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Jun 30, 2021

Population Pharmacokinetics (Pop PK) of MYL‑1402O (a Proposed Biosimilar to Bevacizumab) and Reference Product (Avastin) in Patients With Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC)

Background

MYL-1402O (MYL) is a proposed biosimilar to bevacizumab reference product. A multicenter, double blind randomized, phase 3 study compared the efficacy, safety, PK, and immunogenicity of MYL and Avastin in patients with Stage IV metastatic nsNSCLC. Patients received either MYL or reference product, in combination with carboplatin-paclitaxel up to 18 weeks (6 cycles) followed by monotherapy for up to an additional 24 weeks (8 cycles). The objective was to develop a Pop PK model based on data from a phase 3 study pooled with a single dose healthy volunteer phase 1 study data; to assess PK linearity across the dose levels of 1 mg/kg to 15 mg/kg in 2 clinical studies; to assess the PK similarity of MYL and reference product in patients with nsNSCLC; and to explore potential covariates to account for variability in Pop PK model parameters.

By, Joel Owen, Russell J. Rackley, Matthew A. Hummel, Stefan Roepcke, Hannah Huang, Mark S. Liu, Tazeen A. Idris, Sundara Moorthi Nainar Murugesan, Ashwini Vishweswaramurthy, Subramanian Loganathan, Gopinath Ranganna, Abhijit J. Barve, Cornelius Waller, Mark A. Socinski

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