Hutchings M, Mous R, Clausen MR, et al. - Epcoritamab’s full dose of 48 mg administered subcutaneously in patients with relapsed or refractory B-cell non-Hodgkin lymphoma resulted in overall response rate 88% (47–100), with a complete response in 38%, and was defined as the recommended phase 2 dose. In patients with this disease, safety and efficacy outcomes of single-agent subcutaneous epcoritamab support its investigation in ongoing phase 2 and phase 3 studies.

• Epcoritamab is a novel bispecific antibody that targets CD3 and CD20 and induces T-cell-mediated cytotoxic activity against CD20+ malignant B cells.

• A phase 1/2 study with dose-escalation part involving adults (aged ≥18 years) with relapsed or refractory CD20+ B-cell non-Hodgkin lymphoma.

• Of 73 patients enrolled, 68 underwent escalating full doses (0·0128–60 mg) of subcutaneous epcoritamab.

• There were no dose-limiting toxic effects, maximum tolerated dose was not reached.

• In these 68 patients, common adverse events included pyrexia (47 patients [69%]), mainly related to cytokine release syndrome (CRS; 40 [59%], all grade 1–2), and injection site reactions (32 [47%]; 31 grade 1).

• No grade 3 or higher CRS events occurred, and there were no treatment-related discontinuations.

• In relapsed or refractory diffuse large B-cell lymphoma cases, overall response rate was 68%; a complete response at full doses of 12–60 mg was noted in 45%.

• Not only robust and sustained B-cell depletion as well as CD4+ and CD8+ T-cell activation and expansion were induced by epcoritamab but it also caused modest rises in cytokine levels.