FDA Approval Insights: Epcoritamab in Relapsed/Refractory DLBCL

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Tycel Phillips, MD, about the FDA approval of epcoritamab-bysp (Epkinly) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Phillips is an associate professor in the Division Of Lymphoma and Department Of Hematology & Hematopoietic Cell Transplantation at City of Hope in Duarte, California.

On May 19, 2023, the FDA granted accelerated approval to epcoritamab for adult patients with relapsed/refractory DLBCL not otherwise specified, including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma, who have received at least 2 prior lines of systemic therapy. This regulatory decision was backed by findings from the phase 1/2 EPCORE NHL-1 trial (NCT03625037), in which treatment with epcoritamab led to an overall response rate of 61%. Additionally, in an expansion cohort of patients with CD20-positive DLBCL, epcoritamab elicited a complete response rate of 38%.

In our exclusive interview, Dr Phillips discussed the significance of this approval, key efficacy and safety findings from EPCORE NHL-1, and the potential future of bispecific antibodies in this setting.

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