Phase Ib/II EPCORE NHL-2 trial: First-line epcoritamab + R2 in FL

Results from Arm 6 of the open-label, phase Ib/II EPCORE NHL-2 trial (NCT04663347), evaluating first-line epcoritamab + rituximab + lenalidomide (R2) in 41 patients with CD20⁺ follicular lymphoma (FL), were published in The Lancet Haematology by Falchi et al. The primary endpoint was investigator-assessed overall response rate (ORR).

Key data: At a median follow-up of 35.9 months, the investigator-assessed ORR was 95% (95% confidence interval [CI], 84–99), with a complete response (CR) rate of 88% (95% CI, 74–96). The median duration of response, duration of CR, progression-free survival (PFS), and overall survival (OS) were not reached [NR]; the estimated 33-month proportion of patients with an overall response, proportion of patients in CR, PFS rate, and OS rate were 89% (95% CI, 72–96), 93% (95% CI, 75–98), 90% (95% CI, 74–96), and 88% (95% CI, 73–95), respectively. All measurable residual disease (MRD)-evaluable patients (n = 26) achieved MRD negativity. Treatment-emergent adverse events (TEAEs) occurred in all patients. The most common Grade ≥3 TEAEs included neutropenia (49%), infections (29%), COVID-19 (15%), and alanine aminotransferase increase (12%). Serious adverse events (SAEs) occurred in 71% of patients, including cytokine release syndrome (CRS) in 32% of patients.

Key learning: In the EPCORE NHL-2 trial, fixed-duration epcoritamab + R2 demonstrated deep and durable responses in patients with FL, supporting further evaluation in larger, randomized studies.