Incyte announces frontMIND trial meets primary, secondary endpoints

Incyte (INCY) announced topline results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, and lenalidomide in addition to R-CHOP compared to R-CHOP alone as a first-line treatment for adults with newly diagnosed diffuse large B-cell lymphoma with an International Prognostic Index score of three to five for patients greater than 60 years of age, or age-adjusted IPI of two to three for patients less than or equal to 60 years of age. The trial met its primary endpoint of progression-free survival by investigator assessment, according to Lugano 2014 criteria. The trial also met its secondary endpoint of event-free survival by investigator assessment. No new safety signals were observed. Based on these results, Incyte expects to file a supplemental biologics license application for tafasitamab for the first-line treatment of adults with newly diagnosed DLBCL in the first half of 2026. The frontMIND data will be submitted for presentation at an upcoming scientific meeting.