Clinical lymphoma, myeloma & leukemia · 2026
Epcoritamab Monotherapy as Outpatient Treatment for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Interim Results From EPCORE NHL-6.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Andorsky David, Lopez Adelba Torres, Vaidya Rakhee, Madueno Fernando Vargas, Ibrahimi Sami, Naik Seema, Gandhi Mitul, Haydu Julie Erika, Lash Bradley, Fesler Mark, Hrom John, Lee Eric H, Sundaram Suchitra, Conte Kristin, Osei-Bonsu Kojo, Doerr Thomas, Bai Yang, Dixit Neha, Eskelund Christian W, Boardman Alexander P, Boccia Ralph, Lee Christina Y, Sharman Jeff P
Аннотация
BACKGROUND: Epcoritamab, a CD3 × CD20 bispecific antibody approved for relapsed/refractory diffuse large B-cell lymphoma (DLBCL), is administered subcutaneously with recommended 24 hours inpatient monitoring after the first full dose (FFD). EPCORE NHL-6 (NCT05451810) investigated feasibility of outpatient monitoring after FFD of epcoritamab in second-line or later (2L+) DLBCL.
METHODS: Patients received epcoritamab in 28-day (D) cycles (C): (0.16-mg and 0.8-mg C1 step-up doses, 48-mg full dose C1D15 onward [C1-3, QW; C4-9, Q2W; C ≥ 10, Q4W]). Primary endpoints were grade ≥ 3 cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and neurologic events. Patients remained ≤ 30 minutes from the hospital post-FFD and received mandatory CRS prophylaxis during C1.
RESULTS: Ninety-two patients enrolled at United States and Puerto Rico academic and community sites received ≥ 1 epcoritamab dose. With 7.6-months median follow-up, 50.0% remained on treatment. For administration and planned monitoring of FFD, 81/88 patients were outpatient and 7/88 inpatient (admitted for postdose monitoring [n = 5] and other reason [n = 2]). Twenty-four of 81 patients monitored outpatient developed CRS within 1 week post-FFD. CRS hospitalization rate was 13.6% (11/81). Overall, CRS occurred in 40.2% (grade 1-2, 38.0%; grade 3, 2.2%). ICANS occurred in 7.6% (grade 1-2, 6.5%; grade 3, 1.1%). All CRS and ICANS resolved; none led to treatment discontinuation. Overall response rate (Lugano criteria) was 62.0% (complete response rate, 42.4%).
CONCLUSIONS: CRS and ICANS incidence and severity were consistent with the pivotal EPCORE NHL-1 trial findings. The results support feasibility of outpatient administration and monitoring of epcoritamab in 2L+ DLBCL without mandatory hospitalization for monitoring.
METHODS: Patients received epcoritamab in 28-day (D) cycles (C): (0.16-mg and 0.8-mg C1 step-up doses, 48-mg full dose C1D15 onward [C1-3, QW; C4-9, Q2W; C ≥ 10, Q4W]). Primary endpoints were grade ≥ 3 cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and neurologic events. Patients remained ≤ 30 minutes from the hospital post-FFD and received mandatory CRS prophylaxis during C1.
RESULTS: Ninety-two patients enrolled at United States and Puerto Rico academic and community sites received ≥ 1 epcoritamab dose. With 7.6-months median follow-up, 50.0% remained on treatment. For administration and planned monitoring of FFD, 81/88 patients were outpatient and 7/88 inpatient (admitted for postdose monitoring [n = 5] and other reason [n = 2]). Twenty-four of 81 patients monitored outpatient developed CRS within 1 week post-FFD. CRS hospitalization rate was 13.6% (11/81). Overall, CRS occurred in 40.2% (grade 1-2, 38.0%; grade 3, 2.2%). ICANS occurred in 7.6% (grade 1-2, 6.5%; grade 3, 1.1%). All CRS and ICANS resolved; none led to treatment discontinuation. Overall response rate (Lugano criteria) was 62.0% (complete response rate, 42.4%).
CONCLUSIONS: CRS and ICANS incidence and severity were consistent with the pivotal EPCORE NHL-1 trial findings. The results support feasibility of outpatient administration and monitoring of epcoritamab in 2L+ DLBCL without mandatory hospitalization for monitoring.