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Julie M. Vose, MD, MBA, discusses the investigation of epcoritamab in relapsed/refractory follicular lymphoma.
Julie M. Vose, MD, MBA, division chief, Neumann M. and Mildred E. Harris Professor, physician, oncology and hematology, Division of Hematology and Oncology, University of Nebraska Medical Center; recipient, 2022 Giants of Cancer Care® award for lymphoma, discusses the investigation of epcoritamab-bysp (Epkinly) in patients with relapsed/refractory follicular lymphoma (FL) in the FL C1 OPT cohort of the phase 1/2 EPCORE NHL-1 trial (NCT03625037).
Notably, these data were presented at the 2024 ASCO Annual Meeting following the FDA’sFebruary 2024 decision to grant the agent priority review for the treatment of adult patients with relapsed/refractory FL who have received 2 or more lines of systemic therapy.
In presenting the rationale for the EPCORE study optimization cohort, Vose begins by saying that the goal of evaluating epcoritamab in this cohort was to mitigate cytokine release syndrome (CRS) and neurologic toxicity in patients with FL. Simple measures, such as administering dexamethasone before initial doses, outpatient hydration, and selectively withholding antihypertensives, resulted in significantly reduced CRS rates and eliminated grade 3 CRS incidents, with no observed neurologic toxicity compared with findings from prior studies, she shares. These adjustments were implemented to enhance patient safety and treatment tolerability, Vose notes.
The findings from the FL C1 OPT cohort showcased the safety profile of epcoritamab therapy with these new measures juxtaposed against findings from the overall EPCORE trial population without the optimization cohort, she continues. Notably, the rates of CRS were substantially lower in the FL C1 OPT cohort, and epcoritamab was associated with negligible neurotoxicity, in contrast to the safety findings in the overall EPCORE population, Vose reports. Furthermore, hospitalization when receiving the full dose of epcoritamab, which was previously mandatory, became optional in this updated cohort, facilitating outpatient treatment for many patients and underscoring the feasibility and benefits of the optimization strategies employed, she explains.
These safety enhancements mark significant progress in refining the treatment protocol for patients with FL within the EPCORE study, promising improved outcomes and treatment experiences, Vose concludes.