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Genmab and AbbVie confirm epcoritamab Phase 3 misses survival endpoint
The Phase 3 EPCORE DLBCL-1 trial failed to show a statistically significant overall survival improvement in transplant-ineligible patients, keeping epcoritamab’s accelerated FDA approval but requiring a new regulator discussion.
Genmab and AbbVie clarified a key setback for their jointly developed T-cell engaging bispecific antibody, epcoritamab (DuoBody-CD3xCD20), after results from the Phase 3 EPCORE DLBCL-1 study. The trial compared epcoritamab monotherapy with investigator’s choice of chemoimmunotherapy in transplant-ineligible adults with relapsed or refractory diffuse large B-cell lymphoma, and the companies confirmed that in the United States overall survival was the sole primary endpoint.
According to Yahoo Finance, the study did not demonstrate a statistically significant improvement in overall survival, meaning it missed its primary endpoint. Even so, the drug maintains its accelerated FDA approval, and both companies now plan to review the full data set with regulators to determine the path forward.
The companies’ financial starting points differ in scale, with Genmab reporting $2.051 billion of total revenue in the first half of 2026, up 25% from $1.640 billion in the first half of 2025. Genmab said growth was driven by royalties of $1.708 billion, up 24%, and it raised its full-year 2026 revenue guidance to $4.325–$4.525 billion, with adjusted operating profit guidance of $1.065–$1.385 billion.
AbbVie, by contrast, reported net revenues of $16.99 billion in the second quarter of 2026, up 10.2% year over year, and adjusted diluted EPS of $3.65, up 22.9%. The outlet also highlighted that AbbVie’s immunology portfolio generated $8.79 billion of sales in the quarter, and neuroscience revenue rose 20.3% to $3.23 billion.