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EPKINLY™ (epcoritamab-bysp) Approved by U.S. Food and Drug Administration as the First and Only Bispecific Antibody to Treat Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
Company Announcement
Results from phase 2 clinical trial demonstrated EPKINLY™ (epcoritamab-bysp) delivered 61 percent overall response rate, 38 percent complete response, and 15.6-month median duration of response in challenging-to-treat R/R DLBCL patients
EPKINLY represents the seventh approved medicine incorporating Genmab innovation and third created via Genmab’s DuoBody® technology platform
COPENHAGEN, Denmark; May 19, 2023 – Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY™ (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody 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, after two or more lines of systemic therapy. EPKINLY was 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). EPKINLY is being co-developed and co-commercialized by Genmab and AbbVie (NYSE: ABBV) as part of the companies’ oncology collaboration.
“The approval of EPKINLY in the U.S. is an incredibly important milestone for patients with relapsed or refractory DLBCL, who are in need of a new, innovative treatment option administered subcutaneously,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “As the first and only bispecific antibody approved in the U.S. to treat relapsed or refractory DLBCL, and the third approved medicine developed using Genmab’s DuoBody technology, EPKINLY is a testament to our dedication to turn novel science into medicine and develop innovative and differentiated antibody therapeutics with the goal of improving the lives of patients. Together with AbbVie, we are committed to further evaluating and developing epcoritamab as a potential future core therapy across B-cell malignancies.”
EPKINLY features a dual-targeted approach continuously binding to T-cells and CD20+ lymphoma B-cells. In the pivotal Phase 2 clinical study, subcutaneous EPKINLY monotherapy demonstrated responses in challenging-to-treat, relapsed or refractory DLBCL patients who have received at least two prior treatments. An overall response (complete or partial response) was seen in 61 percent (90/148 [95 percent confidence interval (CI): 52.5-68.7]) of patients and 38 percent (56/148 [95 percent CI: 30.0-46.2]) achieved complete remission. The median duration of response was 15.6 months (95 percent CI: 9.7-Not reached). EPKINLY can cause serious side effects, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections, and cytopenias. Please see additional Important Safety Information, including Important Warnings on CRS and ICANS, below.
“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 Phillips, M.D., City of Hope Associate Professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation. “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 two or more prior systemic therapies.”
DLBCL is a fast-growing type of B-cell non-Hodgkin’s lymphoma (B-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.i,ii
"Despite recent advances in treating advanced DLBCL, due to the aggressive nature and complexity of the disease, there remains a need for new options that can provide remission, are tolerable, and can be administered upon relapse. The approval of EPKINLY brings a new option – and with it – new hope to patients and the greater lymphoma community,” said Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation.
About the Phase 1/2 EPCORE NHL-1 trial
In the expansion cohort of the trial, 157 patients with large B-cell lymphoma (LBCL) were enrolled. Among them, 148 patients with DLBCL or high-grade B-cell lymphoma were enrolled, 89 percent of which were diagnosed with DLBCL NOS, including 28 percent with DLBCL transformed from indolent lymphoma, and 14 percent with high-grade B-cell lymphoma (HGBCL). The median number of prior therapies was three (range: 2 to 11), with 29 percent receiving two prior therapies, 32 percent receiving three prior therapies, and 39 percent receiving four or more prior therapies. Eighteen percent had prior autologous hematopoietic stem cell transplantation (HSCT), and 39 percent had prior chimeric antigen receptor (CAR) T-cell therapy. Eighty-two percent of patients had disease refractory to last therapy and 29 percent of patients were refractory to CAR T-cell therapy.
The prescribing information has a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome (ICANS). Warnings and precautions include infections and cytopenias. The majority of treatment-emergent adverse events (TEAEs) occurred during the first 12 weeks of treatment and resolved. The most common (= 20 percent) adverse reactions were CRS, injection site reactions, fatigue, musculoskeletal pain, pyrexia, abdominal pain, nausea, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (=10 percent) were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets.