Yasmin Karimi, Chan Y. Cheah, Michael Roost Clausen, David Cunningham, Umar Farooq, Tatyana Feldman, Hervé Ghesquieres, Wojciech Jurczak, Kim M. Linton, Tycel Phillips, Julie M. Vose, Won Seog Kim, Pegah Jafarinasabian, Barbara D’Angelo Månsson, David Soong, Andrew J. Steele, Zhu Li, Christian Winther Eskelund, Martin Hutchings, Catherine Thieblemont
Epcoritamab, a CD3xCD20 bispecific antibody, resulted in deep, durable responses with a manageable safety profile in patients with relapsed/refractory large B-cell lymphoma (LBCL) in EPCORE® NHL-1 (NCT03625037). We report results from a 3-year follow-up. Adults with relapsed/refractory LBCL received epcoritamab until progressive disease or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Median age was 64.0 years, 39% of patients received prior CAR T-cell treatment, and 75% were refractory to ≥ 2 consecutive lines of treatment. As of May 3, 2024 (median follow-up 37.1 months [range, 0.3–45.5]), ORR was 59% and complete response (CR) rate 41% by investigator assessment. Median duration of response was 20.8 months (95% confidence interval [CI], 13.0–32.0). Median duration of CR was 36.1 months (20.2–not reached [NR]); the longest ongoing CR was > 43 months. Median progression-free survival was 4.2 months (95% CI, 2.8–5.5) in all patients and 37.3 months (26.0–NR) in patients with CR. Median overall survival was 18.5 months (95% CI, 11.7–27.7) in all patients and NR in patients with CR. Of 119 patients evaluable for minimal residual disease (MRD) assessments, 54 (45%) were MRD-negative at any time during the study. Most common adverse events were cytokine release syndrome (51%), fatigue (25%), and pyrexia (25%), with no new safety signals. Grade 1, 2, and 3 infections occurred in 23%, 34%, and 24% of patients, respectively. The durability of responses and prolonged survival in complete responders suggest long-term disease-free survival with epcoritamab in these patients with relapsed/refractory LBCL.