Efficacy and Safety of Biosimilar G-CSF and Originator G-CSF for Haematopoietic Stem Cell Mobilisation: A Randomised Comparison

Abstract Abstract 4392 OBJECTIVES: Recombinant granulocyte colony-stimulating factor (G-CSF) is widely used to mobilise haematopoietic stem cells. Biosimilar filgrastim is now available in Europe. No differences were observed between biosimilar filgrastim (n=40) and a retrospective cohort of patients receiving originator filgrastim for stem cell mobilisation in a previous comparison, although no safety findings were reported (Lefrère et al. Adv Ther 2011;28:304−10). We compared the efficacy and safety of a biosimilar filgrastim (EP-2006, Sandoz Biopharmaceuticals) with originator filgrastim (Neupogen®, Amgen) in patients with haematological malignancies. METHODS: A total of 108 patients were included in this study, 59 of whom were female (49 male), with an overall median age of 51 years (range 19–69). Patients had multiple myeloma (n=46), Hodgkin’s lymphoma (n=26), non-Hodgkin’s lymphoma (n=28) or other diagnosis (n=8). Median time from diagnosis to mobilisation was 10 months (range 3−122). After administration of mobilising regimens (primarily high-dose etoposide, high-dose cyclophosphamide, intermediate-dose Ara-C or ESHAP), patients were randomised to a standard daily 10 μg/kg dose of EP-2006 (n=54) or originator filgrastim (n=54). RESULTS: Median duration of G-CSF administration was 8 days with both EP-2006 (range 4−17) and originator filgrastim (range 4−14). Both groups had a median of one apheresis with a median time until first apheresis of 11 days. There were no statistically significant differences between groups in the median (range) number of mobilised CD34+ cells/μL in peripheral blood (EP-2006, 62.0 [2−394]; originator filgrastim, 47.5 [2−370]) or the number of CD34+ cells/ kg body weight (EP-2006, 9.1 [0−23]; originator filgrastim, 9.4 [6−48]). Five patients (9%) in each group did not mobilise sufficient CD34+ cells. The adverse event profile was comparable between the EP-2006 and originator filgrastim groups, with similar occurrence of neutropenic fever (9 vs 11 patients) and bone pain (8 vs 6 patients). CONCLUSION: EP-2006 demonstrated similar efficacy and safety as the reference filgrastim in haematopoietic stem cell mobilisation in patients with haematological malignancies. Disclosures: Dmoszynska: Mundipharma: Advisory Board; Roche: Honoraria.