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DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Epcoritamab improved progression-free survival by 26% in a global Phase 3 trial of 483 patients with relapsed/refractory diffuse large B-cell lymphoma ineligible for transplant.
- AbbVie and Genmab revealed topline EPCORE DLBCL-1 results, showing improved progression-free survival with HR: 0.74, on January 13, 2021.
- DLBCL affects roughly 25,000 new U.S. patients each year, and many tumors relapse or become refractory, prompting the EPCORE DLBCL-1 trial starting January 13, 2021 to enroll patients ineligible for HDT-ASCT.
- The global Phase 3 enrolled 483 patients with R/R DLBCL, 73% with two or more prior lines, and Epcoritamab was given subcutaneously as a CD3xCD20 bispecific.
- AbbVie and Genmab will engage global regulatory authorities and submit data for presentation while pursuing additional approvals and sharing U.S. and Japan commercial responsibilities, with AbbVie responsible for further global commercialization.
- While notable as the first Phase 3 PFS win for this class, EPCORE DLBCL-1 did not show a statistically significant overall survival benefit with HR: 0.96 amid COVID-19 pandemic .
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AbbVie Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Based on the topline results from the EPCORE® DLBCL-1 trial, AbbVie along with partner Genmab will engage global regulatory authorities to discuss next steps
·Flint, United States
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Leaning Left1Leaning Right1Center8Last UpdatedBias Distribution80% Center
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C 80%
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