EPKINLY is an innovatively designed T-cell engaging bispecific
antibody that targets CD3/CD20^1-3

Developed using Genmab's innovative DuoBody^® platform, EPKINLY helps activate T cells to target CD20²

Select to learn about specific MOA functions

T-cell activation

In vitro, EPKINLY induced
T-cell-mediated killing of
CD20-expressing B cells.

Humanized IgG1-bispecific antibody

EPKINLY binds to the CD3 receptor expressed on the surface of T cells and CD20 expressed on the surface of B cells, including cancer cells.

CD20-expressing B cell

CD20 is expressed on the
surface of lymphoma cells
and healthy B‑lineage cells.

EPKINLY binds to an epitope on CD20 that is distinct from the epitope rituximab binds to^2,4

Clinical significance of in vitro activity has not been established.

CD3=cluster of differentiation 3; CD20=cluster of differentiation 20; Fc=fragment crystallizable; IgG1=immunoglobulin G1; MOA=mechanism of action.

Learn about the EPCORE^™ NHL-1 trial

EXPLORE NOW

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

CRS

CRS occurred in 51% of patients in the clinical trial (37% grade 1, 17% grade 2, and 2.5% grade 3) and recurred in 16% of patients. Most events (92%) occurred during cycle 1, with 61% occurring after the 48 mg dose in cycle 1, day 15. In patients who experienced CRS, the signs and symptoms included pyrexia, hypotension, hypoxia, dyspnea, chills, and tachycardia. Concurrent neurological adverse reactions associated with CRS occurred in 2.5% of patients and included headache, confusional state, tremors, dizziness, and ataxia.
Administer pretreatment medications to reduce the risk of CRS. Following administration of the first 48 mg dose, patients should be hospitalized for 24 hours.
Monitor patients for potential CRS. At the first signs or symptoms of CRS, manage per current practice guidelines and administer supportive care as appropriate.

ICANS

ICANS occurred in 6% of patients in the clinical trial (4.5% grade 1, 1.3% grade 2, 0.6% fatal). Of the 10 ICANS events, 9 occurred in cycle 1 of treatment. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical manifestations of ICANS included, but were not limited to, confusional state, lethargy, tremor, dysgraphia, aphasia, and non-convulsive status epilepticus.
Monitor patients for potential ICANS. At the first signs or symptoms of ICANS, manage per current practice guidelines and administer supportive care as appropriate.

Infections

EPKINLY can cause serious and fatal infections. In the clinical trial, serious infections, including opportunistic infections, were reported in 15% of patients treated with EPKINLY at the recommended dose (14% grade 3 or 4, 1.3% fatal).
Monitor patients for signs and symptoms of infection prior to and during treatment and treat appropriately. Avoid administration in patients with active infections. Withhold or consider permanent discontinuation of EPKINLY based on severity. Prior to starting EPKINLY, provide Pneumocystis jirovecii pneumonia (PJP) prophylaxis and consider prophylaxis against herpes virus.

Cytopenias

EPKINLY can cause serious or severe cytopenias. In the clinical trial, grade 3 or 4 events occurred in 32% (neutropenia), 12% (anemia), and 12% (thrombocytopenia) of patients. Febrile neutropenia occurred in 2.5%.
Monitor complete blood counts throughout treatment. Based on severity of cytopenias, temporarily withhold or permanently discontinue EPKINLY. Consider prophylactic granulocyte colony-stimulating factor administration as applicable.

Embryo-Fetal Toxicity

EPKINLY may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with EPKINLY and for 4 months after the last dose. Verify pregnancy status in females of reproductive potential prior to initiating EPKINLY.

Adverse Reactions

Most common (≥20%) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. Most common grade 3 to 4 laboratory abnormalities (≥10%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.

Lactation

Advise women not to breastfeed during treatment and for 4 months after the last dose of EPKINLY.

INDICATION

EPKINLY is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after 2 or more lines of systemic therapy.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Please see full Prescribing Information, including Boxed Warnings.

References:

1. EPKINLY [package insert]. Plainsboro, NJ: Genmab US, Inc. and North Chicago, IL: AbbVie Inc. 2023. 2. Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. doi:10.1016/j.ebiom.2019.102625 3. Hutchings M, Mous R, Clausen MR, et al. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021;398(10306):1157-1169. doi:10.1016/S0140-6736(21)00889-8 4. Epling-Burnette PK, Dandamudi DB, Konieczna IM, et al. Evaluation of epcoritamab and rituximab combination in preclinical models of B-cell non-Hodgkin’s Lymphoma (NHL). Poster presented at: the 64th American Society for Hematology (ASH) Annual Meeting; December 10-13, 2022, New Orleans, LA, and virtual.

