• Study Design: The Heritage Trial

     

    The HERITAGE trial: Designed per FDA guidelines to detect any potentially clinically meaningful difference between OGIVRI® and reference trastuzumab9

    A confirmatory, double-blind, phase 3 equivalence trial in patients with HER2+ metastatic breast cancer10

    Study Endpoints
    • Primary endpoint was week 24 ORR (complete and partial response )10
    • Other endpoints included adverse events, LVEF, and immunogenicity at week 24 and 48 and PFS and OS at month 36 2,10
    Baseline Characteristics
    • Demographic, disease, and baseline characteristics were similar between treatment groups with no clinically relevant differences observed.10
    The Heritage Study experience… could serve as a blueprint for development of other biosimilar products. 11
    LVEF: Left ventricular ejection fraction; ORR: Overall response rate; OS: Overall survival; PFS: Progression-free survival

  • Statistical therapeutic equivalence in ORR at 24 weeks10

     

    Primary end point of ORR met at 24 weeks.

    ORR ratio (1.09; 90% CI: 0.974–1.211) and ORR difference (5.53; 95% CI: −3.08–14.04) were within the defined equivalence boundaries*

    *ORR ratio 90% CI equivalence boundaries were defined as 0.81 to 1.24 and ORR difference equivalence boundaries were defined as -15% and 15%.
    Findings in the HERITAGE Trial are comparable to other recent multicenter studies of trastuzumab + taxane in HER2+ patients.11

    CI: Confidence interval; ORR: Overall response rate

  • First FDA-approved trastuzumab biosimilar with PFS at 36 months

     

    No significant differences in PFS to reference trastuzumab at 36 months

    Efficacy

    OGIVRI(n=230) Reference trastuzumab (n=228)
    Median PFS 11.1 11.1
    Unstratified HR (95 % CI) 0.98 (0.78-1.24)

    CI: Confidence interval; HR: Hazard ratio; ITT1: Intention-to treat-1; PFS: Progression-free survival

  • First FDA-approved trastuzumab biosimilar with OS at 36 months

     

    No significant differences in OS to reference trastuzumab at 36 months

    Efficacy
    OGIVRI(n=230) Reference trastuzumab (n=228)
    Number of events 109 114
    Median OS 35.0 30.2
    HR (95 % CI) 0.90 (0.69-1.17)
    CI: Confidence interval; OS: Overall survival