Abstract
Abstract Background This randomized, double-blind, multicenter study (NCT02364999) compared PF-06439535 (a potential bevacizumab biosimilar) with reference bevacizumab sourced from the EU (bevacizumab-EU; Avastin®), both with paclitaxel and carboplatin (P/C) in patients (pts) with advanced non-squamous non-small cell lung cancer (NSCLC). Methods Eligible pts were randomized (1:1) to PF-06439535 or bevacizumab-EU, both with P/C on Day 1 of a 3-week cycle followed by PF-06439535 of bevacizumab-EU blinded monotherapy until disease progression or unacceptable toxicity. The primary objective was to compare the objective response rate (ORR) by Week 19 between treatment groups, confirmed by Week 25. Subgroup analysis compared the risk ratio (RR) of ORR by gender, age, race, region, smoking history and disease stage. Secondary objectives included safety, 1-year progression-free survival and 1-year survival rate and immunogenicity. Study was ongoing at time of this interim analysis (data cutoff May 8, 2017). Results In total, 719 pts were randomized to PF-06439535 (n = 358) or bevacizumab-EU (n = 361). Pts had a mean age of 61.3 years, 65.0% were male, 76.1% had Stage IV NSCLC and 70.4% were smokers/ex-smokers. Overall, the RR of ORR was 1.015 (95% confidence intervals, 0.863-1.193), which was entirely within the equivalence margin of 0.729-1.371 agreed by the PMDA. Overall, no marked differences in treatment comparisons of ORR were observed across subgroup categories. Secondary efficacy endpoints were similar between treatment groups. Incidence of all-causality treatment-emergent adverse events (AEs) and serious AEs were similar between treatment groups, as well as safety, including immunogenicity. Conclusion PF-06439535 and bevacizumab-EU showed similar efficacy, safety and immunogenicity in pts with advanced non-squamous NSCLC. Subgroup analysis comparing the RR of ORR by categories supported the results of the primary efficacy endpoint analysis.
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