Genmab eyes US nod after epcoritamab combo clears Phase III hurdle
Danish biotech Genmab (Nasdaq: GMAB) and US partner AbbVie (NYSE: ABBV) have reported a decisive win in a Phase III study of their bispecific therapy Epkinly (epcoritamab) for follicular lymphoma, potentially paving the way for the first approved bispecific combination regimen in the second-line setting.
In the EPCORE FL-1 trial, Epkinly combined with rituximab and lenalidomide (R2) significantly outperformed R2 alone, cutting the risk of disease progression or death by 79% and achieving a 95.7% overall response rate. The results came from a pre-planned interim analysis and will be filed with regulators worldwide.
The American medicines regulator has already accepted a priority review for the combination in patients who have received at least one prior therapy, setting a decision date of November 30. Approval would expand Epkinly’s US label, which currently covers third-line use in follicular lymphoma and relapsed/refractory diffuse large B-cell lymphoma.
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