Genmab A/S (NASDAQ: GMAB) presented subgroup analysis data from its Phase 3 EPCORE FL-1 trial at the European Hematology Association Congress. The analysis examined epcoritamab combined with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma.

The trial randomized 481 patients, with 243 receiving the epcoritamab combination and 238 receiving rituximab and lenalidomide alone. The subgroup analysis evaluated treatment benefits across different patient risk categories, including Follicular Lymphoma International Prognostic Index scores and disease progression patterns.

Progression-free survival benefits favored the epcoritamab combination across all analyzed subgroups. Hazard ratios remained below 0.3 for patients with FLIPI scores of 0-2 (0.18) and FLIPI scores of 3-5 (0.25). The combination also showed benefits in patients with early disease progression and various fitness levels.

Overall response rates were higher with the combination therapy compared to standard treatment. For patients with lower FLIPI scores, the response rate was 96.5% versus 84.8%. In higher-risk patients with FLIPI scores of 3-5, the response rate was 93.0% versus 72.6%.

Complete response rates were consistently higher across all subgroups with the combination treatment. Lower-risk patients achieved complete responses in 86.6% of cases with the combination versus 62.1% with standard therapy.

The safety profile remained consistent with the overall trial population across all patient subgroups. No new safety signals were identified in the subgroup analysis. Adverse events including neutropenia and infections occurred more frequently in patients receiving reduced lenalidomide doses, though efficacy was maintained.

Epcoritamab, approved as EPKINLY in the United States and Japan, is a subcutaneous bispecific antibody developed using Genmab's DuoBody technology. The treatment is co-developed by Genmab and AbbVie and has received regulatory approval for certain lymphoma indications in more than 65 territories.