Hutchings M, Mous R, Clausen MR, et al. - Recommended phase 2 dose of single-agent subcutaneous epcoritamab is the full dose of 48 mg in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, and overall response rate at 48 mg dose was 88% (47–100), with a complete response achieved in 38%. Findings support ongoing phase 2 and phase 3 studies of single-agent subcutaneous epcoritamab for relapsed or refractory B-cell non-Hodgkin lymphoma.

• Adults (aged ≥18 years) with relapsed or refractory CD20+ B-cell non-Hodgkin lymphoma (n = 73) were enrolled for the dose-escalation part, and the dose-expansion part is ongoing.

• Priming and intermediate doses given to eligible patients, followed by full doses of subcutaneous epcoritamab given in 28-day cycles; each subsequent cohort involved escalation of the priming, intermediate, or full dose (0·0128–60 mg).

• A total of 68 patients received escalating full doses (0·0128–60 mg) of subcutaneous epcoritamab.

• No dose-limiting toxic impacts occurred, and the maximum tolerated dose was not reached.

• In 68 patients treated with at least one dose of epcoritamab, common adverse events were pyrexia, mainly linked with cytokine release syndrome (CRS), and injection site reactions.

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

• Overall response rate in diffuse large B-cell lymphoma and in follicular lymphoma, both relapsed or refractory, was 68% and 90%, respectively.

• Epcoritamab resulted in robust and sustained B-cell depletion, as well as CD4+ and CD8+ T-cell activation and expansion, with modest rises in cytokine concentrations.