PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin®), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study

• DOI: 10.1007/s40259-019-00363-4
• Publication Date: 2019-07-23T05:53:04Z
• Authors: Niels Reinmuth; Maciej Bryl; Igor Bondarenko; Kostas Syrigos; Vladimir Vladimirov; Manuela Zereu; Angel H. Bair; Fiona Hilton; Katherine Liau; Kazuo Kasahara
• Keywords: Carboplatin; Clinical endpoint

PF-06439535 is a bevacizumab biosimilar. We aimed to compare the efficacy and safety of with that reference (Avastin®) sourced from EU (bevacizumab-EU), each paclitaxel carboplatin, in first-line treatment advanced non-squamous non-small-cell lung cancer (NSCLC).In this double-blind, parallel-group study, we recruited patients 159 centers 27 countries. Participants were randomized 1:1 receive plus carboplatin or bevacizumab-EU on day 1 21-day cycle for 4-6 cycles, followed by blinded monotherapy until disease progression, unacceptable toxicity, withdrawal consent, end study. Randomization was stratified region, sex, smoking history. The primary endpoint objective response rate (ORR) accordance RECIST 1.1, based responses achieved week 19 confirmed 25.Between 21 May 2015 14 November 2016, 719 group (n = 358) 361). As data cutoff analysis (8 2017), 45.3% (95% confidence interval [CI] 40.01-50.57) 44.6% CI 39.40-49.89) an 25. unstratified ORR risk ratio 1.015 0.863-1.193; 90% 0.886-1.163), difference 0.653% - 6.608 7.908); all three CIs fell within pre-specified equivalence margins. Using final after study completion (22 December no notable differences progression-free survival overall observed between groups. most frequently reported grade 3 higher treatment-emergent adverse events hypertension, neutropenia, anemia. There clinically meaningful safety, pharmacokinetics, immunogenicity across groups.Among NSCLC, demonstrated similarity terms efficacy. Safety profiles two treatments comparable.ClinicalTrials.gov, NCT02364999.Pfizer.