Monday 30 September 2024 Abbvie announced that the Italian Medicines Agency (Aifa) has approved the reimbursement of epcoritamab as monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (Dlbcl) at two or more lines of systemic therapy. Epcoritamab is the first and only bispecific antibody that can be administered subcutaneously. As highlighted by the company, the reimbursement approval «is supported by data from the pivotal phase 1/2, open-label, multi-cohort, multi-center, single-arm Epcore™ NHL-1 study that evaluated the efficacy profile and safety of epcoritamab in patients with R/R large B-cell lymphoma (Lbcl), including its subtype Dlbcl. In this study, Dlbcl patients treated with epcoritamab (N 139) achieved an overall response rate of 62% and a complete response rate of 39%.”
[Se non vuoi perdere tutte le novità iscriviti gratis alla newsletter di FarmaciaVirtuale.it. Arriva nella tua casella email alle 7 del mattino. Apri questo link]
Mechanism of action and functioning of epcoritamab
Pierluigi Zinzani, professor of Hematology at the Institute of Hematology “L. and A. Seràgnoli”, University of Bologna, explained that «for a long time, patients suffering from Dlbcl R/R did not have valid therapeutic alternatives. In recent years the therapeutic landscape has changed considerably with the arrival of new drugs or combinations of drugs without chemotherapy. Among these, epcoritamab represents an important novelty, it is a bispecific IgG1 antibody that derives from a humanized mouse anti-CD3 antibody and a monoclonal anti-human CD20 antibody. The formation of the epcoritamab-CD20-CD3 trimer determines the activation and expansion of T cells and the killing, mediated by T cells, of CD20+ tumor B cells.”
Maintenance of the state of disease remission
«Valid therapeutic option»
According to Maurizio Martelli, professor of Hematology at the Sapienza University of Rome, «patients affected by large B-cell non-Hodgkin lymphoma with aggressive histology who relapse after current standard therapies (immunochemotherapy and Car-T) have an important therapeutic need in when they develop a rapidly evolving aggressive disease that hardly responds to current therapies. The new bispecific monoclonal antibody epcoritamab has proven to be a valid therapeutic option with rates of complete responses in post-Car-T 5 patients. In addition to these significant data regarding efficacy, an improvement in the quality parameters of life and a favorable safety profile. The most common adverse event observed was cytokine release syndrome (Crs) which in almost all cases was grade 1-2 and was found to be predictable in terms of onset times and easily manageable without leading to suspension of treatment” .
Greco (To Abbvie Italia): «Particularly significant milestone»
Fabrizio Greco, CEO of Abbvie Italia, observed that «our company has long been committed to the field of hematology to develop therapeutic solutions that can make a difference in patients’ lives. Aifa’s approval of reimbursement of epcoritamab represents a particularly significant milestone in strengthening our ambition to improve standards of care in the management of various haematological malignancies, where the need and urgency of treatment remain high. We will work to ensure that all eligible patients can easily access this therapeutic innovation throughout Italy, collaborating with patient associations, scientific societies, institutions and treatment centers.”
