AbbVie and Genmab’s Joint Cancer Treatment Receives EMA Validation

AbbVie announced the European Medicines Agency (EMA) validated the company’s Marketing Authorization Application for epcoritamab. Epcoritamab is a bispecific antibody created for the treatment of cancer with the activation of a T-cell response.

The application is supported by the results of the EPCORE™ NHL-1 Trial, which demonstrated favorable results for the investigational bispecific antibody.

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Winning EMA Validation

Diffuse Large B-cell Lymphoma (DLBCL) is a variation of non-Hodgkin’s lymphoma (NHL) characterized by its fast-growing nature. DLBCL affects a type of white blood cell known as B-cell lymphocytes. DLBCL accounts for 30% of NHL cases, making it the most common type of that subset of cancer, and it affects the lymph nodes of a patient. 

For the treatment of DLBCL, AbbVie developed Epcoritamab in conjunction with Genmab. Making use of Genmab’s proprietary DuoBody technology, Epcoritamab simultaneously binds to CD3 on T-cells and CD20 on B-cells, resulting in the cell-mediated killing of cancer cells.

To prove the value of Epcoritamab, the companies conducted the EPCORE™ NHL-1 Trial. The clinical trial included a Phase 1 testing first-in-human, dose escalation, and a Phase 2 expansion part. Published in The Lancet in 2021, the dose escalation trial found that patients treated with Epcoritamab saw an overall response rate of 68%.

As a result of the trial findings, the EMA validated AbbVie’s marketing authorization submission. This validation comes as Genmab submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). 

On the recent wins, Mohamed Zaki, M.D., Ph.D., vice president, and head of global oncology development at AbbVie, said, “The regulatory submissions for epcoritamab exemplify our pursuit to deliver innovative care for people living with large B-cell lymphoma and diffuse large B-cell lymphoma who have limited treatment options. This achievement represents an initial step in our commitment to scientific research and providing an important treatment option with the potential to become a core therapy for people living with B-cell malignancies such as LBCL and DLBCL.”

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.

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Author

Max Heirich