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pegfilgrastim (GBS010 / GBS 010)

✓ Approved

Kidswell Bio · CSF3R · 重组蛋白

什么是 pegfilgrastim？

pegfilgrastim 是一种重组蛋白，由Kidswell Bio研发。该药已获批，用于治疗相关适应症，给药途径：Unknown。

药物档案

商品名GBS010, GBS 010
公司Kidswell Bio
药物类别重组蛋白
分子靶点CSF3R
给药途径Unknown
状态Approved
来源： ClinicalTrials.gov, Kidswell Bio

作用机制

分子靶点

pegfilgrastim 作用于 1 个分子靶点：

CSF3Rcolony stimulating factor 3 receptor (CD114, GCSFR)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

pegfilgrastim 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Blood and lymphatic system disordersBone marrow disorder✓ Approved

相关研究文献

PubMedCancer treatment and research communications2026-06-03

Pegfilgrastim versus filgrastim for chemo-mobilized stem cell collection in multiple myeloma: A retrospective real-world study.

Zhang Yan-Lin YL, Qin Xin-Yi XY, Cao Chun C, Luo Zhi-Ming ZM et al.

Autologous stem cell transplantation (ASCT) is a standard treatment for newly diagnosed multiple myeloma (MM). Achieving sufficient stem cell yield via effective mobilization promotes successful hematological reconstitution. However, clinical evidence regarding the comparative outcomes of pegfilgrastim (PEG) versus filgrastim (FIL) remains controversial, lacking regimen-specific comparisons. To evaluate the efficacy, safety, efficiency, and costs of PEG versus FIL in MM patients, and compare the impact of cyclophosphamide-based chemo-mobilization on these outcomes. This single-center retrospective study included 102 MM patients (PEG: n = 49; FIL: n = 53). Primary endpoints were CD34⁺ cell yield, mobilization success, duration, and time to engraftment. Statistical analyses included propensity score matching (PSM), overlap weighting (OW), and subgroup analysis. In the overall cohort, PEG and FIL showed equivalent median CD34⁺ yields (3.90 vs. 4.99 × 10⁶/kg, P = 0.096), mobilization success rates, and total hospitalization costs (P = 0.53). FIL yielded a higher total mononuclear cell count (P < 0.001). Subgroup analysis revealed PEG reduced mobilization duration (10 vs. 15 days, P < 0.001) and sessions in chemo-mobilization. PSM showed comparable yields and engraftment. To address PSM sample attrition and balance covariates, OW was utilized, further confirming that PEG significantly shortened overall duration (P = 0.04) and reduced sessions (P = 0.02). Both regimens exhibited similar engraftment kinetics and safety. Both PEG and FIL demonstrate equivalent efficacy for stem cell mobilization in MM. PEG offers superior efficiency by shortening duration and reducing sessions without increasing the total economic burden.

PMID 42229263
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PubMedTransfusion2026-05-29

Usefulness of pegfilgrastim for allogeneic peripheral blood stem cell collection from healthy donors.

Shimizu Tomoshige T, Jo Tomoyasu T, Yoshinaga Noriyoshi N, Sakamoto Takashi T et al.

Granulocyte colony-stimulating factor (G-CSF)-based mobilization is essential for peripheral blood stem cell (PBSC) collection for allogeneic transplantation. Conventional daily G-CSF requires repeated dosing and dose adjustment and often necessitates leukapheresis over multiple consecutive days, increasing donor burden. Single-dose pegfilgrastim has emerged as an alternative; however, real-world data on its impact on CD34+ cell collection in healthy donors remain limited. Healthy related or unrelated donors who received either a single dose of pegfilgrastim or daily filgrastim and subsequently underwent PBSC collection at Kyoto University Hospital between July 2014 and September 2025 were included. CD34+ cell harvest outcomes and donor burden were compared. A total of 39 donors were analyzed (20 pegfilgrastim, 19 filgrastim), with comparable baseline characteristics. At the start of leukapheresis, peripheral blood white blood cell counts were significantly higher in the pegfilgrastim group. Pegfilgrastim achieved greater total CD34+ cell yield (median 398.0 × 106 vs. 302.4 × 106 cells, p = .025) and higher yields per 10 L of processed blood (median 407.8 × 106 vs. 302.4 × 106 cells, p = .032). Single-session leukapheresis was more frequent with pegfilgrastim (95.0% vs. 63.2%, p = .002), and the estimated processing time required to collect 2 × 106/kg CD34+ cells was shorter (median 62.7 vs. 111.1 min, p = .040). No severe adverse events were observed. These findings suggest that single-dose pegfilgrastim enables more efficient PBSC collection with reduced donor burden and may represent a practical mobilization strategy in healthy allogeneic donors.

