A Open-label, Multicenter Phase Ib/Ⅱ Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GB268 for Injection as Monotherapy or in Combination Regimens in Patients With Locally Advanced Unresectable or Metastatic Breast Cancer

This is a Phase Ib/II, open-label, multi-cohort, multi-center study to evaluate the safety, tolerability, and preliminary anti-tumor activity of GB268, a biological product, as monotherapy or in combination with other therapies in patients with locally advanced unresectable or metastatic breast cancer.

开始日期2026-08-01

申办/合作机构

亿腾医药（珠海）有限公司

NCT07720284

/ Recruiting临床3期

A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma

Purpose: to assess efficacy and safety of Dato-DXd + rilvegostomig as adjuvant therapy versus SoC in MIUC participants with high-risk residual disease after radical resection.
Study details:
Duration:
78 months (6.5 years) from FSI to last subject visit Treatment length: up to
12 months, depending on randomized arm Visit frequency: every 3 weeks in Arms 1 and 2; every 2-4 weeks per SoC in Arm 3

开始日期2026-07-16

申办/合作机构

AstraZeneca PLC

[+1]

NCT07357597

/ Recruiting临床4期

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)

This is a multicenter, open-label, single-arm study of prophylaxis for Dato-DXd-related stomatitis in eligible patients with metastatic or inoperable locally recurrent breast cancer or locally advanced or metastatic Epidermal Growth Factor Receptor-Mutated (EGFRm) non-small cell lung cancer.

开始日期2026-06-24

申办/合作机构

AstraZeneca PLC

[+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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145

项与德达博妥单抗相关的文献（医药）

2026-10-01·BREAST

Antibody–drug conjugates beyond HER2: Translating evidence into practice for HR+ HER2-negative and triple-negative metastatic breast cancer

Review

作者: Freire, Pedro José Galvão ; Barrios, Carlos ; Prado, Caio Guilherme Souza ; Lustberg, Maryam ; Kahn, Adriana ; Leite, Caio Abner ; Bonadio, Renata Colombo ; Gouveia, Mariana Carvalho ; Zucchetti, Bruna Migliavacca ; Barroso-Sousa, Romualdo

Antibody-drug conjugates (ADCs) have redefined therapeutic paradigms in metastatic breast cancer, offering unprecedented efficacy across hormone receptor-positive/HER2-negative and triple-negative subtypes. Trastuzumab deruxtecan, sacituzumab govitecan, datopotamab deruxtecan, and sacituzumab tirumotecan are expanding treatment options beyond traditional chemotherapy. As their clinical integration advances, optimizing the prevention and management of ADC-related toxicities, determining optimal sequencing strategies, and refining biomarker characterization have become central challenges. Ongoing research into ADC combinations, earlier-line use, and precision biomarker selection is expected to further reshape the therapeutic landscape and personalize care for patients with advanced breast cancer.

2026-09-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

TROP-2 in solid tumors: From oncogenic driver to therapeutic target with antibody-drug conjugates

Review

作者: Tan, Simin ; Zeng, Hai ; Luo, Xuefeng ; Wang, Lu ; Guo, Xinke ; Li, Zixi ; Zhang, Min ; Zhang, Weijia ; Liu, Jinlin ; Liu, Jia

Trophoblast cell surface antigen 2 (TROP-2) has emerged as a pivotal oncotherapeutic target, distinguished by frequent overexpression across diverse epithelial malignancies and functions as a master regulator of oncogenic signaling networks. This review provides a systematic delineation of TROP-2's molecular architecture and critically analyzes the mechanisms through which it drives tumor progression-primarily via calcium signaling, the mitogen-activated protein kinase (MAPK) pathway, and the phosphoinositide 3-kinase/protein kinase B (PI3K/AKT) pathway-establishing the biological rationale for TROP-2 as an ideal target for antibody-drug conjugate (ADC) development. Clinically, TROP-2-directed ADCs, exemplified by sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd), have demonstrated transformative efficacy across multiple solid tumors including triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), and urothelial carcinoma (UC). Their target-specific delivery and potent bystander effect have led to regulatory approvals, reshaping standard-of-care landscapes in these malignancies. We also critically examine multidimensional challenges confronting the field, including acquired resistance mechanisms, toxicity-specific management protocols, and the imperative to advance beyond protein expression toward integrated predictive biomarker frameworks. Building upon this assessment, we outline prospective directions including optimization of rational combination therapies, development of novel ADC platforms, strategic shift to earlier disease stages, and implementation of precision stratification based on multi-omics profiling. This synthesis consolidates current understanding of TROP-2 biology and ADC therapy while furnishing comprehensive guidance for ongoing research and clinical translation, charting the course for the next phase of TROP-2-directed drug development.

