Promising response rates found for epcoritamab in patients with multiply relapsed/refractory follicular lymphoma (FL)
Epcoritamab, a CD3xCD20 bispecific antibody, has shown positive results in a phase 2 cohort of the EPCORE NHL-1 study. The drug was administered subcutaneously and demonstrated an overall response rate (ORR) of 82.0% among patients with multiply relapsed/refractory FL during the median follow-up of 17.4 months.
What is epcoritamab?
Epcoritamab is a novel CD3xCD20 bispecific antibody that can simultaneously bind to CD3 on T-cells and CD20 on B-cells. It is designed to eliminate cancerous B-cells by redirecting T cells towards them.
About follicular lymphoma (FL)
Follicular lymphoma (FL) is a type of non-Hodgkin lymphoma (NHL) that arises from B cells in the lymphatic system. FL is the most common subtype of indolent NHL and accounts for approximately 20-30% cases of NHL in the United States. FL is characterized by slow-growing tumors in the lymph nodes, bone marrow, and spleen. Although it is not considered a curable disease, patients with FL can enjoy a good quality of life if managed appropriately.
EPCORE NHL-1 study design
The EPCORE NHL-1 study is a multicenter, open-label, phase 1/2 study that evaluates the safety and efficacy of epcoritamab in patients with NHL, including those with FL. In the phase 2 cohort of the study, 60 patients with multiply relapsed/refractory FL were enrolled. The primary endpoints were overall response rate (ORR) and the rate of grade 2 or higher or any-grade cytokine release syndrome (CRS) during cycle 1. The secondary endpoints included complete response (CR) rate and overall survival.
Patient characteristics
The median age of patients in the study was 65 years, and 38% were female. The majority of patients had an Ann Arbor stage of IV (60%) and a Follicular Lymphoma International Prognostic Index (FLIPI) of 3-5 (61%). There were 26% of patients with bulky disease and bone marrow involvement was present in 30%. Patients had received at least 2 prior lines of therapy that included an anti-CD20 monoclonal antibody and an alkylating agent or lenalidomide. The median time from diagnosis to epcoritamab was 6 years, and the median time for the previous treatment was 5 months. The median number of prior lines of therapy was 3, with 31% of patients having had 4 or more prior lines. There were 70% and 54% of patients with double or primary refractory disease, respectively. Chimeric antigen receptor T-cell therapy had been given to 5% of patients.
Treatment protocol and outcomes
Epcoritamab was administered weekly during the first 3 cycles, then biweekly from cycles 4 to 9 and then every 4 weeks until disease progression or unacceptable toxicity. During a median follow-up of 17.4 months, the ORR was 82.0%. There were 62.5% of patients who achieved a complete response (CR). The ORR was similar in most subgroups, but was 68% for patients who had 4 or more prior lines of treatment, 74% in patients who were refractory to their last systemic therapy, 76% in patients with double refractory disease, and 77% in patients with a FLIPI of 3-5. The CR rate was highest in the subgroup that was not refractory to their last systemic therapy at 88%. The lowest CR rate was present in the group with 4 or more prior lines of therapy at 45%. The 18-month overall survival rate was 70.2%.
Safety profile
The most common any grade treatment-emergent adverse events (TEAEs) observed were injection-site reaction (57%), COVID-19 (40%), fatigue (30%), diarrhea (27%), and pyrexia (25%). Neutropenia was the most common grade 3-4 TEAE, which occurred in 25% of patients.
Conclusion
Epcoritamab demonstrated promising response rates among patients with multiply relapsed/refractory FL. As a subcutaneous therapy with a treatment-to-progression dosing strategy, it is a potential alternative to current treatment options in this setting. Further studies are needed to confirm these findings.
Disclosure
The EPCORE NHL-1 study was supported by Genmab and AbbVie. Please refer to the original reference for a complete list of disclosures.
Originally Post From https://www.hematologyadvisor.com/news/follicular-lymphoma-epcoritamab-promising-results-treatment-risk/
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