Applications for Epcoritamab Submitted to FDA and EMA in Relapsed/Refractory LBCL/DLBCL

Patients with relapsed/refractory large B-cell lymphoma may benefit from epcoritamab, the biologics license applications of which were submitted to the FDA.

A biologics license application for subcutaneous epcoritamab (DuoBody-CD3xCD20) was submitted to the FDA for patients with relapsed/refractory large B-cell lymphoma (LBCL) following 2 or more lines of systemic therapy and a marketing authorization application was validated by the European Medicines Agency for patients with relapsed/refractory diffuse large B-Cell lymphoma (DLBCL) after 2 or more lines of therapy, according to a press release from Genmab.1

Both submissions were based on data from the phase 1/2 EPCORE NHL-1 trial (NCT04663347), where the safety and preliminary findings were presented during the 2022 Presidential Symposium at the 27th Annual Meeting of the European Hematology Association in Vienna, Austria.2

“Even with existing therapies to treat these lymphomas, there is a significant medical need for alternative and accessible treatment options for patients who are unable to tolerate current treatments or whose treatments have failed,” Jan van de Winkel, PhD, chief executive officer at Genmab, said in the press release. “Together with our partner AbbVie, we believe epcoritamab has the potential to become a core therapy for patients with B-cell malignancies, and the submission of these regulatory applications to the FDA and EMA is an important step in potentially bringing epcoritamab to people living with relapsed/refractory B-cell lymphomas.”

Epcoritamab is an IgG1-bispecific antibody that was created with BuoBody-CD3 technology, which can utilize cytotoxic T-cell selectivity to generate an immune response. The agent binds to both CD3 for T cells and CD20 for B cells and encourages T-cell–medicated destruction of CD20-positive cells, which is commonly expressed in several B-cell malignancies.

The open-label, multicenter study consists of a dose escalation and dose expansion portion and was designed to evaluate subcutaneous epcoritamab in a population of patients with CD20-positive relapsed, progressive, or refractory B-cell non-Hodgkin lymphoma such as LBCL and DLBCL.

In the dose escalation portion of the study, which had a population of 68 patients, investigators reported an overall response rate (ORR) of 68% (95% CI, 45%-86%) in a population of patients with relapsed/refractory DLBCL treated with 12 mg to 60 mg of epcoritamab, including a complete response (CR) rate of 45%.2 Among those with follicular lymphoma, the ORR was 90% (95% CI, 55%-100%) with a CR rate of 50% at a dose of 0.76 mg to 48 mg.

The trial has a primary end point of ORR by independent review committee, with key secondary end points including duration of response, CR, progression-free survival, overall survival, time to response, time to next therapy, and minimal residual disease negativity.


  1. Genmab Announces submissions of regulatory applications for epcoritamab (DuoBody®-CD3xCD20) for the treatment of relapsed/refractory large B-cell lymphoma (LBCL) and diffuse large B-cell lymphoma (DLBCL). News release. Genmab. October 28, 2022. Accessed October 28, 2022.
  2. 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):P1157-1169. doi:10.1016/S0140-6736(21)00889-8