Delving into the Latest Updates on Pegfilgrastim biosimilar (Cinfa Biotech SL) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Colony-stimulating factors

Synonyms

Pegfilgrastim biosimilar, Pegfilgrastim biosimilar (Cinfa Biotech), Pegylated granulocyte colony stimulating factor

+ [3]

Target

CSF-3R

Mechanism

CSF-3R agonists(Colony stimulating factor 3 receptor agonists)

Therapeutic Areas

Hemic and Lymphatic Diseases

Active Indication

Febrile NeutropeniaNeutropenia

Inactive Indication-

Originator Organization

Cinfa Biotech SL

Active Organization

Mundipharma International Ltd.

Inactive Organization

Purdue Pharma, Inc.

Cinfa Biotech SL

Drug Highest PhaseApproved

First Approval Date

EU (20 Nov 2018),

Febrile NeutropeniaNeutropenia

Regulation-

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Gene Sequence

Sequence Code 4190

The sequence is quoted from: *****

Granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells have become the preferred source of hematopoietic stem cells. We compared the effectiveness of G-CSF and pegylated G-CSF (peg-G-CSF) for hematopoietic stem cell mobilization in haploidentical hematopoietic stem cell transplantation (haplo-HSCT) donors, and evaluated the transplant outcomes. We conducted a matched retrospective cohort study. Donors mobilized with peg-G-CSF (n = 70) and G-CSF (n = 70). 140 consecutive patients diagnosed with acute leukemia who underwent haplo-HSCT were included in this study. The findings revealed that the peg-G-CSF cohort exhibited significantly elevated myeloid-derived suppressor cells (MDSCs) levels in their grafts when compared to the G-CSF cohort (P < 0.001). The 100-day cumulative incidence (CI) of grade III-IV acute graft-versus-host disease (GVHD) and 1-year CI of moderate-to-severe chronic GVHD were 4.3% vs 14.3 % (P = 0.047) and 11.2% vs 27.4 % (P = 0.023), in the peg-G-CSF group and G-CSF group. Patients reveiving mobilized stem cell with peg-G-CSF had a significantly greater likelihood of 1-year GVHD-free relapse-free survival (GRFS) compared to patients reveiving mobilized stem cell with G-CSF (74.9% vs 37.9 %, P < 0.001). The higher graft MDSCs proportion was associated with lower grade II-IV aGVHD, cGVHD (P < 0.05) and higher GRFS in the univariate analysis (P < 0.05). Multivariate analysis showed that MDSCs proportion higher than 11.36 % (HR, 0.305; 95 % CI, 0.154-0.606; P = 0.001) and peg-G-CSF for stem cell mobilization (HR, 0.466; 95 % CI, 0.251-0.865; P = 0.016) were independent prognostic factors of GRFS. The superior survival rates observed in recipients of peg-G-CSF-mobilized cells are likely due to reduced acute GVHD, potentially mediated by the increased MDSCs within the grafts.

01 Oct 2023·JTO clinical and research reports

Docetaxel Plus Ramucirumab With Primary Prophylactic Pegylated Granulocyte-Colony Stimulating Factor Support for Elderly Patients With Advanced NSCLC: A Multicenter Prospective Single Arm Phase 2 Trial: DRAGON Study (WJOG9416L).

Article

Author: Ota, Keiichi ; Tachihara, Motoko ; Wakuda, Kazushige ; Nakamura, Atsushi ; Takayama, Yusuke ; Tokito, Takaaki ; Miura, Satoru ; Sato, Yuki ; Okada, Hideaki ; Toyozawa, Ryo ; Watanabe, Hiroshi ; Hata, Akito ; Yamamoto, Nobuyuki ; Nakagawa, Kazuhiko ; Tabata, Eriko ; Shimokawa, Mototsugu ; Hara, Satoshi

