THERAPY DOSSIER · th-07c521227198

Pegylated granulocyte colony-stimulating factor (pegfilgrastim) combined with Alxn4100TPO

Biologic · Granulocyte colony stimulating factor receptor agonist (AGONIST, direct interaction; ChEMBL mec_id 670). ATC L03AA13. Applies to the pegfilgrastim component only, NOT to the Alxn4100TPO partner, which has no ChEMBL entry and no dedicated trial.

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Evidence & regulatory context

Mechanism: Granulocyte colony stimulating factor receptor agonist (AGONIST, direct interaction; ChEMBL mec_id 670). ATC L03AA13. Applies to the pegfilgrastim component only, NOT to the Alxn4100TPO partner, which has no ChEMBL entry and no dedicated trial.
Target: CHEMBL1996
Injury models: Radiation
Reported indication: Not recorded
First approval: 2002
Development stage: Not recorded
ChEMBL record: CHEMBL1201568 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Neulasta; Neupopeg; Udenyca; Ziextenzo; Fulphila; Pelgraz
Note: Not recorded

Clinical trials 6

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT04759586 ↗PHASE3active not recruiting

Nivolumab plus chemo-immunotherapy with pegfilgrastim support in primary mediastinal B-cell lymphoma

Primary Mediastinal Large B-Cell Lymphoma

Enrolment: 244 · Results not recorded

NCT03559387 ↗PHASE2terminated

ANF-RHO versus pegfilgrastim (Neulasta) for chemotherapy-induced neutropenia in breast cancer

Chemotherapy-induced Neutropenia

Enrolment: 9 · Results not recorded

NCT00392834 ↗PHASE2completed

R-CODOX-M/IVAC with filgrastim and pegfilgrastim in HIV-associated Burkitt lymphoma

Lymphoma

Enrolment: 34 · Results not recorded

NCT00404066 ↗PHASE2completed

Neoadjuvant AC-docetaxel with lapatinib and pegfilgrastim in HER2+ breast cancer

Breast Cancer

Enrolment: 21 · Results not recorded

NCT01782339 ↗PHASE2completed

Single arm phase II for relapsed germ cell tumours with poor prognosis (G-CSF support)

Germ Cell Tumour

Enrolment: 45 · Results not recorded

NCT00615901 ↗NAcompleted

Dose dense adjuvant CMF with PEG-filgrastim in early stage breast cancer

Breast Cancer

Enrolment: 38 · Results not recorded

Preclinical evidence 2

2 studies reported at therapy level; 2 evidence entries itemised.

PMID 28850300 ↗2017Reported benefit

Combined Therapy of Pegylated G-CSF and Alxn4100TPO Improves Survival and Mitigates Acute Radiation Syndrome after Whole-Body Ionizing Irradiation Alone and Followed by Wound Trauma.

MouseRadiationB6D2F1/JFemalen = 16 to 20 mice per group at randomisation, 16 to 22 per grou…SubcutaneousPegylated G-CSF 1,000 micrograms/kg in 0.2 ml, equivalent t…First dose 4 h after irradiation alone or combined injury

Model: Whole-body cobalt-60 gamma irradiation at 9.5 Gy delivered at 0.4 Gy/min in a bilateral field, alone or followed within 1 to 2 h by a 15 per cent total body surface area full-thickness skin wound between the scapulae

Combined pegylated G-CSF and Alxn4100TPO raised 30-day survival from 60 to 95 per cent after radiation alone and from 35 to 55 per cent after combined injury, limited body weight loss, reduced acute radiation syndrome and improved haematopoiesis and ileal structure, but did not accelerate wound hea…

Extraction: extract · Supplied extraction confidence: 0.92. Machine-extracted fields require source verification.

PMID 24276547 ↗2014Mixed findings

Survival efficacy of the PEGylated G-CSFs Maxy-G34 and neulasta in a mouse model of lethal H-ARS, and residual bone marrow damage in treated survivors.

MouseRadiationC57BL/6 (H-ARS studies); B6.BoyJ (B6.Ptrc Pep3/BoyJ) and C57BL/6 x B6.BoyJ F1 hybrid used as transplant recipients and competitor cell donorsMale and female (50/50)n = Groups of 20-30 mice per arm in the PEGylated G-CSF surviva…SubcutaneousMaxy-G34 and Neulasta 0.1, 0.3 or 1.0 mg/kg; Neupogen 125 u…First dose 24 +/- 4 h after total body irradiation

Model: Single uniform total body gamma irradiation (137Cs, 7.76-9.04 Gy, 0.60-0.66 Gy/min) producing the haematopoietic syndrome of the acute radiation syndrome (H-ARS)

All three growth factors significantly increased 30-day survival after lethal irradiation. Neupogen gave 80.2 per cent 30-day survival versus 51.6 per cent for vehicle (p=0.02, 212 pooled irradiated mice). A single 1.0 mg/kg dose of Neulasta at 24 h was as effective as two doses (p=0.003 and p=0.00…

Extraction: extract · Supplied extraction confidence: 0.92. Machine-extracted fields require source verification.

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