The Food and Drug Administration (FDA) has granted accelerated approval to Epkinly™ (epcoritamab-bysp) 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 after 2 or more lines of systemic therapy.
Epcoritamab is an IgG1-bispecific antibody designed to bind to CD3 on T-cells and CD20 on B-cells, inducing T-cell mediated killing of CD20+ cells. The approval was based on data from the LBCL cohort of the open-label, multicenter phase 2 EPCORE NHL-1 trial (ClinicalTrials.gov Identifier: NCT03625037), which evaluated subcutaneous epcoritamab in patients with relapsed or refractory B-cell lymphoma.
The efficacy population included 148 patients with DLBCL, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after 2 or more lines of systemic therapy, including an anti-CD20 monoclonal antibody-containing therapy.
Results showed an overall response rate (ORR; primary endpoint) of 61% (95% CI, 52.5-68.7), with 38% (95% CI, 30-46.2) of patients having a complete response and 23% (95% CI, 16.5-30.6) having a partial response. The median duration of response was 15.6 months (95% CI, 9.7, not reached).
Commonly reported adverse reactions included cytokine release syndrome (CRS), fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea. The most common grade 3 to 4 laboratory abnormalities were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets.
The prescribing information for Epkinly includes a Boxed Warning regarding the potential for CRS and immune effector cell-associated neurotoxicity syndrome (ICANS). Among 157 study participants, CRS and ICANS occurred in 51% and 6% of patients, respectively. Epkinly should only be administered by a qualified health care professional with appropriate medical support to manage severe reactions such as CRS and ICANS.
Epkinly is administered as a subcutaneous injection. The Epkinly 4mg/0.8mL is supplied as a single-dose vial that must be diluted prior to use. The Epkinly 48mg/0.8mL vial is supplied as ready-to-use solution that does not need dilution prior to administration.
- Epkinly™ (epcoritamab-bysp) approved by US 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). News release. May 19, 2023. https://www.businesswire.com/news/home/20230518005495/en/EPKINLY%E2%84%A2-epcoritamab-bysp-Approved-by-U.S.-Food-and-Drug-Administration-as-the-First-and-Only-Bispecific-Antibody-to-Treat-Adults-with-Relapsed-or-Refractory-RR-Diffuse-Large-B-cell-Lymphoma-DLBCL.
- Package insert. Genmab and AbbVie; 2023. Accessed May 19, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761324Orig1s000lbl.pdf.