Genmab and AbbVie said Monday that a combination of their bispecific antibody Epkinly and standard chemotherapy cut the risk of disease progression or death by 51 percent compared with chemotherapy alone in a Phase 3 trial in newly diagnosed diffuse large B-cell lymphoma, the most common form of lymphoma. The EPCORE DLBCL-2 trial enrolled newly diagnosed patients with an International Prognostic Index score of 2 to 5, randomized to a widely used chemotherapy combination known as R-CHOP plus either Epkinly or a placebo, and showed a hazard ratio of 0.49 with a p-value below 0.0001.
The readout topped what Roche’s antibody-drug conjugate Polivy delivered in its own testing, though cross-trial comparisons carry the usual caveats. It also moves the bispecific antibody class decisively earlier in treatment. Epkinly won an accelerated U.S. approval in the third-line setting in 2023; a standard clearance in newly diagnosed patients would make it the first drug of its kind approved in first-line DLBCL.
Genmab’s U.S.-listed shares jumped as much as 14 percent Monday. Genmab, which splits ownership with AbbVie, reported $312 million in global Epkinly net sales in the first half of the year. Analysts moved quickly: TD Cowen’s Yaron Werber called the data the basis for Epkinly becoming the “undisputed” standard of care with eventual sales of $3 billion a year, while Jefferies said its forecast of $1.4 billion in peak first-line sales alone could prove conservative. The companies said they will discuss the results with regulators and present them at a future medical meeting. Rivals are not standing still: Roche’s Lunsumio has completed a Phase 2 trial and AstraZeneca’s Calquence is in a Phase 3 frontline study with results expected early next year.