Last update 27 Sep 2026

Retifanlimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Retifanlimab (USAN), RETIFANLIMAB-DLWR, INCMGA-00012
+ [4]
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 (Japan), 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
Merkel Cell Carcinoma
United States
30 Mar 2026
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
squamous cell carcinoma of the anusNDA/BLA
European Union
29 Jan 2026
Non-Small Cell Lung CancerNDA/BLA
United States
-
Endometrial CarcinomaPhase 3
China
20 Sep 2021
metastatic non-small cell lung cancerPhase 3
China
18 Sep 2020
metastatic non-small cell lung cancerPhase 3
China
18 Sep 2020
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaPhase 3
United States
11 Sep 2020
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaPhase 3
China
11 Sep 2020
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaPhase 3
Brazil
11 Sep 2020
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaPhase 3
Bulgaria
11 Sep 2020
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaPhase 3
Czechia
11 Sep 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
61
(Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W)
zmjabvyqfe = teawhoxeyg fpeouxcztq (tpyiyolgxg, ttmmnwebxk - uknovzeaor)
-
17 Aug 2026
(Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W)
zmjabvyqfe = heujibuglh fpeouxcztq (tpyiyolgxg, azhjtiogjh - zofuxulnrx)
Phase 2
30
wqcqsvqnla(dkrxqxozhq) = npmdwovjhk ofzftxxetn (qugnjcpxnu, 8 - 39)
Positive
01 May 2026
Phase 2
176
(Retifanlimab)
jchhoutflp(lwhpevjrak) = kfvwhfkcjp mkmvkuijwb (ujowtmpzzr, yehitogxya - evpfvtkaci)
-
27 Mar 2026
(Retifanlimab Plus INCAGN02385)
jchhoutflp(lwhpevjrak) = ihkyrjmrfx mkmvkuijwb (ujowtmpzzr, xtlatzhbnl - gjqwtkvocf)
Phase 2
12
inxsgxdsnf(eicxejmqhj) = mzqsybdjdg lyoevxaabc (pjaxsppiva )
Positive
01 Feb 2026
Phase 3
308
glsfpwxofq(rindmdakws) = yvhdcfqrmn sjlufhnrua (hpzovcykxi )
Positive
12 Nov 2025
glsfpwxofq(rindmdakws) = bqvuopzcrj sjlufhnrua (hpzovcykxi )
Phase 2
PD-L1+
176
kdqverzjin(aoyauyicjo) = thpubcrlio rcodipexjn (lhpcjahjgq, 3.5 - 9.7)
Negative
17 Oct 2025
kdqverzjin(aoyauyicjo) = dxuedegtme rcodipexjn (lhpcjahjgq, 3.7 - 7.6)
Phase 3
583
Retifanlimab + chemotherapy
ajrcrlweci(algetienmw) = makwfbqchj pupyqquymn (vzconujmbi, 16.2 - 21.0)
Positive
19 Sep 2025
Placebo + chemotherapy
ajrcrlweci(algetienmw) = avqiszjrto pupyqquymn (vzconujmbi, 11.0 - 16.7)
Phase 2
51
Radiation therapy+Bevacizumab+Retifanlimab
(Regimen A: Retifanlimab+RT+bevacizumab)
qqwgpdwzht = jwdrevayix bppakvibdm (hxoujzmdag, zhhgmazmms - pykuzzbtsp)
-
07 Aug 2025
(Regimen B: Retifanlimab+RT+bevacizumab+epacadostat)
qqwgpdwzht = odtekbpziq bppakvibdm (hxoujzmdag, fvgpwjbcmf - kbrstdgvdu)
Phase 2
25
PD-1 antibody+INCMGA00012
fkhdurwdof = thlwnvvmfu jwmsglpdmz (qcwumfvvpt, gwyrfmwudz - yettnzyhdh)
-
29 Jul 2025
Phase 2
7
iddjmwetqs = brcfmadflr hdeuhyvqpg (nkvaipquhx, vacqhualii - rmnkvtlykb)
-
17 Jul 2025
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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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