{
  "abstract": "Background Nivolumab, an anti-PD-1 antibody, has shown efficacy and favorable safety in the treatment of advanced/metastatic melanoma, but poses a risk for immune-related adverse events (irAEs).This study (category 3 EU-PASS) evaluated the incidence and severity of irAEs in melanoma patients using nivolumab, along with the management and outcomes of irAEs, and the overall survival (OS).Methods This observational, multicenter, prospective study enrolled 417 melanoma patients, with 395 evaluable. Patients receiving nivolumab for first time, alone or with ipilimumab, in routine oncology practice were included.Data were collected from 2016 to 2024 through electronic case report forms. Incidence of irAEs were reported, with severity graded using the Common Terminology Criteria for Adverse Events (CTCAE). OS was assessed using Kaplan-Meier analysis.Results Of the 395 patients, 245 (62%) received nivolumab monotherapy, and 150 (38%) received nivolumab in combination with ipilimumab. At enrollment, in monotherapy group, mean age was 66.5 years (SD 12.9), 60.4% were male, 68.2% had stage IV disease, and 24.9% had prior systemic cancer treatment. In combination group, the mean age was 60.7 (SD 12.3), 51.3% were male, 98.0% had stage IV disease, and 32.7% had prior systemic cancer treatment.In monotherapy patients, 103 (42%) experienced irAEs, with skin reactions (18.8%) and endocrinopathies (14.3%) in ≥ 10% of patients. In combination therapy, 107 (71.3%) experienced irAEs, with skin reactions (35.3%), colitis (26.7%), hepatitis and endocrinopathies (23.3% each) and pneumonitis (10.7%) in ≥ 10% of patients. IrAEs led to treatment discontinuation in 9.0% of monotherapy and 29.3% of combination therapy patients. Six fatal irAEs were reported (1.5%; four on monotherapy [1.6%] and two on combination therapy [1.3%]). Grade 3 or 4 irAEs occurred in 9.4% of monotherapy and 42% of combination therapy.To manage irAEs, systemic corticosteroids were common treatment for events such as colitis, hepatitis, nephritis and pneumonitis (for 50-89% of cases); topical corticosteroids for skin-related irAEs (for 60% of cases); and hormonal therapies for endocrinopathies (for 73% of cases).Most irAEs resolved without sequelae (57.6% monotherapy, 72.1% combination), with median time to resolution of 29 days for monotherapy and 22 days for combination.The median OS (95% CI) was 47.40 months (27.3, n/a) for monotherapy and 24.08 months (17.81, 50.49) for combination therapy.Conclusions The incidence and severity of irAEs in melanoma patients treated with nivolumab was consistent with safety profile from clinical trials. No new safety signals were identified, and the benefit-risk profile of nivolumab for melanoma patients remains favorable.",
  "authors": [
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, NJ, USA"
      ],
      "name": "Sari Hopson"
    },
    {
      "affiliations": [
        "University of Lübeck, Lübeck, Germany"
      ],
      "name": "Patrick Terheyden"
    },
    {
      "affiliations": [
        "Fachklinik hornheide, Munster, Germany"
      ],
      "name": "Carmen Loquai"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, NJ, USA"
      ],
      "name": "Yuan Gao"
    },
    {
      "affiliations": [
        "Syneos Health, Morrisville, NC, USA"
      ],
      "name": "Darren Hughes"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, NJ, USA"
      ],
      "name": "Margarita Askelson"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, NJ, USA"
      ],
      "name": "Julie Scotto"
    }
  ],
  "title": "422 Safety and effectiveness of nivolumab in treating advanced/metastatic melanoma in routine oncology practice",
  "uid": "13695f27-0f3b-5ca4-96d5-074d5e98c881"
}