PMID 42212441
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PubMedThe American journal of managed care2026-05-26

Biosimilar adoption and provider performance in Medicare value-based payment models.

Chaudhry Basit B, Yue Andrew A, Shelbaya Ahmed A, Tran Lisa L et al.

To quantify the impact of biosimilar adoption on oncology provider financial risk under the Oncology Care Model (OCM) using real-world data. Retrospective study of Medicare fee-for-service beneficiaries potentially eligible for an OCM episode of care initiating between January 2019 and June 2021. Cancer treatment episodes were identified from the Medicare 5% Limited Data Set (LDS). The study sample consisted of episodes with use of any of the following agents or their biosimilars: bevacizumab, rituximab, trastuzumab, epoetin alfa, filgrastim, and pegfilgrastim. Financial risk was defined as the difference in observed total cost of care vs OCM benchmark episode cost. The primary outcome was the difference in financial risk (expressed in nominal US$) under observed use of reference agents and/or biosimilars vs hypothetical use of 100% reference product. The sample included 8851 episodes. Biosimilar adoption resulted in a mean cost reduction of $1023 per 6-month episode vs hypothetical 100% use of reference agents. Biosimilar use increased markedly over the study horizon-with use in 65% of episodes initiating in half 1 (H1) of 2021. The mean cost of care reduction in episodes initiating in H1 2021 ($2060; 4.1% of mean episode benchmark price) improved nearly 10-fold vs H1 2019 ($201; 0.4% of mean episode benchmark price). Rapid adoption of biosimilars for Medicare beneficiaries included in the LDS led to substantial cost savings for cancer episodes evaluated under the OCM methods-suggesting that adoption of biosimilars is a key strategy that providers should consider to manage financial risk in value-based payment models.

PMID 42189077
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PubMedJournal of clinical oncology : official journal of the American Society of Clinical Oncology2026-05-26

Neoadjuvant Durvalumab ± Tremelimumab in Combination With Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Muscle-Invasive Bladder Carcinoma: Results of the Phase I/II NEMIO Study.

Thibault Constance C, Bennamoun Mostefa M, Fléchon Aude A, Gravis Gwenaelle G et al.

To evaluate the efficacy and safety of neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) combined with durvalumab ± tremelimumab in patients with muscle-invasive bladder cancer (MIBC). NEMIO (ClinicalTrials.gov identifier: NCT03549715) is a multicenter, randomized, noncomparative phase II trial in cT2-T4a N0-1 cisplatin-eligible MIBC planned for radical cystectomy (RC). Patients received ddMVAC (cisplatin 70 mg/m2, methotrexate 30 mg/m2, doxorubicin 30 mg/m2, and vinblastine 3 mg/m2 on days 1, and pegfilgrastim 6 mg on days 2) once every 2 weeks × four cycles plus durvalumab ± tremelimumab (durvalumab 1,500 mg and tremelimumab 75 mg) once every 4 weeks × two doses (C1D1 and C3D1) before RC. Coprimary end points (local assessment) were pathologic complete response (pCR; ypT0N0) and grade ≥3 treatment-related adverse events (TRAEs). The study was considered positive if the pCR rate was ≥45% and the rate of grade ≥3 TRAEs was ≤30%. From 2018 to 2022, 119 patients received ddMVAC + durvalumab (n = 60) or ddMVAC + durvalumab + tremelimumab (n = 59); 113 underwent RC. The overall Bayesian posterior mean pCR rate was 48.70% (95% CI, 35.93 to 61.56) with doublet and 46.27% (95% CI, 33.92 to 58.85) with triplet. Among 103 patients with PD-L1 data (exploratory), Bayesian posterior mean pCR was 68.25% (95% CI, 54.57 to 80.49) in PD-L1-high tumors versus 33.49% (95% CI, 22.13 to 45.91) in PD-L1-low/negative tumors. Bayesian posterior mean grade ≥3 TRAEs occurred in 40.95% (95% CI, 32.50 to 49.69) overall (30.48% [95% CI, 20.00 to 42.08] doublet; 49.63% [95% CI, 37.55 to 61.73] triplet); immune-related adverse events occurred in 26.9% (grade ≥3 4.2%). Two-year event-free survival and overall survival rates were 75% and 85% in the doublet arm, and 77% and 88% in the triplet arm, respectively. Neoadjuvant ddMVAC plus durvalumab demonstrated encouraging pCR rates, favorable early survival outcomes, and manageable safety profile. Adding tremelimumab provides similar pCR but worse toxicity. These results support further study of ddMVAC plus durvalumab as a neoadjuvant chemoimmunotherapy strategy for localized MIBC, to be evaluated in comparative trials within an evolving perioperative treatment landscape.

