Genmab and AbbVie's Epcoritamab Plus R-CHOP Cuts Frontline DLBCL Progression Risk by 51% in Phase 3

Genmab and AbbVie reported on October 5 that the Phase 3 EPCORE DLBCL-2 trial succeeded: adding epcoritamab to standard R-CHOP chemotherapy reduced the risk of disease progression or death by 51% versus R-CHOP alone in patients with newly diagnosed diffuse large B-cell lymphoma and International Prognostic Index scores of 2 to 5 (HR 0.49, 95% CI 0.36 to 0.67, p < 0.0001). The primary endpoint, measured in the higher-risk IPI 3 to 5 group, came in at the same hazard ratio of 0.49 (95% CI 0.35 to 0.69).

The companies describe EPCORE DLBCL-2 as the first Phase 3 study of a bispecific antibody combination to show a statistically significant improvement in progression-free survival in frontline DLBCL. That matters because R-CHOP has been the backbone of first-line treatment for this aggressive lymphoma for a long time, and a positive add-on trial opens the largest segment of the market to a drug that today is approved only in later lines. Epcoritamab is sold as EPKINLY in the U.S. and Japan and TEPKINLY in the EU, approved for certain lymphoma indications in more than 65 countries; the R-CHOP combination remains investigational. Safety was described as generally well tolerated and consistent with the known profiles of the individual agents.

The economics are shared: Genmab and AbbVie split commercial responsibilities in the U.S. and Japan, while AbbVie handles other markets, so a frontline label would matter more to Genmab's revenue mix than to AbbVie's much larger base. Genmab's U.S.-listed shares were up 10.7% at $38.48 in our latest delayed quote, on a day that also brought separate Rina-S ovarian cancer data, so the move cannot be attributed to this readout alone.

What to watch: full data at an upcoming medical meeting, including overall survival, which the release did not report, and how regulators respond. The companies said only that they will engage global regulatory authorities to determine next steps, so no filing timeline has been set.