Author of

• 20168

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  P2.04 - Clinical Design, Statistics and Clinical Trials (ID 705)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Clinical Design, Statistics and Clinical Trials
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 23338

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    P2.04-009 - Randomized, Single-Blind Phase 1 Study of Pharmacokinetic Equivalence of ABP 215 Relative to Bevacizumab in Japanese Subjects (ID 9349)

    09:30 - 09:30  |  Author(s): R. Markus
    • Abstract

    Background:
    ABP 215 is a proposed biosimilar that is similar to bevacizumab, a VEGF inhibitor, in analytical and functional comparisons. Pharmacokinetic (PK) similarity between ABP 215 and bevacizumab has been demonstrated in a separate phase 1 study. Here we present results from a phase 1 study demonstrating PK similarity between ABP 215 and bevacizumab in healthy adult Japanese men.
    
    Method:
    PK similarity was evaluated in a randomized, single-blind, single-dose, parallel-group study in healthy Japanese men comparing ABP 215 with EU-authorized bevacizumab. Primary endpoints were maximum observed serum concentration (C~max~) and area under the serum concentration-time curve from time 0 to infinity (AUC~inf~). Secondary endpoints included AUC from time 0 to the time of the last quantifiable concentration (AUC~last~), safety, tolerability, and immunogenicity.
    
    Result:
    Baseline characteristics were similar among the 48 subjects (n=24 in each group). PK similarity was demonstrated for the comparison of ABP 215 with bevacizumab. After 3 mg/kg intravenous infusion, the geometric means (GMs) of C~max,~ AUC~inf~, and AUC~last~ were 71.2 µg/mL, 25259 µg·h/mL, and 22499.3 µg·h/mL for ABP 215 and 70.16 µg/mL, 25801µg·h/mL, and 22604.6 µg·h/mL for bevacizumab respectively. The GM ratios for C~max,~ AUC~inf~, and AUC~last~ were 1.015 (90% confidence interval; CI, 0.946–1.088), 0.979 (90% CI, 0.914–1.049), and 0.995 (90% CI, 0.941–1.053) for ABP 215 vs bevacizumab respectively. All CIs fell within the prespecified bioequivalence criteria of 0.80–1.25. The incidence of treatment-emergent adverse events (TEAEs) was comparable between treatment groups. Adverse events (AEs) occurred in 2/24 subjects receiving ABP 215 and 1/24 subjects receiving bevacizumab. There were no deaths, no serious AEs or AEs leading to study discontinuation; no subject was positive for binding antidrug antibodies (ADAs) at any time point during the study.
    
    Conclusion:
    ABP 215 was shown to have similar pharmacokinetics compared with bevacizumab in this PK study in Japanese men; CIs were within the standard bioequivalence criteria of 0.80–1.25. Safety was comparable between the two groups; no subjects developed binding ADAs.