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Valdimir Hanes



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    P2.13 - Targeted Therapy (Not CME Accredited Session) (ID 962)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.13-40 - ABP 215 and Bevacizumab in NSCLC Patients: Time Course and Magnitude of Response in the Phase 3 Comparative Trial (MAPLE) (ID 13813)

      16:45 - 18:00  |  Presenting Author(s): Valdimir Hanes

      • Abstract
      • Slides

      Background

      ABP 215 (MVASITM (bevacizumab-awwb)) has been approved as the first biosimilar to bevacizumab. Here we present the results of efficacy analyses from the phase 3 comparative trial of ABP 215 and bevacizumab.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      The phase 3 study was a double-blind trial designed to demonstrate clinical equivalence of ABP 215 and bevacizumab (BEV) in patients with NSCLC. Adult patients with non-squamous NSCLC receiving first-line chemotherapy with carboplatin and paclitaxel were randomized 1:1 to ABP 215 or BEV (15 mg/kg IV Q3W for up to 6 cycles). Clinical evaluations included efficacy, safety, PK, and immunogenicity. Results of the primary analysis have been reported previously. A post hoc analysis of individual patient response data was performed using independent, central radiologists’ evaluations of the time course and magnitude of tumor response. Imaging assessments of tumor response were completed using RECIST v1.1 to generate waterfall plots for the magnitude of target lesion response.

      4c3880bb027f159e801041b1021e88e8 Result

      The proportion of patients with an objective response was similar between ABP 215 and BEV treatment groups by week 7, 13, 19, and overall. By week 19, 36.9% of patients receiving ABP 215 and 39.2% of patients receiving BEV had a first objective response. The risk difference in ORR by week 19 was -2.6% (95% CI: -10.05%, 4.93%). Both groups had a highly similar magnitude of target lesion response, as depicted in the Figure below.fig 1.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      The analyses of the time to response and the magnitude of reduction of target lesions in the phase 3 comparative trial provide further support for clinical similarity of ABP 215 and bevacizumab.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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