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Epcoritamab for patients with R/R FL: Results from EPCORE NHL-1 trial
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The ongoing phase I/II EPCORE NHL-1 trial (NCT03625037) is evaluating the safety and efficacy of epcoritamab, a subcutaneous CD3×CD20 bispecific antibody, in patients with relapsed/refractory (R/R) B-cell lymphoma.1 Results from this trial were reported previously by the Lymphoma Hub. Part 2 of the EPCORE NHL-1 trial includes a cohort of 128 adult patients with follicular lymphoma (FL) with ≥2 prior lines of therapy.1 Primary results from this cohort were published in Lancet Hematology by Linton, et al.1 Results from this trial led to the approval of epcoritamab for patients with R/R FL with ≥2 prior lines of therapy by the U.S. Food and Drug Administration (FDA), as well as issue of a positive opinion for the treatment of this population from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). |
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Epcoritamab demonstrated a significant overall response rate of 82.0% and a complete response rate of 62.5%, with responses observed in all prespecified subgroups, including in patients with high-risk features. |
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The safety profile of epcoritamab was manageable and consistent with that previously observed with epcoritamab for the treatment of a cohort of patients with diffuse large B-cell lymphoma. |
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Cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome were manageable, with mostly low-grade events, and were further reduced in the Cycle 1 optimization cohort (n = 86), with similar or favorable incidences and severity compared to CAR T-cell therapies. |
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These findings indicate that epcoritamab is an efficacious treatment option for patients with R/R FL, including those with high-risk disease features. Cycle 1 optimization is important to improve the safety profile of epcoritamab and can facilitate removal of mandatory hospitalization. |
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