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Poster display session

4448 - Efficacy and safety of RGB-02, a proposed biosimilar pegfilgrastim to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind, phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving docetaxel/doxorubicin

Date

10 Sep 2017

Session

Poster display session

Presenters

Karoly Horvat-Karajz

Citation

Annals of Oncology (2017) 28 (suppl_5): v543-v567. 10.1093/annonc/mdx388

Authors

K. Horvat-Karajz1, D. Grecea2, M. Smakal3, A. Illes1, Z. Kahan4

Author affiliations

  • 1 Clinical Development Of Biologics, Gedeon Richter Plc., 1103 - Budapest/HU
  • 2 Radiotherapy I. Department, Ion Chiricuta Oncology Institute-IOCN, 400015 - Cluj-Napoca/RO
  • 3 Oncology Station, Hospital Horovice, a.s., 26831 - Horovice/CZ
  • 4 Department Of Oncotherapy, University of Szeged, 6720 - Szeged/HU
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Resources

Abstract 4448

Background

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).

Methods

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.

Results

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.

Conclusions

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.

Funding

Gedeon Richter Plc.

Disclosure

K. Horvat-Karajz, A. Illes: Employee of Gedeon Richter Plc. All other authors have declared no conflicts of interest.

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