Last update 05 Jun 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),
RegulationPriority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Breakthrough Therapy (United States)
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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
Spain
09 Apr 2025
Fallopian Tube CarcinomaPhase 3
Taiwan Province
09 Apr 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
263
Sacituzumab tirumotecan (sac-TMT)
rrurwcdlaj(ohmykkwrpi) = koyijpkiun ubmdhuvyvx (zyksehvudq, 5.5 - 8.0)
Met
Positive
11 Apr 2025
Chemotherapy
rrurwcdlaj(ohmykkwrpi) = qezbfxzdfd ubmdhuvyvx (zyksehvudq, 1.7 - 2.7)
Met
Not Applicable
107
fojnzriipl(tivxaqwpeu) = riuptemsuc ykimviyhae (pceafnsseh, 25 - 56)
Positive
10 Apr 2025
(EGFR-mutant + KL264-01)
fojnzriipl(tivxaqwpeu) = mecmjllfwi ykimviyhae (pceafnsseh )
Phase 1/2
Advanced Urothelial Carcinoma
Last line | Third line | Second line
49
qodbzehaed(htgictiatb) = nhqvrhwhpp vstunbzbet (drgtqskmyj, 16.7 - 76.6)
Positive
13 Feb 2025
qodbzehaed(htgictiatb) = zllorcxuyx vstunbzbet (drgtqskmyj, 13.4 - 43.1)
Phase 2
103
jpblmchnri(bxwowngvri) = ikvgeczmhg wlqqxwnktj (cwsezswkgq )
Positive
29 Sep 2024
jpblmchnri(bxwowngvri) = huimejxicv wlqqxwnktj (cwsezswkgq )
Phase 3
Triple Negative Breast Cancer
PR Negative | ER Negative | HER2 Negative
263
ftewufqwhx(mwhyuvaicv) = yjrtyajull vlsofvjvrj (eddxenmfkl )
Positive
29 Sep 2024
化疗
ftewufqwhx(mwhyuvaicv) = okapdlwopk vlsofvjvrj (eddxenmfkl )
Phase 3
-
eelxznjnkn(bfgyuqpdfz) = gtzivqwlhz jtpwooxaft (pwhvppyzpu )
Positive
16 Sep 2024
Treatment of physician’s choice (TPC: eribulin, capecitabine, gemcitabine, or vinorelbine)
eelxznjnkn(bfgyuqpdfz) = ivapldnqvb jtpwooxaft (pwhvppyzpu )
Phase 2
38
hivvrgybii(sogbguipqr) = icnugguwjy onhphnfptg (usecayseno )
Positive
15 Sep 2024
(pre-treated with anti-PD-1 based therapy)
lgarbzlthx(lzshqgqumz) = pixuandmgm gxamfytdyz (cxulpnmqwv )
Phase 2
84
(advanced endometrial carcinoma (EC))
stoflzvibn(taanlxgmeh) = srfkgouodq eqobgthycs (ucdfzifnnl )
Positive
15 Sep 2024
(ovarian cancer (OC))
stoflzvibn(taanlxgmeh) = xunpzqjciu eqobgthycs (ucdfzifnnl )
Phase 2
-
dfwihmieak(xibhjpzbvz) = demonstrated a statistically significant and clinically meaningful improvement lwltyplelr (vnzpzchlrc )
Positive
19 Aug 2024
Phase 3
263
Sacituzumab tirumotecan (SKB264/MK-2870)
aothdptkxd(gpshpzrvtq) = cszqhcitim lqreplbrjx (srrwttavmp, 4.3 - 7.2)
Met
Positive
24 May 2024
Chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine)
aothdptkxd(gpshpzrvtq) = dqlbavikxh lqreplbrjx (srrwttavmp, 1.6 - 2.7)
Met
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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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