USA — Genmab and Abbvie have submitted cancer treatment candidate epcoritamab for regulatory review by the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA).
The application is supported by the findings of the EPCORETM NHL-1 Trial, which showed that the investigational bispecific antibody performed well.
AbbVie developed Epcoritamab in conjunction with Genmab for the treatment of diffuse large B-cell lymphoma (DLBCL) making use of Genmab’s proprietary DuoBody technology.
Diffuse large B-cell lymphoma (DLBCL) is an aggressive type of non-Hodgkin lymphoma that develops from the B-cells, a type of white blood cell in the lymphatic system. There are an estimated 150,000 new LBCL cases each year globally.
AbbVie paid Genmab US$750 million upfront for a stake in a pipeline of anti-cancer bispecifics led by epcoritamab in 2020.
The deal, which features up to US$3.2 billion in milestones, positions AbbVie to race Regeneron to market with a bispecific antibody that could compete with CAR-T therapies. Epcoritamab is a bispecific antibody designed to treat cancer by activating a T-cell response.
Epcoritamab simultaneously binds to CD3 on T-cells and CD20 on B-cells, resulting in the cell-mediated killing of cancer cells. CD20 is expressed on B-cells and is a clinically validated therapeutic target in many B-cell malignancies.
The companies conducted the EPCORETM NHL-1 Trial to demonstrate the efficacy of Epcoritamab. The clinical trial included a first-in-human phase, dose escalation, and a Phase 2 expansion phase.
The dose escalation trial, which was published in The Lancet in 2021, discovered that patients treated with Epcoritamab had an overall response rate of 68%.
Consequently, EMA has validated AbbVie’s marketing authorization submission as a result of the trial findings.
This approval comes after Genmab filed a Biologics License Application (BLA) with the US Food and Drug Administration (FDA).
While AbbVie and Genmab share commercial responsibilities for Epcoritamab in the United States and Japan, AbbVie is solely responsible for global commercialization as in the European Union.
An ongoing Phase 3 trial continues the examination of Epcoritamab as a monotherapy, with the results from it likely intended for the further support of global approvals after this EMA validation.
In a separate development for hematological malignancy treatment, the FDA has granted Tecvayli (teclistamab) by Johnson & Johnson accelerated approval to treat adult patients with relapsed or refractory multiple myeloma.
Tecvayli is a first-in-class bispecific T-cell engager antibody used to treat patients who have had four or more lines of therapy previously.
A bispecific antibody has the ability to bind to two distinct targets on two distinct cells at the same time.
Tecvayli is a prescription drug that targets the CD3 receptor on the surface of T cells and the B-cell maturation antigen (BCMA) on the surface of multiple myeloma cells.
In another milestone in the fight against cancer, the FDA has cleared AstraZeneca’s Imjudo (tremelimumab) in combination with the blockbuster drug Imfinzi (durvalumab) for unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.