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GUIDELINES/RECOMMENDATIONS Approval was based on the phase 2 EPCORE NHL-1 trial, featuring an efficacy population of 148 patients.
Recent FDA approval of Epkinly (epcoritamab-bysp) introduces a new therapeutic option for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma, promising a significant shift in current treatment practices.
Key Points:
- The FDA has granted accelerated approval to Epkinly for adults with relapsed or refractory DLBCL and high-grade B-cell lymphoma after 2+ lines of systemic therapy.
- Epcoritamab is an IgG1-bispecific antibody targeting CD3 on T cells and CD20 on B cells, thus promoting T-cell-mediated killing of CD20-positive cells.
- Study results indicated an overall response rate of 61%, with 38% of patients achieving complete response and 23% achieving partial response.
- The median duration of response was 15.6 months.
Additional Points:
- Reported adverse reactions included cytokine release syndrome (CRS), fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea.
- The most common grade 3-4 laboratory abnormalities were decreased lymphocyte count, neutrophil count, white blood cell count, hemoglobin, and platelets.
- A boxed warning for Epkinly highlights potential for CRS and immune effector cell-associated neurotoxicity syndrome (ICANS), which occurred in 51% and 6% of study participants, respectively.
Conclusion:
- Epkinly, now approved for treating relapsed or refractory DLBCL and high-grade B-cell lymphoma, shows considerable promise, but healthcare professionals must be aware of the potential severe reactions such as CRS and ICANS.
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Did You Know?
DLBCL is the most common type of non-Hodgkin lymphoma in adults, accounting for about 25% of all non-Hodgkin lymphoma cases.
