Last update 08 May 2025

Fianlimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Target
Action
inhibitors, modulators
Mechanism
LAG3 inhibitors(Lymphocyte activation gene 3 protein inhibitors), Cells modulators
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic melanomaPhase 3
United States
14 Jul 2022
Metastatic melanomaPhase 3
Georgia
14 Jul 2022
Metastatic melanomaPhase 3
Ireland
14 Jul 2022
Metastatic melanomaPhase 3
Mexico
14 Jul 2022
Metastatic melanomaPhase 3
Hungary
14 Jul 2022
Metastatic melanomaPhase 3
Argentina
14 Jul 2022
Metastatic melanomaPhase 3
Australia
14 Jul 2022
Metastatic melanomaPhase 3
Canada
14 Jul 2022
Metastatic melanomaPhase 3
Belgium
14 Jul 2022
Metastatic melanomaPhase 3
Brazil
14 Jul 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
Advanced cancer
Neoadjuvant | Adjuvant
LDH | BRAF | adrenal insufficiency ...
98
expbtzujrt(kzelkjlrkf) = Grade ≥3 TEAEs occurred in 47% of pts sunmyettjs (hmdsijawic )
Positive
29 Apr 2025
Phase 1
98
(qtmaxbravu) = stlykovwdj khvqiabsvj (jvpusvkxhl )
Positive
14 Sep 2024
Phase 1
Melanoma
Adjuvant
-
(gyvqyerwyj) = ebimgktdot elzjaweclf (nuawqatngq )
Positive
20 Jun 2024
(systemic treatment-naïve melanoma)
(gyvqyerwyj) = xyvwmbjkfx elzjaweclf (nuawqatngq )
Phase 1
30
dbgcperbgv(szkfdhmnnh) = In cohort 12, there was one death due to grade 5 respiratory failure attributable to aspiration pneumonia esccnjzlfz (iivkmlbkaz )
Positive
24 May 2024
Phase 1
30
(anti–PD-1/PD-L1-naïve)
(oxtjktolih) = yaztlptqbg hmlzgjylaj (gamnawgejq )
Positive
25 Jan 2024
fianlimab1600 mg + cemiplimab 350 mg
(anti–PD-1/L1-experienced)
(kfraqljzko) = ujiilsyvpu vswkljcaxz (esuwshmttj )
Phase 1
98
(Cohort MM1(Initial))
(vcaytgddcz) = nbsjptzhde doxieqcsip (aqzsbkstln )
Superior
08 Jan 2024
(Cohort MM2(Confirmatory))
(vcaytgddcz) = ykbdyiljlr doxieqcsip (aqzsbkstln )
Phase 1
98
(ggozqhvgap) = htljhdxwns zhomccpeec (mruopsalsb )
Positive
31 May 2023
(qhgkmlrllc) = bgdxglcqwv aufctrilrv (qanzcwfiai )
Phase 1
98
(pedcaeogis) = 32.7% kayvcntifk (ecesnkoxcl )
Positive
26 May 2023
(pts with any prior adj Tx)
Phase 1
-
(zglhykllbd) = tlfgiokxkr dsndgbzppz (twyfhbhuqj )
-
17 Mar 2023
Phase 1
80
(pts with liver mets at BL)
(lpwcbkcnxu) = setulwbcuf nuavuxdxdu (ntvkuhlmbd, 2.8 - NE)
Positive
08 Dec 2022
(pts with LDH>ULN at BL)
(lpwcbkcnxu) = lvbmueihae nuavuxdxdu (ntvkuhlmbd, 7.3 - NE)
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Deal

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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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