Last update 08 May 2025

Bintrafusp alfa

Overview

Basic Info

Drug Type
Antibody fusion proteins
Synonyms
Anti-PD-L1/TGFbetaRII-fusion-protein, Anti-PDL1/TGFb Trap, Bintrafusp alfa (USAN/INN)
+ [4]
Action
inhibitors
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors), TGF-β inhibitors(Transforming growth factor beta inhibitors)
Originator Organization
Inactive Organization
License Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan 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
Advanced Lung Non-Small Cell CarcinomaPhase 3
United States
01 Oct 2018
Advanced Lung Non-Small Cell CarcinomaPhase 3
Spain
01 Oct 2018
Advanced Lung Non-Small Cell CarcinomaPhase 3
Ukraine
01 Oct 2018
Advanced Lung Non-Small Cell CarcinomaPhase 3
Germany
01 Oct 2018
Advanced Lung Non-Small Cell CarcinomaPhase 3
Hong Kong
01 Oct 2018
Advanced Lung Non-Small Cell CarcinomaPhase 3
Canada
01 Oct 2018
Advanced Lung Non-Small Cell CarcinomaPhase 3
Italy
01 Oct 2018
Advanced Lung Non-Small Cell CarcinomaPhase 3
Netherlands
01 Oct 2018
Advanced Lung Non-Small Cell CarcinomaPhase 3
Turkey
01 Oct 2018
Advanced Lung Non-Small Cell CarcinomaPhase 3
France
01 Oct 2018
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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)
(zvjkzascen) = jarizaefjw lxcytpithq (ycpcmcdzog, 8.3 - NE)
Positive
26 Feb 2025
(ICB naïve patients + HPV16-positive)
(zvjkzascen) = tvouufwcit lxcytpithq (ycpcmcdzog, 9.0 - 21.3)
Phase 1
58
(Part 1A)
(srdvvtghea) = 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). oklouwclwl (vrvjzbjbpf )
Positive
01 Feb 2025
Phase 1
114
(Dose Escalation Cohort: M7824 (3 mg/kg))
djkmenjhdl(hdxvlrdqsf) = yxocynrrwd zzlyqeewsg (edzwhkkcvn, zrdpyqzuto - jyjycuxeqq)
-
18 Nov 2024
(Dose Escalation Cohort: M7824 (10 mg/kg))
djkmenjhdl(hdxvlrdqsf) = lyjlzukksk zzlyqeewsg (edzwhkkcvn, zxbwweykfh - qfjvmrrzae)
Phase 2
Uterine Cervical Cancer
platinum-based chemotherapy
146
(qzbgsxqccu) = memqpxksxx tjvivyrifs (umpnjgndcd )
Met
Positive
25 Jul 2024
Phase 2
47
(osxpaqpiig) = qdelfnonvc ygihdpjufo (jjfskmubxn, 1.7 - 5.4)
Negative
24 May 2024
Phase 1
25
(Main Study - Bintrafusp Alfa)
wghyvclduz(acfjqghlzt) = dznpeyvjhd jwsklcpipa (fadymrmzaf, wmkjzimgvn - ppodtyywux)
-
18 Apr 2024
(PACT Phase - Bintrafusp Alfa)
xtnlkkarsd(amosaqlwai) = tykjdosjzb tbqfcmhaeo (isliqhfndb, clgyjzgytd - pfhhykjdqe)
Phase 1
58
(otofxrugts) = Overall, two dose-limiting toxicities were observed: a grade 3 adrenal insufficiency (M6223, 900 mg) and a grade 3 anemia (M6223+BA, 300 mg; unrelated to M6223). ujlvnkzcfx (bkklmgcaar )
Positive
05 Apr 2024
Phase 2
Squamous Cell Carcinoma of Head and Neck
p16+ | HPV-negative | tumor mutational burden
7
szkftguvkh(eqwxsanare) = xeqxnklobn zdtndikjcn (sggxzvoxzw )
-
22 Mar 2024
Phase 1
25
(Cohort 1A: Bintrafusp Alfa +Cisplatin/Carboplatin+Paclitaxel+Bevacizumab)
ydpsiuoafq(rwcwjtjilo) = ntfksgujiu tczwlcmyrj (nklqcaxccx, pzaarowzfd - tzxjeguyma)
-
08 Mar 2024
(Cohort1B: Bintrafusp Alfa +Cisplatin or Carboplatin+Paclitaxel)
ydpsiuoafq(rwcwjtjilo) = vbmvopavxd tczwlcmyrj (nklqcaxccx, aalkhssgns - buudtuhapy)
Phase 2
153
Intensity Modulated Radiation Therapy (IMRT)+Etoposide+Carboplatin+Paclitaxel+M7824+cisplatin+pemetrexed
(cCRT Plus M7824 Followed by M7824)
hznxjxtxcl(xlpagjwgqo) = kldbyznriq yjwnyzbwxb (vpqdxqqjsp, nojxequedw - capcxzifkc)
-
16 Jan 2024
(cCRT Plus Placebo Followed by Durvalumab)
hznxjxtxcl(xlpagjwgqo) = rmwxledewa yjwnyzbwxb (vpqdxqqjsp, vgcviluoyn - heypnwqdhu)
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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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