PMID 42190158
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PubMedQJM : monthly journal of the Association of Physicians2026-05-19

Intravitreal pegfilgrastim for indirect traumatic optic neuropathy: a first-in-human phase 1/2a study.

Huang Chin-Te CT, Wen Yao-Tseng YT, Liu Pei-Kang PK, Tsai Rong-Kung RK

Indirect traumatic optic neuropathy (TON) is associated with severe vision loss and no proven treatment. To evaluate the safety and exploratory functional outcomes of intravitreal pegfilgrastim in patients with indirect TON. Single-center, open-label, single-arm phase 1/2a proof-of-concept study. Twelve adults with acute unilateral indirect TON received a single intravitreal injection of 0.15 mL pegfilgrastim and were followed for 3 months. Outcomes included adverse events, best-corrected visual acuity (BCVA), visual field mean deviation, retinal nerve fiber layer thickness, and flash visual evoked potentials (VEP). No serious ocular or systemic treatment-related adverse events were observed. Transient leukocytosis occurred after treatment and resolved spontaneously. Within-subject improvements in BCVA were observed at 1 week, 1 month, and 3 months (p < 0.05), and visual field mean deviation improved at 3 months (p < 0.05). Retinal nerve fiber layer thickness declined progressively during follow-up. No significant change was detected in VEP latency or amplitude. Intravitreal pegfilgrastim was feasible and well tolerated in this first-in-human study of indirect TON. Exploratory functional improvements were observed in a subset of participants, but controlled studies are required to determine whether these changes exceed the natural history of the disease.

PMID 42155034
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PubMedIn vivo (Athens, Greece)2026-04-29

Risk Factors and Clinical Significance of Grade ≥3 Neutropenia During the First Cycle of Cabazitaxel Therapy With Primary Pegfilgrastim Prophylaxis in Metastatic Castration-resistant Prostate Cancer.

Sato Ryo R, Yoshimi Yukihiro Y, Nishio Tetsuharu T, Matsunaga Y U YU et al.

Cabazitaxel is an established treatment for metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen; however, it is frequently associated with severe neutropenia. Although primary prophylaxis with pegfilgrastim is widely used, severe neutropenia still occurs. The present study aimed to identify risk factors for grade ≥3 neutropenia during the first cabazitaxel cycle (Cycle 1) under universal pegfilgrastim prophylaxis and to evaluate its clinical significance. This retrospective study analyzed 40 patients with mCRPC treated with cabazitaxel at our institution between January 2015 and January 2025. All patients received primary prophylactic pegfilgrastim on day 3 of each cycle. The primary endpoint was the occurrence of grade ≥3 neutropenia during Cycle 1. A logistic regression analysis was performed to identify associated factors. Overall survival (OS) and progression-free survival (PFS) were analyzed using the Kaplan-Meier method and compared using the Log-rank test. Grade ≥3 neutropenia during Cycle 1 occurred in 18 patients (45.0%). A univariate analysis identified age ≥75 years and prior docetaxel exposure ≥9 cycles as significant risk factors for grade ≥3 neutropenia. In a multivariate analysis, prior docetaxel exposure ≥9 cycles was identified as an independent predictor. Febrile neutropenia occurred in six patients (15.0%) during Cycle 1. There were no significant differences in OS or PFS between patients with and without grade ≥3 neutropenia. Despite universal pegfilgrastim prophylaxis, severe neutropenia during the first cabazitaxel cycle remains common, particularly in patients with extensive prior docetaxel exposure. However, early grade ≥3 neutropenia was not associated with poorer survival outcomes. These results suggest that under adequate supportive care, early hematologic toxicity alone does not preclude continued cabazitaxel treatment.

PMID 42049400
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