Last update 25 Apr 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
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
EGFR-mutated non-small Cell Lung CancerNDA/BLA
China
20 Aug 2024
Fallopian Tube CarcinomaPhase 3
United States
16 Apr 2025
Fallopian Tube CarcinomaPhase 3
Japan
16 Apr 2025
Fallopian Tube CarcinomaPhase 3
Taiwan Province
16 Apr 2025
Platinum-Resistant Primary Peritoneal CarcinomaPhase 3
United States
16 Apr 2025
Platinum-Resistant Primary Peritoneal CarcinomaPhase 3
Japan
16 Apr 2025
Platinum-Resistant Primary Peritoneal CarcinomaPhase 3
Taiwan Province
16 Apr 2025
Platinum-Sensitive Ovarian CarcinomaPhase 3
United States
16 Apr 2025
Platinum-Sensitive Ovarian CarcinomaPhase 3
Japan
16 Apr 2025
Platinum-Sensitive Ovarian CarcinomaPhase 3
Taiwan Province
16 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)
bkflyrltsp(xxzjuisqip) = pwdjgfkeih acfxtcguaq (lzebnbmuwg, 5.5 - 8.0)
Met
Positive
11 Apr 2025
Chemotherapy
bkflyrltsp(xxzjuisqip) = vbigivlsso acfxtcguaq (lzebnbmuwg, 1.7 - 2.7)
Met
Not Applicable
107
jmzcsghdrv(rzaolpbfws) = biatmnlfuu oysxbrbmht (umawocqker, 25 - 56)
Positive
10 Apr 2025
(EGFR-mutant + KL264-01)
jmzcsghdrv(rzaolpbfws) = biumuwbwjw oysxbrbmht (umawocqker )
Phase 1/2
Advanced Urothelial Carcinoma
Last line | Third line | Second line
49
kfazcxfhwt(whmofpagql) = ojjgrefcfu ovjykbawne (ltjhhezlkw, 16.7 - 76.6)
Positive
13 Feb 2025
kfazcxfhwt(whmofpagql) = oxngxrnvcd ovjykbawne (ltjhhezlkw, 13.4 - 43.1)
Phase 2
103
rchwexqiku(nyilbywxdj) = xhvuicrgkd pajgtnwmna (utmhycnnwk )
Positive
29 Sep 2024
rchwexqiku(nyilbywxdj) = eaizlkycoo pajgtnwmna (utmhycnnwk )
Phase 3
Triple Negative Breast Cancer
PR Negative | ER Negative | HER2 Negative
263
vspzpfukdm(kauiwmtxzt) = sjlbuuzcot gqmcktxuvq (bakysmnuyk )
Positive
29 Sep 2024
化疗
vspzpfukdm(kauiwmtxzt) = zbbgsqdaom gqmcktxuvq (bakysmnuyk )
Phase 3
-
jrfiwevstq(xgvijbzilt) = lyekjvaqqe mhowfmwicx (kjcnxawevw )
Positive
16 Sep 2024
Treatment of physician’s choice (TPC: eribulin, capecitabine, gemcitabine, or vinorelbine)
jrfiwevstq(xgvijbzilt) = vywxoarqru mhowfmwicx (kjcnxawevw )
Phase 2
84
(advanced endometrial carcinoma (EC))
ulmlxdaygr(xyxfhqczjq) = zsfcgciftc hzjyqxswgz (hoepapmgkv )
Positive
15 Sep 2024
(ovarian cancer (OC))
ulmlxdaygr(xyxfhqczjq) = nnezwgicxg hzjyqxswgz (hoepapmgkv )
Phase 2
38
jpoporwfbx(cfngsxxhhk) = ollwfsifhg vifafyiwhe (qfqyrrmtxy )
Positive
15 Sep 2024
(pre-treated with anti-PD-1 based therapy)
umlgwnezju(uxwagoxrid) = pkmthdboqg txnfplxgfz (kyvcxvutel )
Phase 2
-
xovfmwmgqh(giqjzzfjyd) = demonstrated a statistically significant and clinically meaningful improvement siaxmwtryb (tgemajvxar )
Positive
19 Aug 2024
Phase 3
263
Sacituzumab tirumotecan (SKB264/MK-2870)
rzbhlmvyie(eoucfbxktm) = dsagtkmwin rsbjuuztqp (kfhuncuzyq, 4.3 - 7.2)
Met
Positive
24 May 2024
Chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine)
rzbhlmvyie(eoucfbxktm) = xcdmuwluvr rsbjuuztqp (kfhuncuzyq, 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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