INDICATION

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

INDICATION

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving EPKINLY. Initiate treatment with the EPKINLY step-up dosing schedule to reduce the incidence and severity of CRS. Withhold EPKINLY until CRS resolves or permanently discontinue based on severity.
Immune effector cell–associated neurotoxicity syndrome (ICANS), including life-threatening and fatal reactions, can occur with EPKINLY. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold EPKINLY until ICANS resolves or permanently discontinue based on severity.

CRS

CRS occurred in 51% of patients in the clinical trial (37% grade 1, 17% grade 2, and 2.5% grade 3) and recurred in 16% of patients. Most events (92%) occurred during cycle 1, with 61% occurring after the 48 mg dose in cycle 1, day 15. In patients who experienced CRS, the signs and symptoms included pyrexia, hypotension, hypoxia, dyspnea, chills, and tachycardia. Concurrent neurological adverse reactions associated with CRS occurred in 2.5% of patients and included headache, confusional state, tremors, dizziness, and ataxia.
Administer pretreatment medications to reduce the risk of CRS. Following administration of the first 48 mg dose, patients should be hospitalized for 24 hours.
Monitor patients for potential CRS. At the first signs or symptoms of CRS, manage per current practice guidelines and administer supportive care as appropriate.

ICANS

ICANS occurred in 6% of patients in the clinical trial (4.5% grade 1, 1.3% grade 2, 0.6% fatal). Of the 10 ICANS events, 9 occurred in cycle 1 of treatment. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical manifestations of ICANS included, but were not limited to, confusional state, lethargy, tremor, dysgraphia, aphasia, and non-convulsive status epilepticus.
Monitor patients for potential ICANS. At the first signs or symptoms of ICANS, manage per current practice guidelines and administer supportive care as appropriate.

Infections

EPKINLY can cause serious and fatal infections. In the clinical trial, serious infections, including opportunistic infections, were reported in 15% of patients treated with EPKINLY at the recommended dose (14% grade 3 or 4, 1.3% fatal).
Monitor patients for signs and symptoms of infection prior to and during treatment and treat appropriately. Avoid administration in patients with active infections. Withhold or consider permanent discontinuation of EPKINLY based on severity. Prior to starting EPKINLY, provide Pneumocystis jirovecii pneumonia (PJP) prophylaxis and consider prophylaxis against herpes virus.

Cytopenias

EPKINLY can cause serious or severe cytopenias. In the clinical trial, grade 3 or 4 events occurred in 32% (neutropenia), 12% (anemia), and 12% (thrombocytopenia) of patients. Febrile neutropenia occurred in 2.5%.
Monitor complete blood counts throughout treatment. Based on severity of cytopenias, temporarily withhold or permanently discontinue EPKINLY. Consider prophylactic granulocyte colony-stimulating factor administration as applicable.

Embryo-Fetal Toxicity

EPKINLY may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with EPKINLY and for 4 months after the last dose. Verify pregnancy status in females of reproductive potential prior to initiating EPKINLY.

Adverse Reactions

Most common (≥20%) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. Most common grade 3 to 4 laboratory abnormalities (≥10%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.

Lactation

Advise women not to breastfeed during treatment and for 4 months after the last dose of EPKINLY.

INDICATION

Please see full Prescribing Information, including Boxed Warnings.

EPKINLY is an innovatively designed T-cell engaging bispecific antibody that targets CD3/CD201-3

Developed using Genmab's innovative DuoBody® platform, EPKINLY helps activate T cells to target CD202

T-cell activation

Humanized IgG1-bispecific antibody

CD20-expressing B cell

EPKINLY binds to an epitope on CD20 that is distinct from the epitope rituximab binds to2,4

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

CRS

ICANS

Infections

Cytopenias

Embryo-Fetal Toxicity

Adverse Reactions

Lactation

INDICATION

References:

INDICATION

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

INDICATION

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS: CRS and ICANS

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

CRS

ICANS

Infections

Cytopenias

Embryo-Fetal Toxicity

Adverse Reactions

Lactation

INDICATION

EPKINLY is an innovatively designed T-cell engaging bispecific
antibody that targets CD3/CD20^1-3

Developed using Genmab's innovative DuoBody^® platform, EPKINLY helps activate T cells to target CD20²

EPKINLY binds to an epitope on CD20 that is distinct from the epitope rituximab binds to^2,4