{
  "abstract": "Background Nivolumab, an anti-PD-1 antibody, has shown efficacy and favorable safety in treating advanced/metastatic NSCLC. However, its mechanism of action poses risks for immune-related adverse events (irAEs).This study (category 3 EU-PASS) aims to evaluate the incidence and severity of irAEs, their management, outcomes, and overall survival (OS) in NSCLC patients treated with nivolumab.Methods This observational, multicenter, prospective study enrolled 759 NSCLC patients, with 718 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 718 patients, 701 (97.6%) received nivolumab monotherapy, and 17 (2.4%) received nivolumab in combination with ipilimumab. The histological types of NSCLC were 41.9% squamous and 58.1% non-squamous.At enrollment, in monotherapy group, the mean age was 67.7 years (SD 8.9), 65.8% were male, 84% had stage IV disease, and all (100%) had prior systemic cancer treatment. In combination group, the mean age was 65.9 (SD 8.7), 70.6% were male, all (100%) had stage IV disease, and 23.5% had prior systemic cancer treatment.Among monotherapy patients, 155 (22.1%) experienced irAEs, with skin reactions (12.3%) occurring in ≥ 10% of patients. In combination therapy, 6 (35.3%) experienced irAEs, with endocrinopathies and skin reactions (23.5% each) occurring in ≥ 10% of patients. IrAEs led to treatment discontinuation in 3.9% of monotherapy and 5.9% of combination therapy patients. Two fatal irAEs were reported (0.3%; both in the monotherapy therapy group). Grade 3 or 4 irAEs occurred only in monotherapy group (5.3%).To manage irAEs, systemic corticosteroids were common treatment for events such as colitis, hepatitis, nephritis and pneumonitis (for 50-71% of cases); topical corticosteroids for skin-related irAEs (for 53% of cases); and hormonal therapies for endocrinopathies (for 69% of cases).Most irAEs resolved without sequelae (68.5% monotherapy, 47.1% combination), with median time to resolution of 43 days for monotherapy and 261. 5 days for combination.The median OS (95% CI) was 10.28 months (9.56, 11.79) for monotherapy and 13.47 months (5.19, 20.50) for combination therapy.Conclusions The incidence and severity of irAEs in NSCLC 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 NSCLC remains favorable.",
  "authors": [
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, NJ, USA"
      ],
      "name": "Sari Hopson"
    },
    {
      "affiliations": [
        "Universitätsklinikum Giessen und Marburg GmbH, Giessen, Germany"
      ],
      "name": "Bastian Eul"
    },
    {
      "affiliations": [
        "Kliniken der Stadt Koeln gGmbH, Koeln-Merheim, Koenl-Merheim, Germany"
      ],
      "name": "Eva-lotte Buchmeier"
    },
    {
      "affiliations": [
        "Bristol Myers Squibb, Princeton, NJ, USA"
      ],
      "name": "Julie Scotto"
    },
    {
      "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": "Yuan Gao"
    }
  ],
  "title": "421 Safety and effectiveness of nivolumab in treating advanced/metastatic non-small cell lung cancer (NSCLC) in routine oncology practice",
  "uid": "21076ef7-8164-52d9-b8cf-d44f17a9bc71"
}