Tuesday, July 16, 2024

Follicular Lymphoma Patients Gain New Hope with FDA Approval of EPKINLY®

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Follicular lymphoma patients with relapsed or refractory (R/R) disease after two or more lines of systemic therapy now have a new treatment option, as the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp), announced Genmab. This approval is based on the positive results from the Phase 1/2 EPCORE® NHL-1 study, which demonstrated durable, clinically meaningful treatment responses in patients with challenging-to-treat R/R FL.

The EPCORE® NHL-1 clinical trial evaluated 127 adult patients with R/R FL, with a median of three prior lines of therapy, 70% of whom had double refractory disease. The study revealed an overall response rate (ORR) of 82% and a complete response (CR) rate of 60%, with 67% of patients achieving minimal residual disease (MRD) negativity. Importantly, more than half of the patients who responded to EPKINLY treatment remained responsive at the time of data analysis, with a median follow-up of 14.8 months and the median duration of response (DoR) not yet reached. These results were recently published in The Lancet Haematology.

EPKINLY is the first and only T-cell-engaging bispecific antibody approved in the U.S. to treat both relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. It offers an off-the-shelf treatment option administered subcutaneously, which enables treatment across various practice settings, addressing a high clinical need. This approval is under accelerated approval based on response rate, with continued approval contingent upon verification and description of clinical benefit in confirmatory trials.

Follicular Lymphoma Approval of EPKINLY Offers New Hope Amidst Treatment Challenges

Follicular lymphoma is the second most common form of non-Hodgkin’s lymphoma (NHL), accounting for 20-30% of all NHL cases in the U.S., where approximately 15,000 people develop FL annually. Current standard therapies for FL are considered incurable, and patients often relapse, facing shorter durability of response with each subsequent line of therapy. “Patients with relapsed or refractory follicular lymphoma face significant treatment challenges, especially in third-line settings where there is currently no clear standard of care treatment,” said Jeff Sharman, MD, Disease Chair, Hematology Research, Sarah Cannon Research Institute. The approval of EPKINLY and the durable responses observed in the trial highlights its potential for patients with limited therapeutic options post-relapse.

The most common treatment-emergent adverse events (TEAEs) in the FL cohort of the trial were injection site reactions, cytokine release syndrome (CRS), COVID-19, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, fever, cough, and headache. CRS was primarily low grade, with no grade 3 CRS events observed. The prescribing information includes a Boxed Warning for serious or life-threatening CRS and immune effector cell-associated neurotoxicity syndrome (ICANS). Other warnings and precautions include infections, cytopenias, and embryo-fetal toxicity.

Follicular Lymphoma

FDA Approval of EPKINLY Brings New Hope for Follicular Lymphoma Patients

“With this approval, patients whose follicular lymphoma has relapsed or is refractory to at least two or more lines of systemic therapy now have the option to be treated with EPKINLY, which has demonstrated durable responses without mandatory hospitalization using a 3-step-up dosage regimen in clinical trials,” said Jan van de Winkel, Ph.D., CEO of Genmab. “EPKINLY has received a second indication in the U.S., making it the first and only bispecific antibody approved to treat both DLBCL and FL after two or more lines of systemic therapy.”

Lee Greenberger, Ph.D., Chief Scientific Officer at The Leukemia & Lymphoma Society, emphasized the significance of the approval: “People living with follicular lymphoma need additional options when their cancer returns. Today’s approval is welcome news for patients, as it provides another tool in the physician’s arsenal for this difficult-to-treat form of cancer.”

The FDA’s approval of EPKINLY® (epcoritamab-bysp) marks a significant advancement for patients with relapsed or refractory follicular lymphoma, providing a new, effective treatment option that addresses a critical unmet need in oncology. The durable responses and the convenience of subcutaneous administration make EPKINLY a promising therapy for patients with limited options, highlighting its potential to become a core treatment across B-cell malignancies.

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Resource: Genmab, June 27, 2024

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