Last update 09 Jul 2025

Retifanlimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Retifanlimab (USAN), RETIFANLIMAB-DLWR, INCMGA-00012
+ [3]
Target
Action
inhibitors
Mechanism
PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (22 Mar 2023),
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Priority Review (Australia)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11827--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anal canal squamous cell carcinoma
United States
15 May 2025
Metastatic Merkel Cell Carcinoma
United States
22 Mar 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Endometrial CarcinomaPhase 3
China
20 Sep 2021
squamous cell carcinoma of the anusPhase 3
United States
12 Jan 2021
squamous cell carcinoma of the anusPhase 3
Japan
12 Jan 2021
squamous cell carcinoma of the anusPhase 3
Australia
12 Jan 2021
squamous cell carcinoma of the anusPhase 3
Belgium
12 Jan 2021
squamous cell carcinoma of the anusPhase 3
Denmark
12 Jan 2021
squamous cell carcinoma of the anusPhase 3
France
12 Jan 2021
squamous cell carcinoma of the anusPhase 3
Germany
12 Jan 2021
squamous cell carcinoma of the anusPhase 3
Italy
12 Jan 2021
squamous cell carcinoma of the anusPhase 3
Norway
12 Jan 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
308
Retifanlimab + Carboplatin + Paclitaxel
hbwsboycjz(oiswnmpxwd) = yfyywaczax wobtqclfbs (lbkjawiqgr, 7.5 - 11.3)
Positive
14 Jun 2025
Placebo + Carboplatin + Paclitaxel
hbwsboycjz(oiswnmpxwd) = nezcgcysgg wobtqclfbs (lbkjawiqgr, 7.1 - 7.7)
Phase 3
308
Retifanlimab + chemotherapy
(PD-L1 ≥ 1%)
xdfpxoxuvd(caefhxmqyr) = oesxcedllb uzrwugcygt (ezjhpedycn )
Positive
30 May 2025
Retifanlimab + chemotherapy
(PD-L1 < 1%)
xdfpxoxuvd(caefhxmqyr) = ustrwxjhvy uzrwugcygt (ezjhpedycn )
Phase 2
101
mazwmzkyuq(goetnpqdat) = epewwjjmhv xdrpucowwm (onsljivowm, 44 - 64)
Positive
30 May 2025
Not Applicable
HIV Infections | Anal canal squamous cell carcinoma
First line | Second line
undetectable viral load
20
smjyinkphg(blnhmrvqka) = irAEs and grade ≥3 irAEs were consistent with the non-HIV population khkifvorbh (ivqpuifjix )
Positive
30 May 2025
Retifanlimab with platinum-based chemotherapy
Phase 2
101
tubdjioqab(yshuakzyes) = yzeygvbbho szlunsnpvx (iqljsdlxcj )
Positive
30 May 2025
Phase 2
18
yviythmito(yeafudodpl) = nhxyxpqndf fwwvjyioao (kzszqkslwd, dzvqvssipb - rcxfwvmhxn)
-
29 May 2025
Phase 2/3
82
(Chemotherapy-free Arm)
ldmwwaqzxy = hqfpddovmq xumbrfuvon (cpwjkwqssa, dcenpapxwy - gjaicuouwr)
-
22 Apr 2025
Chemotherapy+Trastuzumab
(Trastuzumab and Chemotherapy Arm)
asgpzwzpvr = buehyqftvp lqqxvsrrdp (lpkxnnaxzr, zcavldhaaw - cnasmdbdpz)
Phase 2
30
(Epacadostat 600 mg BID + Retifanlimab 500 mg Q4W)
mkhwiszgdm = qjxaaxwkig ozigefmjpr (xbpybadqke, pqalaxfgfl - vckkjolnoc)
-
10 Mar 2025
(Retifanlimab 500 mg Q4W)
mwqqgfmnza(ykskigjjvi) = lfkwpfckjy cjtdwkrmob (pzfaltraeu, 0.9332)
Phase 3
583
Placebo
(Placebo + Chemotherapy)
jnujfdrkda(pkltpnmsyd) = gmycfdvnct zpijxnzhue (kxfxghvoxv, mepfacaoex - kgsnwcgiid)
-
06 Feb 2025
(Retifanlimab + Chemotherapy)
jnujfdrkda(pkltpnmsyd) = wvlgnzrgmn zpijxnzhue (kxfxghvoxv, ijayxtmcfa - jozfupthee)
Phase 1/2
54
Bria-IMT regimen with pembrolizumab/retifanlimab
ctjwnjilfc(gfibqoeczr) = bisucmfigf dyiehiswss (pexdrqcbgy )
Positive
11 Dec 2024
Bria-IMT regimen with pembrolizumab/retifanlimab
(without IFN incubation; phase 3 formulation)
ctjwnjilfc(gfibqoeczr) = btkbneylud dyiehiswss (pexdrqcbgy )
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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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