Multicenter, randomized phase II study of epcoritamab for patients with large B-cell lymphomas achieving a partial response after CD19-directed CAR T-cell therapy (CAR-T).

• DOI: 10.1200/jco.2024.42.16_suppl.tps7100
• Publication Date: 2024-06-10T18:42:23Z
• Authors: Allison Marie Bock; Sandeep Raj; Sharmila Giri; Lori Ann Leslie; Dilan Anil Patel; Madiha Iqbal; Natalie Sophia Gr...; Boyu Hu; Miguel-Angel Perales; Grzegorz S. Nowak...
• Keywords: CAR T-cell therapy; Cell therapy

TPS7100 Background: Despite the promising efficacy of CAR-T for patients with relapsed or refractory (R/R) large B-cell lymphomas (LBCL), more than 60% will relapse, majority which occur in first 6 months. Approximately 30% LBCL treated achieve a partial response (PR) on day 30 (D30) PET-CT assessment. Of D30 PR, 70% eventually progress, yet standard care remains close observation. Early consolidative treatment strategies utilizing therapies different mechanism action may improve outcomes, but there are currently no reliable biomarkers. Epcoritamab (Epco), bispecific antibody directed against CD20 and CD3, has been approved by FDA who relapse after at least 2 lines therapy. In phase study, Epco was associated an overall rate (ORR) 63% complete (CR) 39%, including similar responses subset were 100 days post CAR-T. This study is trial-in-progress that evaluate epco compared to observation LBCLs achieving PR Methods: investigator-initiated, randomized, II, multicenter, open-label (NCT06238648) evaluating monotherapy fixed duration 12 cycles A maximum 120 be randomized 1:1 across 10 academic centers. Stratification factors include line (second vs third line) costimulatory domain (CD28 4-1BB). Key inclusion criteria PET evidence PR. non-bulky disease ( <7.5cm), ANC >1000, hemoglobin >7 g/dL if asymptomatic >8 symptomatic, platelet count >50,000. G-CSF, pRBCs transfusions allowed. exclusion prior anti CD20xCD3 therapy, ongoing uncontrolled CRS ICANS, active symptomatic CNS disease. administered subcutaneously dose 0.16mg 1, 0.8mg 8, full 48mg 15. weekly 28 (C) C1-3, 1 15 C4-9 C10-12. assessed 2014 Lugano cycles, then every 3 months during treatment. The primary objective efficacy, measured as conversion from CR. secondary endpoints frequency severity emergent adverse events, ORR, response, progression free survival, event survival. Peripheral blood samples collected pre-treatment assess biomarkers resistance. activated January 2024 recruitment ongoing. Clinical trial information: NCT06238648 .