OVERALL SAFETY
Vectibix tolerability and infusion toxicity profile

  • Tolerability profile

    Study discontinuation rates

    In 394 clinical study patients with wild-type KRAS mCRC treated with Vectibix monotherapy:

    • Commonly (≥1%) reported adverse reactions leading to discontinuation included dermatitis acneiform, erythema, paronychia, exfoliative rash, and pruritus

    In clinical studies of Vectibix monotherapy:

    • No overall differences in efficacy or safety were observed between patients ≥65 years old and those that were
      <65 years old
    • In patients with wild-type KRAS mCRC enrolled in clinical studies, the incidences of adverse events leading to permanent
      discontinuation were:
      • 408 Study: 10% in patients ≥65 years old and 6% in patients <65 years old
      • ASPECCT Study: 18% in patients ≥65 years old and 12% in patients <65 years old
      • 007 Study: 9% in patients ≥65 years old and 7% in patients <65 years old
  • Infusion reactions

    Incidence of infusion reactions in the wild-type RAS safety analysis set for the PRIME Study1

    Infusion reactions Vectibix + FOLFOX (n=256) FOLFOX alone (n=250)
    All incidences 25% (65) 27% (67)
    Severe (Grade ≥3) 2.7% (7) 1.6% (4)
    One patient with wild-type RAS mCRC (0.4%) discontinued Vectibix due to infusion reactions.

    Infusion reactions in Vectibix monotherapy trials

    The incidence of infusion reactions (occurring within 24 hours of any dose) reported in monotherapy clinical trials (N=842):1

    • 3% (29/842) of Vectibix-treated patients
    • 0.6% (5/842) were severe (NCI-CTC Grade 3–4)

    Most symptoms of potential infusion reactions:

    • Were mild in intensity
    • Were resolved without treatment
    • Were isolated occurrences
    • Did not require alteration or interruption of Vectibix administration

    In the post-marketing setting, serious infusion reactions have been reported, very rarely with a fatal outcome.
    Fatal reactions have also been observed in patients with a history of hypersensitivity to Vectibix.

    Infusion reactions: including anaphylactic reactions, bronchospasm, dyspnea, fever, chills, and hypotension.
    Discontinue infusions when severe or life-threatening.1

FOLFOX, infusional 5-fluorouracil, leucovorin, and oxaliplatin; KRAS, Kirsten rat sarcoma viral oncogene homologue; mCRC, metastatic colorectal cancer; NCI-CTC, National Cancer Institute Common Terminology Criteria; RAS, Rat sarcoma viral oncogene homologue.