Efbemalenograstim alfa for chemotherapy induced neutropenia: A meta-analysis and systematic review of randomized controlled trials

Purpose: Chemotherapy-induced neutropenia (CIN) is a common complication that increases the risk of infection, hospitalization, and treatment delays. While granulocyte colony-stimulating factors (G-CSFs) like filgrastim and pegfilgrastim are used to reduce these risks, limitations in dosing schedules and variability remain. Efbemalenograstim alfa (F-627), a novel long-acting recombinant G-CSF, has emerged as a potential alternative. This systematic review and meta-analysis aimed to evaluate its comparative safety and efficacy against standard G-CSFs in patients undergoing chemotherapy for non-myeloid malignancies. Methods: A comprehensive literature search was conducted across six databases for randomised controlled trials (RCTs) comparing F-627 to standard G-CSFs. Data from three active-controlled trials were pooled using Review Manager (RevMan) 5.4.1, with results expressed as risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes. Heterogeneity was assessed using the I² statistic. Narrative synthesis was performed for the data in the placebo-controlled trial and outcomes with insufficient data for meta-analysis. Risk of bias and evidence quality were evaluated using the Cochrane RoB 2.0 tool and GRADE guidelines, respectively. Results: Four RCTs comprising 973 patients were included, with 533 receiving F-627. F-627 showed comparable efficacy to standard G-CSFs in reducing duration of Grade 4 neutropenia in cycle 1 (MD = 0.04 days; 95% CI: − 0.04 to 0.13; I² = 0%). Incidence of severe neutropenia and febrile neutropenia were also similar (RR = 1.02; 95% CI: 0.97–1.07 and RR = 1.33; 95% CI: 0.41–4.30, respectively). However, a placebo-controlled trial showed a significant reduction in neutropenia and febrile neutropenia incidence with F-627. Secondary outcomes and adverse event profiles were broadly comparable across treatment arms. Conclusion Efbemalenograstim alfa offers a comparable safety and efficacy profile to standard G-CSFs for the prevention of CIN, supporting its role as a viable therapeutic option in non-myeloid cancers.