Genmab Announces Epcoritamab Added to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for ‘B-Cell Lymphomas’

Media Release

COPENHAGEN, Denmark; June 22, 2023 – Genmab A/S (Nasdaq: GMAB) today announced that epcoritamab, a T-cell engaging bispecific antibody, has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for “B-cell Lymphomas” (Version 4.2023) for third-line and subsequent therapy for patients with diffuse large B-cell lymphoma (DLBCL), including patients with disease progression after transplant or chimeric antigen receptor (CAR) T-cell therapy and as a Category 2A, preferred regimen for patients with histologic transformation of indolent lymphomas to DLBCL and no intention to proceed to transplant, including patients with disease progression after transplant or CAR T-cell therapy. This recommendation is based on uniform NCCN consensus that the intervention is appropriate.ⁱ Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV) as part of the companies' oncology collaboration.

Epcoritamab-bysp (EPKINLY) was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s).

“The NCCN Guidelines are a resource for treating various types of cancer and providing healthcare providers with information for making informed treatment decisions,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “We are pleased that the NCCN has updated its Guidelines to include epcoritamab in a speedy manner.”

About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of B-cell non-Hodgkin’s lymphoma (B-NHL) worldwide, accounting for approximately 30 percent of all NHL cases and comprising an estimated 30,400 U.S. cases in 2022. DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.^{ii, iii} DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.^iv,v