Pegilodecakin
Also known as: AM0010, BMS-986253, PEG-rHuIL-10, PEG‑IL‑10, pegilodecakin
Source Pegilodecakin at Peptiology
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Summary
Pegilodecakin is a pegylated recombinant human IL‑10 protein investigated as an immunotherapy for solid tumours. It is administered subcutaneously and has shown activity in combination with checkpoint inhibitors.
Mechanism of Action
Agonist of the IL-10 receptor; exerts immunomodulatory effects by enhancing CD8+ T‑cell activity and reducing immunosuppressive tumor microenvironment.
Routes of Administration
Goals & Uses
- Immune checkpoint combination therapyImmunotherapyModerate
- Pancreatic cancer treatmentOncologyModerate
- Non-small cell lung cancer treatmentOncologyLow
- reduce tumor‑associated inflammationOncologyLow
- Enhance anti‑tumor immunityOncologyModerate
- Renal cell carcinoma treatmentOncologyModerate
- Anti-tumor immunity enhancementOncologyModerate
Contraindications
- Severe hepatic impairmentOrganModerateLiver function concerns
- Active infectionInfectiousModerate
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Active autoimmune diseaseAutoimmunityHigh
- hypersensitivity to IL‑10 or PEGImmunologicModerate
Adverse Effects
- Injection site reactionsLocalCommon
- ThrombocytopeniaHematologicUncommonLow platelet count
- HypertriglyceridemiaMetabolicUncommon
- AnemiaHematologicUncommonLow red blood cell count or hemoglobin
- FatigueGeneralCommonLow energy or tiredness
- Elevated inflammatory markers / flu-like symptomsConstitutionalCommon
- Injection‑site reactionLocalCommon
Drug Interactions
- Immunosuppressants (e.g., corticosteroids)Moderate
- FOLFOX chemotherapyModerate
- PembrolizumabLow
Population Constraints
- PregnancyReproductive SafetyAbsolute
- Severe renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
- Pregnant or lactating womenReproductiveRelative
- Patients with prior severe immune-related adverse eventsImmunologicRelative
Regulatory Status
- European UnionInvestigationalUnder clinical investigation; EMA has not granted marketing authorisation.
- United StatesInvestigationalPhase II/III trials ongoing; not FDA‑approved.
- United KingdomInvestigationalNot approved by MHRA; clinical trial participation only.
Not approved by FDA or EMA; currently enrolled in Phase II/III clinical trials for melanoma, renal cell carcinoma and other solid tumours.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Pegilodecakin?
Pegilodecakin is a pegylated recombinant human IL‑10 protein investigated as an immunotherapy for solid tumours. It is administered subcutaneously and has shown activity in combination with checkpoint inhibitors.
What is Pegilodecakin used for?
Pegilodecakin is educationally associated with: Immune checkpoint combination therapy, Pancreatic cancer treatment, Non-small cell lung cancer treatment, reduce tumor‑associated inflammation, Enhance anti‑tumor immunity, Renal cell carcinoma treatment, Anti-tumor immunity enhancement. Educational only — not medical advice.
How is Pegilodecakin administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Pegilodecakin?
Reported adverse effects include: Injection site reactions, Thrombocytopenia, Hypertriglyceridemia, Anemia, Fatigue, Elevated inflammatory markers / flu-like symptoms, Injection‑site reaction. This list is not exhaustive — consult a qualified clinician.
Who should avoid Pegilodecakin?
Recorded contraindications: Severe hepatic impairment, Active infection, Pregnancy, Active autoimmune disease, hypersensitivity to IL‑10 or PEG. Consult a qualified clinician before use.