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更新于：2026-05-10
Sacituzumab tirumotecan
芦康沙妥珠单抗
更新于：2026-05-10
概要
基本信息
药物类型 ADC |
别名 Sac-TMT、TROP-2-targeted antibody-drug conjugate、A-264 + [7] |
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) |
在研适应症 |
非在研适应症 |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-11-22), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国) |
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结构/序列
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Sequence Code 27958L
来源: *****
Sequence Code 319372635H
来源: *****
关联
117
项与 芦康沙妥珠单抗 相关的临床试验NCT07511023
Phase 2 Trial Of Sacituzumab Tirumotecan For Treatment Of Refractory Metastatic Or Unresectable Squamous Cell Carcinoma Of The Anus/Rectum
ACTRN12625001382460
Phase 2 trial of SaciTuzumAb TirumotEcan (sac-TMT) in patients with MetastAtic castration resistant prostate cancer (mCRPC): a high dimeNesional collection and characterization Platform (STATEsMAN)
NCT07438626
Phase II Trial of Sacituzumab Tirumotecan in Patients With SMARCB1-Deficient Renal Medullary Carcinoma
100 项与 芦康沙妥珠单抗 相关的临床结果
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100 项与 芦康沙妥珠单抗 相关的转化医学
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100 项与 芦康沙妥珠单抗 相关的专利（医药）
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28
项与 芦康沙妥珠单抗 相关的文献（医药）2026-03-23Zhonghua zhong liu za zhi [Chinese journal of oncology]
[Expert consensus on the clinical application of TROP2-targeted antibody-drug conjugates in non-small cell lung cancer (2026 edition)].
Review
Antibody-drug conjugates (ADCs) have demonstrated groundbreaking progress in the treatment of non-small cell lung cancer (NSCLC). Trophoblast cell surface antigen 2 (TROP2) has emerged as a pivotal therapeutic target, and TROP2-directed ADCs, including Sacituzumab Tirumotecan, Datopotamab Deruxtecan, and Sacituzumab Govitecan have shown substantial antitumor activity and survival benefits in clinical studies. To further standardize the clinical use and safety management of TROP2 ADCs, this expert consensus systematically reviews current evidence regarding their efficacy and safety in NSCLC. Particular emphasis is placed on strategies for the prevention and management of treatment-related adverse events such as mucositis, myelosuppression, and gastrointestinal toxicities, aiming to provide guidance for the rational and safe application of TROP2 ADCs in NSCLC.
2026-03-01ANNALS OF ONCOLOGY
Sacituzumab tirumotecan in participants with advanced or metastatic urothelial carcinoma and disease progression after chemotherapy and immune checkpoint inhibitors
Article
作者: Ge, Y ; Liu, T ; Zhang, S ; Wang, X ; Yuan, F ; Seneviratne, L ; Li, Y ; Li, X ; Wang, S ; Jiang, K ; Chen, X ; Zhang, M ; Ge, J ; Blumenthal, G ; Liu, Y ; Zhou, F ; Ye, D ; Akala, O ; Zhang, X ; Jiang, S ; Chen, M ; Shi, Y ; Yu, G ; Zhu, Y
BACKGROUND:
Trophoblast cell-surface antigen 2 (TROP2) is overexpressed in advanced or metastatic urothelial cancer (UC), representing a promising therapeutic target. Sacituzumab tirumotecan (sac-TMT) is a TROP2-directed antibody-drug conjugate with a unique, bifunctional linker that maximizes payload delivery to tumor cells. We present preliminary results for sac-TMT monotherapy from cohort 9 of the phase 1/2 2870-001/KL264-01 study in participants with advanced or metastatic UC.
PARTICIPANTS AND METHODS:
Eligible participants with locally advanced or metastatic UC and disease progression on one or more prior line of platinum-based chemotherapy and anti-programmed cell death protein 1/programmed cell death-ligand 1 therapy received sac-TMT 5 mg/kg intravenously every 2 weeks until disease progression, unacceptable toxicity, or participant/physician decision. The primary endpoint was investigator-assessed objective response rate (ORR) per RECIST version 1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.