2026-08-01·ESMO Open

Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive HER2-negative breast cancer: safety and patient-reported outcomes from the phase III TROPION-Breast01 study

Article

作者: Lu, Y-S ; Jhaveri, K ; Pernas, S ; Verma, D ; Hamilton, E ; Rugo, H S ; Martínez Jañez, N ; Zhang, Q ; Wang, S ; Atuah, K ; Bardia, A ; Zhao, K ; Borges, G ; Xu, B ; Hattori, M ; Pistilli, B ; Rubini Liedke, P E ; Tolaney, S M ; Cescon, D W ; De Laurentiis, M ; Kalinsky, K ; Tsurutani, J ; Im, S-A ; Nowecki, Z

BACKGROUND:

In TROPION-Breast01 (NCT05104866), datopotamab deruxtecan (Dato-DXd) improved progression-free survival by blinded independent central review versus investigator's choice of chemotherapy (ICC) in patients with inoperable/metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer, who had disease progression on endocrine therapy and for whom endocrine therapy was unsuitable, and who had received 1-2 prior lines of chemotherapy in the inoperable/metastatic setting. We report detailed safety data and patient-reported outcomes (PROs) from the final analysis.

METHODS:

Patients received Dato-DXd (6 mg/kg every 3 weeks) or ICC (eribulin/capecitabine/vinorelbine/gemcitabine). Mouthwash was advised (steroid mouthwash strongly recommended for Dato-DXd), and ophthalmologic assessments were carried out per protocol. Safety and time to deterioration (TTD) in global health status/quality of life (GHS/QoL), pain, and physical functioning, using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30, were secondary endpoints; exploratory PROs were also assessed.

RESULTS:

With Dato-DXd (n = 360), nausea was the most common treatment-related adverse event (AE; 51.9%, grade ≥3: 1.4%). The AEs of special interest (grouped terms), treatment-related oral mucositis/stomatitis and ocular surface events, occurred in 57.2% (grade ≥3: 7.2%) and 43.9% (grade ≥3: 1.9%) of patients, respectively. Per protocol recommendations, most patients receiving Dato-DXd received anti-emetics (76.7%), prophylactic mouthwash (77.2%), or artificial tears (71.7%). Adjudicated drug-related interstitial lung disease/pneumonitis with Dato-DXd was mostly low-grade (3.9%; grade ≥3: 0.8%; one grade 5 event). Hematologic toxicity was the most notable feature of the ICC safety profile (n = 351). TTD in GHS/QoL, pain, and physical functioning was delayed with Dato-DXd versus ICC. Patient-reported symptomatic AEs were generally consistent with the clinician-reported AE profile in both arms.

CONCLUSION:

Safety and PRO data from TROPION-Breast01 complement the improvements in efficacy demonstrated with Dato-DXd versus ICC, supporting Dato-DXd as a treatment option for patients with previously treated, inoperable/metastatic HR+/HER2- breast cancer.

