AbbVie Announces EMA Acceptance of New Indication Application for Epcoritamab in Relapsed/Refractory Follicular Lymphoma

Nov 28, 2023 17:45 CST Updated 17:45

AbbVie

Innovative Drug Developer

European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.

On November 27, AbbVie announced that the European Medicines Agency (EMA) has accepted the marketing application for a new indication of epcoritamab for the treatment of patients with relapsed or refractory follicular lymphoma (R/R FL) who have received at least two prior systemic therapies. On the same day, epcoritamab also received Breakthrough Therapy Designation from the FDA for this indication.

FL belongs to non-Hodgkin lymphoma (NHL) and is one of the more common types of B-cell lymphoma, accounting for approximately 20%-30% of the total NHL patient population. The most common presentation is painless lymphadenopathy, typically involving multi-site lymphoid tissue invasion, sometimes with palpable enlargement of the supratrochlear lymph nodes. FL generally progresses slowly, with patients having a longer survival period, but it is prone to transformation into diffuse large B-cell lymphoma, and the recurrence rate after remission is extremely high.

The acceptance by EMA this time is mainly based on the positive results of the Phase I/II EPCORETM NHL-1 study. This study is a global, multicenter, open-label clinical trial that enrolled 128 adult patients with CD20-positive (CD20+) R/R FL who had received at least two prior systemic therapies (one of which was a CD20 antibody drug), evaluating the safety and preliminary efficacy of epcoritamab.

Results showed that the overall response rate (ORR) assessed by the Independent Review Committee (IRC) was 82%, surpassing the pre-specified efficacy threshold set in the protocol. The median duration of response (DOR) has not yet been reached.

In terms of safety, no new safety signals were observed. The most common treatment-emergent adverse events (TEAEs) were cytokine release syndrome (66.4%), with 1.6% of the events being grade 2 or higher in severity.

Epcoritamab is an IgG1 bispecific antibody developed by Genmab using its proprietary DuoBody technology. It can simultaneously target CD3 on T cells and CD20 on B cells, inducing T cell-mediated killing of CD20+ cells. In June 2020, AbbVie and Genmab reached an agreement to co-develop and commercialize three bispecific antibodies, including this product.

Mechanism of Action of Epcoritamab (Source: AbbVie Official Website)

In May this year, epcoritamab was approved for marketing in the United States for the first time, under the trade name Epkinly, for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have received second-line or multi-line systemic therapy. This product has also become the first bispecific antibody applied in the field of DLBCL and the second CD3/CD20 bispecific antibody approved by the FDA after mosunetuzumab (Biogen/Roche).

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