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

Chemotherapy-induced neutropenia (CIN) is a frequent and clinically significant complication of systemic cancer therapy, associated with increased infection risk, hospitalization, and treatment delays. Granulocyte colony-stimulating factors (G-CSFs) are used to mitigate these risks. Efbemalenograstim alfa (F-627) is a novel long-acting recombinant G-CSF developed as a potential alternative. We conducted a systematic review and meta-analysis to evaluate the comparative safety and efficacy of efbemalenograstim alfa versus standard G-CSFs in patients with non-myeloid malignancies receiving chemotherapy. A comprehensive literature search of six databases identified four randomized controlled trials (RCTs) comparing F-627 with standard G-CSFs. Data from three active-controlled trials were pooled using Review Manager (RevMan) 5.4.1, with risk ratios (RR) calculated for dichotomous outcomes and mean differences (MD) for continuous outcomes; heterogeneity was assessed using the I 2 statistic. Narrative synthesis was performed for the placebo-controlled trial and outcomes with insufficient data for meta-analysis. Risk of bias and certainty of evidence were assessed using the Cochrane RoB 2.0 tool and GRADE framework. Pooled analysis demonstrated comparable efficacy between efbemalenograstim alfa and standard G-CSFs in reducing the duration of Grade 4 neutropenia during cycle 1. The incidence of severe neutropenia and febrile neutropenia was also similar between treatment groups. Secondary efficacy outcomes and adverse event profiles, including bone pain and hematologic toxicities, were broadly comparable across treatment arms. Overall, efbemalenograstim alfa demonstrates a safety and efficacy profile comparable to established G-CSFs, supporting its role as a viable option for the prevention of chemotherapy-induced neutropenia in patients with non-myeloid malignancies.