Xiamen Amoytop Biotech Co.ltd · CSF3R · Recombinant Proteins
pegfilgrastim is a recombinant proteins developed by Xiamen Amoytop Biotech Co.ltd. It is approved for therapeutic indications via injectable (others) or subcutaneous injection.
| Brand Names | Peijin, Paijin |
| Company | Xiamen Amoytop Biotech Co.ltd |
| Drug Class | Recombinant Proteins |
| Molecular Target | CSF3R |
| Route | Injectable (Others), Subcutaneous Injection |
| Status | Approved |
pegfilgrastim acts on 1 molecular target:
| CSF3R | colony stimulating factor 3 receptor (CD114, GCSFR) |
pegfilgrastim is developed for 2 unique indications across 1 therapeutic area.
| Therapeutic Area | Condition | Phase |
|---|---|---|
| Blood and lymphatic system disorders | Bone marrow disorder | ✓ Approved |
| Blood and lymphatic system disorders | Neutropenia | Phase II |
Otake Kaori K, Morikawa Naoto N, Kurihara Makoto M, Kumagai Fumiyoshi F et al.
Lin Jinhai J, Peng Hengxin H, Zhang Yijia Y, Yi Yufang Y et al.
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.
Shih Lauren L, Arnold Kathryn B KB, Bansal Aasthaa A, Bell-Brown Ari A et al.
Primary prophylactic colony-stimulating factor (PP-CSF) is recommended for patients receiving chemotherapy with high risk of febrile neutropenia (FN). The impact of PP-CSF delivery method on FN is unknown. We performed a secondary analysis of SWOG S1415CD (Trial Assessing CSF Prescribing Effectiveness and Risk), a pragmatic, cluster-randomized trial evaluating a guideline-informed standing order system to improve PP-CSF use, to evaluate associations between PP-CSF delivery method and FN. Female patients with breast cancer receiving first-line chemotherapy and PP-CSF with a known delivery method (administration in-clinic [IC], home delivery via an on-body device [OBD], or home self-injection [SI]) were included. The primary outcome was FN within 6 months of chemotherapy initiation, defined per the Common Terminology Criteria for Adverse Events. Among 1,713 patients, the median age was 55 years (IQR, 46-64). By stage, 566 (33%) were local, 709 (41%) regional, 41 (2%) distant, and 397 (23%) unknown. PP-CSF was delivered IC in 773 (45%), OBD in 862 (50%), and SI in 78 (5%). Most received high-risk FN regimens. Pegfilgrastim use was nearly exclusive in IC and OBD (98% and 99%), versus 29% in SI. FN incidence was low: IC 3.8% (95% CI, 2.5 to 5.3), OBD 5.0% (95% CI, 3.6 to 6.6), and SI 6.4% (95% CI, 2.1 to 14.3; P = .29). FN was associated with high-risk FN regimens (odds ratio [OR], 2.97 [95% CI, 1.2 to 9.9]; P = .04) and Zubrod performance status ≥2 (OR, 4.99 [95% CI, 1.12 to 15.9]; P = .01), but not with delivery method or PP-CSF agent. Women with breast cancer receiving chemotherapy and PP-CSF had low rates of FN regardless of PP-CSF delivery method or agent. Delivery decisions may be guided by patient-centered factors including cost, convenience, and access.
London Jonathan J, Patresan John J, Belkin Alexander A, Elnair Radowan R
Sweet syndrome (acute febrile neutrophilic dermatosis) is characterized by fever, leukocytosis, and tender erythematous skin lesions with neutrophilic infiltrate. Although associated with granulocyte colony-stimulating factor (G-CSF) use, its occurrence with pegfilgrastim-the pegylated form-is rare, with fewer than five reported cases. Sweet syndrome has also been rarely linked to FLT3 inhibitors such as quizartinib. We report a 71-year-old male with acute myeloid leukemia who developed bullous Sweet syndrome following concurrent exposure to pegfilgrastim and quizartinib.
Scotté Florian F, Lustberg Maryam M, Aapro Matti M, Ben Abid Fatma F et al.
Although multiple antibody-drug conjugates (ADCs) have demonstrated sufficient efficacy and safety to warrant their approval, many patients require supportive treatment to reduce the severity of ADC-associated toxicities. Clinical guidelines recommend the use of granulocyte colony-stimulating factors (G‑CSFs), such as filgrastim, lenograstim, and long-acting pegfilgrastim, to reduce the duration and severity of chemotherapy-induced neutropenia and the risk of febrile neutropenia (FN). The objective of this literature review was to summarize the available data on the use of G-CSFs in patients treated with ADCs as a strategy to mitigate the risk of severe neutropenia and FN. The identified literature highlight the importance of prophylactic G-CSF use to reduce the occurrence of FN and severe neutropenia in patients treated with ADCs. Although data evaluating the effect of G-CSF use as secondary prophylaxis are limited, available studies highlight the clinical necessity of mitigating neutropenia risk associated with ADCs.
Khamis Mohamed M MM, Finnie John W JW
A woman in her early 60s with stage 3A diffuse large B-cell lymphoma developed anaphylaxis to pegfilgrastim after her first cycle of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) chemotherapy, presenting with syncope, severe diarrhoea and persistent hypotension requiring hospitalisation. Three further cycles were given without growth factor support. After cycle four she developed neutropenic fever and received sargramostim (granulocyte-macrophage colony-stimulating factor) under intensive premedication and intensive care monitoring, which she initially tolerated; on the third administration she developed anaphylaxis requiring epinephrine. She completed all six cycles of R-CHOP without growth factor support, using prophylactic antibiotics and close monitoring, achieved complete remission and remains disease-free 41 months after treatment. To our knowledge, this is the second documented case of anaphylaxis to agents from both the granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor classes in one patient, and the first involving pegfilgrastim.
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