Efficacy and safety of BCD-017, a novel pegylated filgrastim: Results of open-label controlled phase II study in patients with breast cancer receiving myelosuppressive chemotherapy.
Pegfilgrastim (conjugate of filgrastim and 20 kDa polyethylene glycol (PEG) is approved for treatment of chemotherapy-associated neutropenia. BCD-017 (empegfilgrastim) is a covalent conjugate of filgrastim with 30 kDa PEG. Increased molecular weight of PEG molecule may provide additional benefits compared to pegfilgrastim. To compare efficacy and safety of filgrastim and BCD-017 at 3 mg and 6 mg doses an open-label， randomized， active-comparator， non-inferiority trial was conducted. 60 patients with histologically or cytologically confirmed breast cancer were randomly assigned to receive either subcutaneous (s.c.) injection of 3 mg BCD-017 (n=21)， 6 mg BCD-017 (n = 20)， or 5 mg/kg s.c. injections of filgrastim (n=19) administered daily until ANC 10x10cells/L (maximum of 14 days) after chemotherapy (doxorubicin 60 mg/mand docetaxel 75 mg/m) with stratification for weight and prior chemotherapy exposure. The primary efficacy endpoint was the incidence of severe neutropenia (ANC < 1.0x10cells/L) during the first cycle of chemotherapy. Incidence of severe neutropenia during the first chemotherapy cycle was 85，7%， 65，0% and 61，1% in BCD-017 3 mg， BCD-017 6 mg and filgrastim groups， respectively. Differences between BCD-017 groups and filgrastim group were not significant. Mean duration of grade 4 neutropenia in cycle 1 was 0，43， 0，40 and 0，33 days， accordingly (95% CI for difference between BCD-017 3 mg an