Genmab and AbbVie Announce Positive Topline Results from Phase 1/2 EPCORE NHL-1 Trial Evaluating Epcoritamab (DuoBody CD3xCD20) in Patients with Relapsed/Refractory Follicular Lymphoma (FL)

Company Announcement

• Based on the topline results from the EPCORE NHL-1 clinical trial, Genmab and AbbVie will engage with global regulatory authorities to discuss next steps
• Data from the clinical trial will be presented at a future medical meeting
• Follicular Lymphoma is a common form of non-Hodgkin’s lymphoma (NHL) and currently has limited treatment options, particularly in the relapsed/refractory setting
  
  

COPENHAGEN, Denmark; June 28, 2023 – Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) today announced topline results from the follicular lymphoma (FL) cohort of the phase 1/2 EPCORE NHL-1 clinical trial evaluating epcoritamab (DuoBody CD3xCD20), an investigational T-cell engaging bispecific antibody administered subcutaneously. The study cohort includes 128 adult patients with relapsed/refractory follicular lymphoma (FL) who received at least two prior lines of systemic therapy. 70.3 percent of patients were double refractory to an anti-CD20 monoclonal antibody and an alkylating agent. Based on the topline results, the companies will engage with global regulatory authorities to determine next steps. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.

The topline results from this cohort showed an overall response rate (ORR) of 82 percent as confirmed by an independent review committee (IRC), which exceeded the protocol prespecified threshold for efficacy. The observed median duration of response (DOR) was not reached. No new safety signals were observed with epcoritamab in this study at the time of analysis. The most common treatment-emergent adverse event was cytokine release syndrome (CRS) with 66.4 percent (1.6 percent grade >2). Aligned with the U.S. Food and Drug Administration’s (FDA) Project Optimus, the optimization part of the trial is continuing to evaluate alternative step-up dosing regimens to mitigate the risk of CRS; preliminary data on the initial patients enrolled indicate a clinically meaningful improvement in CRS rate. The results from this cohort, along with the results from the optimization part of the trial, will be submitted for presentation at an upcoming medical congress.