A phase 3 trial of GB-K02 pegfilgrastim biosimilar for preventing chemotherapy-induced neutropenia in breast cancer
Abstract
Chemotherapy-induced neutropenia (CIN) constitutes a substantial disease burden globally. Although pegfilgrastim (a long-acting granulocyte-colony stimulating factor) has demonstrated efficacy in preventing CIN, it is not yet available in China. This is the first clinical study to evaluate a pegfilgrastim biosimilar in China. This multicenter, randomized, double-blind, parallel-controlled, phase 3 equivalence study aims to evaluate the efficacy and safety of GB-K02 (a pegfilgrastim biosimilar) in preventing CIN among 250 patients with breast cancer. The primary efficacy endpoint was the duration of grade 4 neutropenia (DG4N) in cycle 1 of chemotherapy. The DG4N (LSMean ± SE) in cycle 1 was 0.58 ± 0.13 days versus 0.80 ± 0.13 days (p = 0.2139) for the GB-K02 group and the pegfilgrastim group, respectively. Other efficacy endpoints and safety were also similar between the two groups in 4 cycles of chemotherapy. Overall, GB-K02 demonstrated proper equivalence to pegfilgrastim and might offer an option in preventing CIN in China.
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BibTeX
@article{lin2026phase,
title = {{A phase 3 trial of GB-K02 pegfilgrastim biosimilar for preventing chemotherapy-induced neutropenia in breast cancer}},
author = {Jinhai Lin and Hengxin Peng and Yijia Zhang and Yufang Yi and Kangsheng Yang and Yanqing Lin and Huiping Li and Suofu Qin},
journal = {iScience},
year = {2026},
month = oct,
doi = {10.1016/j.isci.2026.117766},
url = {https://www.cell.com/iscience/fulltext/S2589-0042(26)03147-0},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - A phase 3 trial of GB-K02 pegfilgrastim biosimilar for preventing chemotherapy-induced neutropenia in breast cancer
AU - Jinhai Lin
AU - Hengxin Peng
AU - Yijia Zhang
AU - Yufang Yi
AU - Kangsheng Yang
AU - Yanqing Lin
AU - Huiping Li
AU - Suofu Qin
PY - 2026
DA - 2026/10/09
JO - iScience
DO - 10.1016/j.isci.2026.117766
UR - https://www.cell.com/iscience/fulltext/S2589-0042(26)03147-0
AB - Chemotherapy-induced neutropenia (CIN) constitutes a substantial disease burden globally. Although pegfilgrastim (a long-acting granulocyte-colony stimulating factor) has demonstrated efficacy in preventing CIN, it is not yet available in China. This is the first clinical study to evaluate a pegfilgrastim biosimilar in China. This multicenter, randomized, double-blind, parallel-controlled, phase 3 equivalence study aims to evaluate the efficacy and safety of GB-K02 (a pegfilgrastim biosimilar) in preventing CIN among 250 patients with breast cancer. The primary efficacy endpoint was the duration of grade 4 neutropenia (DG4N) in cycle 1 of chemotherapy. The DG4N (LSMean ± SE) in cycle 1 was 0.58 ± 0.13 days versus 0.80 ± 0.13 days (p = 0.2139) for the GB-K02 group and the pegfilgrastim group, respectively. Other efficacy endpoints and safety were also similar between the two groups in 4 cycles of chemotherapy. Overall, GB-K02 demonstrated proper equivalence to pegfilgrastim and might offer an option in preventing CIN in China.
SN - 2589-0042
ER -