RESULTS:
By data cut-off (17 February 2025), 49 participants were treated with sac-TMT; 37 (76%) had received two or more prior lines of therapy. Median follow-up for this analysis was 18.8 months. The confirmed ORR was 31% [95% confidence interval (CI), 18% to 45%] and the disease control rate was 71% (95% CI 57% to 83%). Median DOR was not reached [range 2.1-22.2+ (+ indicates censored data for the longest DOR, suggesting that patients may have achieved longer remission duration) months], and the 12-month probability of sustained response was 53%. Median PFS and OS were 5.5 months (95% CI 3.6-7.2 months) and 12.1 months (95% CI, 9.9-15.3 months), with 18-month rates of 26% and 33%, respectively. Grade 3/4 treatment-related adverse events (AEs) occurred in 31 participants (63%), and the most common (≥5%) were anemia (41%), decreased neutrophil count (35%), decreased white blood cell count (20%), stomatitis (12%), and decreased platelet count (8%). There were no grade 5 treatment-related AEs or febrile neutropenia events.
CONCLUSIONS:
Sac-TMT 5 mg/kg monotherapy every 2 weeks demonstrated promising antitumor activity in participants with heavily pretreated advanced or metastatic UC, with a manageable safety profile, warranting further evaluation of sac-TMT in this population.
2026-02-15CANCER
Sacituzumab tirumotecan improved survival for patients with EGFR TKI–resistant, EGFR‐mutant advanced NSCLC
作者: Lawrence, Leah
100 项与 芦康沙妥珠单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| HR阳性/HER2阴性乳腺癌 | 中国 | 2026-02-02 | |
| EGFR突变的非小细胞肺癌 | 中国 | 2025-09-30 | |
| EGFR阳性非鳞状非小细胞肺癌 | 中国 | 2025-03-04 | |
| 三阴性乳腺癌 | 中国 | 2024-11-22 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 局部晚期尿路上皮癌 | 临床3期 | 美国 | 2026-04-23 | |
| 局部晚期尿路上皮癌 | 临床3期 | 中国 | 2026-04-23 | |
| 局部晚期尿路上皮癌 | 临床3期 | 日本 | 2026-04-23 | |
| 局部晚期尿路上皮癌 | 临床3期 | 阿根廷 | 2026-04-23 | |
| 局部晚期尿路上皮癌 | 临床3期 | 澳大利亚 | 2026-04-23 | |
| 局部晚期尿路上皮癌 | 临床3期 | 比利时 | 2026-04-23 | |
| 局部晚期尿路上皮癌 | 临床3期 | 以色列 | 2026-04-23 | |
| 局部晚期尿路上皮癌 | 临床3期 | 荷兰 | 2026-04-23 | |
| 局部晚期尿路上皮癌 | 临床3期 | 西班牙 | 2026-04-23 | |
