FDA Approves EPKINLY® for Relapsed/Refractory Follicular Lymphoma

AbbVie has announced the U.S. Food and Drug Administration (FDA) approval of EPKINLY® (epcoritamab-bysp), marking it as the first bispecific antibody in the U.S. to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL). This bispecific antibody is administered subcutaneously and has been approved under the FDA's Accelerated Approval program based on overall response rate (ORR) and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trials.

Mariana Cota Stirner, M.D., Ph.D., vice president and therapeutic area head for hematology at AbbVie, highlighted that EPKINLY offers a new treatment option for patients with relapsed or refractory follicular lymphoma, especially following the failure of other therapies. The treatment has demonstrated significant and durable responses in many patients, and its subcutaneous dosing offers the convenience of administration without mandatory hospitalization.

Epcoritamab, co-developed by AbbVie and Genmab, is part of a collaborative effort to advance cancer treatment. The two companies will share commercial responsibilities in the U.S. and Japan, with AbbVie taking charge of further global commercialization. Follicular lymphoma, an indolent form of non-Hodgkin's lymphoma, affects about 15,000 people annually in the U.S. and is considered incurable with current standard therapies. Relapse is common, and with each relapse, the remission period shortens. More than a quarter of FL patients may experience transformation to the more aggressive DLBCL, which has poor survival outcomes.

The EPCORE NHL-1 clinical trial, a Phase 1/2 trial, evaluated the efficacy and safety of EPKINLY in 127 adult patients with R/R FL who had previously received a median of three lines of therapy. The results demonstrated an ORR of 82%, with a complete response (CR) rate of 60% and a partial response (PR) rate of 22%. At a median follow-up of 14.8 months, more than half of the responders maintained their response to treatment.

Safety data from the study, involving 213 patients, revealed that the most common adverse reactions included injection site reactions, cytokine release syndrome (CRS), COVID-19, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, fever, cough, and headache. A separate dose optimization cohort evaluated the 3-step dosage schedule for CRS mitigation in 86 patients, showing no Grade 3 CRS events in FL patients who received EPKINLY.

The prescribing information for EPKINLY includes a Boxed Warning for serious or life-threatening CRS and immune effector cell-associated neurotoxicity syndrome (ICANS). Additional warnings and precautions encompass infections, cytopenias, and embryo-fetal toxicity.

EPKINLY has been recognized in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas as a preferred recommendation for third-line and subsequent therapy for FL patients.

EPKINLY, an IgG1-bispecific antibody, employs Genmab's DuoBody® technology, designed to direct cytotoxic T cells to target and kill CD20+ cells. This mechanism enables EPKINLY to bind simultaneously to CD3 on T cells and CD20 on B cells, facilitating targeted cell killing. EPKINLY has received regulatory approval in several countries for certain lymphoma indications.

AbbVie and Genmab are actively pursuing regulatory submissions for epcoritamab across international markets and continue to evaluate its use as a monotherapy and in combination therapies for various hematologic malignancies. Both companies are committed to advancing the treatment landscape for difficult-to-treat cancers, aiming to improve patient outcomes and survival rates.