Despite the late-stage miss, analysts maintained confidence in the Epkinly program, with Truist Securities saying the result “doesn’t waver our optimism” regarding the bispecific antibody’s ongoing frontline trial.
AbbVie and Genmab’s bispecific antibody Epkinly did not significantly improve overall survival in a late-stage study of patients with a specific type of relapsed or refractory diffuse large B cell lymphoma.
Analysts appeared to find these results discouraging but maintained faith in the Epkinly franchise. In a note to investors on Friday, William Blair called the outcome “unfortunate” but added that it “doesn’t detract from key second/first-line DLBCL readouts in 2026.” Similarly, while Truist Securities found the overall survival (OS) miss “disappointing,” the analysts said in a Friday note that it “doesn’t waver our optimism on [Epkinly’s] frontline trial.”
The Phase III EPCORE DLBCL-1 trial, which is still ongoing, has enrolled 483 patients with relapsed or refractory disease who can’t undergo high-dose chemotherapy or autologous stem cell transplantation. Results announced on Friday showed a 4% improvement in OS in patients treated with Epkinly versus those given an investigator’s choice of chemotherapy. This effect did not reach statistical significance.
The FDA is considering OS as a primary endpoint for EPCORE DLBCL-1, William Bair explained on Friday. The analysts added that failing to elicit a significant benefit here has raised questions/concerns from investors as to whether the current relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) indication, approved under the accelerated pathway in May 2023, is at risk.
As an accelerated nod, Epkinly’s continued approval in this indication depends on the verification of its clinical benefit in a Phase III confirmatory study.
Despite the miss, “we believe it is unlikely Epkinly would lose accelerated approval in DLBCL,” the analysts added.
Beyond OS, Epkinly did show a significant improvement in progression-free survival, cutting the risk of disease progression or death by 26% compared to chemotherapy. The bispecific also led to improvements in other endpoints, including complete response rate, duration of response and time to next treatment.
With these findings, AbbVie and Genmab said they will approach global health authorities to determine the best path forward for Epkinly in this indication.
The two companies originally partnered in June 2020 to collaborate on the development of Epkinly and today share commercialization responsibilities in the U.S.
In DLBCL, the companies are also running the Phase III EPCORE-DLBCL-4 study, which is assessing Epkinly in combination with lenalidomide against chemo-immunotherapy, according to Friday’s release. There is also the late-stage EPCORE DLBCL-2, combining Epkinly with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone. Both studies are set to read out this year.