| 局部晚期尿路上皮癌 | 临床3期 | 瑞典 | 2026-04-23 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | EGFR突变的非小细胞肺癌 EGFR Mutation | 137 | 鑰壓壓製簾淵願憲夢鏇(繭構鏇獵觸膚鬱觸獵鑰) = 蓋顧憲淵觸築醖廠築積 積醖構憲範觸衊鏇夢艱 (廠餘齋襯網夢糧鹹壓膚 ) 更多 | 积极 | 2026-03-27 | ||
鑰壓壓製簾淵願憲夢鏇(繭構鏇獵觸膚鬱觸獵鑰) = 醖壓製製願淵餘淵網廠 積醖構憲範觸衊鏇夢艱 (廠餘齋襯網夢糧鹹壓膚 ) 更多 | |||||||
临床3期 | 529 | 構顧範廠選廠鹽餘鹹膚(醖糧餘鑰憲壓膚築膚鬱) = 憲鹽觸繭鹽遞簾鹽選獵 醖願顧網鑰鹽觸願齋夢 (艱築構構選鑰鬱憲鑰鬱 ) 更多 | 积极 | 2026-02-28 | |||
選廠壓積窪夢壓鑰鏇鑰(醖壓衊壓鏇鹽醖廠築選) = 鏇構鹹糧鑰糧餘遞築築 鬱衊蓋糧鹹齋鬱鹹壓窪 (廠蓋壓夢夢廠廠鹹範艱 ) 更多 | |||||||
临床3期 | - | 鏇遞簾築齋鏇積醖艱願(顧鏇願鑰鹽廠網壓壓窪) = Sac-TMT, in combination with pembrolizumab, as a first-line treatment for PD-L1-positive NSCLC, has demonstrated a statistically significant and clinically meaningful improvement in PFS, the study's primary endpoint. 築遞窪淵襯遞醖憲糧簾 (糧壓積鏇壓簾窪蓋遞鹹 ) 达到 更多 | 积极 | 2025-11-24 | |||
临床1/2期 | 49 | Sacituzumab Tirumotecan 5 mg/kg | 餘鏇觸襯鬱醖膚簾夢鏇(鏇構積製鏇獵醖製鏇顧) = 網衊襯襯獵鹹蓋繭獵繭 憲憲襯選築鑰製糧膚夢 (齋鬱醖獵蓋選鏇構鹹鑰, 18 ~ 45) 更多 | 积极 | 2025-11-20 | ||
临床2期 | 晚期非小细胞肺癌 一线 | 103 | 簾鏇壓簾遞夢顧糧齋簾(鬱簾網齋齋鹹製網艱鬱) = 廠鏇簾壓齋淵鏇糧簾繭 繭壓糧繭遞壓齋糧蓋鹹 (夢鹹鹽獵築築襯膚簾艱 ) 更多 | 积极 | 2025-11-01 | ||
Sacituzumab tirumotecan 5 mg kg-1 every 2 weeks + Tagitanlimab 900 mg every 2 weeks | 簾鏇壓簾遞夢顧糧齋簾(鬱簾網齋齋鹹製網艱鬱) = 網鏇繭艱觸鑰衊淵糧壓 繭壓糧繭遞壓齋糧蓋鹹 (夢鹹鹽獵築築襯膚簾艱 ) 更多 | ||||||
临床3期 | EGFR突变的非小细胞肺癌 EGFR Mutation | 376 | 鑰繭壓夢鬱顧夢鹹夢淵(願鑰範蓋鹽鹽齋構齋夢) = 鹽夢選鑰網鑰構築鹽膚 齋積構願簾鹽糧蓋構鏇 (簾鏇遞願衊築糧壓膚壓 ) 更多 | 积极 | 2025-10-19 | ||
Pemetrexed + platinum-based chemotherapy | 鑰繭壓夢鬱顧夢鹹夢淵(願鑰範蓋鹽鹽齋構齋夢) = 範鑰構鏇築衊鑰選構積 齋積構願簾鹽糧蓋構鏇 (簾鏇遞願衊築糧壓膚壓 ) 更多 | ||||||
临床3期 | 399 | Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W | 範鹹襯憲繭範窪艱餘願(鏇醖憲觸網窪淵選鏇鏇) = 簾鏇餘築簾網願淵簾繭 繭選選夢獵鹹鹽糧繭壓 (淵窪製鹽築夢襯範襯選 ) 更多 | 积极 | 2025-10-17 | ||
Investigator's choice of chemotherapy (ICC) | 範鹹襯憲繭範窪艱餘願(鏇醖憲觸網窪淵選鏇鏇) = 築顧鹹醖壓蓋遞顧淵遞 繭選選夢獵鹹鹽糧繭壓 (淵窪製鹽築夢襯範襯選 ) 更多 | ||||||
临床2期 | 46 | 窪醖製壓憲廠鏇獵願憲(鑰膚繭膚製構繭衊壓襯) = 鹽積鹽艱鹽網蓋築鬱範 醖窪醖鏇鹽鏇簾糧觸艱 (窪觸衊繭衊衊憲築獵製, 12.2–73.8) 更多 | 积极 | 2025-10-17 | |||
窪醖製壓憲廠鏇獵願憲(鑰膚繭膚製構繭衊壓襯) = 獵願簾窪蓋淵膚廠醖繭 醖窪醖鏇鹽鏇簾糧觸艱 (窪觸衊繭衊衊憲築獵製, 20.8–53.8) 更多 | |||||||
临床2期 | 128 | 蓋遞範鏇網壓顧選願淵(遞獵簾觸選積簾製廠艱) = 願遞醖獵憲夢繭淵餘衊 築糧鹽顧構遞鹽窪廠鏇 (鹹鏇觸顧鬱齋鏇製鹽遞 ) 更多 | 积极 | 2025-10-17 | |||
蓋遞範鏇網壓顧選願淵(遞獵簾觸選積簾製廠艱) = 選鬱遞鏇憲糧遞範觸顧 築糧鹽顧構遞鹽窪廠鏇 (鹹鏇觸顧鬱齋鏇製鹽遞 ) 更多 | |||||||
临床1/2期 | 晚期宫颈癌 TROP2 expression | 58 | 淵範餘構觸廠窪範觸遞(齋築遞獵繭壓襯齋網願) = 襯獵顧顧艱築觸膚繭遞 窪積鑰獵製遞窪鹹製選 (夢鑰顧憲蓋憲鹽選艱願, 17 ~ 41) 更多 | 积极 | 2025-10-17 |
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