AbbVie and Genmab Announce FDA Approval of Epkinly (Epcoritamab-bysp), the First Bispecific Antibody for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

On May 19, AbbVie and Genmab jointly announced that the Biologics License Application (BLA) for the CD3/CD20 bispecific antibody Epkinly (epcoritamab-bysp) has been approved by the FDA for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have received two or more lines of systemic therapy.The product is FDA-approved.The first bispecific antibody product applied in the DLBCL field, and also the second CD3/CD20 bispecific antibody approved by the FDA.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL), accounting for approximately 31% of all NHL cases. According to GLOBOCAN 2020, there were approximately 544,000 new cases and 260,000 deaths from NHL globally.

Epkinly is an IgG1 bispecific antibody developed by Genmab using its proprietary DuoBody technology. It can simultaneously target CD3 on T cells and CD20 on B cells, inducing T cell-mediated killing of CD20+ cells. In June 2020, AbbVie and Genmab reached an agreement to jointly develop and commercialize three bispecific antibodies, including this product.

Mechanism of Action of Epcoritamab (Source: AbbVie Official Website)

This approval was based on the results of the Phase I/II EPCORE NHL-1 study. The study is divided into three parts: a dose-escalation study (Phase I), a dose-expansion study, and a dose-optimization study (Phase II), aiming to evaluate the preliminary efficacy and safety of Epkinly in patients with relapsed, progressive, or refractory NHL. The primary efficacy endpoint was the objective response rate (ORR).

The dose expansion portion of the study enrolled 148 patients with CD20+ DLBCL who had received a median of 3 prior lines of therapy. The results showed an overall response rate (ORR) of 61%, a complete response rate (CR) of 38%, and a median duration of response (mDOR) of 15.6 months.

In terms of safety, the most common (incidence rate ≥20%) adverse reactions are cytokine release syndrome (CRS), fatigue, musculoskeletal pain, injection site reactions, fever, abdominal pain, nausea, and diarrhea.

The first CD3/CD20 bispecific antibody to reach the market, mosunetuzumab from Roche, was approved for marketing in the EU and the US in June and December 2022, respectively, for the treatment of patients with relapsed or refractory follicular lymphoma who have received two or more prior lines of therapy.

Glofitamab, another CD3/CD20 bispecific antibody developed by Roche, has had its marketing application submitted to the European Commission and FDA for the treatment of relapsed or refractory DLBCL patients based on the expanded study data from Phase II NP30179. In March 2023, the product was approved for marketing in Canada.

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