What's Happening?
AbbVie and Genmab's 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 EPCORE DLBCL-1 trial, which is still ongoing, enrolled 483 patients who were not candidates for high-dose chemotherapy or autologous stem cell transplantation. The results showed a 4% improvement in OS for patients treated with Epkinly compared to those receiving an investigator's choice of chemotherapy, but this did not reach statistical significance. Despite this setback, analysts remain optimistic about Epkinly's potential in other trials, noting improvements in progression-free survival and other endpoints.
Why It's Important?
The failure to meet the primary endpoint raises concerns about the future of Epkinly's approval for treating relapsed or refractory DLBCL, which was initially granted under an accelerated pathway in May 2023. The continued approval of Epkinly in this indication depends on the verification of its clinical benefit in a Phase III confirmatory study. The outcome of this trial is crucial for AbbVie and Genmab, as it could impact investor confidence and the companies' strategic plans. However, the significant improvement in progression-free survival and other secondary endpoints provides a silver lining, suggesting that Epkinly may still hold promise in other treatment settings.
What's Next?
AbbVie and Genmab plan to engage with global health authorities to determine the best path forward for Epkinly in treating DLBCL. The companies are also conducting additional Phase III studies, including EPCORE-DLBCL-4 and EPCORE DLBCL-2, which are expected to report results later this year. These studies will assess Epkinly in combination with other therapies, potentially offering alternative treatment options for patients. The outcomes of these trials will be critical in shaping the future of Epkinly's use in lymphoma treatment.
