SignalFDA/Bio
AbbVie and Genmab Announce Epcoritamab in Combination with R-CHOP Demonstrates Significant Improvement in Progression-Free Survival versus R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell
Epcoritamab plus R-CHOP significantly improved progression-free survival in newly diagnosed DLBCL.
Context
What happened: AbbVie (NYSE: ABBV) and Genmab (Nasdaq: GMAB) reported positive topline results from the Phase 3 EPCORE DLBCL-2 trial of epcoritamab plus R-CHOP versus R-CHOP alone in newly diagnosed diffuse large B-cell lymphoma.
Key numbers: Risk of disease progression or death reduced by 51% (HR 0.49 [95% CI 0.36, 0.67]; p-value <
Why it matters: The companies said this is the first Phase 3 study of a bispecific antibody combination to show a statistically significant PFS improvement in frontline DLBCL. Based on the results, AbbVie and Genmab will engage global regulatory authorities.
What changed
AbbVie (NYSE: ABBV) and Genmab (Nasdaq: GMAB) reported positive topline results from the Phase 3 EPCORE DLBCL-2 trial of epcoritamab plus R-CHOP versus R-CHOP alone in newly diagnosed diffuse large B-cell lymphoma.
Why it matters
The companies said this is the first Phase 3 study of a bispecific antibody combination to show a statistically significant PFS improvement in frontline DLBCL. Based on the results, AbbVie and Genmab will engage global regulatory authorities.