Subcutaneous Epcoritamab With or Without Lenalidomide as First Line Therapy for Diffuse Large B-Cell Lymphoma

Summary

The purpose of the study is to examine efficacy and safety of epcoritamab with and without lenalidomide in newly diagnosed elderly patients with Diffuse Large B-Cell Lymphoma (DLBCL) who cannot tolerate anthracycline therapy. Epcoritamab (also known as EPKINLY™, GEN3013 and DuoBody®-CD3xCD20) is an antibody that has already been tested in several clinical studies. All patients will receive active treatment. There is an equal chance of receiving epcoritamab or epcoritamab plus lenalidomide.

Timeline

Start

2023-03-06

Primary completion

2026-06-10

Completion

2026-06-10

Outcome

Outcome not reported

Stopped: “The study was terminated because sufficient data had been collected to meet the objectives of the development program. No new or unexpected safety findings were identified, and the decision to terminate was not related to participant safety.”

Publications

• Vitolo U, Burgues JMB, Duell J, Kwiatek M, Belada D, Jurczak W, Maerevoet M, Sibon D, Greil R, Kumode T, Lopez-Jimenez J, Meert C, Cia JS, Thieblemont C, Alcaide SO, Kim WS, Cordoba R, Wielgos-Bonvallet M, Jiang T, Wang Y, McGoldrick S, Guo E, Morschhauser F, Woei-A-Jin FJSH. Epcoritamab monotherapy or epcoritamab with lenalidomide as first-line therapy for patients with diffuse large B-cell lymphoma (EPCORE DLBCL-3): primary analysis of an open-label, multicentre, randomised, phase 2 trial. Lancet Haematol. 2026 Jul;13(7):e435-e448. doi: 10.1016/S2352-3026(26)00112-2. Epub 2026 Jun 12.

Drugs

Indications