Press release
Incyte Announces Positive Topline Results from Pivotal Study of Tafasitamab (Monjuvi®/Minjuvi®) as a First-line Treatment for Diffuse Large B-Cell Lymphoma
- Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®/Minjuvi®) and lenalidomide in addition to R-CHOP met its primary
About this update from Incyte Corporation
[{"type":"text","content":"\n- Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®/Minjuvi®) and lenalidomide in addition to R-CHOP met its primary endpoint of progression-free survival (PFS)\n\n\n- Based on these results, Incyte plans to file a supplemental Biologics License Application (sBLA) for tafasitamab and lenalidomide in addition to R-CHOP in first-line diffuse large B-cell lymphoma (DLBCL) in the first half of 2026\n\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced positive topline results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®/Minjuvi®), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, and lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared to R-CHOP alone as a first-line treatment for adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL) with an International Prognostic Index (IPI) score of three to five (3-5) for patients >60 years of age, or age-adjusted IPI (aaIPI) of two to three (2-3) for patients ≤60 years of age.\n\n\nThe trial met its primary endpoint of progression-free survival (PFS) by investigator assessment (Hazard Ratio 0.75 [0.59,0.96]; p-value 0.019), according to Lugano 2014 criteria. The trial also met its key secondary endpoint of event-free survival (EFS) by investigator assessment. No new safety signals were observed.\n\n\n“The frontMIND study results highlight the potential benefit of combining tafasitamab and lenalidomide with R-CHOP as an effective treatment option, offering the possibility of cures for more newly diagnosed DLBCL patients,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “Despite improvement in treatment for patients with DLBCL, outcomes for many high-risk patients are not optimal. We look forward to working with regulatory authorities globally and to providing a new treatment option for patients in the future.”\n\n\nDLBCL is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, representing 40% of all cases.1 It is characterized as an aggressive, fast-growing type of lymphoma that can emerge in lymph nodes or extranodal sites such as the gastrointestinal tract, skin and brain.2 Each year, approximately 24,000 people in the U.S. and up to 36,000 people in Europe ...