Nivolumab Clearance Is Stationary in Resected Melanoma Patients on Adjuvant Therapy: Implications of Disease Status on Time-Varying Clearance.

Nivolumab Clearance Is Stationary in Resected Melanoma Patients on Adjuvant Therapy: Implications of Disease Status on Time-Varying Clearance.

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.

Concepts Keywords
Adjuvant Pharmacokinetics
Adjuvant Therapy Antibodies
Lung Cancer Adjuvant therapy
MEL Melanoma
Melanoma Nivolumab
Metastatic Breakthrough therapy
Pharmacokinetic Antineoplastic drugs
Pharmacokinetics Bristol-Myers Squibb
Surgical Resection Monoclonal antibodies
Time Cancer treatments
Tumor Clinical medicine
Adjuvant therapy

Semantics

Type Source Name
pathway BSID Non-small cell lung cancer
disease DOID non-small cell lung cancer
disease MESH non-small cell lung cancer
disease MESH tumor
gene UNIPROT RAB8A
pathway BSID Melanoma
disease DOID Melanoma
disease MESH Melanoma
drug DRUGBANK Nivolumab

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