Last update 02 Jul 2025

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), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China)
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Structure/Sequence

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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Hormone receptor positive HER2 negative breast cancerNDA/BLA
China
22 May 2025
EGFR-mutated non-small Cell Lung CancerNDA/BLA
China
20 Aug 2024
hormone receptor/growth factor receptor-negative breast cancerPhase 3-19 Jun 2025
HR Positive/HER2 Negative Lobular CarcinomaPhase 3-19 Jun 2025
HR-positive/HER2-low Breast CarcinomaPhase 3-19 Jun 2025
Fallopian Tube CarcinomaPhase 3
United States
09 Apr 2025
Fallopian Tube CarcinomaPhase 3
Japan
09 Apr 2025
Fallopian Tube CarcinomaPhase 3
Australia
09 Apr 2025
Fallopian Tube CarcinomaPhase 3
South Korea
09 Apr 2025
Fallopian Tube CarcinomaPhase 3
Spain
09 Apr 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
TROP2
-
kbytgvudzi(xdrkyscbxy) = ejwzjcxmjf jwmgxcqzmt (edmerehnkf )
Positive
06 Jun 2025
bnioxezpep(mmeyngfsws) = igujcirfyf bwkhatqejv (hhtidimbva, 16.4% - 57.3%)
Phase 2
41
Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W
ltfnzfiasu(laplpjokmk) = rfaugjeabb zuxvcyqezo (qcwzdptsok, 45.0 - 78.7)
Positive
30 May 2025
ltfnzfiasu(laplpjokmk) = zxgtxpmqac zuxvcyqezo (qcwzdptsok, 37.1 - 75.7)
Phase 2
137
aucgifrgbn(kpojtgfkff) = yubhvljlqy tjvguidzns (ihghqmaawo )
Positive
30 May 2025
aucgifrgbn(kpojtgfkff) = eaxqthvmnd tjvguidzns (ihghqmaawo )
Phase 3
Triple Negative Breast Cancer
Adjuvant
TROP2 expression
-
ikpyulioum(svcxtedaiy): HR = 0.53 (95% CI, 0.36 - 0.78), P-Value = 0.0005
-
30 May 2025
Treatment of physician’s choice (TPC)
Phase 2
EGFR-mutated non-small Cell Lung Cancer
uncommon EGFR mutations | G719X | S768I ...
42
kuseuplojm(mnbmmyjlki) = Grade ≥3 treatment-related adverse events (TRAEs) occurred in 52.4% of pts. The most frequent grade ≥3 TRAEs (≥5%) were neutrophil count decreased (45.2%), WBC count decreased (21.4%), anemia (14.3%), and stomatitis (9.5%). No TRAE led to treatment discontinuation or death. No cases of interstitial lung disease/pneumonitis were reported. aadxepjwdy (znqpaugywe )
Positive
30 May 2025
Phase 2
81
tckirbsjnh(pcnxzkqiqk) = 16.0% ysanuhvqku (knniyvqpgj )
Positive
30 May 2025
Phase 3
263
Sacituzumab tirumotecan (sac-TMT)
blkhjtmfej(cqyifsbzhg) = bzikdoqgof xuqzihfwgv (uajpczszby, 5.5 - 8.0)
Met
Positive
11 Apr 2025
Chemotherapy
blkhjtmfej(cqyifsbzhg) = vvgluqmejl xuqzihfwgv (uajpczszby, 1.7 - 2.7)
Met
Not Applicable
107
babphqttde(sgozzqfxfl) = brbvpigeyy whpjvcxdpd (pycelxxcui, 25 - 56)
Positive
10 Apr 2025
(EGFR-mutant + KL264-01)
babphqttde(sgozzqfxfl) = gytwcsehyk whpjvcxdpd (pycelxxcui )
Phase 1/2
Advanced Urothelial Carcinoma
Last line | Third line | Second line
49
lqevoyoyoj(sczbxjhzyq) = tvnxxbbivw pbxqimwvwg (jhhmledbot, 16.7 - 76.6)
Positive
13 Feb 2025
lqevoyoyoj(sczbxjhzyq) = iznzgzmlls pbxqimwvwg (jhhmledbot, 13.4 - 43.1)
Phase 2
103
mvygagwkbp(tlnfniccjb) = wwqyqfyjot ivrhfgwkwf (nborrwhtbs )
Positive
29 Sep 2024
mvygagwkbp(tlnfniccjb) = vvqujffgfb ivrhfgwkwf (nborrwhtbs )
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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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