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Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition and Cancer Risk: Insights from a Large

Inbar Nardi Agmon1,2,3,4, Chen Gurevitz1,2, Tzippy Shochat5

  • 1Division of Cardiology, Rabin Medical Center, Petach Tikva, Israel.

Clinical Pharmacology and Therapeutics
|February 10, 2026
PubMed

Insights

Proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) show no overall increased cancer risk and reduce mortality. Men on PCSK9 mAbs had a slightly higher cancer incidence, possibly due to baseline factors.

Area of Science:

  • Cardiovascular Medicine
  • Oncology
  • Immunology

Background:

  • Proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) effectively lower LDL cholesterol.
  • PCSK9 mAbs may influence cancer via immunomodulatory pathways, but their impact on human cancer incidence is unknown.

Purpose of the Study:

  • To investigate the effect of PCSK9 mAbs on human cancer incidence compared to ezetimibe.
  • To assess the association of PCSK9 mAbs with all-cause mortality.

Main Methods:

  • Retrospective, propensity score-matched study of 9,876 patients (2,469 PCSK9 mAb, 7,407 ezetimibe) from Clalit Health Services (2010-2023).
  • Patients received treatment for ≥6 months, with a 1-year latency period applied. Analysis included sex-stratification.

Main Results:

  • Overall cancer incidence was similar between PCSK9 mAb users (12%) and ezetimibe users (11%) (HR 1.09).
  • Men on PCSK9 mAbs showed a higher cancer incidence (12.5% vs. 10.3%, P=0.03), while women showed no difference.
  • All-cause mortality was significantly lower in the PCSK9 mAb group (3% vs. 5%; HR 0.65).

Conclusions:

  • PCSK9 mAb therapy appears safe concerning overall cancer risk.
  • PCSK9 mAbs are associated with a significant reduction in all-cause mortality.
  • The observed higher cancer incidence in men may be linked to baseline risk factor prevalence.

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