IntroductionDocetaxel plus ramucirumab could be a promising treatment for chemo-naive elderly patients with NSCLC, but high incidence of febrile neutropenia (FN) is a critical concern. We thus adopted a routine primary prophylactic pegylated-granulocyte-colony stimulating factor (PEG-G-CSF) to reduce FN and maximize the efficacy of docetaxel plus ramucirumab in elderly patients.MethodsThis is a single arm phase 2 trial for chemo-naive elderly patients (aged ≥75 y) with advanced NSCLC. Docetaxel (60 mg/m², d 1) plus ramucirumab (10 mg/kg, d 1) with PEG-G-CSF (3.6 mg, d 2) was administered every 3 weeks until progression. The primary end point was overall response rate (ORR) (expected ORR: 35%).ResultsBetween February 2018 and January 2021, 54 patients were enrolled. Median age was 78 (range: 75-86). A total of 21 (38.9%) partial response, 22 (40.7%) stable disease, nine (16.7%) progressive disease, and two (3.7%) not assessable were confirmed, resulting in ORR of 38.9% (90% confidence interval [CI]: 27.7%-51.0%) and disease control rate of 79.6%. Median progression-free survival and overall survival were 5.2 (95% CI: 4.2-6.9) and 12.7 (95% CI: 10.2-18.9) months, respectively. There were one (1.9%) FN, two (3.7%) bleeding grade greater than or equal to 3, and one (1.9%) treatment-related death (pneumonitis). Pneumonitis occurred in five patients (9.3%). Main adverse events grade greater than or equal to 3 were observed: four (7%) thrombocytopenia; three (5.6%) neutropenia; six (11.1%) hyposodium; five (9.3%) infection; five (9.3%) hypertension; four (7.4%) anorexia; and three (5.6%) oral mucositis.ConclusionsDocetaxel plus ramucirumab with PEG-G-CSF revealed efficacy and safety for chemo-naive elderly patients with NSCLC. Primary prophylactic PEG-G-CSF highly prevented FN.

01 Aug 2023·Clinical Pharmacology in Drug Development

Clinical Impact of Antipolyethylene Glycol (PEG) Antibody in Hematological Patients Administered PEGylated‐Granulocyte Colony‐Stimulating Factor

Article

Author: Taro, Shimizu ; Nakamura, Shingen ; Abe, Masahiro ; Goda, Mitsuhiro ; Kitahara, Takashi ; Ishizawa, Keisuke ; Ishida, Tatsuhiro ; Ando, Hidenori ; Okada, Naoto

AbstractPolyethylene glycol (PEG) is a polymer covalently attached to proteins to improve their half‐life and efficacy. We previously reported that the PEGylated granulocyte colony‐stimulating factor (PEG‐G‐CSF) is immunogenic, which could adversely impact drug efficacy and safety in animal models. Here, we analyzed the relationship between anti‐PEG antibody titers and the clinical impact of PEG‐G‐CSF in 19 hematological patients. A gradual decrease of anti‐PEG antibody titers from baseline was observed after PEG‐G‐CSF administration. Of the 19 participants, 10 were assessed for noninfectious fever after the first administration of PEG‐G‐CSF and three experienced this reaction. The receiver operating characteristic curve revealed that the cut‐off values of pretreated anti‐PEG IgM and IgG titers for noninfectious fever were set at 5.0 and 96.6 U/mL, respectively. All patients who experienced noninfectious fever had anti‐PEG antibody titers above this cut‐off value (P = .033). An enzyme‐linked immunosorbent assay revealed that some anti‐PEG antibodies in patients with anti‐PEG antibody titers above the cut‐off value reacted with the PEGylated liposome. These results indicate the reactivity of the anti‐PEG antibodies to PEGylated therapeutics observed in hematologic patients and the possibility of the relationship between high titers of anti‐PEG antibodies and the development of adverse events after PEG‐G‐CSF administration.

100 Deals associated with Pegfilgrastim biosimilar (Cinfa Biotech SL)

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External Link

KEGG	Wiki	ATC	Drug Bank
D06889	-	L03AA13	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Febrile Neutropenia	IS	Mundipharma International Ltd.	20 Nov 2018
Febrile Neutropenia	LI	Mundipharma International Ltd.	20 Nov 2018
Febrile Neutropenia	NO	Mundipharma International Ltd.	20 Nov 2018
Febrile Neutropenia	EU	Mundipharma International Ltd.	20 Nov 2018
Neutropenia	IS	Mundipharma International Ltd.	20 Nov 2018
Neutropenia	EU	Mundipharma International Ltd.	20 Nov 2018
Neutropenia	LI	Mundipharma International Ltd.	20 Nov 2018
Neutropenia	NO	Mundipharma International Ltd.	20 Nov 2018