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FDA Approves New Bispecific Antibody for Non-Hodgkin Lymphoma Subtype

Rye Brook, N.Y., May 31, 2023 – The U.S. Food and Drug Administration (FDA) on May 19, 2023, approved epcoritamab (Epkinly™) to treat adults with diffuse large B-cell lymphoma (DLBCL), whose disease has not responded or relapsed after two prior therapies.

“Epcoritamab is the second newest drug in 2023 to be approved to treat DLBCL, the most common form of lymphoma. This decision comes just weeks after the FDA approved polatuzumab vedotin in combination with chemotherapy for a group of patients with newly diagnosed DLBCL,” said LLS’s Chief Scientific Officer Lee Greenberger, PhD. “These two approvals show the benefit of harnessing the power of the immune system to treat blood cancer, something The Leukemia & Lymphoma Society has supported for a long time.”

Epcoritamab is a bispecific antibody, meaning that it has two different targets — one piece of the antibody binds to the CD3 protein on immune T cells. The second half of the antibody binds to CD20 protein on the surface of cancer cells. This dual targeting helps the immune system zero in on and kill the cancer cells. 

Findings from the trial that led to the approval showed that some form of response occurred in more than half of the 148 patients in the clinical trial. Thirty-eight percent of patients achieved a complete response, meaning there were no detectable signs of cancer at follow up. The median progression-free survival, which is the time a patient’s disease remains stable without getting worse, was approximately four months. 

There were, however, manageable side-effects. Approximately 50% of patients developed so-called cytokine release syndrome (CRS) of low grade. CRS can develop as a side effect of immunotherapy, and it occurs when immune cells become over-activated. If this occurs, people may experience increased inflammation throughout the body which may interfere with body functions. 

CRS is commonly experienced with immunotherapies of this type and typically resolve with no treatment or with the use of other therapeutics. Most of the patients, however, experienced some form of mild neurotoxic events such as headache and memory loss. Unfortunately, one person in the trial died because of this side-effect. 

Dr. Greenberger, however, noted that the fact that epcoritamab is an off-the-shelf immunotherapy is a benefit for patients. An off-the-shelf-immunotherapy is developed by producing large amounts of T cells from healthy donors that are stored until a patient needs them, allowing treatment to occur quickly.

“Off-the-shelf therapies are attractive because they are easier to administer, immediately available — unlike CAR T cells that require weeks to prepare — and are effective in treating disease that has failed to respond to CD19 CAR T-cell therapy as well as rituximab,” said Dr. Greenberger. “LLS has made off-the-shelf therapies one of its many research priorities to expand on the benefits of immunotherapy. In fact, LLS has invested more than $10 million over the past year to explore next generation immunotherapies.”
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