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DRUG:

Epkinly (epcoritamab-bysp)

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Other names: GEN-3013, DuoBody-CD3xCD20, Duobody-CD3-CD20, ABBV-GEN3013, ABBV-GMAB-3013, GEN3013
Company:
AbbVie, Genmab
Drug class:
CD20 inhibitor, CD3 agonist
Related drugs:
7d
New P2 trial
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CD20 (Membrane Spanning 4-Domains A1)
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CD20 positive
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gemcitabine • Rituxan (rituximab) • oxaliplatin • Epkinly (epcoritamab-bysp) • Truxima (rituximab-abbs) • Mabtas (rituximab biosimilar)
12d
Trial suspension
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Tazverik (tazemetostat) • Epkinly (epcoritamab-bysp)
18d
T-cell engaging antibodies for B-cell lymphomas. (PubMed, Semin Hematol)
This review focused on 4 CD20 × CD3 BsAbs, as well as surovatamig, a CD19 × CD3 BsAb currently under investigation that has demonstrated promising efficacy against relapsed/refractory B-cell lymphomas. All 4 CD20 × CD3 BsAbs are approved as third-line and beyond therapies: mosunetuzumab for follicular lymphoma (FL), glofitamab for diffuse large B-cell lymphoma (DLBCL), and epcoritamab and odronextamab for both FL and DLBCL (the latter in European Union only)...Multiple studies are currently evaluating these agents in both the relapsed/refractory and frontline settings, either as monotherapy or in combination with other agents. This review summarizes the efficacy and safety of each agent across B-cell lymphoma subtypes, along with their dosing schedules and CRS mitigation strategies.
Journal
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CD20 (Membrane Spanning 4-Domains A1)
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Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab) • surovatamig (AZD0486)
20d
EPCORE DLBCL-3: Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
P2, N=111, Active, not recruiting, Genmab | Trial completion date: Jul 2027 --> Jun 2026 | Trial primary completion date: Jan 2026 --> Jun 2026
Trial completion date • Trial primary completion date
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CD20 (Membrane Spanning 4-Domains A1)
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lenalidomide • Epkinly (epcoritamab-bysp)
25d
EPCORE NHL-2: Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (clinicaltrials.gov)
P1/2, N=543, Active, not recruiting, Genmab | Trial completion date: Sep 2028 --> Sep 2027 | Trial primary completion date: Sep 2028 --> Sep 2027
Trial completion date • Trial primary completion date
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CD20 (Membrane Spanning 4-Domains A1)
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CD20 positive
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carboplatin • gemcitabine • Rituxan (rituximab) • lenalidomide • cytarabine • doxorubicin hydrochloride • cyclophosphamide • ifosfamide • oxaliplatin • etoposide IV • vincristine • prednisone • dexamethasone • bendamustine • Epkinly (epcoritamab-bysp)
26d
EPCORE CLL-1: Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome (clinicaltrials.gov)
P1/2, N=424, Recruiting, Genmab | Trial completion date: Aug 2029 --> Apr 2028 | Trial primary completion date: Jun 2029 --> Feb 2028
Trial completion date • Trial primary completion date
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BCL2 (B-cell CLL/lymphoma 2) • CD20 (Membrane Spanning 4-Domains A1)
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CD20 positive
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Venclexta (venetoclax) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Jaypirca (pirtobrutinib) • Epkinly (epcoritamab-bysp)
27d
Study of Epcoritamab as a Consolidation Therapy in CLL/SLL (clinicaltrials.gov)
P2, N=22, Recruiting, Zulfa Omer | Not yet recruiting --> Recruiting
Enrollment open
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MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • SF3B1 (Splicing Factor 3b Subunit 1) • CD79B (CD79b Molecule) • FBXW7 (F-Box And WD Repeat Domain Containing 7) • BIRC3 (Baculoviral IAP repeat containing 3) • CD5 (CD5 Molecule) • POT1 (Protection of telomeres 1) • H1-4 (H1.4 Linker Histone, Cluster Member) • NFKBIE (NFKB Inhibitor Epsilon) • ZMYM3 (Zinc Finger MYM-Type Containing 3) • CHD2 (Chromodomain Helicase DNA Binding Protein 2) • FCER2 (Fc Fragment Of IgE Receptor II)
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Chr del(11q)
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clonoSEQ
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Gazyva (obinutuzumab) • Epkinly (epcoritamab-bysp)
1m
Development and biomarkers of CD20/CD3 bispecific antibodies in diffuse large B-cell lymphoma. (PubMed, J Clin Exp Hematop)
BsAbs targeting CD20/CD3, such as epcoritamab, glofitamab, mosunetuzumab, and odronextamab, are rapidly progressing toward widespread clinical application. Although monotherapy remains the standard approach, clinical trials are exploring earlier-line use and combination strategies to further enhance outcomes. Particular attention is given to predictive biomarkers of response and mechanisms of resistance, including target antigen loss, tumor histology, prior therapies, intratumoral and peripheral T-cell status, and the emerging role of minimal residual disease monitoring.
Review • Journal
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CD20 (Membrane Spanning 4-Domains A1)
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Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab)
2ms
Enrollment open
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Epkinly (epcoritamab-bysp) • Zynlonta (loncastuximab tesirine-lpyl)
2ms
Enrollment open
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BCL2 (B-cell CLL/lymphoma 2)
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Rituxan (rituximab) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • vincristine • daunorubicin • Epkinly (epcoritamab-bysp) • Truxima (rituximab-abbs) • Mabtas (rituximab biosimilar)
2ms
New P1/2 trial
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Epkinly (epcoritamab-bysp) • Monjuvi (tafasitamab-cxix)
2ms
Immune Effector Cell-Associated HLH-Like Syndrome (IEC-HS) in CAR-T and TCE-Treated Myeloma and B-Cell Malignancies: Insights from a Pharmacovigilance Study. (PubMed, Transplant Cell Ther)
IEC-HS is a rare but potentially fatal complication. Our disproportionality analysis identifies significant reporting signals for tisa-cel and cilta-cel. The high absolute number of cases observed for products like axi-cel appears to reflect high utilization rather than a disproportionate risk, underscoring the necessity of using statistical signal detection methods when interpreting spontaneous reports.
Journal • Adverse events
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ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
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Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Epkinly (epcoritamab-bysp) • Elrexfio (elranatamab-bcmm) • Tecartus (brexucabtagene autoleucel) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel) • Lunsumio (mosunetuzumab-axgb) • Talvey (talquetamab-tgvs) • Tecvayli (teclistamab-cqyv) • Columvi (glofitamab-gxbm)