Epcoritamab Demonstrates 88% Objective Response Rate in Phase 1/2 Trial for Relapsed/Refractory B-cell NHL

Recently, Genmab and AbbVie announced that the results of the Phase 1/2 clinical trial EPCORE NHL-1 for their investigational CD3/CD20 bispecific antibody epcoritamab were published in the prestigious academic journal *The Lancet*. The trial evaluated the safety and efficacy of this therapy in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).

A bispecific antibody is an antibody molecule capable of specifically binding to two distinct antigens. Epcoritamab is a bispecific T-cell redirecting antibody. One arm binds to the CD20 antigen on the surface of B cells, while the other arm binds to the CD3 receptor on the surface of T cells, thereby recruiting T cells to the vicinity of CD20-expressing B cells and inducing T-cell-mediated killing of lymphoma B cells. CD20 is a clinically validated therapeutic target and is expressed on numerous B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia, among others.

The dose-escalation portion of the open-label, multicenter EPCORE NHL-1 trial was conducted in 68 patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL), including diffuse large B-cell lymphoma and follicular lymphoma.

The trial results showed that no dose-limiting toxicities were observed during dose escalation, and the recommended phase 2 dose (RP2D) was determined to be 48 mg. The common adverse events (AEs) in patients with relapsed/refractory DLBCL were fever (69%), primarily associated with cytokine release syndrome (CRS) (59%, all grade 1–2) and injection site reactions (47%, all grade 1). One case of tumor lysis syndrome (TLS) (1%, grade 3) was observed.

Among patients with relapsed/refractory DLBCL receiving treatment at the RP2D (n=8), preliminary efficacy results reported in the trial showed an overall response rate (ORR) of 88% and a complete response (CR) rate of 38%. Furthermore, patients receiving 12–60 mg epcoritamab (n=22) achieved an ORR of 68% and a CR rate of 45%. Additionally, patients receiving 0.76–48 mg epcoritamab (n=10) achieved an ORR of 90% and a CR rate of 50%.

References:

[1] Clinical Trial of Investigational Epcoritamab (DuoBody®-CD3xCD20) in Patients with Relapsed/Refractory B-cell non-Hodgkin’s Lymphoma (B-NHL) Published in The Lancet. Retrieved September 9, 2021, from https://www.businesswire.com/news/home/20210909005284/en

(Abridged from the original)

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