Joel S Owen, Russell J Rackley, Matthew A Hummel, Stefan Roepcke, Hannah Huang, Mark Liu, Tazeen A Idris, Sundara Moorthi Nainar Murugesan, Ashwani Marwah, Subramanian Loganathan, Gopinath Ranganna, Abhijit Barve, Cornelius F Waller, Mark A Socinski
BACKGROUND AND OBJECTIVES: MYL-1402O is a bevacizumab (Avastin® ) biosimilar. Pharmacokinetic and safety similarity of MYL-1402O and reference Avastin® authorized in the European Union (EU-Avastin® ) and the US (US-Avastin® ) was demonstrated in healthy subjects (phase I, NCT02469987). The key objectives of this study were to establish a population pharmacokinetic (PopPK) model on pooled data from the phase I and phase III clinical studies to assess pharmacokinetic linearity of MYL-1402O and Avastin® across dose ranges, to assess the pharmacokinetic similarity of MYL-1402O and Avastin® in patients with non-squamous non-small cell lung cancer (nsNSCLC), and to explore potential covariates to account for systematic sources of variability in bevacizumab exposure...
November 2023: European Journal of Drug Metabolism and Pharmacokinetics