AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY(R) for the Treatment of Adults with Relapsed/Refractory Diffuse Large B

AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization for epcoritamab (TEPKINLY®) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The final European Commission decision on this indication for epcoritamab is anticipated later this year. AbbVie's application for the approval of epcoritamab is supported by results from the pivotal EPCORE? NHL-1 Phase 1/2 open-label, multi-center trial evaluating the preliminary efficacy and safety of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL), including DLBCL.

The primary endpoint of the study was overall response rate, as assessed by an independent review committee (63.1%). The most common treatment-emergent adverse event was cytokine release syndrome. Updated results were recently presented at multiple medical congresses. DLBCL is an aggressive type of cancer that develops in the lymphatic system. It is the most common type of B-cell NHL worldwide and accounts for approximately 30% of all global cases. Because NHL affects B-cell lymphocytes, the disease and its subtypes, including DLBCL, are classified as B-cell malignancies. Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.

The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. EPCORE? NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that includes a Phase 1 first-in-human, dose escalation part; a Phase 2a expansion part; and a dose optimization part.

The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL), including large B-cell lymphoma (LBCL) and diffuse large B-cell lymphoma (DLBCL). Data from the dose escalation part of the study, which determined the recommended Phase 2 dose, were published in September 2021. In the Phase 2 expansion part, additional patients were treated with epcoritamab to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed or refractory (R/R) B-cell NHLs who had limited therapeutic options. The primary endpoint of the Phase 2 expansion part was overall response rate as assessed by an independent review committee. Secondary efficacy endpoints included duration of response, complete response rate, progression-free survival, overall survival, time to response, time to next therapy, and rate of minimal residual disease negativity.

The most common treatment-emergent adverse events were cytokine release syndrome (49.7%; grade 1 or 2: 47.1%; grade 3: 2.5%), pyrexia (23.6%) and fatigue (22.9%). Results from the Phase 2 expansion part of the study were published in December 2022.