Pharma Focus Europe

Novel Drug Introduced by Genmab for R/R DLBCL Treatment

Genmab A/S has recently launched EPKINLY™ (epcoritamab-bysp), a groundbreaking drug designed for the treatment of relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). 

This innovative medication, developed in collaboration with AbbVie as part of their oncology partnership, has received FDA approval through accelerated approval, primarily based on its response rate and the durability of response.

EPKINLY™ is the first and only T-cell-engaging bispecific antibody available for adult patients with R/R DLBCL, including cases arising from indolent lymphoma and high-grade B-cell lymphoma after multiple lines of therapy. 

Its mechanism of action involves simultaneously binding to both T-cells and CD20+ lymphoma B-cells, employing a dual-targeted approach.

The efficacy of EPKINLY™ was demonstrated in a pivotal Phase 2 clinical trial, where it was administered as a subcutaneous monotherapy to patients with relapsed or refractory DLBCL who had previously received at least two treatments. 

Encouragingly, 61 percent of patients responded positively to EPKINLY™, with 38 percent achieving full remission. The average duration of response was 15.6 months.

However, it's important to note that EPKINLY™ is associated with some significant adverse effects, including cytokine release syndrome (CRS), immunological effector cell-associated neurotoxicity syndrome (ICANS), infections, and cytopenias. DLBCL is an aggressive form of B-cell non-Hodgkin's lymphoma (B-NHL) that affects B-cell lymphoid cells, a type of white blood cell.

Individuals diagnosed with DLBCL often face challenges such as cancer relapse, when the disease returns after treatment, or refractoriness, when the disease does not respond to therapy. While new medications have emerged, effectively managing DLBCL treatment remains a complex task.

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