Genmab A/S (Nasdaq: GMAB) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization for epcoritamab (TEPKINLY®). This T-cell engaging bispecific antibody is intended as a monotherapy for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have undergone two or more lines of systemic therapy. The final decision by the European Commission regarding this indication for epcoritamab is expected later this year.
“Jan van de Winkel, Ph.D., CEO of Genmab, highlighted the challenges faced by many with relapsed or refractory follicular lymphoma, underscoring the significance of the CHMP’s positive opinion on epcoritamab (TEPKINLY®). This recognition addresses the unmet needs in the EU for these difficult-to-treat patients, potentially offering a new therapeutic avenue.”
“The CHMP opinion draws from data in the Phase 1/2 EPCORE® NHL-1 trial, involving 128 patients with R/R FL treated with epcoritamab post multiple systemic therapies. The trial encompassed patients refractory to anti-CD20 monoclonal antibody and alkylating agent, those failing prior treatments, and those with disease progression within two years of initial therapy. Adverse reactions, including CRS and injection site issues, were among the notable findings.”
“An additional cohort of 86 patients assessed an optimized step-up dosing strategy to mitigate CRS severity, resulting in a 49% incidence with no grade 3 or higher events. Published in Lancet Haematology and highlighted at major conferences, these results affirm epcoritamab’s potential.”
“Dr. Catherine Thieblemont from Hôpital Saint-Louis, Paris, emphasized the necessity for new FL treatments amidst annual diagnoses in Europe, acknowledging the pivotal step towards broader epcoritamab availability.”
“EPCORE® NHL-1, a comprehensive trial assessing epcoritamab’s efficacy in various relapsed/refractory B-NHLs, includes safety evaluations and CRS management. Its primary endpoint focused on response rates, with secondary measures encompassing survival outcomes and disease progression markers.”
“Follicular Lymphoma (FL), characterized by indolent progression, presents challenges with recurrent relapses despite initial remission, highlighting ongoing therapeutic gaps.”
“Epcoritamab, a subcutaneously administered IgG1-bispecific antibody utilizing Genmab’s DuoBody® technology, targets CD3 on T cells and CD20 on B cells, inducing T-cell mediated cytotoxicity against CD20+ cells.”
“Approved as EPKINLY and TEPKINLY in select regions, epcoritamab is part of Genmab’s collaboration with AbbVie, aiming for expanded global regulatory approvals.”
