AbbVie and Genmab's Epkinly Shows Promise in Follicular Lymphoma, Poised for Expansion

AbbVie and Genmab have reported significant progress in their efforts to expand the use of their blood cancer drug Epkinly (epcoritamab) for the treatment of follicular lymphoma (FL). New phase 3 trial results demonstrate the drug's efficacy in earlier lines of treatment, potentially reshaping the therapeutic landscape for this form of cancer.

Promising Phase 3 Results

Genmab announced on Thursday that adding Epkinly to a regimen of Rituxan (rituximab) and Revlimid (lenalidomide), known as R2, led to statistically significant and clinically meaningful improvements in overall response rate (ORR) and progression-free survival (PFS) in patients with relapsed or refractory FL. The combination therapy reduced the risk of disease progression or death by an impressive 79% compared to R2 alone, according to a pre-planned interim analysis.

Dr. Tahamtan Ahmadi, Genmab's chief medical officer, emphasized the potential impact of these results, stating that the data highlight Epkinly's "potential to completely transform and disrupt the current treatment paradigm."

Regulatory Progress and Market Positioning

The U.S. Food and Drug Administration (FDA) has accepted the partners' application to approve Epkinly plus R2 for patients with relapsed or refractory FL who have received at least one prior systemic therapy. The FDA has set a decision date of November 30, 2025. If approved, this combination would become the first bispecific antibody regimen available as a second-line option for FL patients.

Epkinly, a CD20xCD3 T-cell engager, has already secured approvals in other indications. It was initially approved in 2023 for diffuse large B-cell lymphoma (DLBCL) after at least two lines of systemic therapy, followed by an approval in 2024 for FL after at least two lines of therapy. The drug's subcutaneous administration gives it a potential edge over competitors in the same class, such as Roche's Lunsumio and Columvi.

Financial Performance and Market Impact

Genmab reported that Epkinly's sales reached $211 million in the first half of 2025, representing a 74% year-over-year increase. This contributed to the company's overall revenue of $1.64 billion for the same period, a 19% boost from the first half of 2024.

The expanding indications and strong sales performance of Epkinly underscore its growing importance in the treatment of blood cancers and its potential to significantly impact AbbVie and Genmab's market positions in the oncology space.