FDA Approves Epcoritamab-bysp for Relapsed, Refractory Diffuse Large B-Cell Lymphoma


Treatment with epcoritamab-bysp showed a 61% overall response rate and a 38% complete response rate in heavily pretreated patients with R/R DLBCL.

The FDA has approved epcoritamab-bysp (Epkinly; AbbVie, Genmab) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL) after 2 or more lines of systemic therapies.

Credit: Vitalii Vodolazskyi - stock.adobe.com

Credit: Vitalii Vodolazskyi - stock.adobe.com

DLBCL is a type of aggressive, fast-growing non-Hodgkin lymphoma (NHL), which develops in the lymphatic system and affects B cells. DLBCL is the most common type of NHL with an estimated 30,400 cases in the United States in 2022 and 150,000 new cases globally each year. Patients with DLBCL typically receive chemoimmunotherapy-based regimens.

For relapsed or refractory patients, several targeted therapies have recently emerged, including T-cell mediated treatments. However, single-agent and ready-available or off-the-shelf treatment options are limited for this population.

“DLBCL is an aggressive cancer type that can rapidly progress and resist treatment,” said Thomas Hudson, MD, senior vice president of research and development and chief scientific officer at AbbVie, in a press release. “The FDA approval of Epkinly represents a new treatment mechanism of action for third line DLBCL patients. As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that Epkinly can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off the shelf form for physicians.”

Epcoritamab-bysp is an IgG1-bispecific antibody that uses Genmab’s proprietary DuoBody technology, which directs cytotoxic T cells selectively to elicit an immune response toward target cell types. It is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells, inducing T cell-mediated killing of CD20-positive cells.

In the expansion cohort of the EPCORE NHL-1 trial, 148 patients with CD20-positive DLBCL were enrolled, 86% of whom were diagnosed with DLBCL not otherwise specified, not including 27% with DLBCL transformed from indolent lymphoma, and 14% with HGBL. The median number of prior therapies was 3, with 30% receiving 2 prior therapies, 30% receiving 3 prior therapies, and 40% receiving 4 or more prior therapies. Additionally, 18% had prior autologous hematopoietic stem cell transplantation and 39% had prior chimeric antigen receptor (CAR) T-cell therapy. Eighty-two percent of participants had disease refractory to their last therapy and 29% were refractory to CAR T-cell therapy.

According to the study results, treatment with epcoritamab-bysp showed a 61% overall response rate, a 38% complete response rate, and a 15.6-month median duration of response in heavily pretreated relapsed or refractory patients with DLBCL.

The most common adverse reactions in 20% or more of patients included cytokine release syndrome (CRS), fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. The prescribing information includes a Boxed Warning for serious or life-threatening CRS and immune effector cell-associated neurotoxicity syndrome.

“Patients with DLBCL who relapse or are refractory to currently available therapies have limited options. Generally, the prognosis for these patients is poor and management of this aggressive disease can be challenging,” said Tycel Philips, MD, City of Hope Associate Professor in the Division of Lymphoma, Department of Hematology and Hematopoietic Cell Transplantation, in the press release. “Epcoritamab is a subcutaneous bispecific antibody that offers an additional treatment option for this patient population. With this approval, patients who are in need of additional therapy may have the opportunity to receive epcoritamab after failure to response or relapse after 2 or more systemic therapies.”

Epcoritamab-bysp was approved under the FDA’s Accelerated Approval program based on response rate and durability of response. Continued approval may be contingent on verification and description of clinical benefit in confirmatory trials.


Epkinly (epcoritamab-bysp) Approved by US FDA as the First and Only Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL). News release. AbbVie. May 19, 2023. Accessed May 19, 2023. https://news.abbvie.com/news/press-releases/epkinly-epcoritamab-bysp-approved-by-us-fda-as-first-and-only-bispecific-antibody-to-treat-adult-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-dlbcl.htm

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