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Metastatic Melanoma

A well-characterized adverse reaction profile,
plus the assurance of an established
management plan1

Adverse reactions occurring in ≥10% in OPDIVO® + YERVOY® or OPDIVO arm*

Adverse reactions occurring in ≥10% in OPDIVO® + YERVOY® or OPDIVO
Adverse reactions occurring in ≥10% in OPDIVO® + YERVOY® or OPDIVO

No overall differences in safety or efficacy were reported between older and younger patients1

    Toxicity was graded per NCI CTCAE v4.
  • ARs occurring at a higher incidence in the YERVOY arm (between-arm difference of ≥5% (all grades) or ≥2% (Grades 3-4).
  • Includes asthenia and fatigue.
  • Includes pustular rash, dermatitis, acneiform dermatitis, allergic dermatitis, atopic dermatitis, bullous dermatitis, exfoliative dermatitis, psoriasiform dermatitis, drug eruption, exfoliative rash, erythematous rash, generalized rash, macular rash, maculopapular rash, morbilliform rash, papular rash, papulosquamous rash, and pruritic rash.
  • Includes back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, myalgia, neck pain, pain in extremity, and spinal pain.
  • Includes upper respiratory tract infection, nasopharyngitis, pharyngitis, and rhinitis.
  • Includes hypertension and blood pressure increased.
  • AR=adverse reaction; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

Adjuvant Treatment of Melanoma

OPDIVO: Well-tolerated with a low
discontinuation rate

Adverse reactions occurring in ≥10% in patients treated with OPDIVO1,2

Adverse reactions in OPDIVO® or OPDIVO + YERVOY®
Adverse reactions in OPDIVO® or OPDIVO + YERVOY®
Adverse reactions occurring in ≥10% of patients treated with OPDIVO®
Adverse reactions occurring in ≥10% of patients treated with OPDIVO®
  • In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO‐treated patients (n=452) vs ipilimumab‐treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%)

    The most common immune‐mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%)

  • In Checkmate 238, serious adverse reactions occurred in 18% of patients receiving OPDIVO (n=452)

    Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO‐treated patients (n=452)

    The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO‐treated patients were diarrhea and increased lipase and amylase

AE=adverse event.

Learn About Efficacy
Learn About Dosing
Reference
  1. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
References
  1. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. Weber J, Mandalá M, Del Vecchio M, et al. Adjuvant nivolumab versus ipilimumab in resected stage III or IV melanoma [published online ahead of print September 10, 2017]. N Engl J Med. 2017;377(19):1824-1835.