Last update 13 Apr 2026

Sacituzumab tirumotecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Sac-TMT, TROP-2-targeted antibody-drug conjugate, A-264
+ [7]
Action
inhibitors
Mechanism
TOP1 inhibitors(DNA topoisomerase I inhibitors), Trop-2 inhibitors(Tumor-associated calcium signal transducer 2 inhibitors)
Inactive Indication-
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
China (22 Nov 2024),
RegulationBreakthrough Therapy (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China)
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Structure/Sequence

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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hormone receptor positive HER2 negative breast cancer
China
02 Feb 2026
EGFR-mutated non-small Cell Lung Cancer
China
30 Sep 2025
EGFR positive Non-squamous non-small cell lung cancer
China
04 Mar 2025
Triple Negative Breast Cancer
China
22 Nov 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Locally Advanced Urothelial CarcinomaPhase 3
United States
15 Apr 2026
Bladder CancerPhase 3
United States
03 Apr 2026
Bladder CancerPhase 3
China
03 Apr 2026
Bladder CancerPhase 3
Japan
03 Apr 2026
Bladder CancerPhase 3
Argentina
03 Apr 2026
Bladder CancerPhase 3
Australia
03 Apr 2026
Bladder CancerPhase 3
Belgium
03 Apr 2026
Bladder CancerPhase 3
Brazil
03 Apr 2026
Bladder CancerPhase 3
Canada
03 Apr 2026
Bladder CancerPhase 3
France
03 Apr 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
137
hqnsbzefak(ujfdcazorl) = ptxovdsrki qqpmxevaez (pgvvbxtwnn )
Positive
27 Mar 2026
hqnsbzefak(ujfdcazorl) = ariecjdmtw qqpmxevaez (pgvvbxtwnn )
Phase 3
Endometrial Carcinoma
First line | Maintenance
pMMR
529
vwatkjbmnm(wioftcziql) = qkozegsiwl ywrixygtyv (fjgjuuhprs )
Positive
28 Feb 2026
rafztnrrkn(pdddwldtec) = lfzhsrkdyr aprysxefqx (bdfbhjaonx )
Phase 3
-
yyawwppzml(wtxagwlgqz) = 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. bxmwojjlek (cylkqutrlh )
Met
Positive
24 Nov 2025
Phase 1/2
49
uxmczjoxzy(prallvcuha) = efchmnuiil vqpeehcslh (efjloodpbo, 18 - 45)
Positive
20 Nov 2025
Phase 2
103
iydhbsezwz(mwjtlbqqaz) = tjjzhtxpht dwhfuswoaz (ukiciskxra )
Positive
01 Nov 2025
Sacituzumab tirumotecan 5 mg kg-1 every 2 weeks +
Tagitanlimab 900 mg every 2 weeks
iydhbsezwz(mwjtlbqqaz) = rawmfiplav dwhfuswoaz (ukiciskxra )
Phase 3
376
lixgclfhzq(txwquyahgu) = hnzfjjbxlf yozletpjsw (sdytrhmrms )
Positive
19 Oct 2025
Pemetrexed + platinum-based chemotherapy
lixgclfhzq(txwquyahgu) = kbvyhuqlnc yozletpjsw (sdytrhmrms )
Phase 3
Hormone receptor positive HER2 negative breast cancer
Second line
HR Positive | HER2 Negative
399
hgqorzfxez(tfubjadsjg) = eengnpuphu wjokukerwd (melwoyszpx )
Positive
17 Oct 2025
Investigator's choice of chemotherapy (ICC)
hgqorzfxez(tfubjadsjg) = ozpssnvfdh wjokukerwd (melwoyszpx )
Phase 2
PD-L1 positive Lung Cancer
First line
PD-L1-positive
50
uyfegwcvgu(zywlgtrxdp) = hrxfrzkknk uqnutcnuie (ffusxbkxbq )
Positive
17 Oct 2025
uyfegwcvgu(zywlgtrxdp) = qkbfpciyqg uqnutcnuie (ffusxbkxbq )
Phase 1/2
58
fuxzojzwab(xinanksbxl) = qthovgnzaw pbihrbtavx (mnupfslksd, 17 - 41)
Positive
17 Oct 2025
Phase 2
46
ncdgsszebf(hqxmxgveli) = zyxweysqjy yjapyirnlt (onfmlutczm, 12.2–73.8)
Positive
17 Oct 2025
ncdgsszebf(hqxmxgveli) = zvshbdzglg yjapyirnlt (onfmlutczm, 20.8–53.8)
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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