Epcoritamab (DuoBody®-CD3xCD20) Demonstrates 68%–90% Overall Response Rate in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

September 11, 2021 /BioonBIOON/ --AbbVie and Genmab A/S recently jointly announced the Phase 1/2 EPCORE NHL-1 first-in-human (FIH) dose-escalation and cohort expansionClinical TrialThe results of the dose-escalation part have been published in *The Lancet*; for details, see:Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. This trial is investigatingepcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)Patient safety and preliminary efficacy.

Epcoritamab is a bispecific antibody., co-developed by AbbVie and Genmab. The FIH trial was designed to evaluate subcutaneous administration of epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-NHL, including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). In the dose-escalation phase, patients received subcutaneous epcoritamab (dose range: 0.0128–60 mg) for 28 days to assess the safety and anti-TumorActivity and ImmunityBiomarker。

During dose escalation,No dose-limiting toxicity was observed, and 48 mg was determined as the RP2D.. Common adverse events (AEs) included fever (69%), primarily associated with cytokine release syndrome (CRS) (59%, all Grade 1–2), and injection site reactions (47%, all Grade 1). One case ofTumorTumor lysis syndrome (TLS) (1%, Grade 3). No Grade ≥3 CRS events or discontinuations due to treatment-related adverse events or death were observed.

The preliminary efficacy results reported in the trial were:In patients with relapsed/refractory DLBCL treated with epcoritamab at the RP2D of 48 mg (n=8), the overall response rate (ORR) was 88% and the complete response (CR) rate was 38%.Among patients treated with epcoritamab at doses of 12-60 mg (n=22), the ORR was 68% and the CR was 45%. Additionally, among patients with relapsed/refractory FL treated with epcoritamab at doses of 0.76-48 mg (n=10), the ORR was 90% and the CR was 50%.

Epcoritamab is an investigational IgG1 bispecific antibody generated using Genmab's proprietary DuoBody technology. The DuoBody-CD3 technology is designed to selectively direct cytotoxic T cells toTumor, thereby eliciting an immune response against malignant cells.Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells, and induce T cell-mediated killing of lymphoma B cells.

CD20 is a clinically validated therapeutic target in many B-cell malignanciesTumorexpressed on, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and chronic lymphocyticLeukemia. epcoritamab is widely ... by AbbVie and GenmabTumorpart of the collaboration, jointly developed by both parties. (Bioon.com)

Original Source:Clinical Trial of Investigational Epcoritamab (DuoBody?-CD3xCD20) in Patients with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL) Published in The Lancet