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Evaluation of the potential for QTc prolongation in patients with solid tumors receiving nivolumab

Shruti Agrawal1, Ian Waxman2, Alexandre Lambert3

  • 1Bristol-Myers Squibb, Route 206 & Province Line Road, Princeton, NJ, 08543, USA. shruti.agrawal@bms.com.

Cancer Chemotherapy and Pharmacology
|February 11, 2016
PubMed
Abstract

Insights

Nivolumab, a cancer treatment, was evaluated for its effect on the corrected QT interval (QTc). Studies show nivolumab does not significantly prolong QTc, indicating a favorable cardiac safety profile for cancer patients.

Area of Science:

  • Oncology
  • Cardiology
  • Pharmacology

Background:

  • Nivolumab is a fully human monoclonal antibody targeting the programmed death-1 (PD-1) receptor.
  • It blocks PD-1 interactions on tumor cells, preventing T cell exhaustion in cancer patients.
  • Assessing cardiac safety, specifically corrected QT interval (QTc) prolongation, is crucial for cancer therapeutics.

Purpose of the Study:

  • To evaluate the potential for QTc prolongation with nivolumab administration.
  • To assess the cardiac safety of nivolumab in a subset of cancer patients.

Main Methods:

  • Electrocardiograms (ECGs) were collected predose and post-dose from patients receiving nivolumab.
  • QTc intervals, calculated using Fridericia's formula (QTcF), were analyzed.
  • Central tendency, categorical, and concentration-response analyses were performed.

Main Results:

  • No patients exhibited QTcF intervals or changes from baseline (ΔQTcF) exceeding thresholds for borderline or prolonged QTc.
  • Maximum mean increases in ΔQTcF were minimal across different nivolumab dosage groups (0.3, 2.0, 10.0 mg/kg).
  • No relationship was found between ΔQTcF and nivolumab serum concentration.

Conclusions:

  • Intensive ECG analyses indicate nivolumab has no clinically meaningful effect on the QTc interval.
  • Nivolumab is safe regarding QTc prolongation at doses up to 10.0 mg/kg.
  • These findings support the cardiac safety profile of nivolumab in cancer treatment.
Keywords:
CancerECGNivolumabQT intervalQTcSolid tumor

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