Genmab and AbbVie reported Monday that adding their bispecific antibody Epkinly to standard R-CHOP chemotherapy cut the risk of disease progression or death by 51% in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). The Phase 3 study enrolled 900 people at intermediate or high risk, comparing the combination against chemotherapy plus placebo. The companies said they will discuss the data with regulators and present full results at a future medical meeting.
Epkinly belongs to a class of bispecific antibodies that bridge tumor cells and T cells to provoke an immune attack. It already holds accelerated U.S. approval for third-line DLBCL, but these results could make it the first bispecific cleared for initial treatment of the disease. The drug class carries immune-related side effects that sometimes require inpatient monitoring, though providers have developed remote assessment methods that are broadening use.
Analysts responded enthusiastically. Leerink's Asthika Goonewardene called the outcome a 'blockbuster affirming' moment, while TD Cowen's Yaron Werber said Epkinly should become the 'undisputed' standard of care, potentially reaching $3 billion in annual sales. Jefferies' Benjamin Jackson cautioned that peak sales forecasts depend on gaining market share. Rival therapies are in development, including Roche's Lunsumio and AstraZeneca's Calquence, with the latter's Phase 3 results expected early next year.