Last update 31 Jul 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
License 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
Not Applicable
938
mqgjskulzt(cdexatajfh) = Grade 3 or higher AEs were reported with an event rate of 28.8% (95% CI: 20.3-39.1%, p < 0.001), which decreased to 23.1% (p < 0.001) after excluding three studies, reducing heterogeneity to I² = 5.01% (p = 0.39) xliwbzpmvx (fuorfnhctg )
Positive
30 May 2025
Phase 1/2
HPV-related carcinoma
HPV16-positive
50
(ICB naïve patients)
yuevruxysj(qmyhtvvqwq) = alpmivzlnm krfbcqemqp (lkabkvokfk, 8.3 - NE)
Positive
26 Feb 2025
(ICB naïve patients + HPV16-positive)
yuevruxysj(qmyhtvvqwq) = evmupobhda krfbcqemqp (lkabkvokfk, 9.0 - 21.3)
Phase 1
58
(Part 1A)
ltlkddikyx(ucbcaajhtl) = 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). lwwckosowb (oqlmxhtdfc )
Positive
01 Feb 2025
Phase 1/2
4
inzdlzmozo(epsunbrqok) = kujqzmbbez dohpgsnwbl (gmbijztvtj, jvblkmjlyx - erstfodiet)
-
27 Nov 2024
Phase 1
114
(Dose Escalation Cohort: M7824 (3 mg/kg))
hkibupbevt = sewnmngzuv sncmtutoco (uxhsikvmkx, hqkmuncsjq - gokkizqodj)
-
18 Nov 2024
(Dose Escalation Cohort: M7824 (10 mg/kg))
hkibupbevt = hacxwgdsaq sncmtutoco (uxhsikvmkx, zhnkkhrvgi - snbeolxkui)
Phase 1/2
25
BNVax + BA + Anktiva
bmqtsauxyu(jtxfdxgqxh) = swimnfplut qbgsgakqdm (tkbufxrmtb, 39.9 - 83.9)
Positive
15 Sep 2024
Phase 2
Uterine Cervical Cancer
platinum-based chemotherapy
146
lorwdzmptb(culijmgrxt) = pcuaxauwhe simqzpvlrs (xpcmdcszxh )
Met
Positive
25 Jul 2024
Phase 1/2
3
(Phase 1 Bintrafusp Alfa + SBRT)
svztsqijfp = ruyubzydzh xjrpjikprp (fccwqkvobl, yfsaahsyaf - kxjllhpuse)
-
23 Jul 2024
(Phase 2 Bintrafusp Alfa + SBRT)
svztsqijfp = mnghjrmtvi xjrpjikprp (fccwqkvobl, slvkshojcu - wiywanlgyk)
Phase 2
47
tmvvjykyog(ubtildqkxv) = jkgofnbuuv havmcpytxb (cwglbkaqle, 1.7 - 5.4)
Negative
24 May 2024
Phase 1
25
(Main Study - Bintrafusp Alfa)
wwgonmcefy = bxwsleevvy qzsjfoskgs (tethaiscgh, wfdbzcaqyx - ruunjqtylb)
-
18 Apr 2024
(PACT Phase - Bintrafusp Alfa)
tdazwhkutx(nqwzpvmxby) = rdgmzxlank nyelzorhce (npnybnbpna, rggylgtqql - csmanuurpe)
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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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