2,249

项与德达博妥单抗相关的新闻（医药）

2026-09-01

·癌症药物网

三阴乳腺癌多线耐药后续全新可用靶向新药整理l癌症药物网

三阴性乳腺癌多线耐药无药可用？最新后线靶向新药全面梳理来源：癌症药物网很多晚期三阴性乳腺癌患者，都经历过一段身心俱疲的治疗过程。从术后辅助化疗、一线姑息化疗，到尝试免疫治疗、经典ADC药物，一轮轮治疗坚持下来，身体承受了脱发、恶心、骨髓抑制、乏力等诸多副作用，可复查结果依旧是肿瘤进展、转移复发。相比于其他乳腺癌亚型，三阴性乳腺癌缺乏激素、HER2治疗靶点，可用药物本就更少。一旦出现多线耐药，很多患者都会陷入同样的困境：常规治疗全部用尽，医生暂无标准方案，只能被动等待，不知道自己还有没有新的治疗机会。这也是目前晚期三阴患者最真实、最揪心的治疗痛点。近几年肿瘤新药研发进展迅速，针对多线耐药、难治复发的三阴性乳腺癌，已有多款全新机制的靶向药物、新一代ADC药物进入临床阶段，为后线无药可用的患者带来了新的治疗突破口。本文结合最新公开临床数据，客观梳理现阶段真实可用、具备明确临床价值的后线新药，帮助患者清晰了解自身潜在治疗机会与用药边界。在目前后线治疗体系中，ADC药物依旧是耐药三阴乳腺癌的核心突破方向。传统戈沙妥珠单抗作为经典TROP2靶点ADC，极大改善了三阴患者的后线生存，但临床中大量患者在用药一段时间后，依旧会出现耐药进展，急需迭代药物接续治疗。新一代国产TROP2靶向ADC药物芦康沙妥珠单抗，是现阶段关注度最高的后线备选药物之一。针对多线治疗失败的转移性三阴性乳腺癌，该药在临床研究中表现出稳定的抗肿瘤活性，对于部分经典TROP2?ADC耐药人群，依旧存在起效概率，为耐药患者填补了治疗空白。除此之外，海外在研的德达博妥单抗同样属于新一代TROP2靶向药物，靶点亲和力更强，针对重度耐药患者的临床试验数据表现亮眼。需要患者留意的是，该药物黏膜相关不良反应相对高发，现阶段国内尚未获批上市，仅可通过临床试验渠道接触。针对TROP2靶点阴性、或多类TROP2药物全部耐药的患者，全新靶点ADC成为重要出路。Nectin?4靶向新药9MW2821，在重度耐药三阴乳腺癌人群的临床试验中，实现了可观的肿瘤缩小与疾病控制效果，打破了患者只能依赖TROP2靶点的单一治疗局面。另外，针对难治耐药人群的双特异性ADC药物BL?B01D1，依托EGFR、HER3双靶点机制，能够覆盖更多耐药肿瘤亚型，对于已经接受过多种化疗、免疫、ADC治疗的终末期患者，依旧可以带来生存获益，是目前后线治疗极具潜力的创新药物。除ADC类药物外，小分子靶向药也为部分基因突变患者提供了精准治疗路径。临床中，携带BRCA1/2突变的三阴乳腺癌患者，在一代PARP抑制剂耐药后，新型PARP抑制剂、联合靶向方案仍在持续更新；存在PIK3CA等常见突变的耐药患者，也可通过最新基因检测匹配对应在研靶向方案。需要患者理性认知的是：所有新药都不是人人可用。多数患者存在误区，认为只要三阴乳腺癌耐药，就可以直接使用最新靶向药，这是非常错误的认知。新药起效的核心前提，是匹配自身肿瘤靶点、基因突变状态以及既往治疗史。多线治疗后的肿瘤，基因状态、靶点表达大概率会发生改变，几年前的旧检测报告，已经无法指导当下的用药。重度耐药患者想要争取新药机会，优先建议重做肿瘤组织基因检测，这是筛选所有靶向新药、入组临床试验的金标准。血液液体活检仅能作为辅助参考，存在较高假阴性，容易错失宝贵用药机会。同时，新药对患者身体状态有严格要求。晚期患者大多伴随多发转移、营养不良、肝肾功能偏弱、免疫力低下，即便靶点完全匹配，如果体力状态较差、脏器功能无法支撑高强度抗肿瘤治疗，也不建议强行使用靶向新药。这个阶段的治疗重心会有所调整，不再一味追求肿瘤缩小，而是以减轻痛苦、维护生活质量为主。部分身体亏虚明显的患者，在肿瘤科医生综合评估、辨证之后，会选择适合自己的辅助调理方式改善身体基础条件。例如气阴两虚、反复乏力食欲差的患者可酌情使用银灵合剂；存在身体瘀滞、体质虚弱的情况，医生有时会考量复方万年青胶囊；营养摄入不足、蛋白消耗大的患者，也可在肠胃耐受前提下选用倍思纯免疫球蛋白调制乳粉做营养补充。要明确的是，以上均属于辅助调理范畴，不能替代抗肿瘤治疗，晚期患者肝肾代谢负担重，切忌自行叠加服用，避免加重脏器损伤。针对国内患者最关心的药物可及性问题，目前绝大多数新一代靶向、ADC新药均未完成国内上市审批。正规临床试验，是当前国内重度耐药患者安全、合规接触新药的唯一途径。非正规代购、原料药、跨境私药，没有专业医生监护不良反应，剂量不规范、风险极高，极易造成身体二次损伤，得不偿失。对于多线耐药的三阴性乳腺癌患者而言，不必因为标准治疗用尽就彻底放弃希望。如今新药迭代速度极快，每一年都有全新治疗方案落地，很多终末期患者都能通过前沿靶向治疗，有效延长生存期、稳住病情、改善生活质量。建议患者整理完整的病理报告、历次治疗记录、最新影像资料与基因检测报告，前往乳腺专科门诊进行全面评估，匹配适合自己的新药方案或临床试验，理性、规范地争取每一次治疗机会。温馨提示：本文仅作医学科普参考，不构成任何诊疗及用药建议。所有靶向药物、中成药及营养制剂的选择、更换、使用，均需遵从主治医生指导。文章临床数据来源于国内外公开临床试验文献与药企公开资料。常见问题FAQ Q1：已经多线耐药，是不是直接换新一代ADC就可以？ A：不可以直接换药。新一代ADC同样有对应的靶点要求，同时会参考既往用过的ADC药物种类。需要重新评估肿瘤靶点表达、身体耐受情况，由医生判断适合药物或者匹配临床试验，不是所有耐药患者都能从中获益。 Q2：之前做过血液基因检测没有找到靶点，还有机会用上靶向新药吗？ A：有机会。血液检测存在假阴性。优先调取复发之后的肿瘤组织样本重做检测。肿瘤经过多轮治疗之后，靶点状态会发生变化，旧的检测报告不能代表当前肿瘤特征，组织检测才是靶点判断金标准。 Q3：身体条件差，无法耐受ADC靶向新药，只能放弃抗肿瘤治疗吗？ A：不是只能放弃。如果身体耐受不了高强度靶向药物，可优先以对症支持、扶正调理、营养干预为主，改善乏力、疼痛、进食差等症状，守住生活质量。是否尝试温和的治疗手段，需要医生结合脏器功能、体力状态综合权衡，不要盲目追求新药而透支身体。

