Genmab Showcases Data From Comprehensive Epcoritamab Development Program in Patients Across B-Cell Lymphomas

Genmab has announced data from its ongoing phase 1/2 EPCORE™ NHL-2 trial investigating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab-lenalidomide (R2) showed an overall response rate (ORR) of 98 percent and complete metabolic response (CMR) of 87 percent in response evaluable patients (n=104) with relapsed or refractory (R/R) follicular lymphoma (FL).

These preliminary results will be presented today during an oral presentation at the 2023 European Hematology Association (EHA) Congress, being held in Frankfurt, Germany and virtually, June 8-11, 2023 (Abstract #S222). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV) as part of the companies’ oncology collaboration.

Additional findings from the study observed consistent ORR and CMR across high-risk subgroups, including a 98 percent ORR and a 75 percent CMR in patients whose disease progressed within 24 months (POD24, n=40), a 95 percent ORR and 75.7 percent CMR in patients who were double refractory (refractory to both an anti-CD20 and an alkylating agent, n=37), a 100 percent ORR and 83.8 percent CMR in patients who were primary refractory (no response or relapse within six months after first-line treatment, n=37), and a 96 percent ORR and 80.9 percent CMR in patients refractory to prior anti-CD20 treatment (n=47). Median time to any response and CMR was 1.4 months. Estimated nine-month progression-free survival was 85 percent.

“Follicular lymphoma is a challenging cancer where disease progression within two years of initial treatment with chemoimmunotherapy, known as POD24, occurs in approximately 20 percent of patients and is a strong predictor of poor outcomes. Currently, there is no standard treatment approach for patients with high-risk, relapsed or refractory follicular lymphoma, including POD24,” said Anna Sureda, MD, PhD, Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Català d’Oncologia, IDIBELL, Universitat de Barcelona, L’Hospitalet de Llobregat, Barcelona, Spain. “The results being presented today are encouraging and warrant further evaluation of epcoritamab in combination with R2 in this patient population to determine if this combination could potentially be offered as a treatment option for patients in need of alternative therapeutic options.”

Among the 111 patients in the safety analysis, the most common treatment emergent adverse events (TEAE) were neutropenia (57 percent) and cytokine release syndrome (CRS) (48 percent), injection-site reactions (41 percent), and fatigue (36 percent). CRS events were mostly low grade (G1-2, 46 percent; G3, 2 percent) and mostly occurred following the first full dose (cycle 1, day 15). All events resolved and none led to treatment discontinuation. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in two patients (G1, G2) and resolved. Results from this study were also presented at this year’s American Society of Clinical Oncology (ASCO) Meeting on June 6, 2023.

“Together with AbbVie, through our comprehensive clinical development program, we remain committed to evaluating epcoritamab, alone or in combination with other therapies, as a potential treatment option across a variety of people affected by hematologic cancers,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “The data being presented at EHA demonstrate our shared commitment to develop epcoritamab as a potential core therapy for B-cell malignancies.”