The European Commission has granted marketing authorization to epcoritamab (TEPKINLY® ) in combination with rituximab and lenalidomide (R2) for the treatment of relapsed or refractory follicular lymphoma in the second-line setting.
The marketing authorization was granted based on the phase 3 EPCORE FL-1 trial, a randomized, open-label trial that evaluated the triplet against R2 alone in patients with relapsed or refractory FL. The study demonstrated epcoritamab + R2 reduced the risk of disease progression or death by 79% (HR, 0.21; 95% CI, 0.13 – 0.33; P<0.0001) compared with R2 alone, according to a press release from AbbVie, the manufacturer. The company reported that the most common (≥ 20%) adverse reactions included neutropenia, rash, upper respiratory tract infections, and cytokine release syndrome. Serious adverse reactions occurred in 44% of patients, according to the company, and in ≥ 5% of patients those included CRS, pneumonia, COVID-19, and febrile neutropenia.
“Follicular lymphoma is a persistent form of cancer that remains incurable, which means patients need more treatment options. Patients often relapse and experience shorter remissions and have fewer treatment options each time the disease returns,” said Catherine Thieblemont, MD, PhD, head of the hemato-oncology department at Paris Cité University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris. “The results shown in the EPCORE FL-1 trial are clinically meaningful, demonstrating the potential for TEPKINLY + R2 to change the treatment paradigm for patients, offering the chance at a durable response with a chemotherapy-free option.”
The triplet regimen was approved by the US Food and Drug Administration in 2025.
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