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A prospective cohort study on the pharmacokinetics of nivolumab in metastatic non-small cell lung cancer, melanoma, and renal cell cancer patients

Journal for ImmunoTherapy of Cancer Jul 25, 2019

Hurkmans DP, et al. - Considering a recent report of a potential exposure-response relationship for nivolumab in patients with non-small cell lung cancer (NSCLC), that may argue against the current weight-based or fixed-flat dosing regimen, researchers sought to determine nivolumab pharmacokinetics (PK) and examined how drug clearance is associated with clinical outcome in NSCLC, melanoma, and renal cell cancer (RCC). In this prospective observational cohort study, they analyzed 1,715 plasma samples from two-hundred-twenty-one patients with metastatic cancer receiving nivolumab-monotherapy. Based on the first real-world population-PK model of nivolumab, covariate analysis unveiled that nivolumab clearance is significantly influenced by gender, body surface area, and albumin. In NSCLC, a strong inverse correlation of drug clearance and response was noted; in RCC, a non-significant similar trend was observed; however, in melanoma, a clearance-response relationship was not observed. This real-world study suggests considering dosing regimens based on patient parameters to enhance efficacy, particularly in NSCLC.
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