Proposed biosimilar pegfilgrastim (LA-EP2006) compared with reference pegfilgrastim in Asian patients with breast cancer: an exploratory comparison from two Phase III trials.

Journal Article (Clinical Trial, Phase III;Journal Article)

AIM: This is a pooled subgroup analysis of Asian patients enrolled in two Phase III confirmatory studies comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer. PATIENTS & METHODS: Women were randomized to LA-EP2006 (n = 90) or reference (n = 84) pegfilgrastim (Neulasta®, Amgen, Inc., CA, USA) for ≤6 cycles of TAC chemotherapy. Primary end point was duration of severe neutropenia during Cycle 1 (number of consecutive days with absolute neutrophil count <0.5 × 109/l) with equivalence confirmed if 95% CIs were within a ±1-day margin. RESULTS: Mean duration of severe neutropenia (days) in Cycle 1 was 1.36 ± 0.98 (LA-EP2006) versus 1.35 ± 1.06 (reference) (difference 0.01 days; 95% CI: -0.30-0.32, indicating equivalence). CONCLUSION: LA-EP2006 showed similar clinical efficacy and safety compared with reference pegfilgrastim.

Full Text

Duke Authors

Cited Authors

  • Harbeck, N; Gascon, P; Jones, CM; Nixon, A; Krendyukov, A; Nakov, R; Li, Y; Blackwell, K

Published Date

  • July 2017

Published In

Volume / Issue

  • 13 / 16

Start / End Page

  • 1385 - 1393

PubMed ID

  • 28453299

Electronic International Standard Serial Number (EISSN)

  • 1744-8301

Digital Object Identifier (DOI)

  • 10.2217/fon-2017-0041


  • eng

Conference Location

  • England