Incyte (NASDAQ: INCY) reported that its Phase 3 frontMIND trial met its primary endpoint, showing that adding tafasitamab and lenalidomide to standard R-CHOP therapy reduced the risk of disease progression or death by 25% in patients with previously untreated, high-risk diffuse large B-cell lymphoma.

The trial evaluated 899 adults with high-risk DLBCL and high-grade B-cell lymphoma. Patients receiving the combination therapy showed a progression-free survival rate of 71.1% at two years compared to 62.9% for those receiving R-CHOP alone. At three years, the rates were 67.3% versus 60.7%, respectively.

The combination also improved event-free survival with a hazard ratio of 0.79. Interim overall survival analysis showed a positive trend with a hazard ratio of 0.85, though this did not reach statistical significance.

The most common side effects in the combination group were neutropenia (70.7%), anemia (46.3%) and peripheral neuropathy (40.6%). Grade 3 or higher adverse events occurred more frequently with the combination therapy (86.7%) compared to R-CHOP alone (76.1%).

Treatment discontinuation rates were similar between groups at approximately 5%. Fatal adverse events occurred in 5.9% of combination therapy patients versus 3.8% in the control group, though overall deaths were lower in the combination arm (18.5% versus 21.7%).

The company plans to submit global regulatory applications based on these results. The data were presented at the American Society of Clinical Oncology Annual Meeting and published simultaneously in The Lancet.

DLBCL represents 40% of all non-Hodgkin lymphoma cases, with approximately 24,000 new diagnoses annually in the United States. About 40% of patients do not respond to initial therapy or experience relapse.