Session: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III
Hematology Disease Topics & Pathways:
Research, clinical trials, Biological therapies, Lymphomas, Bispecific Antibody Therapy, Clinical Research, B Cell lymphoma, Combination therapy, Diseases, Therapies, immunology, Lymphoid Malignancies
Study Design and Methods: EPCORE FL-1 (NCT05409066) is a global, randomized, open-label, multicenter phase 3 trial designed to evaluate efficacy and safety of epcoritamab in combination with R2 vs R2 alone in adults with histologically confirmed grades 1 to 3a R/R FL after at least 1 prior line of systemic anti-lymphoma therapy, including an anti-CD20 monoclonal antibody (not including prior radiotherapy). Other key eligibility criteria include Eastern Cooperative Oncology Group performance status 0 to 2, fluorodeoxyglucose positron emission tomography–avid disease, and at least 1 measurable disease site. Lenalidomide-refractory FL is excluded. Approximately 642 patients will be randomized in a 1:1:1 ratio to receive alternative full doses of epcoritamab in combination with R2 or R2 alone (Figure). Epcoritamab will be subcutaneously administered using a step-up dosing regimen followed by a full dose of epcoritamab in cycle 1 (28 days/cycle). Full doses of epcoritamab will be administered weekly in cycle 2 and monthly in cycles 3 and beyond. Patients will receive up to 12 cycles of treatment and will be assessed for disease progression per the 2014 Lugano criteria. Primary endpoint is progression-free survival (PFS) as assessed by blinded independent review committee (IRC). Secondary efficacy endpoints include response rates (per Lugano criteria by IRC), overall survival and minimal residual disease negativity. Other efficacy endpoints include duration of response, duration of complete response, event-free survival, time to next anti-lymphoma treatment, and patient-reported outcomes. Safety endpoints include incidence and severity of treatment-emergent adverse events and adverse events of special interest. Exploratory endpoints include assessments of pharmacodynamic and pharmacokinetic data. The study opened for enrollment in 2022 in North America, South America, Europe, Africa, Asia, and Australia.
Disclosures: Falchi: AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Genentech/Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Genmab: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; ADC Therapeutics: Membership on an entity's Board of Directors or advisory committees; Astrazeneca: Membership on an entity's Board of Directors or advisory committees; Seagen: Membership on an entity's Board of Directors or advisory committees. Morschhauser: Janssen: Speakers Bureau; Miltenyi: Membership on an entity's Board of Directors or advisory committees; Allogene therapeutics: Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Epizyme: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genentech: Consultancy; Bristol Myers Squibb: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead Sciences: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genmab: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Gribben: Novartis: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Morphosys AG: Consultancy; Gilead Sciences: Consultancy, Honoraria; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; AstraZeneca: Consultancy, Honoraria, Research Funding; AbbVie: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; European Hematological Association: Membership on an entity's Board of Directors or advisory committees. Dinh: AbbVie: Current Employment, Current equity holder in publicly-traded company. Conlon: AbbVie: Current Employment, Current equity holder in publicly-traded company. Chen: AbbVie: Current Employment, Current equity holder in publicly-traded company. Elliot: Genmab: Current Employment, Current equity holder in publicly-traded company. Seymour: TG Therapeutics: Consultancy; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Consultancy, Research Funding, Speakers Bureau; Genor Biopharma: Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau.