Genmab and AbbVie's Epcoritamab Fails Primary Endpoint in Phase 3 DLBCL Trial
Event summary
- Genmab and AbbVie's Phase 3 EPCORE® DLBCL-1 trial for epcoritamab failed to meet its primary endpoint of overall survival in the U.S.
- The study compared epcoritamab monotherapy against investigator's choice of chemoimmunotherapy in relapsed/refractory DLBCL patients ineligible for stem cell transplant.
- Topline results were previously announced on January 16, 2026, with additional data presented at the EHA 2026 Congress on June 12, 2026.
- Epcoritamab is already approved under FDA's accelerated approval pathway for relapsed/refractory DLBCL after two or more lines of therapy.
The big picture
This setback comes amid intense competition in the relapsed/refractory DLBCL space, where bispecific antibodies are vying for dominance. The failure highlights the challenges of developing next-generation immunotherapies that can outperform existing chemoimmunotherapy regimens. Both Genmab and AbbVie have significant stakes in this collaboration, with epcoritamab representing a key growth driver in their oncology portfolios.
What we're watching
- Pipeline Resilience
- Whether Genmab and AbbVie can offset this setback with positive data from other epcoritamab trials, including EPCORE DLBCL-2 and EPCORE DLBCL-4.
- Regulatory Impact
- How this failure might affect the accelerated approval status of epcoritamab in existing indications.
- Commercial Strategy
- The pace at which Genmab and AbbVie can pivot to other combination therapies or indications for epcoritamab to maintain market momentum.
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