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Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.

Publication ,  Journal Article
Blackwell, K; Semiglazov, V; Krasnozhon, D; Davidenko, I; Nelyubina, L; Nakov, R; Stiegler, G; Singh, P; Schwebig, A; Kramer, S; Harbeck, N
Published in: Ann Oncol
September 2015

BACKGROUND: Biosimilars of filgrastim are in widespread clinical use in Europe. This phase III study compares biosimilar filgrastim (EP2006), with the US-licensed reference product, Neupogen(®), in breast cancer patients receiving (neo)adjuvant myelosuppressive chemotherapy (TAC). PATIENTS AND METHODS: A total of 218 patients receiving 5 µg/kg/day filgrastim over six chemotherapy cycles were randomized 1:1:1:1 into four arms. Two arms received only one product (nonalternating), biosimilar or reference, and two arms (alternating) received alternating treatments during each cycle (biosimilar then reference or vice versa). The primary end point was duration of severe neutropenia (DSN) during cycle 1. RESULTS: The baseline characteristics were balanced between the four treatment arms. Noninferiority of biosimilar versus the reference was demonstrated: DSN (days) in cycle 1 was 1.17 ± 1.11 (biosimilar, N = 101) and 1.20 ± 1.02 (reference, N = 103), 97.5% confidence interval lower boundary for the difference was -0.26 days (above the predefined limit of -1 day). No clinically meaningful differences were observed regarding any other efficacy parameter: incidence of febrile neutropenia (FN); hospitalization due to FN; incidence of infections; depth and time of absolute neutrophil count (ANC) nadir and time to ANC recovery during cycle 1 and across all cycles. The pattern and frequency of adverse events were similar across all treatments. CONCLUSION: This study demonstrates that biosimilar and the reference filgrastim are similar with no clinically meaningful differences regarding efficacy and safety in prevention of severe neutropenia. Biosimilar filgrastim could represent an important alternative to the reference product, potentially benefiting public health by increasing access to filgrastim treatment. STUDY NUMBER: NCT01519700.

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Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

September 2015

Volume

26

Issue

9

Start / End Page

1948 / 1953

Location

England

Related Subject Headings

  • Young Adult
  • Oncology & Carcinogenesis
  • Neutropenia
  • Neoadjuvant Therapy
  • Middle Aged
  • Humans
  • Granulocyte Colony-Stimulating Factor
  • Filgrastim
  • Female
  • Double-Blind Method
 

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Blackwell, K., Semiglazov, V., Krasnozhon, D., Davidenko, I., Nelyubina, L., Nakov, R., … Harbeck, N. (2015). Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol, 26(9), 1948–1953. https://doi.org/10.1093/annonc/mdv281
Blackwell, K., V. Semiglazov, D. Krasnozhon, I. Davidenko, L. Nelyubina, R. Nakov, G. Stiegler, et al. “Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.Ann Oncol 26, no. 9 (September 2015): 1948–53. https://doi.org/10.1093/annonc/mdv281.
Blackwell K, Semiglazov V, Krasnozhon D, Davidenko I, Nelyubina L, Nakov R, Stiegler G, Singh P, Schwebig A, Kramer S, Harbeck N. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Sep;26(9):1948–1953.
Journal cover image

Published In

Ann Oncol

DOI

EISSN

1569-8041

Publication Date

September 2015

Volume

26

Issue

9

Start / End Page

1948 / 1953

Location

England

Related Subject Headings

  • Young Adult
  • Oncology & Carcinogenesis
  • Neutropenia
  • Neoadjuvant Therapy
  • Middle Aged
  • Humans
  • Granulocyte Colony-Stimulating Factor
  • Filgrastim
  • Female
  • Double-Blind Method