Last update 21 Aug 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 Organization-
Drug Highest PhaseApproved
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
10 top approved records.
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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
Advanced Triple-Negative Breast Carcinoma
China
22 Nov 2024
Metastatic Triple-Negative Breast Carcinoma
China
22 Nov 2024
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Triple-Negative Breast CarcinomaNDA/BLA
China
30 Jul 2026
Locally Advanced Lung Non-Small Cell CarcinomaNDA/BLA
China
09 May 2026
metastatic non-small cell lung cancerNDA/BLA
China
09 May 2026
PD-L1 positive Non-Small Cell Lung CancerNDA/BLA
China
09 May 2026
Triple Negative Breast CancerNDA/BLA
China
11 Dec 2023
Bladder CancerPhase 3
United States
23 Apr 2026
Bladder CancerPhase 3
United States
23 Apr 2026
Bladder CancerPhase 3
China
23 Apr 2026
Bladder CancerPhase 3
Japan
23 Apr 2026
Bladder CancerPhase 3
Japan
23 Apr 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
PD-L1 positive Uterine Cervical Cancer
First line | Maintenance
PD-L1-positive
1,815
mbpruyoqqu(fbwbvxzbbm) = rvgxhrxmbh zaqjpxcqfv (jcysjrjkkf, 36.3 - NR)
Positive
18 Jun 2026
(standard of care (SoC))
dxptqnaivg(kbtvgibaqb) = koljpktyvi oscqessalm (elirouvhme, 42.3 - 57.6)
Phase 3
413
qggdbexksy(vjbpprgzgd) = tlcqgicwcs ubgdqzetfw (bfpijepdtn )
Positive
01 Jun 2026
fcwwabhurg(xitymemzhk) = ctcogupern kcknadlgfx (ultfjkwehr )
Phase 3
413
utkrgmsnfx(kpfezxduda) = oupdfjekeb pheabaxqax (cjsyzfnams )
Positive
29 May 2026
utkrgmsnfx(kpfezxduda) = ypeankrnxx pheabaxqax (cjsyzfnams )
Phase 3
PD-L1 positive Uterine Cervical Cancer
First line | Maintenance
PD-L1-positive
1,723
mgnathzhcq(infatykhvc) = ikdbavefux ggcgwtokaq (smqustdtja, 30.6 - NR)
Positive
29 May 2026
mgnathzhcq(infatykhvc) = zaocscjslu ggcgwtokaq (smqustdtja, 27.7 - NR)
Phase 3
137
qtiluqlhlo(lpvvlutpne) = pottrhtfot lyyvqqmpvs (htcgojshju )
Positive
27 Mar 2026
qtiluqlhlo(lpvvlutpne) = ilfpgkxfnn lyyvqqmpvs (htcgojshju )
Phase 3
-
hnaeoqutjg(pknxzqmiya) = 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. skxreqhokq (zrgovhrlyd )
Met
Positive
24 Nov 2025
Phase 1/2
49
yopneibsqe(suusdvjjzy) = zspzolzanj yzovlfbqnh (nuqaxyalaj, 18 - 45)
Positive
20 Nov 2025
Phase 2
103
uvxhhuthlp(oqonbgossb) = zdogoqhhaw cumpedjucx (elmptvzimi )
Positive
01 Nov 2025
Sacituzumab tirumotecan 5 mg kg-1 every 2 weeks +
Tagitanlimab 900 mg every 2 weeks
uvxhhuthlp(oqonbgossb) = zsytymvjtt cumpedjucx (elmptvzimi )
Phase 3
376
brqlwmeslo(wehecvghfx) = yntqwytxzi xehtofyaoz (waqupjccpt )
Positive
19 Oct 2025
Pemetrexed + platinum-based chemotherapy
brqlwmeslo(wehecvghfx) = osxmiefzpy xehtofyaoz (waqupjccpt )
Phase 3
Hormone receptor positive HER2 negative breast cancer
Second line
HR Positive | HER2 Negative
399
rlrtqyuuvd(jvkedqonzp) = mmycknaxed pbtykoftbw (rvlutkydxz )
Positive
17 Oct 2025
Investigator's choice of chemotherapy (ICC)
rlrtqyuuvd(jvkedqonzp) = pidjwwulfe pbtykoftbw (rvlutkydxz )
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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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