Incyte Late-Breaking Tafasitamab (Monjuvi®) Data at ASH 2024 Demonstrate Significantly Improved Progression-Free Survival in Patients with Relapsed or Refractory Follicular Lymphoma

• The pivotal Phase 3 inMIND trial met its primary endpoint of progression-free survival (PFS) and key secondary endpoints in patients with relapsed or refractory follicular lymphoma (FL) treated with tafasitamab (Monjuvi®) in combination with lenalidomide and rituximab
• Positive data featured in a late-breaking oral presentation at the 2024 American Society of Hematology (ASH) Annual Meeting support the planned U.S. filing of a supplemental Biologics License Application (sBLA) for tafasitamab in FL by year-end 2024
• Incyte to host virtual analyst and investor event on Thursday, December 12, 2024, from 4:00-5:00 p.m. ET to discuss key data presented at ASH

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced additional results from the pivotal Phase 3 inMIND trial evaluating treatment with tafasitamab (Monjuvi®), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL). These data are featured today in the Late-breaking Session (LBA-1) at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego.

The late-breaking results, which build on previously announced topline data, show that the study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in 548 patients with FL. Patients treated with tafasitamab achieved a median PFS by investigator assessment of 22.4 months compared to 13.9 months in the control arm (Hazard Ratio [HR]: 0.43; 95% Confidence Interval [CI] (0.32—0.58); P