Mecapegfilgrastim reduces grade 3+ neutropenia in treatment-naive diffuse large B-cell lymphoma patients versus no prophylaxis

BACKGROUND: This study evaluated the efficacy and safety of mecapegfilgrastim for preventing immunochemotherapy-induced neutropenia in treatment-naive patients with diffuse large B-cell lymphoma (DLBCL). METHODS: In this open-label, multicenter exploratory trial, patients were randomized in a 2:1 ratio to receive mecapegfilgrastim or no prophylaxis. All participants received 4 cycles of R-CHOP or R-CHOP-like regimens. The primary endpoint was the incidence of grade ≥ 3 neutropenia during cycle 1. RESULTS: Between October 2021 and June 2024, 42 patients were enrolled (mecapegfilgrastim: n = 28; control: n = 14). Grade ≥ 3 neutropenia in cycle 1 occurred in 32.14% of the mecapegfilgrastim group versus 64.29% in the control group. Across all cycles, mecapegfilgrastim consistently reduced grade ≥ 3 neutropenia; nadir neutrophil counts were higher and the need for short-acting granulocyte colony-stimulating factor was lower in the mecapegfilgrastim group (all nominal p ≤ 0.05). No cases of febrile neutropenia occurred in the mecapegfilgrastim group, compared to one case in the control group. Objective response rates were 75.0% (95% CI: 55.1, 89.3) and 57.1% (95% CI: 28.9, 82.3), respectively (nominal p = 0.298). Mecapegfilgrastim reduced the incidence of grade ≥ 3 neutropenia regardless of treatment response. Grade ≥ 3 treatment-emergent adverse events (TEAEs) occurred in 42.9% of the mecapegfilgrastim group and 92.9% of controls; serious TEAEs were reported in 7.1% of patients in both groups. CONCLUSIONS: Mecapegfilgrastim demonstrated a favorable safety profile and potential efficacy in reducing the incidence and severity of neutropenia in DLBCL patients receiving R-CHOP or R-CHOP-like regimens. These findings may support its prophylactic use in this population and warrant validation in larger trials. TRIAL REGISTRATION: chictr.org.cn: ChiCTR2100048196. Registered on July 4, 2021.