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Phase I pharmacokinetic study of nivolumab in Korean patients with advanced solid tumors

Cited 18 time in Web of Science Cited 18 time in Scopus
Authors

Lee, Keun-Wook; Lee, Dae Ho; Kang, Jin Hyoung; Park, Joon Oh; Kim, Se Hyun; Hong, Yong Sang; Kim, Seung Tae; Oh, Do-YounBang, Yung-Jue

Issue Date
2018-02
Publisher
AlphaMed Press Inc
Citation
Oncologist, Vol.23 No.2, pp.155-e17
Abstract
Background. This phase I study of nivolumab, an anti-programmed cell death-1 (anti-PD-1) monoclonal antibody, investigated the pharmacokinetics and safety of nivolumab in Korean patients with advanced solid tumors. Findings were compared with results from Japan and the U.S. Materials and Methods. In this two-part study, patients received a single dose of nivolumab (1, 3, and 10 mg/kg; ONO-4538-13) and were followed up for 3 weeks. Those who met the required criteria proceeded to the second part (ONO-4538-14), and received the same dose as in part one every 2 weeks. Results. Six patients per dose level were enrolled (n = 18). The mean elimination half-life of nivolumab among the groups ranged from 15.0 to 19.1 days. The maximum serum concentration and area under serum concentration-time curve increased almost dose-proportionally at doses from 1 to 10 mg/kg. Adverse drug reactions (ADRs; mostly grade <= 2) were reported in seven patients (38.9%). ADRs grade >= 3 occurred in one patient (5.6%; pneumonitis). Three patients (16.7%) developed ADRs related to thyroid dysfunction. Conclusion. The pharmacokinetic parameters of nivolumab were similar among patients from Korea, Japan, and the U.S. The safety profile was consistent with findings from previous studies.
ISSN
1083-7159
URI
https://hdl.handle.net/10371/173214
DOI
https://doi.org/10.1634/theoncologist.2017-0528
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  • College of Medicine
  • Department of Medicine
Research Area DNA 손상 반응 타겟 물질의 면역조절 효과, Effect of DNA damage response target substances on immunomodulatory action, Efficacy and biomarker validation studies of targeted therapeutics, Resistance mechanisms according to targeted therapeutics, 표적 항암제 내성 기전 연구, 표적 항암제의 효과 검증 및 바이오마커 규명

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