Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial

• Published in: Leukemia
• Main Authors: Thieblemont, Catherine, Karimi, Yasmin H, Ghesquieres, Herve, Cheah, Chan Y, Clausen, Michael Roost, Cunningham, David, Jurczak, Wojciech, Do, Young Rok, Gasiorowski, Robin, Lewis, David John, Kim, Tae Min, van der Poel, Marjolein, Poon, Michelle Limei, Feldman, Tatyana, Linton, Kim M, Sureda, Anna, Hutchings, Martin, Dinh, Minh H, Kilavuz, Nurgul, Soong, David, Mark, Thomas, Sacchi, Mariana, Phillips, Tycel, Lugtenburg, Pieternella J
• Format: Journal Article
• Language: English
• Published: England 25.09.2024
• ISSN: 0887-6924; 1476-5551; 1476-5551
• DOI: 10.1038/s41375-024-02410-8

Primary results (median follow-up, 10.7 months) from the pivotal EPCORE NHL-1 study in relapsed or refractory (R/R) large B-cell lymphoma (LBCL) demonstrated deep, durable responses with epcoritamab, a CD3xCD20 bispecific antibody, when used as monotherapy. We report long-term efficacy and safety results in patients with LBCL (N = 157; 25.1-month median follow-up). As of April 21, 2023, overall response rate was 63.1% and complete response (CR) rate was 40.1%. Estimated 24-month progression-free survival (PFS) and overall survival (OS) rates were 27.8% and 44.6%, respectively. An estimated 64.2% of complete responders remained in CR at 24 months. Estimated 24-month PFS and OS rates among complete responders were 65.1% and 78.2%, respectively. Of 119 minimal residual disease (MRD)-evaluable patients, 45.4% had MRD negativity, which correlated with longer PFS and OS. CR rates were generally consistent across predefined subgroups: 36% prior chimeric antigen receptor (CAR) T-cell therapy, 32% primary refractory disease, and 37% International Prognostic Index ≥3. The most common treatment-emergent adverse events were cytokine release syndrome (51.0%), pyrexia (24.8%), fatigue (24.2%), and neutropenia (23.6%). These results underscore the long-term benefit of epcoritamab for treating R/R LBCL with deep responses across subgroups, including patients with hard-to-treat disease and expected poor prognosis (ClinicalTrials.gov Registration: NCT03625037).