Genmab and AbbVie announced new data from the ongoing phase 1/2 EPCORE™ NHL-1 clinical trial investigating epcoritamab (DuoBody® CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, demonstrated an overall response rate (ORR) of 82 percent, a complete response (CR) rate of 63 percent and minimal residual disease (MRD) negativity rate of 67 percent in patients with relapsed/refractory (R/R) follicular lymphoma (FL).
The presentation included data from an optimized step-up dosing schedule for FL patients showing a reduction in risk and severity of Grade 2+ cytokine release syndrome (CRS), a common side effect of T-cell engaging cancer treatments. These results were presented at the 2023 65th Annual Meeting and Exposition of the American Society of Hematology, being held in San Diego, California, December 9-12, 2023.
“Despite treatment advances for patients with follicular lymphoma whose disease has unfortunately progressed, treating relapsed or refractory follicular lymphoma remains highly challenging, particularly in the third-line plus setting,” said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. “The patients in this trial represent a historically difficult-to-treat patient population. The data presented today are especially notable because they demonstrated high overall and complete response rates for this investigational follicular lymphoma therapy and a preview for its potential as an alternative treatment option.”
“Follicular lymphoma patients who have experienced a relapse following heavy pre-treatment, or whose disease is not responding to available therapies, are considered high risk and are in need of alternative therapeutic options,” said Jan van de Winkel, Ph.D., CEO of Genmab. “The data presented at ASH reinforce what we have seen from our epcoritamab research and believe that this investigational bispecific antibody could potentially represent an important treatment option for patients living with relapsed or refractory follicular lymphoma. Along with our partner AbbVie, we look forward to progressing epcoritamab in clinical trials and discussing the results with regulatory authorities and remain committed to developing epcoritamab as a potential future core therapy for B-cell malignancies.”
👉 New Pivotal Data for Bispecific Antibody Epcoritamab (DuoBody® CD3xCD20) Demonstrates High Overall and Complete Responses in Patients with Hard-To-Treat Relapsed/Refractory Follicular Lymphoma (FL) – Genmab A/S
