Dr Cherng on Approvals of Epcoritamab and Glofitamab for R/R DLBCL

Hua-Jay "Jeff" Cherng, MD, assistant professor of medicine, Division of Hematology and Oncology, Columbia University's Irving Medical Center, discusses the FDA approvals of epcoritamab-bysp (Epkinly) and glofitamab-gxbm (Columvi) for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

In May 2023, epcoritamab was approved by the regulatory agency for the treatment of adult patients with relapsed/refractory DLBCL not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after 2 or more lines of systemic therapies.

That approval was supported by data from the phase 1/2 EPCORE NHL-1 trial (NCT03625037), where patients with CD20-positive DLBCL enrolled in the trial’s expansion cohort (n = 148) experienced an overall response rate (ORR) of 61% (95% CI, 53%-69%), including a complete response (CR) rate of 38%. The median duration of response (DOR) was 15.6 months (95% CI, 9.7–not reached).

In June 2023, glofitamab received accelerated approval for the treatment of adult patients with relapsed/refractory DLBCL NOS or large B-cell lymphoma arising from follicular lymphoma, after at least 2 lines of systemic therapy. Findings from the phase 1/2 NP30179 trial (NCT03075696), which supported the regulatory decision, showed that glofitamab elicited an ORR of 56% and a CR rate of 43%. The median DOR was 18.4 months (95% CI, 11.4–not estimable).

Both epcoritamab and glofitamab represent promising therapeutic avenues for a patients with relapsed/refractory DLBCL, Cherng says. Their efficacy profiles, underscored by durable responses, underscore their clinical utility and potential to address unmet medical needs in this setting, he explains. He notes that in EPCORE NHL-1, epcoritamab was given continuously until disease progression or unacceptable toxicity, whereas glofitamab was given for 12 cycles or until progression or unacceptable toxicity during NP30179.

Further exploration through ongoing research endeavors will be essential to delineate their optimal placement within the treatment paradigm for DLBCL, as well as to elucidate nuances in safety profiles and long-term outcomes, Cherng concludes.