AbbVie and Genmab's Epcoritamab Lymphoma Treatment Shows Promise in Mid-Stage Trial

AbbVie and Genmab's lymphoma drug epcoritamab has shown positive results in a mid-stage trial when administered in an outpatient setting, with its first full dose. The bispecific antibody is already approved for use in certain lymphoma patients, and the new data suggests it can be safely and effectively administered in an outpatient setting. The trial aims to evaluate the drug's efficacy and safety in patients with non-Hodgkin lymphoma.

Genmab A/S (Nasdaq: GMAB) and AbbVie have presented promising results from the Phase 2 EPCORE® NHL-6 trial, which evaluated the safety and efficacy of epcoritamab, a T-cell engaging bispecific antibody, in an outpatient setting for adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The trial demonstrated the feasibility of treating and monitoring patients in an outpatient setting following the first dose of epcoritamab, with 92% of patients receiving the first full dose in an outpatient setting [1].

The study, which enrolled 92 patients with R/R DLBCL who had received at least one prior line of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy, showed an overall response rate (ORR) of 64.3% and a complete response (CR) rate of 47.6% in patients treated with epcoritamab after only one prior line of systemic therapy [1]. For patients treated with epcoritamab following two or more lines of systemic therapy, the ORR was 60.0% and the CR rate was 38.0% [1].

Adverse events associated with epcoritamab were consistent with previous studies, with 40.2% of patients experiencing cytokine release syndrome (CRS) events, primarily low grade (Grade 1-2), and 7.6% experiencing immune cell-associated neurotoxicity syndrome (ICANS) events, also primarily low grade (Grade 1-2) [1]. No events led to treatment discontinuation.

"The EPCORE NHL-6 trial results are notable as current bispecific antibody treatments for R/R DLBCL patients may require in-hospital monitoring for CRS after certain initial doses and as needed after subsequent doses," said Jeff Sharman, M.D., Disease Chair, Hematology Research, Sarah Cannon Research Institute (SCRI) at Willamette Valley Cancer Institute in Eugene, Oregon [1].

Genmab's commitment to advancing research that supports people living with blood cancer is evident through the development of epcoritamab. The drug is designed to simultaneously bind to CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20+ cells [1].

The safety and efficacy of epcoritamab for use in the outpatient setting for first full dose in R/R DLBCL in the second-line setting have not been approved by US FDA or any other health authority. Further studies are ongoing to evaluate the drug's potential across various lines of therapy and hematologic malignancies.

References:
[1] https://finance.yahoo.com/news/genmab-announces-updated-results-phase-123000574.html