AbbVie, Genmab clarify epcoritamab Phase 3 EPCORE DLBCL-1 misses US primary endpoint overall survival
ABBV•Next steps
Additional trial results are slated for submission to a peer-reviewed medical journal.
Phase 3 trial endpoint clarification
AbbVie issued a clarification on the Phase 3 EPCORE DLBCL-1 trial endpoints for epcoritamab in relapsed or refractory DLBCL.
- Overall survival was the sole U.S. primary endpoint.
- The trial did not show a statistically significant improvement in overall survival.
Implications for accelerated approval support
The miss on the U.S. primary endpoint raises pressure on epcoritamab’s confirmatory evidence supporting its accelerated approval in DLBCL.
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