Genmab's Epcoritamab Shows Positive Phase 3 Results in Lymphoma Treatment

Genmab's bispecific antibody epcoritamab, developed with AbbVie, has shown positive results in a Phase 3 trial for a lymphoma therapy. The trial demonstrated that the combination therapy met the primary endpoint of superior overall response rate compared to standard of care. Genmab's stock rose on the news.

Copenhagen, Denmark - Genmab A/S (Nasdaq: GMAB), a leading biotechnology company with a market capitalization of $13.2 billion, has announced significant results from its Phase 3 EPCORE FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) for the treatment of relapsed or refractory follicular lymphoma. The trial demonstrated substantial improvements over R2 alone, meeting both primary endpoints with an overall response rate (ORR) of 95.7% (p 0.0001) and a 79% reduction in the risk of progression or death (HR 0.21, p-value 0.0001) [1].

The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for this combination therapy, with a target action date of November 30, 2025. If approved, epcoritamab plus R2 would become the first bispecific antibody combination regimen available as a second-line treatment option for patients with relapsed or refractory follicular lymphoma in the United States [2].

The trial's results were presented at the American Society of Hematology (ASH) Annual Meeting and will serve as the basis for global regulatory submissions. The safety profile of the combination therapy was consistent with the known profiles of the individual components, with no new safety signals observed [1].

Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and is being co-developed with AbbVie as part of their oncology collaboration. The trial's success positions Genmab as a pivotal player in the rapidly evolving bispecific antibody (bsAb) market for lymphoma treatment [2].

The U.S. market for R/R FL treatments is projected to exceed $2.5 billion by 2030, driven by the shift from chemoimmunotherapy to targeted therapies and the growing prevalence of relapsed cases. Epcoritamab's potential as a second-line therapy, approved for patients with just one prior line of therapy, positions it to capture a significant share of this market [2].

Genmab's stock rose on the news, reflecting investor optimism about the trial results and the potential market opportunity. The company's strong market position is reflected in its financial health, earning a "GREAT" overall score from InvestingPro, which identifies the stock as currently undervalued based on its comprehensive Fair Value analysis [1].

References:

[1] https://www.investing.com/news/company-news/epcoritamab-plus-r2-shows-strong-results-in-follicular-lymphoma-trial-93CH-4177509
[2] https://www.ainvest.com/news/genmab-epcore-fl-1-trial-strategic-leap-bispecific-antibody-market-lymphoma-treatment-2508/