Danish pharmaceutical company Genmab has unveiled phase 3 results demonstrating that Epkincly, when combined with rituximab and lenalidomide, reduces the risk of disease progression or death by 79 percent compared to the standard R2 treatment. The study focused on patients with relapsed or refractory follicular lymphoma.
The combination therapy also achieved an overall response rate of 95 percent, significantly higher than the 79 percent reported in the R2 arm. The safety profile was consistent with the individual treatments, although serious adverse events were more frequent in the combination group.
“The pivotal results from the EPCORE FL-1 study showcase the potential of epcoritamab, in combination with established therapies, to enable earlier intervention across diverse care settings and deliver improved outcomes for patients with relapsed or refractory follicular lymphoma,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer at Genmab.
“We remain committed to advancing epcoritamab, both as a monotherapy and in combination, as a potential core treatment for B-cell malignancies and as a therapeutic innovation that could reshape the treatment paradigm,” she added.
In November this year, the U.S. Food and Drug Administration (FDA) approved the EPKINLY + R2 combination for the treatment of patients with relapsed or refractory follicular lymphoma following one or more lines of systemic therapy. EPKINLY is also approved in the United States for treating adults with relapsed/refractory follicular lymphoma after two or more prior therapies.
