A Randomized Multicenter Phase III Study of Single Administration of Mecapegfilgrastim (HHPG-19K), a Pegfilgrastim Biosimilar, for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC).

Abstract

BACKGROUND:

Mecapegfilgrastim (code name HHPG-19K) is a biosimilar to pegylated recombinant human granulocyte-colony stimulating factor (PEG-rhG-CSF). The efficacy and safety of mecapegfilgrastim, using a regimen of once-per-cycle injection of 100-μg/kg or a fixed 6-mg dose, were evaluated for the prophylactic therapy for neutropenia in patients with advanced non-small-cell lung cancer (NSCLC) who were treated with myelosuppressive chemotherapy.

MATERIALS AND METHODS:

Patients were randomized (1:1:1) blindly to 3 treatment arms to receive a single injection of mecapegfilgrastim 100 μg/kg, a 6-mg fixed dose of mecapegfilgrastim, or saline (control) in cycle 1. In cycles 2 to 4 following unblinding at the end of cycle 1, patients in the control arm received daily injections of short-acting rhG-CSF at a dose of 5 μg/kg, whereas patients in the 2 mecapegfilgrastim arms continued the same treatment as in cycle 1. All patients received 4 chemotherapy cycles of docetaxel combined with cisplatin or carboplatin every 21 days. The primary endpoint was the incidence of grade ≥ 3 neutropenia in cycle 1.

RESULTS:

A single dose of 100 μg/kg or a fixed 6-mg dose of mecapegfilgrastim per cycle effectively reduced chemotherapy-induced neutropenia and was comparable to daily rhG-CSF with regard to all efficacy endpoints, including incidence of grade ≥ 3 neutropenia, incidence of febrile neutropenia, duration of grade ≥ 3 neutropenia, and time to neutrophil recovery. No difference in efficacy parameters was observed between the 2-dose regimens of mecapegfilgrastim across all cycles. Mecapegfilgrastim was well-tolerated and was as safe as daily rhG-CSF.

CONCLUSION:

Once-per-cycle injection of mecapegfilgrastim is as effective and safe as daily rhG-CSF for prophylaxis of chemotherapy-induced neutropenia in patients with NSCLC. Mecapegfilgrastim (fixed 6-mg dose) is recommended in clinical practice for its convenient dose management.

• Authors: Caicun Zhou, Yunchao Huang, Donglin Wang, Changshan An, Fuxiang Zhou, Yali Li, Gongyan Chen, Changping Wu, Jianxing He, Gang Wu, Xia Song, Jianfei Gao, Wei Liu, Baolan Li, Jianhua Shi, Cheng Huang, Jingrui Yu, Jueping Feng, Hongmei Yue, Meiqi Shi, Jielai Xia
• Journal: Clinical lung cancer (Clin Lung Cancer) Vol. 17 Issue 2 Pg. 119-27 (Mar 2016) ISSN: 1938-0690 [Electronic] United States
• PMID: 26781346 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

Chemical References

• Biosimilar Pharmaceuticals
• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• Polyethylene Glycols
• pegylated granulocyte colony-stimulating factor

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Biosimilar Pharmaceuticals (administration & dosage)
• Carcinoma, Small Cell (complications, drug therapy, pathology)
• China
• Clinical Protocols
• Female
• Granulocyte Colony-Stimulating Factor (administration & dosage)
• Humans
• Lung Neoplasms (complications, drug therapy, pathology)
• Male
• Middle Aged
• Myelopoiesis (drug effects)
• Neoplasm Staging
• Neutropenia (etiology, prevention & control)
• Neutrophils (drug effects, physiology)
• Polyethylene Glycols (administration & dosage)
• Recombinant Proteins (administration & dosage)
• Treatment Outcome