AbbVie and Genmab have announced that their bispecific antibody, Epkinly, did not achieve a statistically significant improvement in overall survival (OS) in a Phase III trial involving patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL). The study, known as EPCORE DLBCL-1, enrolled 483 patients who were not eligible for high-dose chemotherapy or autologous stem cell transplantation.
The results showed a 4% improvement in OS for those treated with Epkinly compared to an investigator’s choice of chemotherapy. However, this difference was not statistically significant. Analysts from William Blair described the outcome as “unfortunate” but noted that it “doesn’t detract from key second/first-line DLBCL readouts in 2026.” Truist Securities analysts called the OS miss “disappointing,” but stated it “doesn’t waver our optimism on [Epkinly’s] frontline trial.”
The FDA is using OS as a primary endpoint for the EPCORE DLBCL-1 trial. William Blair analysts explained that the lack of significant benefit has led to concerns among investors about whether Epkinly's current indication—approved under the accelerated pathway in May 2023—might be at risk. As part of its accelerated approval, continued authorization depends on confirmation of clinical benefit through further study.
Despite these concerns, William Blair analysts said: “we believe it is unlikely Epkinly would lose accelerated approval in DLBCL.”
While overall survival did not meet expectations, Epkinly demonstrated other benefits. It significantly improved progression-free survival by reducing the risk of disease progression or death by 26% compared to chemotherapy. Additional improvements were seen in complete response rate, duration of response, and time to next treatment.
AbbVie and Genmab plan to consult with global health authorities regarding future steps for Epkinly in this patient group.
The companies began their collaboration on Epkinly development in June 2020 and currently share U.S. commercialization responsibilities. They are also conducting other late-stage studies: EPCORE-DLBCL-4 is evaluating Epkinly combined with lenalidomide versus chemo-immunotherapy; EPCORE DLBCL-2 is studying its combination with rituximab and standard chemotherapy agents. Results from both studies are expected later this year.
