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

Abstract

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.

• Authors: Nadia Harbeck, Pere Gascon, Clyde M Jones, Allen Nixon, Andriy Krendyukov, Roumen Nakov, Yuhan Li, Kimberly Blackwell
• Journal: Future oncology (London, England) (Future Oncol) Vol. 13 Issue 16 Pg. 1385-1393 (Jul 2017) ISSN: 1744-8301 [Electronic] England
• PMID: 28453299 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Biosimilar Pharmaceuticals
• Granulocyte Colony-Stimulating Factor
• pegfilgrastim
• Polyethylene Glycols
• Filgrastim

Topics

• Adult
• Aged
• Asian People (genetics)
• Biosimilar Pharmaceuticals (adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy, genetics, pathology)
• Drug-Related Side Effects and Adverse Reactions (pathology)
• Female
• Filgrastim (adverse effects, therapeutic use)
• Granulocyte Colony-Stimulating Factor (genetics)
• Humans
• Middle Aged
• Neutropenia (chemically induced)
• Polyethylene Glycols (adverse effects, therapeutic use)
• Treatment Outcome