Epcoritamab-bysp (Epkinly) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
Epcoritamab-bysp, is a bispecific CD20-directed CD3 T-cell engager, a monoclonal antibody,
Trade names Epkinly, Tepkinly.
Routes of administration Subcutaneous.
Epcoritamab, a monoclonal antibody anticancer medication used for the treatment of diffuse large B-cell lymphoma.
Epcoritamab is indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including diffuse large B-cell lymphoma arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
EPCORE NHL-1 is an open-label, multi-cohort, multicenter, single-arm trial in patients with relapsed or refractory B-cell lymphoma.
The main efficacy outcome measure was overall response rate (ORR) was 61% with 38% of patients achieving complete responses.
With a median follow-up of 9.8 months among responders, the estimated median duration of response (DOR) was 15.6 months.
In the EPCORE NHL-1 trial in 148 particpants with relapsed or refractory B-cell lymphoma after two or more lines of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy.
The overall response rate (ORR), which was 61%.
Of those patients, 38% of patients achieved complete response.
It has a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome (ICANS).
Precautions include infections and cytopenias.
Among the 157 patients with relapsed or refractory large B-cell lymphoma who received epcoritamab-bysp at the recommended dose, CRS occurred in 51% of patients, ICANS in 6%, and serious infections in 15%.
Because of the risk of CRS and ICANS, patients should be hospitalized for 24 hours after the Cycle 1 Day 15 dosage of 48 mg.
The most common (≥20%) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, nausea, and diarrhea.
The most common Grade 3 to 4 laboratory abnormalities (≥10%) were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, decreased hemoglobin, and decreased platelets.
The recommended regimen consists of epcoritamab-bysp administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity.
The recommended dose is step-up dosing in Cycle 1 (0.16 mg on Day 1, 0.8 mg on Day 8, and 48 mg on Day 15 and Day 22) followed by fixed dosing of 48 mg weekly dosing during Cycles 2 through 3, every other week during Cycle 4 through 9, and then every four weeks on Day 1 of subsequent cycles.