AbbVie and Genmab's Epkinly Shows Promise in Follicular Lymphoma, Paving Way for Expanded Use

Genmab and AbbVie have made significant strides in advancing their blood cancer drug Epkinly (epcoritamab) for the treatment of follicular lymphoma (FL). Recent phase 3 trial results have demonstrated the drug's efficacy in earlier lines of treatment, potentially reshaping the therapeutic landscape for this hematological malignancy.

Phase 3 Trial Results Bolster Epkinly's Efficacy

In a pivotal phase 3 trial, the addition of Epkinly to a regimen of Rituxan (rituximab) and Revlimid (lenalidomide), known as R2, showed statistically significant and clinically meaningful improvements in patients with relapsed or refractory FL. The Epkinly combination demonstrated a remarkable 79% reduction in the risk of disease progression or death compared to R2 alone, according to a pre-planned interim analysis.

The trial's impressive results included enhancements in both overall response rate (ORR) and progression-free survival (PFS), though specific figures are yet to be disclosed. These findings are slated for presentation at the upcoming American Society of Hematology (ASH) annual meeting in Orlando this December, where the medical community eagerly awaits the detailed data.

Regulatory Progress and Market Implications

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

This potential approval would mark a significant expansion of Epkinly's indications. The drug 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.

Genmab CEO Jan van de Winkel, Ph.D., emphasized the importance of these developments, stating, "These important phase 3 results support our goal to move Epkinly into earlier lines of therapy in order to benefit more cancer patients." The company's chief medical officer, Tahamtan Ahmadi, M.D., Ph.D., went further, suggesting that the data highlight Epkinly's "potential to completely transform and disrupt the current treatment paradigm."

Competitive Landscape and Market Performance

Epkinly enters a competitive field of CD20xCD3 T-cell engagers, including Roche's Lunsumio and Columvi. However, Epkinly distinguishes itself as the only approved drug in its class to be administered subcutaneously, potentially offering a significant advantage in terms of patient convenience and treatment administration.

The drug's market performance has been robust, with Genmab reporting Epkinly's first-half sales at $211 million, representing a 74% year-over-year increase. This strong showing contributed to Genmab's overall revenue growth, with the company posting first-half revenues of $1.64 billion, a 19% increase from the same period in 2024.

As the pharmaceutical industry continues to evolve, the potential expansion of Epkinly's use in follicular lymphoma represents a significant development in the ongoing effort to improve outcomes for patients with hematological malignancies.