The approval was based on data from the phase 1/2 EPCORE NHL-1 clinical trial.
The FDA has approved AbbVie’s epcoritamab-bysp, a T-cell engaging bispecific antibody marketed as Epkinly, for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after 2 or more lines of systemic therapies, under the accelerated approval pathway, making it the first and only T-cell engaging bispecific antibody for this indication.
"DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line DLBCL patients. As a nonchemotherapy, 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," Thomas Hudson, MD, the senior vice president of research and development and chief scientific officer at AbbVie, said in a statement. "The approval is just the first step, with our partner Genmab, towards a shared goal of developing a core therapy for patients with B-cell malignances."
EPKINLY’s approval was based on of data from the phase 1/2 EPCORE NHL-1 clinical trial (NCT03625037). The EPCORE NHL-1 trial enrolled 148 participants with CD20+ diffuse large B-cell lymphoma (DLBCL), 86% had DLBCL NOS, including 27% with DLBCL transformed from indolent lymphoma, and 14 percent with HGBL. The participants had received a median of 3 prior therapies (range, 2-11), with 30% receiving 2 prior therapies, 30% receiving 3 prior therapies, and 40% receiving 4 or more prior therapies. Eighteen percent of patients had received prior autologous hematopoietic stem cell transplant (HSCT) 39% had received prior chimeric antigen receptor (CAR) T-cell therapy. Eighty-two percent of patients had disease refractory to their last therapy and 29% of patients were refractory to CAR T-cell therapy.
"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," Tycel Philips, MD, an associate professor in the division of lymphoma and department of hematology and hematopoietic cell transplantation at City of Hope, added to the statement. "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 respond or relapse after 2 or more systemic therapies."
Patients in the EPCORE NHL-1 trial with relapsed/refractory HLBCL had an overall response rate of 61%, a complete response rate of 38%, and a median duration of response of 15.6 months. Participants experienced serious adverse events (AEs) including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). The most common AEs were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea.
"The FDA approval of Epkinly represents a new treatment for diffuse large B-cell lymphomas among patients who have relapsed or have refractory disease and are looking for a new medication," Meghan Gutierrez, the chief executive officer of the Lymphoma Research Foundation, added.