Saturday, June 29, 2024
Genmab A/S has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending conditional marketing authorization for epcoritamab (TEPKINLY®). This T-cell engaging bispecific antibody is administered subcutaneously and is proposed as a monotherapy for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The European Commission's final decision on this indication is expected later this year.
"Follicular lymphoma patients who face relapse or refractory disease often confront significant treatment challenges and a poor prognosis," said Jan van de Winkel, Ph.D., CEO of Genmab. "This positive opinion underscores the unmet need within the EU for effective treatments for difficult-to-treat follicular lymphoma, positioning epcoritamab as a potential new therapeutic option."
The CHMP's opinion is based on data from the Phase 1/2 EPCORE® NHL-1 clinical trial, which involved 128 patients with R/R FL treated with epcoritamab following two or more lines of systemic therapy. The study included patients refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent, those refractory to their last treatment, and those whose disease progressed within two years of initial systemic therapy. Common (≥10%) adverse reactions in the trial included CRS, injection site reactions, pyrexia, neutropenia, anemia, thrombocytopenia, diarrhea, nausea, headache, upper respiratory tract infection, pneumonia, and rash.
An additional cohort of 86 patients evaluated an optimized step-up dosing (SUD) schedule aimed at reducing the incidence and severity of cytokine release syndrome (CRS), a known side effect of immune-engaging cancer treatments. Hospitalization was not mandatory for the optimization cohort, where CRS incidence was 49% (42 of 86 patients; 9% were grade 2) with no grade 3 or higher CRS events. Results from the EPCORE NHL-1 trial, including the optimization cohort, were published in Lancet Haematology and presented at the 2024 ASCO Annual Meeting and the 2024 EHA Congress.
"Each year, thousands in Europe are diagnosed with follicular lymphoma, and many experience relapse and refractory disease," stated Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department at Paris University, Hôpital Saint-Louis APHP. "This positive opinion is a critical step towards providing new treatment options for these patients."
The EPCORE® NHL-1 trial is an open-label, multi-center safety and preliminary efficacy study of epcoritamab, consisting of three parts: dose escalation, expansion, and optimization. The trial evaluates subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including FL. The expansion phase included patients with various types of relapsed/refractory B-NHLs and generated pivotal data from FL and DLBCL patients. The optimization phase focused on CRS mitigation strategies. The primary endpoint of the expansion phase was overall response rate (ORR), with secondary endpoints including duration of response, complete response rate, progression-free survival, and time to response. The primary endpoint of the optimization phase was the rate of ≥ Grade 2 CRS events.
FL is an indolent (slow-growing) form of non-Hodgkin’s lymphoma (NHL) that originates from B-lymphocytes. Despite its indolent nature, FL is incurable with conventional therapy, and patients often experience relapse. Each relapse typically shortens the time to the next treatment.
Epcoritamab is an IgG1-bispecific antibody created using Genmab's DuoBody® technology and administered subcutaneously. It is designed to bind to CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20+ cells. Epcoritamab is approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU. Genmab and AbbVie are co-developing epcoritamab as part of their oncology collaboration, sharing commercial responsibilities in the U.S. and Japan, with AbbVie handling further global commercialization.
Genmab and AbbVie are conducting ongoing evaluations of epcoritamab as a monotherapy and in combination with other therapies across various hematologic malignancies. This includes four Phase 3 trials: one comparing epcoritamab monotherapy to investigator's choice chemotherapy in R/R DLBCL patients (NCT04628494), one evaluating epcoritamab with R-CHOP in newly diagnosed DLBCL patients (NCT05578976), one combining epcoritamab with rituximab and lenalidomide (R2) in R/R FL patients (NCT05409066), and one comparing epcoritamab with R2 to chemoimmunotherapy in previously untreated FL patients (NCT06191744). The safety and efficacy of epcoritamab for these investigational uses have not been established. For more information, visit www.clinicaltrials.gov.
Source: globenewswire.com
