Publication date: May 15, 2019
Nivolumab clearance (CL) in patients with advanced melanoma (MEL) decreases over the treatment duration with change in CL associated with improved disease status, measured by reduced tumor burden. Here, we characterize the pharmacokinetics of nivolumab administered as adjuvant therapy for patients with melanoma whose tumors were removed by surgical resection (AdjMEL). A population pharmacokinetic model was developed using data from 1773 patients with AdjMEL, MEL, non-small cell lung cancer, and other solid tumors who received nivolumab over a dose range of 0.1-20 mg/kg Q2W. In patients with AdjMEL, the geometric mean nivolumab CL of 6.0 mL/h was 40% lower at baseline and did not vary with time, and 20% lower at steady state compared with MEL patients. Lower nivolumab CL in AdjMEL patients and absence of time dependence is supportive of the hypothesis that changes in nivolumab CL in the metastatic setting are associated with disease status after treatment. This article is protected by copyright. All rights reserved.
Hamuro, L., Statkevich, P., Bello, A., Roy, A., and Bajaj, G. Nivolumab Clearance Is Stationary in Resected Melanoma Patients on Adjuvant Therapy: Implications of Disease Status on Time-Varying Clearance. 22635. 2019 Clin Pharmacol Ther.
|pathway||BSID||Non-small cell lung cancer|
|disease||DOID||non-small cell lung cancer|
|disease||MESH||non-small cell lung cancer|