Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim

Summary

The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

Timeline

Start

2011-12

Primary completion

2013-06

Completion

2013-06

Outcome

Met primary endpoint

paper Noninferiority of biosimilar versus the reference was demonstrated: PMID 26122726 ↗

paper 97.5% confidence interval lower boundary for the difference was -0.26 days (above the predefined limit of -1 day). PMID 26122726 ↗

Publications

• 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. doi: 10.1093/annonc/mdv281. Epub 2015 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EP2006	Protein / enzyme biologic	5 ug/kg	—
Comparator	filgrastim	Protein / enzyme biologic	5 ug/kg	—

Indications