Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.

TitleRandomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.
Publication TypeJournal Article
Year of Publication2016
AuthorsHarbeck, Nadia, Oleg Lipatov, Mona Frolova, Dmitry Udovitsa, Eldar Topuzov, Doina Elena Ganea-Motan, Roumen Nakov, Pritibha Singh, Anita Rudy, and Kimberly Blackwell
JournalFuture Oncol
Volume12
Issue11
Pagination1359-67
Date Published2016 Jun
ISSN1744-8301
KeywordsAntineoplastic Agents, Biosimilar Pharmaceuticals, Breast Neoplasms, Double-Blind Method, Female, Filgrastim, Granulocyte Colony-Stimulating Factor, Humans, Middle Aged, Neutropenia, Polyethylene Glycols, Recombinant Proteins
Abstract

AIM: This randomized, double-blind trial compared proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer (PROTECT-1).PATIENTS & METHODS: Women (≥18 years) were randomized to receive LA-EP2006 (n = 159) or reference (n = 157) pegfilgrastim (Neulasta(®), Amgen) for ≤6 cycles of (neo)-adjuvant TAC chemotherapy. Primary end point was duration of severe neutropenia (DSN) during cycle 1 (number of consecutive days with absolute neutrophil count <0.5 × 10(9)/l) with equivalence confirmed if 90% and 95% CIs were within a ±1 day margin.RESULTS: For DSN, LA-EP2006 was equivalent to reference (difference: 0.07 days; 90% CI: -0.09-0.23; 95% CI: -0.12-0.26).CONCLUSION: LA-EP2006 and reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy.

DOI10.2217/fon-2016-0016
Alternate JournalFuture Oncol
Original PublicationRandomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.
PubMed ID27020170
PubMed Central IDPMC5705792
Grant ListP01 CA142538 / CA / NCI NIH HHS / United States