Author of

• 17556

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  P2.03a - Poster Session with Presenters Present (ID 464)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17581

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    P2.03a-025 - Randomized, Double-Blind, Phase 3 Study Comparing Biosimilar Candidate ABP 215 with Bevacizumab in Patients with Non-Squamous NSCLC (ID 6068)

    14:30 - 14:30  |  Author(s): J.H. Goldschmidt
    • Abstract

    Background:
    ABP 215 is a biosimilar candidate that is similar to bevacizumab, a VEGF inhibitor, in analytical and functional comparisons. Pharmacokinetic similarity between ABP 215 and bevacizumab has been demonstrated in a phase 1 study. Here we present results from a pivotal phase 3 clinical study in non–small-cell lung cancer (NSCLC).
    
    Methods:
    In this double-blind, active-controlled study in adults with non-squamous NSCLC receiving first-line chemotherapy with carboplatin and paclitaxel, subjects were randomized (1:1) to receive investigational product (IP; ABP 215 or bevacizumab 15 mg/kg) Q3W for 6 cycles as an IV infusion. Clinical equivalence was demonstrated by comparing the 2-sided 90% confidence interval (CI) of the risk ratio (RR) of the objective response rate (ORR; primary endpoint) with pre-specified margin of (0.67, 1.5) Secondary endpoints were risk difference (RD) of the ORR, duration of response (DOR), progression-free survival (PFS), treatment-emergent adverse events, and overall survival (OS).
    
    Results:
    A total of 642 subjects (ABP 215 [Arm 1], n=328; bevacizumab [Arm 2], n=314) were randomized. Demographic and baseline characteristics were balanced between arms. There were 128 (39.0%) responders in Arm 1 and 131 (41.7%) responders in Arm 2. The RR for ORR was 0.93 (90%CI, 0.80–1.09). The RD for ORR was −2.90% (90%CI, −9.26%–3.45%). Among the responders the estimated median DOR was 5.8 months in Arm 1 versus 5.6 months in Arm 2. The estimated median PFS in Arm 1 was 6.6 months versus 7.9 months in Arm 2; the analysis included all 256 PFS events, 131 (39.9%) in Arm 1 and 125 (39.8%) in Arm 2. The safety population included 324 treated subjects in Arm 1 and 309 in Arm 2; 139 (42.9%) subjects in Arm 1 and 137 (44.3%) in Arm 2 experienced grade ≥3 TEAEs. TEAEs leading to IP discontinuation affected 61 (18.8%) subjects in Arm 1 and 53 (17.2%) in Arm 2; 85 (26.2%) subjects in Arm 1 and 71 (23.0%) in Arm 2 experienced at least one serious AE; 13 (4.0%) in Arm 1 and 11 (3.6%) in Arm 2 had a fatal TEAE. OS analysis included 79 deaths, 43 (13.3%) in Arm 1 and 36 (11.7%) in Arm 2. Binding antibodies developed during the study in 4 (1.4%) subjects in Arm 1 versus 7 (2.5%) in Arm 2; no subject tested positive for neutralizing antibodies.
    
    Conclusion:
    The study met the primary and secondary objectives demonstrating that ABP 215 and bevacizumab are clinically equivalent.