• Safety data demonstrates the biosimilarity

     
    As part of the totality of evidence, no notable differences between OGIVRI® and reference trastuzumab in the incidence, severity of immune response and treatment-emergent adverse events10

    All grade TEAEs by Week 24 in the overall safety population (≥10% in either group)

    Events OGIVRI + taxane (n=247) Reference trastuzumab + taxane (n=246)
    ≥1 TEAE 239 (96.8) 233 (94.7)
    CTCAE preferred term
    Alopecia 142 (57.5) 135 (54.9)
    Neutropenia 142 (57.5) 131 (53.3)
    Peripheral neuropathy 57 (23.1) 61 (24.8)
    Diarrhea 51 (20.6) 51 (20.7)
    Asthenia 54 (21.9) 40 (16.3)
    Leukopenia 42 (17.0) 51 (20.7)
    Nausea 49 (19.8) 34 (13.8)
    Anemia 40 (16.2) 40 (16.3)
    Peripheral edema 35 (14.2) 28 (11.4)
    Fatigue 28 (11.3) 33 (13.4)
    Vomiting 26 (10.5) 19 (7.7)
    Pyrexia 21 (8.5) 30 (12.2)
    Arthralgia 30 (12.1) 11 (4.5)
    CTCAE: Common Terminology Criteria for Adverse Events; TEAE: Treatment-emergent adverse event

  • No Difference in Median LVEF between OGIVRI and reference trastuzumab

     
    No difference in the median LVEF between the two arms (safety population at 24 weeks)10

    The overall antidrug antibody rate was10:

    • 2.4% for OGIVRI + taxane
    • 2.8% for reference trastuzumab
    LVEF: Left ventricular ejection fraction; TEAEs: Treatment emergent adverse events

  • No new safety signals in long-term follow up*

     

    All grade TEAEs in patients who continued on monotherapy (10% in either group)*

    OGIVRI (n=179) Trastuzumab (n=164)
    TEAEs, n(%) All grades All grades
    Any TEAE 124 (69.3) 119 (72.6)
    Headache 19 (10.6) 23 (14.0)

    *Safety data are cumulative from start of monotherapy at 24 weeks through 36 months of follow-up from the last patient on study.

    LVEF: Left ventricular ejection fraction; TEAEs: Treatment emergent adverse events