Genmab Announces Phase 3 Study Evaluating Epcoritamab in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

Company Announcement

• First Phase 3 study of epcoritamab as part of broad clinical development plan with AbbVie
• Diffuse Large B-cell Lymphoma is the most common form of non-Hodgkin’s lymphoma worldwide

Copenhagen, Denmark; November 5, 2020 – Genmab A/S (Nasdaq: GMAB) announced today that it will initiate a Phase 3 study of epcoritamab in diffuse large B-cell lymphoma (DLBCL).  The study will evaluate the efficacy and safety of subcutaneous epcoritamab, a fully-human IgG1-bispecific antibody designed to recognize and bind to both CD3 and CD20, versus investigators’ choice of chemotherapy regimen (either bendamustine and rituximab or gemcitabine, oxaliplatin, and rituximab) in patients with relapsed or refractory DLBCL. Epcoritamab is being co-developed by Genmab and AbbVie.

DLBCL is aggressive and the most common form of non-Hodgkin’s lymphoma worldwide, with 36% of DLBCL patients in the U.S. expected to die from their disease within five years of diagnosis.¹ Prevalence rates are expected to increase, driven by growth in aging populations. ²

“In collaboration with AbbVie, we have planned a broad, expansive, accelerated epcoritamab clinical development plan to maximize the potential of this promising bispecific antibody, with the ultimate goal of bringing new differentiated treatment options as soon as possible to patients. We look forward to the data from this first Phase 3 trial, especially for relapsed or refractory DLBCL patients as it remains an area of high unmet medical need,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the Study
The Phase 3, open-label, randomized study (GCT3013-05) will include approximately 480 patients with relapsed or refractory DLBCL who failed or are ineligible for autologous stem cell transplant (ASCT). Patients will be randomized to receive either subcutaneous epcoritamab or one of two chemotherapy regimens as per investigator’s choice, either rituximab, gemcitabine and oxaliplatin (R-GemOx) or bendamustine and rituximab (BR). The primary endpoint of the study is overall survival.

About Diffuse Large B-cell Lymphoma
DLBCL is the most common type of non-Hodgkin lymphoma (NHL) in the United States and worldwide, with an average age at diagnosis of mid-60s.^2,3 It is an aggressive form of NHL with relative 10-year survival rates of approximately 46% and relative 5-year survival rates of approximately 64%.^1,3,4 Prevalence is anticipated to increase, driven by growth in aging populations.¹ DLBCL affects B-lymphocytes and can develop in the lymph nodes or in other organs, and may be either localized or generalized.³ The prognosis for relapsed or refractory DLBCL patients is poor, especially for those with high-risk factors, and for most patients with refractory DLBCL there are no curative treatment options.⁵