Genmab A/S introduces EPKINLY™ (epcoritamab-bysp), the first and only T-cell engaging bispecific antibody for adult patients with R/R DLBCL, including DLBCL arising from indolent lymphoma and high-grade B‑cell lymphoma after multiple lines of therapy.
EPKINLY™ receives FDA approval based on response rate and durability of response, utilizing accelerated approval.
Ongoing approval for this indication is subject to confirmation and description of clinical benefits in one or more confirmatory trials. EPKINLY is a collaborative development and commercialization effort between Genmab and AbbVie within their oncology partnership.
EPKINLY utilizes a dual-targeted mechanism, simultaneously binding to both T-cells and CD20+ lymphoma B-cells. In a crucial Phase 2 clinical trial, subcutaneous EPKINLY monotherapy showcased positive responses in difficult-to-treat patients with relapsed or refractory DLBCL, who had undergone a minimum of two previous treatments.
Overall, 61 percent of patients responded to EPKINLY, with 38 percent reaching full remission. The average response time was 15.6 months.
EPKINLY is connected with serious adverse effects such as cytokine release syndrome (CRS), immunological effector cell-associated neurotoxicity syndrome (ICANS), infections, and cytopenias. DLBCL is a fast-developing form of B-cell non-Hodgkin's lymphoma (B-NHL), a lymphatic cancer that affects B-cell lymphoid cells a kind of white blood cell.
Individuals diagnosed with DLBCL frequently confront the issue of cancer relapse, which occurs when the disease returns after therapy, or refractoriness, which occurs when the disease does not react to treatment. While new medicines have evolved, successfully managing DLBCL treatment can still be a difficult undertaking.