Epcoritamab (Epcor) Plus Lenalidomide - (EPCORE DLBCL-4)
- Indication
- Relapsed/Refractory Large B-cell Lymphoma (R/R LBCL)
- Stage
- phase3
- Event
- End of Phase Meeting
- Details
June 29, 2026: Genmab A/S (NASDAQ: GMAB) reported topline results from the global Phase 3, open-label, randomized EPCORE DLBCL-4 trial (NCT06508658) in adult relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after ≥1 prior line of therapy, comparing fixed-duration subcutaneous epcoritamab (GEN3013; CD3xCD20 bispecific) + lenalidomide versus standard rituximab + gemcitabine + oxaliplatin (R-GemOx). The study met its primary endpoint, showing a statistically significant and clinically meaningful progression-free survival (PFS) benefit: risk of progression/death reduced by 60% (HR 0.40; 95% CI 0.30–0.55; p<0.0001) and 56% (HR 0.44; 95% CI 0.33–0.60; p<0.0001) using different U.S. vs ex-U.S. censoring rules. Safety for the combination was consistent with known profiles of the individual agents.
Genmab and AbbVie plan to engage global regulators, and intend to submit data for presentation at a future medical meeting. The trial started August 13, 2024 and is ongoing.
- Source
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