Genmab A/S, a global biotechnology company focused on advancing patient care, has received positive news from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). They have recommended conditional marketing authorization for epcoritamab (Tepkinly), a novel T-cell engaging bispecific antibody. This recommendation is specifically for its use as a monotherapy in treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The final decision by the European Commission on this indication is expected later this year.
Follicular lymphoma, a form of non-Hodgkin lymphoma, presents significant challenges in treatment for patients whose disease has relapsed or shown resistance to existing therapies. Jan van de Winkel, CEO of Genmab, emphasized the importance of this positive opinion in addressing the unmet needs of these patients within the European Union. He expressed optimism that epcoritamab could offer a new therapeutic option to improve outcomes in this difficult-to-treat population.
The CHMP’s decision is underpinned by robust data from the phase 1/2 EPCORE NHL-1 clinical trial, which enrolled 128 patients with R/R FL. These patients had exhausted multiple prior lines of therapy, including those refractory to anti-CD20 monoclonal antibodies and alkylating agents. Common adverse reactions observed in the trial included cytokine release syndrome (CRS), injection site reactions, and hematologic abnormalities such as neutropenia and anemia.
Additionally, an optimized dosing regimen aimed at mitigating CRS was evaluated in a separate cohort of 86 patients. This approach demonstrated a manageable incidence and severity of CRS, a known side effect of immune-engaging cancer therapies. Notably, there were no grade 3 or higher CRS events in this cohort. Results from the EPCORE NHL-1 trial, including insights from the optimized dosing cohort, have been recently published in Lancet Haematology and presented at prestigious oncology conferences, underscoring the clinical significance of these findings.
Dr. Catherine Thieblemont from Paris University’s Hôpital Saint-Louis highlighted the urgency of expanding treatment options for follicular lymphoma patients across Europe. She welcomed the CHMP’s positive opinion as a pivotal step toward making epcoritamab available to more patients in need.
As Genmab awaits the final decision by the European Commission, the pharmaceutical news today marks a significant advancement in the landscape of lymphoma treatment, potentially offering hope to those facing relapsed or refractory disease.