Incyte Reports Positive Phase III Results for Tafasitamab Combo in Newly Diagnosed DLBCL

Incyte has announced positive topline results from the Phase III frontMIND trial evaluating tafasitamab (Monjuvi/Minjuvi) plus lenalidomide in combination with standard R-CHOP therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL). DLBCL is the most common adult form of non-Hodgkin lymphoma, accounting for about 40% of cases worldwide.

The global, randomized, double-blind, placebo-controlled study enrolled around 900 adults aged 18 to 80 years with high-risk disease. Patients receiving tafasitamab and lenalidomide added to R-CHOP showed a significant improvement in progression-free survival, the primary endpoint, with a hazard ratio of 0.75 and a p-value of 0.019. The key secondary endpoint of event-free survival was also met, and no new safety concerns were identified.

Based on these results, Incyte plans to submit a supplemental biologics license application in the first half of 2026 and present detailed findings at a future scientific meeting.

06-01-2026