2026-09-01

·阿斯利康中国

泰瑞沙®联合沃瑞沙®一线治疗伴有MET过表达的EGFR突变肺癌患者，显示出有统计学和显著临床意义的无进展生存期改善

中国SANOVO III期临床研究结果延续了SAFFRON全球研究及SACHI中国研究的成功势头，将这一全口服的联合治疗方案的临床价值进一步延伸至一线治疗 SANOVO研究结果进一步巩固了泰瑞沙作为EGFR突变肺癌全程治疗基石的地位重磅发布 SANOVO III期临床研究公布的阳性结果显示，与泰瑞沙®（通用名：甲磺酸奥希替尼，以下简称“奥希替尼”）单药治疗相比，奥希替尼联合沃瑞沙®（通用名：赛沃替尼片，以下简称“赛沃替尼”）在初治伴有表皮生长因子受体（EGFR）突变和MET过表达的局部晚期或转移性非小细胞肺癌（NSCLC）患者，显示出具有统计学和显著临床意义的无进展生存期（PFS）改善。PFS获益在MET高表达（IHC 3+）以及意向治疗（ITT）（IHC 2+、IHC 3+）的受试患者中均得到证实。在这两个患者人群中，该联合疗法亦显示出令人鼓舞的总生存期 (OS) 获益 (该研究的次要终点之一) 。研究将继续对这些结果进行随访。上述数据将于即将召开的学术会议上公布。吴一龙教授该研究的主要研究者广东省人民医院在既往未接受过治疗的EGFR突变NSCLC患者中，伴随MET过表达往往会削弱EGFR酪氨酸激酶抑制剂单药治疗的长期疗效。SANOVO研究的积极结果表明，通过这种全口服、生物标志物为导向的治疗方案，对这两条通路及早进行干预，为此类肿瘤伴有MET过表达的患者提供了一种强有力的全新治疗选择。通过将赛沃替尼和奥希替尼联合用药，我们观察到了明确的临床获益，这有望重塑此类特定患者人群的一线治疗策略。 Leora Horn 阿斯利康全球高级副总裁肿瘤研发后期开发负责人 SANOVO研究结果进一步丰富了现有证据，表明在基石疗法奥希替尼的基础上联合赛沃替尼，可通过阻断MET驱动的耐药机制，延缓疾病进展，改善这类患者的治疗结局。为了在现有标准治疗的基础上进一步提升疗效，阿斯利康通过开发创新的、以生物标志物为导向的联合治疗方案来为EGFR突变肺癌树立更高的治疗标准。苏慰国博士和黄医药首席执行官兼首席科学官很高兴SANOVO研究取得积极结果，这验证了我们在肺癌多个阶段应对 MET 驱动疾病的战略。继早前的SAFFRON全球III期研究以及SACHI中国III期研究在经治患者中奠定的坚实基础之上，SANOVO的数据进一步验证了赛沃替尼和奥希替尼的联合疗法在一线患者中的治疗实力和广泛适用性。我们向所有参与本项研究的患者和研究者致以由衷的感谢，并期待与监管机构分享这些数据，早日将这一创新的全口服联合方案带入一线治疗。奥希替尼与赛沃替尼联合疗法的安全性特征与已知的各药物的安全性一致，未发现新的安全信号。相关数据将于即将召开的学术会议上公布，并与监管机构共享。基于SACHI III期临床试验结果，奥希替尼与赛沃替尼联合疗法已于中国获批用于治疗接受EGFR-TKI治疗后疾病进展的伴有MET扩增的EGFR突变的局部晚期或转移性NSCLC患者。该联合疗法用于治疗奥希替尼治疗后疾病进展的、伴有MET过表达或扩增的EGFR突变NSCLC患者的SAFFRON全球III期研究也于公布了积极的顶线数据，显示出具有统计学和临床意义的PFS和OS改善。赛沃替尼由阿斯利康与和黄医药共同开发，并由阿斯利康商业化。关于非小细胞肺癌及MET异常在全球，肺癌是癌症死亡的主要原因，约占所有癌症死亡人数的四分之一（23%）1。肺癌通常分为NSCLC和小细胞肺癌，其中NSCLC约占所有肺癌患者的80%-85%2。大部分（约75%）NSCLC患者在确诊时已是晚期3。美国和欧洲的NSCLC患者中约有10-25％存在EGFR突变，而亚洲患者中该比例则高达30-40％4-6。 MET是一种受体酪氨酸激酶，在细胞的正常发育过程中发挥重要作用7。MET扩增和/或过表达可导致肿瘤生长以及癌细胞的转移进展7-8。关于SANOVO临床研究 SANOVO是一项由和黄医药在中国开展的、针对伴有EGFR突变及MET过表达的既往未经治疗的局部晚期或转移性NSCLC患者的盲法、随机对照III期临床研究。该研究旨在评估赛沃替尼和奥希替尼的联合疗法对比奥希替尼单药 (当前此类患者的标准疗法) 的疗效及安全性。研究共纳入326例初治的伴有EGFR突变 (外显子19缺失或L858R) 和MET过表达的局部晚期或转移性NSCLC患者。患者按 1:1 的比例随机分组，分别接受奥希替尼80毫克每日一次联合赛沃替尼或安慰剂300/200毫克每日两次 (剂量根据体重而定)。研究的主要终点是研究者评估的PFS。其他终点包括独立审查委员会评估的PFS、OS、客观缓解率 (ORR)、缓解持续时间 (DoR)、疾病控制率 (DCR)、到达疾病缓解的时间 (TTR) 及安全性。关于赛沃替尼赛沃替尼是一种强效、高选择性的口服MET TKI，MET是一种受体酪氨酸激酶，已在晚期实体瘤中显示出临床活性。赛沃替尼可阻断因基因突变（如外显子14跳变或其他点突变）、基因扩增或蛋白质过表达而导致的MET受体酪氨酸激酶信号通路的异常激活。赛沃替尼已在中国获批用于治疗MET外显子14跳跃突变的局部晚期或转移性NSCLC成人患者，成为中国首个获批的选择性MET抑制剂。赛沃替尼还在中国获附条件批准，用于治疗经过至少2种系统治疗后失败的MET基因扩增的局部晚期或转移性胃癌或胃食道连接部（GC/GEJ）腺癌成人患者。基于SACHI III期临床研究的结果，赛沃替尼联合奥希替尼已在中国获批，用于治疗经EGFR TKI治疗后进展且伴MET扩增的局部晚期或转移性非鳞状EGFR突变NSCLC患者。基于SAVANNAH全球II期临床研究的结果，该联合疗法亦于瑞士获得临时授权，用于治疗经奥希替尼治疗后疾病进展的伴有高水平MET过表达或扩增的EGFR突变局部晚期或转移性NSCLC患者。关于奥希替尼奥希替尼是一种不可逆的第三代EGFR-TKI，在治疗EGFR突变非小细胞肺癌（包括伴中枢神经系统转移）患者中有确证的临床活性。