Findings from an early-phase clinical trial show that treatment with epcoritamab led to a 63.1% response rate in patients with pretreated large B-cell lymphoma.
The use of epcoritamab (DuoBody-CD3xCD20), an investigational drug, elicited promising results in patients with pretreated large B-cell lymphoma (LBCL), according to Genmab, one of the drug manufacturers that are co-developing the agent alongside the pharmaceutical company AbbVie.
In the ongoing phase 1/2 EPCORE NHL-1 clinical trial, 63.1% of patients with relapsed/refractory LBCL that had been treated with two or more prior therapies had their disease shrink after being treated with epcoritamab. On average, responses lasted 12 months.
Genmab and AbbVie will now work with agencies such as the Food and Drug Administration (FDA) to determine next best steps for the epcoritamab, according to a press release.
“Together with our partner, AbbVie, we will work with regulatory authorities to determine next steps and continue to evaluate epcoritamab in a variety of clinical trials as a potential treatment option for patients with various hematological malignancies,” said Jan van de Winkel, CEO of Genmab, in the release. “We look forward to sharing the findings at a future medical meeting.”
Epcoritamab is administered via injection under the skin and works by directing cancer-killing cells called cytotoxic T cells to attack cancer by binding to the CD3 protein on T cells and CD20 on B cells.
The drug is being studied in the EPCORE NHL-1 trial for multiple types of relapsed, progressive or refractory CD20-positive mature B-cell non-Hodgkin lymphoma, including LBCL and diffuse large B-cell lymphoma (the most common type of non-Hodgkin lymphoma).
Early results from EPCORE NHL-1 were published in The Lancet in September 2021. The goal of the first part of the study was to determine the maximum tolerated dose, which was not reached. Further, there were no dose-limiting side effects observed. As such, the full dose of 48 mg was determined to be the dose that patients would receive in the phase 2 portion of the trial.
In the more recently presented data, researchers reported that 49.7% of patients receiving epcoritamab experienced cytokine release syndrome, a condition where the body releases too many inflammatory molecules called cytokines. A total of 2.5% of cytokine release syndrome instances were severe (grade 3).
Epcoritamab is also being studied for other types of blood cancer, including in an ongoing phase 3 clinical trial that is looking at the drug in patients with relapsed/refractory diffuse large B-cell lymphoma.
The results will be presented at a future medical meeting, according to van de Winkel.
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