Session: 627. Aggressive Lymphomas: Clinical and Epidemiological: Poster III
Hematology Disease Topics & Pathways:
Research, clinical trials, Biological therapies, Lymphomas, Bispecific Antibody Therapy, Clinical Research, B Cell lymphoma, Diseases, Therapies, Lymphoid Malignancies
Study Design and Methods: EPCORE NHL-6 is a phase 2, multicenter, open-label study in the United States evaluating the safety of epcoritamab in the outpatient setting without mandatory hospitalization after the first full dose of epcoritamab (NCT05451810). Eligible patients have R/R DLBCL or R/R FL grades 1 to 3a and received at least 2 prior lines of systemic antilymphoma therapies, including at least 1 anti-CD20 monoclonal antibody–containing therapy. Patients must have measurable disease at 1 or more sites and have an Eastern Cooperative Oncology Group performance status of 0 to 2. Approximately 80 patients with R/R DLBCL (n = 40) or R/R FL (n = 40) will be enrolled. Epcoritamab will be administered SC using step-up dosing (priming and intermediate doses on days 1 and 8) followed by full doses on days 15 and 22 in cycle 1 (28 days/cycle) and days 1, 8, 15, and 22 in cycles 2 and 3 (Figure). Additional doses will be administered every 2 weeks for cycles 4 to 9 and every 4 weeks for cycles 10 and beyond until disease progression or at least one of the treatment discontinuation criteria is met. Safety endpoints include the proportion of patients experiencing grade 3 or higher CRS, immune effector cell–associated neurotoxicity syndrome (ICANS), or neurotoxicity (Ntox). CRS and ICANS will be graded using American Society for Transplantation and Cellular Therapy guidelines (Lee et al, Bio Blood Marrow Transplant 2019). Secondary efficacy endpoints include overall response rate and complete response rate (as determined by Lugano 2014 criteria per investigator assessment). Secondary safety endpoints include incidence and severity of treatment-emergent adverse events and serious adverse events as well as median time to onset and resolution of grade 3 or higher CRS, ICANS, and Ntox. Select exploratory efficacy endpoints include duration of response, progression-free survival, and time to response, all of which are determined by Lugano 2014 criteria per investigator assessment, and overall survival. Enrollment will begin in 2022 at approximately 40 US sites.
Disclosures: Sharman: Lilly: Consultancy, Honoraria, Research Funding; Merck: Consultancy; TG Therapeutics: Consultancy, Research Funding; Genentech: Consultancy; Beigene: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Research Funding; ADC Therapeutics: Consultancy, Honoraria, Research Funding; Araris Biotech AG: Consultancy, Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees; Pharmacyclics LLC, an AbbVie Company: Honoraria; AbbVie: Consultancy, Honoraria, Research Funding; AstraZeneca: Consultancy, Honoraria, Research Funding. Boccia: Rigel: Consultancy, Honoraria, Research Funding, Speakers Bureau; AbbVie: Consultancy, Honoraria, Speakers Bureau; Karyopharm: Speakers Bureau; Bristol Myers Squibb: Honoraria, Speakers Bureau; Sanofi: Speakers Bureau; AstraZeneca: Consultancy, Honoraria, Research Funding, Speakers Bureau; Regeneron: Speakers Bureau; Genmab: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Incyte: Consultancy, Honoraria, Research Funding, Speakers Bureau; Genentech: Consultancy, Honoraria, Research Funding, Speakers Bureau; Daiichi Sankyo: Consultancy, Honoraria, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau. Doerr: AbbVie: Current Employment, Current equity holder in publicly-traded company. Conte: AbbVie: Current Employment, Current equity holder in publicly-traded company. Bai: AbbVie: Current Employment, Current equity holder in publicly-traded company. Elliott: Genmab: Current Employment, Current equity holder in publicly-traded company. Andorsky: AbbVie: Research Funding; Astra Zeneca: Consultancy, Research Funding; Epizyme: Research Funding; Novartis: Research Funding.
See more of: Oral and Poster Abstracts