Epcoritamab Produces Promising Responses in Patients With Follicular Lymphoma

Monotherapy with subcutaneous epcoritamab yielded “deep and durable responses” with a promising objective response rate (ORR) and complete response (CR) rate among hard-to-treat patients with high-risk relapsed or refractory follicular lymphoma (FL), according to data from a phase I dose-expansion trial.

The safety profile of epcoritamab was manageable, the development of cytokine release syndrome (CRS) was predictable, and the incidence and severity of CRS was reduced with optimized step-up dosing, reported lead author, Kim Linton, MD, PhD, of the Christie NHS Foundation and Trust and Manchester Cancer Researcher Centre in the United Kingdom.

Dr. Linton and colleagues also noted that responses were comparable between subgroups and that measurable residual disease negativity was correlated with improved progression-free survival (PFS).

Epcoritamab Treatment Effective for Follicular Lymphoma

The study enrolled 128 patients with grade 1-3a relapsed or refractory FL between September 2020 and October 2022. The cohort had a median age of 65 years, 61% had Follicular Lymphoma International Prognostic Index scores of three to five, and 85% had stage III-IV disease. The primary endpoint was the ORR, while measurable residual disease (MRD) was evaluated as a secondary endpoint.

By the data cutoff of April 21, 2023, the median follow-up was 17.4 months, and the ORR and CR rate was 82% and 63%, respectively. The median time to response and to CR was 1.4 months and 1.5 months, respectively. Researchers reported that the ORR and CR rate trended higher in patients with fewer prior lines of therapy. Additionally, the median PFS was 15.4 months, while median duration of response, duration of CR, and overall survival were not reached. Investigators also noted that negative MRD status was correlated with PFS.

The most common any-grade TEAEs were CRS in 66% of patients, injection-site reaction in 57%, COVID-19 in 40%, fatigue in 30%, neutropenia in 28%, diarrhea in 27%, and pyrexia in 25%. CRS events were 40% grade 1, 25% grade 2, and 2% grade 3 and primarily developed after the first full dose. TEAEs that led to treatment discontinuation were reported in 19% of patients, of which COVID-19 was the most common.

Overall, researchers reported that no new safety signals were detected and added that epcoritamab was being evaluated in an ongoing phase III trial on relapsed or refractory FL.

Reference

Linton, K, Jurczak W, Lugtenburg P, et al. Epcoritamab SC monotherapy leads to deep and durable responses in patients with relapsed or refractory follicular lymphoma: first data disclosure from the Epcore NHL-1 follicular lymphoma dose-expansion cohort. Blood 2023; 142 (Supplement 1): 1655. doi: https://doi.org/10.1182/blood-2023-179887