Treatment with recombinant human granulocyte-colony stimulating factor (G-CSF) is accepted standard for prevention of chemotherapy-induced neutropenia. RGB-02, a pegylated G-CSF (pegfilgrastim) developed by Gedeon Richter is a proposed biosimilar to the reference pegfilgrastim product Neulasta®. Here we are presenting the results of a randomized, comparative, double-blind, multicenter study to evaluate efficacy and safety of RGB-02 in breast cancer patients receiving cytotoxic regimen (EudraCT nr: 2013-003166-14).
239 women presenting with breast cancer were randomized to RGB-02 (n = 121) and to the reference pegfilgrastim, Neulasta® (n = 118). All patients received up to 6 cycles of docetaxel/doxorubicin and a once-per-cycle injection of a fixed 6 mg dose of pegfilgrastim. Primary endpoint was the duration of severe neutropenia (ANC < 0.5 x109/L) in Cycle 1 (2-sided CI interval 95%). Secondary endpoints included incidence and duration of severe neutropenia, incidence of febrile neutropenia, time to ANC recovery, depth of ANC nadir, and safety outcomes.
The mean duration of severe neutropenia in Cycle 1 was 1.7 (RGB-02) and 1.6 days (reference), with a difference (LS Mean) of 0.1 days (95% CI -0.2, 0.4). Therapeutic equivalence could be established as the CI for the difference in LS Mean lay entirely within the pre-defined range of ± 1 day. The incidence of severe neutropenia decreased from cycle 1 to 2 in both groups with no statistical significant differences, for RGB-02 from 84.6% (99 patients) to 54.1% (60 patients) and from 77.0% (87 patients) to 43.7% (45 patients) in the comparator group. Both groups were similar regarding mean time to ANC recovery with 3.4 ± 1.84 days (RGB-02) and 3.7 ± 1.88 days (reference) during Cycle 1. Safety profiles were comparable between groups.
Therapeutic equivalence and similar safety profiles between RGB-02 and Neulasta® as once-per-cycle administration could be demonstrated. RGB-02 can provide a biosimilar alternative for the prevention of neutropenia.
Clinical trial identification
EudraCT nr: 2013-003166-14
Legal entity responsible for the study
Gedeon Richter Plc.
Gedeon Richter Plc.
K. Horvat-Karajz, A. Illes: Employee of Gedeon Richter Plc. All other authors have declared no conflicts of interest.