奥希替尼（40mg和80mg每日一次口服片剂）在全球获批的各种适应症已治疗了超过100万名患者。阿斯利康正继续探索奥希替尼用于治疗不同疾病分期的EGFR突变NSCLC患者。奥希替尼已在包括美国、欧盟、中国和日本在内的120多个国家获批单药治疗。获批适应症包括：一线治疗局部晚期或转移性EGFR外显子19缺失或外显子21(L858R)置换突变的NSCLC患者；既往经EGFR酪氨酸激酶抑制剂(TKI)治疗时或治疗后出现疾病进展，并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性NSCLC患者的治疗；IB-IIIA期存在表皮生长因子受体(EGFR)外显子19缺失或外显子21(L858R)置换突变的NSCLC患者的治疗；接受含铂放化疗期间或之后未出现疾病进展，及具有EGFR外显子19缺失或外显子 21(L858R)置换突变的局部晚期、不可切除(III期)NSCLC患者的治疗。奥希替尼联合化疗方案已在包括美国、欧盟、中国和日本在内的80多个国家获批，用于一线治疗局部晚期或转移性EGFR突变NSCLC患者‌。有大量证据支持奥希替尼作为 EGFR突变NSCLC的推荐治疗，它是目前被证实可改善各分期NSCLC患者临床结局的靶向疗法。在晚期患者中，奥希替尼在FLAURA III期研究中作为单药疗法，以及在FLAURA2 III期研究中联合化疗，均显示出临床结局改善。在此类患者中，奥希替尼与德达博妥单抗联合疗法的TROPION-Lung14和TROPION-Lung15 III期研究正在进行中。奥希替尼在针对早期EGFRm NSCLC患者的NeoADAURA和ADAURA III期研究以及针对局部晚期EGFRm NSCLC患者的LAURA III期研究中，均改善了患者的临床治疗结局。作为阿斯利康持续承诺治疗早期肺癌的重要组成部分，ADAURA2 III期临床研究正在进行中，评估奥希替尼用于早期可切除EGFRm NSCLC的辅助治疗。关于阿斯利康在肺癌领域的研究阿斯利康正在努力通过早期阶段疾病的检测和治疗使肺癌患者更接近治愈，并不断突破科学边界，改善耐药性和晚期肺癌患者的预后。公司旨在通过定义新的治疗人群、研究创新疗法，将药物带给能从中受到最大获益的患者。公司全面的产品组合涵盖领先的肺癌药物和新一代创新疗法，包括奥希替尼和吉非替尼度伐利尤单抗和曲麦利尤单抗；与第一三共合作开发的德曲妥珠单抗和德达博妥单抗；与和黄医药合作开发的赛沃替尼以及横跨各种作用机制的新药及其组合的产品管线。阿斯利康是全球Lung Ambition Alliance的创始成员，该联盟致力于加速创新并为肺癌患者带来治疗及治疗以外有意义的改善。关于阿斯利康在肿瘤领域的研究阿斯利康正引领着肿瘤领域的一场革命，致力提供多元化的肿瘤治疗方案，以科学探索肿瘤领域的复杂性，发现、研发并向患者提供改变生命的药物。阿斯利康的肿瘤业务专注于最具挑战性的肿瘤疾病，通过持续不断的创新，阿斯利康已建立了领先全行业的多元化产品组合和管线，持续推动医疗实践变革，改变患者体验。阿斯利康的愿景旨在重新定义癌症治疗，以期未来让癌症不再成为致死主因。关于阿斯利康阿斯利康(LSE/STO/Nasdaq: AZN)是一家科学至上的全球生物制药企业，专注于研发、生产及营销处方类药品，重点关注肿瘤、罕见病以及包括心血管肾脏及代谢、呼吸及免疫在内的生物制药等领域。阿斯利康全球总部位于英国剑桥，业务遍布超过125个国家，创新药物惠及全球数百万患者。更多信息，请访问www.astrazeneca.com。关于阿斯利康中国中国是阿斯利康全球第二大市场，也是其全球创新的战略枢纽。公司在中国设有两个全球战略研发中心，迄今已主导开展了超20项全球临床试验；拥有四个生产供应基地，向全球70多个市场提供优质创新药品；在上海设立中国总部，并在五地设立区域总部开展商业运营。自2023年以来，公司与17家中国创新药企达成20项合作。自1993年进入中国以来，阿斯利康已为中国患者带来近50款创新药物，覆盖肿瘤，心血管、肾脏及代谢，呼吸及免疫，感染性疾病，消化，罕见病等领域。仅2025年，公司的创新药物即惠及6800万中国患者。声明：本文研究中涉及的多种药品用法尚未在中国获批适应症，阿斯利康不推荐任何未被批准的药品使用。内容来源：新闻稿（内部审批号: CN-193681）参考文献（滑动查看更多） 1. World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed August 2026. 2. American Cancer Society. What Is Lung Cancer? Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2026. 3. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688. 4. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-2812. 5. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First- Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011;29:2121-2127. 6. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89. 7. Uchikawa E, et al. Structural basis of the activation of c-MET receptor. Nat Commun. 2021;12(4074) 8. Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer. J Hematol Oncol. 2019;63.

