XM02, the First Biosimilar G-CSF, is Safe and Effective in Reducing the Duration of Severe Neutropenia and Incidence of Febrile Neutropenia in Patients with Small Cell or Non-small Cell Lung Cancer Receiving Platinum-Based Chemotherapy

Background: Recombinant granulocyte colony-stimulating factors such as Neupogen are used to treat chemotherapy-induced neutropenia. The aim of the study was to show that a new granulocyte colony-stimulating factor, XM02, is as safe and effective as Neupogen in the treatment of chemotherapy-induced neutropenia in patients with small cell or non-small cell lung cancer. Patients and methods: A total of 240 patients receiving platinum-based chemotherapy were randomized in cycle I to treatment with daily injections (subcutaneous 5 mu g/kg/d) of XM02 (n = 160) or Filgrastim Neupogen (n = 80) for at least 5 days and a maximum of 14 days. In subsequent cycles, all patients received XM02. Results: The mean duration of severe neutropenia was 0.5 and 0.3 days in cycle I for XM02 and Filgrastim, respectively. In the analysis of covariance for duration of severe neutropenia in cycle 1, the estimated treatment difference "XM02 minus Filgrastim" was 0.157 days, with 95% confidence level (-0.114 days, 0.428 days), which was included in the prespecified equivalence range (-1,1). There was no statistically significant difference of the end point incidence of febrile neutropenia in cycle I between XM02 and Filgrastim (p = 0.2347). The adverse event profile was similar between XM02 and Filgrastim. Conclusion: XM02 demonstrated similar efficacy and safety profile as the reference medication Filgrastim in cycle 1. In conclusion, treatment with XM02 is beneficial in ameliorating severe neutropenia and febrile neutropenia in lung cancer patients receiving myelo-suppressive chemotherapy. XM02 is safe and well tolerated in the doses applied in this study.