Epcoritamab

Epcoritamab is an IgG1-bispecific antibody that simultaneously binds to CD3 on T-cells and CD20 on B-cells. Epcoritamab promotes the activation and expansion of T-cells and, by being able to bind to both CD20 and CD3, it leads to the T-cell–mediated killing of CD20+ malignant B cells. Diffuse large B-cell lymphoma (DLBCL) is an aggressive type of cancer commonly treated with several cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. Although this regimen is effective in up to 60% of patients, patients with relapsed or refractory DLBCL have poor outcomes. The use of epcoritamab in this group of patients has high response rates, durable complete responses and manageable adverse events with few discontinuations.

The use of epcoritamab may lead to cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. It is administered subcutaneously and is currently being evaluated as a monotherapy and in combination for the treatment of a variety of hematologic malignancies. In May 2023, epcoritamab was approved by the FDA under accelerated approval for the treatment of relapsed or refractory DLBCL. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Epcoritamab is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two 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).