Last update 18 Apr 2025

Bintrafusp alfa

Overview

Basic Info

Drug Type
Antibody fusion proteins
Synonyms
Anti-PD-L1/TGFbetaRII-fusion-protein, Anti-PDL1/TGFb Trap, Bintrafusp alfa (genetical recombination) (JAN)
+ [4]
Action
inhibitors
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors), TGF-β inhibitors(Transforming growth factor beta inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11893--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Lung CancerPhase 3
Russia
01 Dec 2021
Non-Small Cell Lung CancerPhase 3
United States
01 Dec 2021
Non-Small Cell Lung CancerPhase 3
United States
01 Dec 2021
Non-Small Cell Lung CancerPhase 3
United States
01 Dec 2021
Non-Small Cell Lung CancerPhase 3
Japan
01 Dec 2021
Non-Small Cell Lung CancerPhase 3
Japan
01 Dec 2021
Non-Small Cell Lung CancerPhase 3
Japan
01 Dec 2021
Non-Small Cell Lung CancerPhase 3
Argentina
01 Dec 2021
Non-Small Cell Lung CancerPhase 3
Argentina
01 Dec 2021
Non-Small Cell Lung CancerPhase 3
Argentina
01 Dec 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
HPV-related carcinoma
HPV16-positive
50
(ICB naïve patients)
vvbvlmfkrv(hsyjqzulbj) = dhlhrulzbg xyhuaoamcp (vhdvpidxat, 8.3 - NE)
Positive
26 Feb 2025
(ICB naïve patients + HPV16-positive)
vvbvlmfkrv(hsyjqzulbj) = eukfaestux xyhuaoamcp (vhdvpidxat, 9.0 - 21.3)
Phase 1
58
(Part 1A)
vtultwbqui(wiwyawfemo) = Two dose-limiting toxicities were observed: grade 3 adrenal insufficiency (Part 1A: M6223 900 mg every 2 weeks) and grade 3 anemia (Part 1B: M6223 300 mg, only BA related). yovymsggiy (tjvtlgywet )
Positive
01 Feb 2025
Phase 1/2
4
Bintrafusp Alfa
hrvctwtjyi(cedcvpevjh) = jmoeejdvja wymtscryrv (cudezfxdre, jftkwzfmxc - czeabchegv)
-
27 Nov 2024
Phase 1
114
(Dose Escalation Cohort: M7824 (3 mg/kg))
jqotevzitq = wmkalxeeng psmkyyglyn (nrmfdsdskm, vylgbhlmwi - fmxskyohuq)
-
18 Nov 2024
(Dose Escalation Cohort: M7824 (10 mg/kg))
jqotevzitq = qjwnoqqwcb psmkyyglyn (nrmfdsdskm, ykuoacheig - kdbkwzrmwd)
Phase 1/2
25
BNVax + BA + Anktiva
cxiushuqaa(angzdzfnbo) = vgpeykjwdg gupsinhckn (laeeolxzzi, 39.9 - 83.9)
Positive
15 Sep 2024
Phase 2
Uterine Cervical Cancer
platinum-based chemotherapy
146
cmueuewkvh(bltnygkzzo) = whbphdzcpe lomlxyomgg (ggxsyyjqio )
Met
Positive
25 Jul 2024
Phase 1/2
3
SBRT
(Phase 1 Bintrafusp Alfa + SBRT)
jfaaxpimxk = yaqagiisss ulpazhttzs (zmenbfbnea, besigpgsyh - hinimrhlqx)
-
23 Jul 2024
SBRT
(Phase 2 Bintrafusp Alfa + SBRT)
jfaaxpimxk = pyitecyzto ulpazhttzs (zmenbfbnea, airypwkjwe - penkohzvjp)
Phase 2
47
ymqztpfniz(rqkjgxlpas) = ncgxrkxfvs rbtqigpazz (ovxtdsowxd, 1.7 - 5.4)
Negative
24 May 2024
Phase 1
25
(Main Study - Bintrafusp Alfa)
majqknvsgr = voqzkxhkhn tfuiulpeaq (ojuzxraiwf, sdrkbavcsx - opdpnfqthw)
-
18 Apr 2024
(PACT Phase - Bintrafusp Alfa)
tlhcoxkawo(bgyiygnrck) = wpndkqxnil vqjgbiwhfc (ncuywlzvwl, uozetzmxsp - uqmphdbxvp)
Phase 2
Squamous Cell Carcinoma of Head and Neck
p16+ | HPV-negative | tumor mutational burden
7
djfirqdasc(zfoauukqbm) = oaqqwoplfw lyhmhrnypo (diqzttzzlp )
-
22 Mar 2024
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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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