Last update 28 Mar 2025

Epcoritamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Anti-CD3 anti-CD20 bispecific antibody, Anti-CD3 anti-CD20 bispecific antibody(Genmab A/S), epcoritamab-bysp
+ [7]
Action
inhibitors, stimulants
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union), Priority Review (United States), Breakthrough Therapy (United States)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Large B-cell lymphoma
Canada
13 Oct 2023
Recurrent Grade 3b Follicular Lymphoma
Canada
13 Oct 2023
Mediastinal large B-cell lymphoma
Japan
25 Sep 2023
Recurrent Follicular Lymphoma
Japan
25 Sep 2023
Refractory Follicular Lymphoma
Japan
25 Sep 2023
Diffuse large B-cell lymphoma recurrent
European Union
22 Sep 2023
Diffuse large B-cell lymphoma recurrent
Iceland
22 Sep 2023
Diffuse large B-cell lymphoma recurrent
Liechtenstein
22 Sep 2023
Diffuse large B-cell lymphoma recurrent
Norway
22 Sep 2023
Diffuse large B-cell lymphoma refractory
European Union
22 Sep 2023
Diffuse large B-cell lymphoma refractory
Iceland
22 Sep 2023
Diffuse large B-cell lymphoma refractory
Liechtenstein
22 Sep 2023
Diffuse large B-cell lymphoma refractory
Norway
22 Sep 2023
Diffuse Large B-Cell Lymphoma
United States
19 May 2023
High grade B-cell lymphoma
United States
19 May 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory Grade 3a Follicular LymphomaPhase 3
United States
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
China
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Japan
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Australia
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Belgium
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Bulgaria
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Croatia
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Czechia
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
Denmark
05 Feb 2024
Refractory Grade 3a Follicular LymphomaPhase 3
France
05 Feb 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
44
(arm A)
atnguczzyd(dgjkdluulz) = awbxjrkqls vnoiaqwzpb (muzbpepges )
Positive
09 Dec 2024
Phase 1/2
40
(expansion cohort (EXP))
fjidakiuoo(xoryrbchqv) = qsosxehkoq gwnyhudxfo (mqjnmcnjux )
Positive
09 Dec 2024
(TP53 aberrations)
fjidakiuoo(xoryrbchqv) = dzftpcfmor gwnyhudxfo (mqjnmcnjux )
Not Applicable
-
Epcoritamab monotherapy
vxtdzxgbpk(yggawpbpve) = 51% (32% G1, 16% G2, 3% G3) trdcirtlzs (dqgfysvmvp )
-
09 Dec 2024
Not Applicable
-
wseflillmo(lffqzqhbqj) = grade 3-4 treatment-emergent adverse events (TEAEs) were CRS (10%) tzjjiruvvd (eogkuwwpqe )
-
08 Dec 2024
Not Applicable
-
Epcoritamab 48 mg + R-mini-CHOP
lbzvipjdtw(bzapktudrk) = All CRS events were low grade (25% grade 1, 29% grade 2), and most events were observed after the first full dose of epcoritamab. All CRS events resolved, and 1 pt (4%) discontinued epcoritamab due to CRS. No ICANS or clinical tumor lysis syndrome events were reported. cjcdrrweoz (jxltrmumyl )
-
08 Dec 2024
Not Applicable
-
-
Epcoritamab + R-CHOP
xrmaxgdfre(aeysepiglh) = 60% hkizavmflf (ruzwtlxxjf )
-
08 Dec 2024
Not Applicable
-
ktmlxkvjmk(dticbesokc) = ypwtrtugok xymksqjddl (jevdklsibp, 42.1 - 75.2)
-
08 Dec 2024
ktmlxkvjmk(dticbesokc) = fhvquihaei xymksqjddl (jevdklsibp, 52.6 - 72.1)
Phase 1/2
25
npimnrqcwt(ntfgrihdne) = ajoyroaphr cnhpbmskvj (bzashqtmra )
Positive
07 Dec 2024
Phase 1/2
Follicular Lymphoma
Second line | Last line | Third line
111
ctadxuiulu(bzeurujqwv) = hakolfmawe chxuzwsqbb (ilekvdrhsk )
Positive
07 Dec 2024
Not Applicable
-
eshmoigufo(yeyfuehbcf) = CRS events were mostly grade 1 (33%) or grade 2 (23%); 4% of pts had grade 3 CRS. CRS was most common following the first full (cycle 1 day 15) dose (median time to onset, 20 h). CRS resolved in all but 2 pts and led to treatment discontinuation in 1 pt zkwaelvuiw (hiubzwwizv )
-
07 Dec 2024
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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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