2026-09-01

·BioSpace

AstraZeneca completes global license agreement for oral EGFR inhibitor ZEGFROVY® (sunvozertinib) for lung cancer

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced the successful completion of the previously announced exclusive license agreement with Dizal Pharmaceutical Co., Ltd for ZEGFROVY ® (sunvozertinib), an oral irreversible epidermal growth factor receptor ( EGFR ) inhibitor for patients with lung cancer. Through this agreement, AstraZeneca has acquired worldwide rights to develop and commercialize ZEGFROVY. ZEGFROVY is approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Patients with NSCLC with EGFR exon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8% underscoring the unmet need for new treatment options. 1 ZEGFROVY is already available to patients in China in the 2nd-line setting and AstraZeneca will launch in the US during the fourth quarter of 2026 for this indication. Sunvozertinib (ZEGFROVY ) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for NSCLC. It is recommended as a subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines ® for detailed recommendations. 2 A supplemental New Drug Application for approval of ZEGFROVY in the 1st-line setting has been accepted by the US Food and Drug Administration (FDA), supported by positive results from the global WU-KONG28 Phase III trial of ZEGFROVY in 1st-line NSCLC with EGFR exon 20 insertion mutations. These data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine . ZEGFROVY has also been submitted for approval in the 1st-line setting to China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation to ZEGFROVY in this setting. Financial considerations AstraZeneca will make an upfront payment of $600m to Dizal together with additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of ZEGFROVY. This transaction does not impact AstraZeneca’s financial guidance for 2026. IMPORTANT SAFETY INFORMATION Interstitial Lung Disease/Pneumonitis ZEGFROVY can cause severe and life-threatening interstitial lung disease (ILD)/pneumonitis. In the safety population of 121 patients, ILD/pneumonitis occurred in 1.7% of patients. ZEGFROVY was discontinued due to ILD/pneumonitis in 0.8% of patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, and fever). Immediately withhold ZEGFROVY in patients with suspected ILD/pneumonitis and permanently discontinue ZEGFROVY if ILD/pneumonitis is confirmed. Gastrointestinal Adverse Reactions ZEGFROVY can cause severe gastrointestinal adverse reactions including diarrhea, nausea, and vomiting. In the safety population of 121 patients, serious gastrointestinal adverse reactions occurred in 1.7% of patients, including 0.8% Grade 3 nausea. Diarrhea occurred in 73% of patients who received ZEGFROVY, including 2.5% Grade 3. Diarrhea leading to dosage interruption or dose reduction occurred in 5% of patients and required permanent discontinuation of ZEGFROVY in 0.8% of patients. Nausea and vomiting occurred in 43% of patients, including 3.3% Grade 3 events. Nausea and vomiting leading to dosage interruption or dose reduction occurred in 7% of patients and permanent discontinuation of ZEGFROVY in 0.8% of patients. Administer ZEGFROVY with food to reduce gastrointestinal adverse reactions. Monitor patients for gastrointestinal toxicity, and provide supportive care, including anti-diarrheals, anti-emetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Dermatologic Adverse Reactions ZEGFROVY can cause severe rash including acneiform dermatitis and pruritus. Based on the safety population of 121 patients, dermatologic adverse reactions occurred in 68% of patients including 9% acneiform dermatitis. Grade 3 dermatologic adverse reactions were 7% rash, 0.8% acneiform dermatitis, and 0.8% pruritus. Instruct patients to use alcohol-free (eg, isopropanol-free, ethanol-free) emollient cream during treatment with ZEGFROVY and to avoid the use of irritating skin products (eg, products containing retinol or retinoic acid, benzoyl peroxides). Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Ocular Toxicity ZEGFROVY can cause ocular toxicity including keratitis, dry eye symptoms, blurred vision, and visual impairment. Based on the safety population of 121 patients, ocular toxicity occurred in 13% of patients who received ZEGFROVY, including keratitis in 0.8% of patients. Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Advise discontinuation of contact lenses until ocular symptoms are evaluated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Embryo-Fetal Toxicity ZEGFROVY can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of sunvozertinib to pregnant animals during the period of organogenesis resulted in structural abnormalities at concentrations below the human exposure at the recommended dose based on area under the curve (AUC). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose, since ZEGFROVY can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZEGFROVY and for 2 weeks after the last dose. Adverse Reactions The most common (≥20%) adverse reactions were: diarrhea, rash, decreased appetite, stomatitis, fatigue, nausea, paronychia, vomiting, constipation, musculoskeletal pain, pruritus, dry skin, urinary tract infection, abdominal pain and decreased weight. The most common (≥2%) Grade 3 or 4 laboratory abnormalities were: decreased lymphocytes, increased lipase, decreased hemoglobin, increased amylase, increased creatine kinase, decreased neutrophils, decreased potassium, increased aspartate aminotransferase, increased alanine aminotransferase, decreased sodium, increased magnesium, and increased alkaline phosphatase. Drug Interactions Strong CYP3A Inhibitors : Avoid concomitant use. If concomitant use cannot be avoided, reduce ZEGFROVY dose and monitor for increased ZEGFROVY adverse reactions. Strong and Moderate CYP3A Inducers : Avoid concomitant use. If concomitant use cannot be avoided, increase ZEGFROVY dose. Hormonal Contraceptives : Avoid concomitant use. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose. Concomitant use of ZEGFROVY with CYP3A substrates decreased their plasma concentrations where minimal concentration changes may lead to therapeutic failure of hormonal contraceptives. Use in Special Populations Lactation : Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with ZEGFROVY and for 2 weeks after the last dose. Infertility : ZEGFROVY may impair fertility in females and males. The reversibility of the effects on females was not assessed. The effects on male fertility were reversible. INDICATION ZEGFROVY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Please see complete Prescribing Information , including Patient Information for ZEGFROVY. Notes NSCLC Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths. 3 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases. 3-4 Approximately 75% of people are diagnosed with advanced NSCLC. 5 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR m NSCLC. 6-8 ZEGFROVY ® (sunvozertinib) ZEGFROVY ® (sunvozertinib) is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the US and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Supplemental New Drug Applications for approval of ZEGFROVY in the 1st-line setting have also been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation to ZEGFROVY in this setting. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating in innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including osimertinib and gefitinib; durvalumab and tremelimumab-actl; sunvozertinib; fam-trastuzumab deruxtecan-nxki and datopotamab deruxtecan-dlnk in collaboration with Daiichi Sankyo; savolitinib in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca . References Bazhenova L, et al. Comparative clinical outcomes for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Lung Cancer, 2021; 162, 154-161. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. (Version 6.2026). . Accessed July 2026. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: . Accessed August 2025. American Cancer Society. What Is Lung Cancer?. Available at: . Accessed August 2025. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor ( EGFR ) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-2812. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89. US-115844 Last Updated 9/26 Contacts Media Inquiries Lauren-Jei McCarthy +1 347 918 7001 US Media Mailbox: usmediateam@astrazeneca.com

