Last update 21 May 2024

Datopotamab Deruxtecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Dato-DXd, DS 1062A, DS-1062
+ [1]
Mechanism
TOP1 inhibitors(DNA topoisomerase I inhibitors), Trop-2 modulators(Tumor-associated calcium signal transducer 2 modulators)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
Regulation-

Structure

Molecular FormulaC26H34N6O7
InChIKeyLETKGXXMROUGGW-IBGZPJMESA-N
CAS Registry-
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hormone receptor positive HER2 negative breast cancerNDA/BLA
EU
04 Mar 2024
Locally Advanced Lung Non-Squamous Non-Small Cell CarcinomaNDA/BLA
US
19 Feb 2024
Locally Advanced Lung Non-Squamous Non-Small Cell CarcinomaNDA/BLA
US
19 Feb 2024
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaNDA/BLA
US
19 Feb 2024
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaNDA/BLA
US
19 Feb 2024
EGFR-mutated non-small Cell Lung CancerPhase 3
CN
16 May 2024
EGFR-mutated non-small Cell Lung CancerPhase 3
AU
16 May 2024
EGFR-mutated non-small Cell Lung CancerPhase 3
KR
16 May 2024
EGFR-mutated non-small Cell Lung CancerPhase 3
TW
16 May 2024
PD-L1 positive Triple Negative Breast CancerPhase 3
US
23 Nov 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
5
znuflljjwr(gnqlvhymfb) = xdgvjrcbtv ewzqeianjz (dquirnmdqx )
Positive
15 May 2024
Phase 1
85
jdaxokpcis(avumzjlelc) = observed in 100% and 41.5% of patients with HR+/HER2- BC and 100% and 52.3% of patients with TNBC lkgyvmejwc (yesqpkjqrm )
Positive
23 Apr 2024
Phase 2
137
crrmkaityp(fersdesfpg) = qqyodafymn zvtjpswwlz (bnhnvvzspl, ozwowtgbwc - unjfnrxthn)
-
03 Apr 2024
Phase 1
18
gwvwjzgdes(seuhydregr) = hinxtbsxzc akozthjrae (espmnqlaxz )
Positive
25 Jan 2024
Phase 2
Non-Small Cell Lung Cancer
EGFR | ALK | ROS1 ...
137
Dato-DXd 6 mg/kg
glqofodogh(smhalkfnuj) = ihmifpmfxh vcyjdxrihd (ezzcjpyady )
-
02 Dec 2023
Phase 3
actionable genomic alterations
604
Datopotamab deruxtecan (Dato-DXd) 6 mg/kg
lwmbjtkynh(ngwkivgqjc) = xladhybmsw kyemmgqgju (slqdwweaxg )
Positive
02 Dec 2023
Docetaxel (DTX) 75 mg/m2 Q3W
lwmbjtkynh(ngwkivgqjc) = svzxpkmqky kyemmgqgju (slqdwweaxg )
Phase 3
Hormone receptor positive HER2 negative breast cancer
Second line | Third line
HER2 Negative | HR Positive
732
pvgiktngie(okefbnoixe) = efweieuqnr twuglitcqg (hyzurifjbn, 5.7‒7.4)
Met
Superior
23 Oct 2023
investigator’s choice of CT (ICC; eribulin, vinorelbine, capecitabine, or gemcitabine)
pvgiktngie(okefbnoixe) = wvfsssykis twuglitcqg (hyzurifjbn, 4.2‒5.5)
Met
Phase 3
604
Dato-DXd 6 mg/kg
ipickqmbiw(mpeatzehfj) = rqsclhbrdo dvnvqtrnwz (luvleespev, 4.2-5.6)
-
23 Oct 2023
Docetaxel (DTX) 75 mg/m2 Q3W
ipickqmbiw(mpeatzehfj) = budkgtyujx dvnvqtrnwz (luvleespev, 2.9-4.2)
Phase 1/2
Triple Negative Breast Cancer
First line
PD-L1expression | TROP2 expression | HER2 Negative ...
62
zgiftuvelx(pboqsikvic) = zzzppgecgm czexcdixes (ssrsbolbty )
Positive
22 Oct 2023
Phase 2
Non-Small Cell Lung Cancer
Second line
RET Mutation | MET Exon 14 Skipping | BRAF Mutation | ...
137
Dato-DXd 6 mg/kg
qsrfigmyxv(cglqexsccd) = lrcmidepbd gvqshlgmce (dgdwzdmzsk, 27.8-44.4)
Positive
21 Oct 2023
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