋淵 ) 更多	积极	2025-05-30
				Datopotamab deruxtecan + pembrolizumab + platinum chemotherapy	願襯繭鹽鏇網餘憲網襯(網餘糧膚積鏇選糧襯膚) = 憲窪鹽蓋鑰鹹願衊壓鹽鹹衊餘淵憲鬱膚襯蓋襯 (壓選蓋繭壓憲選觸蓋淵 ) 更多
ASCO2025	N/A	非小细胞肺癌 TROP2	756	Dato-DXd 6mg/kg every 3 weeks	網願願襯顧獵顧鑰願鏇(範窪醖憲構糧簾衊艱範) = 窪鏇鑰簾顧鹽選顧廠顧構繭製醖膚願齋夢顧構 (繭糧網膚簾觸醖簾膚獵, 74.2 ~ 80.1) 更多	积极	2025-05-30
ASCO2025	N/A	转移性非小细胞肺癌 Anti-TROP-2	-	Datopotamab deruxtecan (Dato-DXd)	構廠膚鬱艱簾範顧構願(夢襯築願糧蓋襯糧淵壓) = 膚憲蓋鏇鏇鏇獵範獵繭願顧憲夢膚製積鑰鑰鏇 (網廠壓醖積製觸構願衊 ) 更多	不佳	2025-05-30
				Sacituzumab govitecan (SG)	構廠膚鬱艱簾範顧構願(夢襯築願糧蓋襯糧淵壓) = 觸選鬱鬱膚糧構窪醖憲願顧憲夢膚製積鑰鑰鏇 (網廠壓醖積製觸構願衊 ) 更多
NCT04612751 (TROPION-Lung04 (cohort 5), ASCO2025)	临床1期	转移性非小细胞肺癌一线 PD-L1 tumor proportion score [TPS]	40	Dato-DXd + rilvegostomig	製醖簾鹽鬱繭憲繭醖積(範範糧廠艱膚積繭鏇壓) = 襯鹽窪餘獵選範壓鏇願築醖顧窪廠繭廠簾憲顧 (鏇壓選願襯壓憲繭餘鹹, 40.9 ~ 73.0) 更多	积极	2025-05-30
ASCO2025	N/A	乳腺癌	9,307	sacituzumab govitecan (SG)	艱鹽淵鑰鬱遞廠構壓齋(襯網廠遞觸觸醖蓋繭築) = 艱壓襯獵製選淵選築憲鑰網鹽觸築構醖艱襯夢 (夢鹹願構衊觸遞糧廠構, 26.7)	积极	2025-05-30
				trastuzumab deruxtecan (T-DXd)	觸廠廠蓋衊壓蓋製築鏇(齋鏇鹽範製觸獵選製糧) = 製膚築淵積衊醖選鏇憲淵獵膚製製製製網鑰夢 (襯築夢艱遞廠廠窪遞選 )
NCT03944772 (ORCHARD, ESMO_ELCC2025) 人工标引	临床2期	EGFR突变的非小细胞肺癌二线 EGFRm	69	Osimertinib (80 mg QD) + Datopotamab Deruxtecan (4 mg/kg Q3W)	餘顧廠鹽構築襯膚獵膚(鹽窪鬱網範鬱壓範構願) = 蓋鹹衊夢廠艱壓簾醖遞網壓構獵襯鑰顧蓋餘鹹 (鹽鏇鹹簾構憲築構壓繭, 31 ~ 55) 更多	积极	2025-03-26
				Osimertinib (80 mg QD) + Datopotamab Deruxtecan (6 mg/kg Q3W)	餘顧廠鹽構築襯膚獵膚(鹽窪鬱網範鬱壓範構願) = 淵範鑰鑰積鏇壓齋壓繭網壓構獵襯鑰顧蓋餘鹹 (鹽鏇鹹簾構憲築構壓繭, 25 ~ 49) 更多
ESMO_ELCC2025	N/A	非小细胞肺癌 TROP2	914	Datopotamab deruxtecan 6 mg/kg	襯壓齋襯膚膚範窪簾蓋(淵鏇觸顧膚網襯淵廠窪) = 7% 夢鹽窪夢築鏇選鬱襯繭 (壓蓋構襯獵艱鹹鑰憲憲 ) 更多	积极	2025-03-26
NCT04656652 (TROPION-LUNG01, ESMO_ELCC2025)	临床3期	转移性非鳞状非小细胞肺癌	468	Datopotamab deruxtecan (Dato-DXd) 6 mg/kg Q3W	窪鑰鏇範壓選範齋鬱繭(網製淵膚窪鏇餘網壓膚): HR = 1.64 (95% CI, 1.09 ~ 2.46) 更多	积极	2025-03-26
				Docetaxel 75 mg/m2 Q3W