Epcoritamab (Epkinly®/Tepkinly®): A Comprehensive Clinical and Pharmacological Monograph

I. Executive Summary

Epcoritamab represents a pivotal advancement in the therapeutic armamentarium for relapsed or refractory (R/R) B-cell malignancies. As a subcutaneously administered, off-the-shelf, T-cell engaging bispecific antibody, it offers a novel mechanism of action that has demonstrated profound and durable clinical activity in heavily pre-treated patient populations. This report provides a comprehensive analysis of epcoritamab, synthesizing data from pivotal clinical trials, regulatory filings, and pharmacological studies to delineate its profile and strategic position in oncology.

The core clinical value of epcoritamab is evidenced by its high response rates in patient populations with significant unmet needs. In the pivotal EPCORE NHL-1 trial, epcoritamab monotherapy induced an overall response rate (ORR) of 61-63% and a complete response (CR) rate of 38-41% in patients with R/R diffuse large B-cell lymphoma (DLBCL), including those who had previously failed CAR T-cell therapy. Long-term follow-up has confirmed the durability of these responses, with a median duration of complete response (mDoCR) extending to 36.1 months, suggesting a potential for long-term disease control in a substantial subset of patients. Similarly, in R/R follicular lymphoma (FL), epcoritamab achieved an ORR of 82% and a CR rate of 60%, leading to its accelerated approval for this indication.