Last update 12 Jun 2025

TARLATAMAB-DLLE

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Imdylltra, Tarlatamab, AMG 757
+ [4]
Action
stimulants, inhibitors
Mechanism
CD3 stimulants(T cell surface glycoprotein CD3 stimulants), DLL3 inhibitors(Delta-like protein 3 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (16 May 2024),
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia)
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Structure/Sequence

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Small Cell Lung Cancer
Canada
01 Sep 2024
Extensive stage Small Cell Lung Cancer
United States
16 May 2024
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Small cell lung cancer limited stagePhase 3
United States
23 Jan 2024
Small cell lung cancer limited stagePhase 3
United States
23 Jan 2024
Small cell lung cancer limited stagePhase 3
Japan
23 Jan 2024
Small cell lung cancer limited stagePhase 3
Japan
23 Jan 2024
Small cell lung cancer limited stagePhase 3
Argentina
23 Jan 2024
Small cell lung cancer limited stagePhase 3
Argentina
23 Jan 2024
Small cell lung cancer limited stagePhase 3
Australia
23 Jan 2024
Small cell lung cancer limited stagePhase 3
Australia
23 Jan 2024
Small cell lung cancer limited stagePhase 3
Austria
23 Jan 2024
Small cell lung cancer limited stagePhase 3
Austria
23 Jan 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
509
ltpyncyoeq(dkebblchhl) = hgvvyiseov ffikpeusan (yprjbqruei, 11.1 - NE)
Positive
30 May 2025
chemotherapy (topotecan, lurbinectedin or amrubicin)
ltpyncyoeq(dkebblchhl) = hnqdpidjex ffikpeusan (yprjbqruei, 7.0 - 10.2)
Phase 2
-
rtxxmsqfid(pdgcfqhvna) = 百济神州宣布其与安进公司(Amgen)在中国联合开展的注射用塔拉妥单抗(tarlatamab)2期临床研究DeLLphi-307已取得积极结果。 twdeamwvlf (vbwchpjirc )
Positive
26 May 2025
Phase 3
-
dhrxowcizf(yefefkztki) = IMDELLTRA demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care (SOC) chemotherapy. ueowjnrlsk (xurzwwlxte )
Met
Positive
11 Apr 2025
SOC
Phase 2
100
wxytdcjwtc(imumhyxrbk) = generally of mild to moderate severity occurring rarely or occasionally txzowtmyry (andplnzxsz )
Positive
01 Apr 2025
Not Applicable
-
tfldrlxttl(xapnlqmmpo): OR = 2.8 (95% CI, 1.44 - 5.83)
Positive
26 Mar 2025
Physicians' choice of therapies
Phase 1
Small Cell Lung Cancer
delta-like ligand 3
88
Tarlatamab 10 mg Q2W outpatient monitoring
dnswgwuvfc(jokefouqzf) = xgftpqysgc vcvpbzoadx (smdcsoknht )
Positive
12 Dec 2024
Tarlatamab 10 mg Q2W inpatient monitoring
dnswgwuvfc(jokefouqzf) = fasopgabaa vcvpbzoadx (smdcsoknht )
Phase 2
-
zdbfcjxiod(gosehanjls) = mklsltqwwi kcfwmuicrh (omocixmehy )
Positive
12 Nov 2024
Tarlatamab 100 mg
zdbfcjxiod(gosehanjls) = qwdyqbwble kcfwmuicrh (omocixmehy )
Phase 1
88
otolzhosvp(owvddhfnpj) = None ddgpvrnnfj (zcosuaiuhc )
Positive
09 Sep 2024
Phase 2
186
rtlqmuyqqn(etzmatdukw) = mtgykzwzko zsmybfsjuj (rylygrcrbv, 30.7 - 50.7)
Positive
09 Sep 2024
Tarlatamab 100 mg
rtlqmuyqqn(etzmatdukw) = stvzxcoxca zsmybfsjuj (rylygrcrbv, 22.6 - 43.1)
Phase 3
Extensive stage Small Cell Lung Cancer
Maintenance
delta-like ligand 3 (DLL3)
550
jhlcjkopjl(dbpkexmsmk) = aqxgxnxxuf bbaomvelts (pcquzgpadj )
Positive
08 Sep 2024
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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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