AbbVie and Genmab have reported positive topline results from a Phase 3 clinical trial evaluating Epkinly (epcoritamab) in combination with Revlimid (lenalidomide) for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The results come just months after Epkinly failed to meet its primary overall survival endpoint as a standalone therapy in a separate late-stage study, offering renewed momentum for the companies’ blood cancer program.
- Epkinly plus Revlimid met the primary endpoint in the Phase 3 EPCORE DLBCL-4 trial.
- The combination reduced the risk of disease progression or death by 60% compared with the standard R-GemOx regimen.
- The study enrolled patients with relapsed or refractory DLBCL who had received at least one previous line of therapy.
- The positive results follow a recent Phase 3 setback for Epkinly as a monotherapy.
- AbbVie and Genmab plan to discuss the data with global regulators to determine the next steps.
The Phase 3 EPCORE DLBCL-4 trial evaluated Epkinly in combination with Revlimid against the current standard treatment regimen of rituximab, gemcitabine, and oxaliplatin (R-GemOx) in adults with relapsed or refractory diffuse large B-cell lymphoma who had previously received at least one line of therapy. According to the companies, the trial successfully achieved its primary endpoint by demonstrating a statistically significant improvement in progression-free survival (PFS), a measure of how long patients live without their disease worsening.
Under the statistical analysis plan used for the U.S. Food and Drug Administration (FDA), patients receiving the Epkinly combination experienced a 60% reduction in the risk of disease progression or death compared with those receiving R-GemOx. Using statistical methods applied by regulators outside the United States, the benefit remained consistent, showing a 56% reduction in progression risk.
The companies said the safety profile of the combination was consistent with the known safety characteristics of Epkinly and Revlimid individually. No new safety signals were identified during the study. While the trial also includes overall survival as a key secondary endpoint, those data have not yet been released. AbbVie and Genmab said they plan to present the full results at a future medical meeting and engage regulatory authorities regarding potential label expansion.
The positive outcome is particularly significant because it follows disappointing results announced earlier this year from the EPCORE DLBCL-1 trial, which evaluated Epkinly as a monotherapy. In that study, the bispecific antibody improved progression-free survival compared with standard chemoimmunotherapy but failed to demonstrate a statistically significant improvement in overall survival, the trial’s primary endpoint. That setback raised questions about Epkinly’s competitive position in the increasingly crowded DLBCL treatment landscape.
Analysts said the latest combination data help restore confidence in the drug’s broader development program. Jefferies, Leerink Partners, and William Blair all noted that the successful Phase 3 study strengthens expectations for the ongoing EPCORE DLBCL-2 trial, which is evaluating Epkinly in combination with the standard R-CHOP regimen as a first-line treatment for newly diagnosed DLBCL patients. Results from that study are expected later this year and are considered one of the most important milestones for the product.
Diffuse large B-cell lymphoma is the most common form of non-Hodgkin lymphoma, accounting for roughly one-third of all newly diagnosed cases worldwide. Although many patients respond to first-line treatment, a substantial proportion experience relapse or become refractory to therapy, creating demand for new treatment options that can improve long-term disease control.
Epkinly is a CD20×CD3 bispecific antibody designed to redirect a patient’s T cells toward malignant B cells by simultaneously binding the CD3 protein on T cells and the CD20 protein on lymphoma cells. Unlike CAR-T cell therapies, which require individualized manufacturing, Epkinly is an off-the-shelf immunotherapy administered by subcutaneous injection. The drug is currently approved in several countries, including the United States, for adults with relapsed or refractory DLBCL after at least two prior lines of systemic therapy and has also received approvals in follicular lymphoma.
The latest results also intensify competition among bispecific antibodies in lymphoma. Roche has advanced two competing CD20×CD3 therapies—Columvi (glofitamab) and Lunsumio (mosunetuzumab)—through late-stage clinical development. Roche’s Lunsumio recently secured FDA acceptance for review in combination with Polivy for second- or later-line DLBCL, with a regulatory decision expected in early 2027. Analysts noted that Epkinly’s combination with oral Revlimid may offer a simpler outpatient treatment regimen compared with intravenous combinations requiring additional infusions.
For AbbVie and Genmab, the positive Phase 3 trial provides an important boost after the earlier monotherapy disappointment. Analysts estimate that the second-line combination opportunity alone could represent approximately $700 million in peak annual sales, while success in the ongoing first-line study would significantly expand the drug’s commercial potential.
The companies said they will meet with global regulatory agencies to discuss potential submissions based on the EPCORE DLBCL-4 results. If approved, the combination regimen could provide a new chemotherapy-free treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma while further strengthening Epkinly’s position in the rapidly evolving market for bispecific antibody therapies.
AbbVie, in collaboration with Genmab, has announced positive results from a Phase 3 clinical trial evaluating the Epkinly (epcoritamab) combination regimen for patients with diffuse large B-cell lymphoma (DLBCL). The study met its primary endpoint, marking an important milestone for AbbVie as it continues to expand its oncology portfolio with innovative immunotherapy treatments.
The encouraging findings suggest that the Epkinly combination could offer a new therapeutic option for patients with DLBCL, particularly those seeking more effective treatment strategies for this aggressive form of non-Hodgkin lymphoma.
AbbVie Strengthens Its Oncology Pipeline
The latest Phase 3 results reinforce AbbVie’s commitment to developing advanced cancer therapies through strategic collaborations and innovative research. Epkinly is a bispecific antibody designed to help the immune system recognize and destroy cancer cells by simultaneously targeting CD3 on T cells and CD20 on B cells.
AbbVie, in collaboration with Genmab, has announced positive results from a Phase 3 clinical trial evaluating the Epkinly (epcoritamab) combination regimen for patients with diffuse large B-cell lymphoma (DLBCL). The study met its primary endpoint, marking an important milestone for AbbVie as it continues to expand its oncology portfolio with innovative immunotherapy treatments.
The encouraging findings suggest that the Epkinly combination could offer a new therapeutic option for patients with DLBCL, particularly those seeking more effective treatment strategies for this aggressive form of non-Hodgkin lymphoma.
AbbVie Strengthens Its Oncology Pipeline
The latest Phase 3 results reinforce AbbVie’s commitment to developing advanced cancer therapies through strategic collaborations and innovative research. Epkinly is a bispecific antibody designed to help the immune system recognize and destroy cancer cells by simultaneously targeting CD3 on T cells and CD20 on B cells.
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