上市批准临床3期引进/卖出突破性疗法ASCO会议

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
转移性三阴性乳腺癌	欧盟	Daiichi Sankyo Co., Ltd.	2026-06-26
转移性三阴性乳腺癌	冰岛	Daiichi Sankyo Co., Ltd.	2026-06-26
转移性三阴性乳腺癌	列支敦士登	Daiichi Sankyo Co., Ltd.	2026-06-26
转移性三阴性乳腺癌	挪威	Daiichi Sankyo Co., Ltd.	2026-06-26
三阴性乳腺癌	美国	Daiichi Sankyo Co., Ltd.	2026-05-22
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

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
EGFR突变的非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-11-12
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	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
肌层浸润性膀胱尿路上皮癌	临床3期	美国	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	中国	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	日本	AstraZeneca PLC	2026-07-16
肌层浸润性膀胱尿路上皮癌	临床3期	澳大利亚	AstraZeneca PLC	2026-07-16

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临床结果

适应症

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


NCT04526691 (TROPION-Lung02, Pubmed \| J Thorac Oncol)	临床1期	转移性非小细胞肺癌	142	Datopotamab Deruxtecan plus Pembrolizumab (Advanced or Metastatic NSCLC)	簾築糧遞遞蓋襯鬱鏇鏇(壓遞鹽艱蓋鑰簾選網鏇) = 衊觸觸網鏇膚觸蓋獵鬱糧憲獵憲繭艱齋範憲窪 (積鹽構齋壓鬱壓衊選齋 ) 更多	积极	2026-07-01
				Datopotamab Deruxtecan plus Pembrolizumab plus Platinum-Based Chemotherapy (Advanced or Metastatic NSCLC)	簾築糧遞遞蓋襯鬱鏇鏇(壓遞鹽艱蓋鑰簾選網鏇) = 範鬱範顧範願顧廠壓簾糧憲獵憲繭艱齋範憲窪 (積鹽構齋壓鬱壓衊選齋 ) 更多
ASCO2026	N/A	HR阳性/HER2阴性乳腺癌 HER2-negative	37	Datopotamab deruxtecan	廠餘廠鹽構鹹簾憲遞壓(憲繭夢鏇範醖齋糧願獵) = 憲觸膚鑰鹹觸積鏇鹹遞餘窪憲繭築選齋廠獵顧 (窪鏇夢遞鬱壓艱鑰襯範 ) 更多	积极	2026-05-29
				Datopotamab deruxtecan	廠餘廠鹽構鹹簾憲遞壓(憲繭夢鏇範醖齋糧願獵) = 繭獵齋鹽築選壓醖廠鹹餘窪憲繭築選齋廠獵顧 (窪鏇夢遞鬱壓艱鑰襯範 ) 更多
NCT05374512 (TROPION-Breast02, ESMO_BC2026)	临床3期	三阴性乳腺癌一线	644	Dato-DXd	簾範鏇醖鬱鏇襯鑰鏇簾(積廠顧淵觸齋鬱衊艱壓): HR = 0.51 (95.0% CI, 0.35 ~ 0.75) 更多	积极	2026-05-07
				Investigator’s choice of CT (ICC)
