New Pivotal Data for Bispecific Antibody Epcoritamab (DuoBody CD3xCD20) Demonstrates High Overall and Complete Responses in Patients with Hard-To-Treat Relapsed/Refractory Follicular Lymphoma (FL)

Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) today announced new data from the ongoing phase 1/2 EPCORE NHL-1 clinical trial investigating epcoritamab (DuoBody CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, demonstrated an overall response rate (ORR) of 82 percent, a complete response (CR) rate of 63 percent and minimal residual disease (MRD) negativity rate of 67 percent in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The presentation included data from an optimized step-up dosing schedule for FL patients showing a reduction in risk and severity of Grade 2+ cytokine release syndrome (CRS), a common side effect of T-cell engaging cancer treatments. These results were presented today at the 2023 65^th Annual Meeting and Exposition of the American Society of Hematology (ASH), being held in San Diego, California, December 9-12, 2023 (Abstract #1655).

“Despite treatment advances for patients with follicular lymphoma whose disease has unfortunately progressed, treating relapsed or refractory follicular lymphoma remains highly challenging, particularly in the third-line plus setting,” said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. “The patients in this trial represent a historically difficult-to-treat patient population. The data presented today are especially notable because they demonstrated high overall and complete response rates for this investigational follicular lymphoma therapy and a preview for its potential as an alternative treatment option.”

Overall results from the pivotal cohort of 128 adult patients showed that:

• At a median follow-up of 17.4 months, the study’s primary endpoint ORR was 82 percent, which exceeded the protocol defined threshold for efficacy, with a CR rate of 63 percent, and 67 percent MRD negativity.
• The median time to response was 1.4 months and median time to CR was 1.5 months.
• Median progression-free survival (PFS) for patients who achieved a CR was not reached nor was the median duration of response, duration of CR, MRD negativity and overall survival.
• An estimated 85 percent and 74 percent of patients who experienced a CR remained in response at 12 and 18 months, respectively.

Among prespecified subgroups, ORR and CR rates were generally consistent with the overall patient population. Notably, high-risk patients who were refractory to both anti-CD20 therapy and an alkylating agent achieved a 76 percent ORR and 56 percent CR; patients who were refractory to last prior treatment achieved a 74 percent ORR and 51 percent CR rate; and patients whose disease progressed within two years of first-line immunochemotherapy (POD24) achieved an 80 percent ORR and 61 percent CR.