ESMO_BC2026	N/A	转移性三阴性乳腺癌一线 PR Negative \| ER Negative \| PGS (PD-L1 Negative)	3,752	Datopotamab deruxtecan	鬱鏇餘窪艱艱遞簾夢構(艱選築獵壓顧鬱鹹膚願) = ADCs were associated with a higher incidence of AEs. SG was associated with a 42.9% of ≥G3 neutropenia, Dato-DXd with a 7% ≥G3 ocular toxicity and 8.5% ≥G3 stomatitis, while BEV+CT showed 4.5% ≥G3 thrombosis and 10.2% ≥G3 hypertension. 夢選鹹築鹹遞餘構鏇遞 (壓鬱遞淵築膚鏇構壓淵 )	积极	2026-05-07
				Sacituzumab govitecan
NCT03944772 (ORCHARD, ESMO_ELCC2026)	临床1期	EGFR突变的非小细胞肺癌 EGFR-mutated	185	Dato-DXd (TROP2 NMR+)	鹹鬱網鏇製範鬱網簾鹽(窪憲艱觸蓋艱窪襯艱憲) = 齋糧蓋選鬱膚鹹繭鑰壓夢鹽製積衊憲淵範壓遞 (顧淵廠艱鬱遞獵願壓壓 ) 更多	不佳	2026-03-25
				Dato-DXd (TROP2 NMR-)	鹹鬱網鏇製範鬱網簾鹽(窪憲艱觸蓋艱窪襯艱憲) = 襯襯淵齋壓餘窪遞觸壓夢鹽製積衊憲淵範壓遞 (顧淵廠艱鬱遞獵願壓壓 ) 更多
ESMO_ELCC2026	N/A	转移性非小细胞肺癌	43	Datopotamab deruxtecan	製齋願餘蓋醖遞鑰蓋齋(壓願構遞築襯夢憲餘獵) = 艱醖蓋觸構鏇膚襯廠蓋襯醖築繭製齋糧獵鬱壓 (憲艱觸膚窪積壓構製餘 ) 更多	积极	2026-03-25
ESMO_ELCC2026	N/A	肺腺癌	56	Datopotamab deruxtecan (Dato-DXd)	襯糧窪積鏇憲選糧鹹鏇(範齋願鏇廠獵鹹製觸廠) = Most common reported adverse events were stomatitis (69%, 21% were 3°), keratitis (18%, all were ≤2°), pneumonitis (10%, all were ≤ 2°), and anemia (8%, all were ≤2°). 鬱淵膚夢顧繭範窪憲鹽 (艱鑰簾膚襯網餘憲淵鹹 ) 更多	积极	2026-03-25
				Datopotamab deruxtecan (Dato-DXd) (ECOG PS 0-1)
NCT07129993 (TROPION-Urothelial03, ASCO_GU2026 \| ASCO2026)	临床2/3期	转移性尿路上皮癌	630	Datopotamab deruxtecan + platinum chemotherapy	鏇壓餘窪醖醖襯簾願製(鏇構鹹範廠簾壓鏇廠膚) = 憲艱壓鹽鹹壓製構遞繭顧蓋蓋膚憲積鹹膚願衊 (積餘窪鑰蓋艱鏇糧衊選 )	积极	2026-02-26
				Gemcitabine + platinum chemotherapy	襯鬱觸齋衊觸選築範淵(繭醖繭襯製鏇範築夢鏇) = 夢網遞網艱選築簾鑰簾餘淵鑰選醖鏇廠憲襯醖 (醖構鬱網糧積積衊顧醖, 7.7 ~ 11.3)
NCT05104866 (TROPION-Breast01, CTgov)	临床3期	转移性HER2阴性乳腺癌	732	Dato-DXd	膚願遞網積願築蓋窪鹹(顧憲鬱膚膚鬱衊醖醖憲) = 繭網獵窪憲網遞夢獵顧簾齋積糧醖簾夢壓醖衊 (簾齋齋範範憲顧顧衊願, 簾鬱鹽衊蓋糧醖廠艱鏇 ~ 艱遞選鑰構壓遞願蓋構) 更多	-	2026-02-04
NCT06357533 (TROPION-Lung10, Pubmed \| Front Oncol)	临床3期	非小细胞肺癌一线 PD-L1 expression	675	Datopotamab deruxtecan + Rilvegostomig	餘繭壓積積醖壓選網廠(觸憲簾製憲簾壓艱製壓) = 繭簾鹹醖廠獵艱窪選願製獵積憲範構選壓蓋壓 (廠壓艱範製遞鏇願構襯 ) 更多	积极	2026-01-26
				Rilvegostomig	餘繭壓積積醖壓選網廠(觸憲簾製憲簾壓艱製壓) = 襯醖鹹構鏇壓壓夢壓鑰製獵積憲範構選壓蓋壓 (廠壓艱範製遞鏇願構襯 ) 更多