{
  "abstract": "Background Lifileucel is a non-engineered, autologous tumor-infiltrating lymphocyte (TIL) therapy approved for advanced melanoma after progression on immune checkpoint inhibitors and BRAF/MEK inhibitors. While a pivotal clinical trial showed promising efficacy and manageable safety, real-world data on adverse events (AEs) are non-existent. Given that death rate related to lifileucel was 7.5% in the trial, understanding the real-world toxicity and safety profile, including incidence of severe AEs and non-relapse mortality (NRM), is critical for guiding clinical use.Methods The FDA Adverse Event Reporting System (FAERS) was queried to evaluate post-marketing adverse events associated with lifileucel. All reports submitted from initial market availability through the most recent FAERS release were included. AEs were categorized into cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), non-ICANS neurotoxicity, cytopenia, general disorders, infections, and other. ‘General disorders’ included pyrexia, malaise, and chills. The ‘other’ category included cardiac and vascular disorders. The primary outcome of interest was NRM, which was defined as death not attributed to melanoma progression.Results Among 215 AE reports related to lifileucel, 144 were unique. The mean patient age was 50–67 years, and sex was unspecified in one-third of reports. Cytopenia had the highest rates of both NRM (29.7%) and hospitalization (34.3%), followed by other (NRM: 22.2%, hospitalization: 23.0%) and general disorders (NRM: 20.0%, hospitalization: 13.9%). ICANS had no reported NRM or hospitalizations, while CRS and infections were associated with lower rates of both outcomes ( table 1).Conclusions Post-marketing surveillance data indicate that lifileucel is associated with serious AEs, most notably cytopenia, which showed the highest rates of NRM and hospitalization, likely due to IL-2 usage after the product infusion. While ICANS and CRS were less frequently linked to severe outcomes, ongoing monitoring is essential. Real-world evaluation of TIL therapies remains critical to understanding their full safety profile outside clinical trial settings.Abstract 386 Table 1Adverse events Abbreviations: CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; NRM/RM, non-relapse mortality/relapse mortality*Includes all other AEs including infections, gastrointestinal disorders, psychiatric disorders, vascular disorders, Injury, poisoning and procedural complications.Data are no. (%) unless otherwise indicated.",
  "authors": [
    {
      "affiliations": [
        "UT Health, Houston, TX, USA"
      ],
      "name": "Parasto Mousavi"
    },
    {
      "affiliations": [
        "University of Houston, Houston, TX, USA"
      ],
      "name": "Tyler Varisco"
    },
    {
      "affiliations": [
        "UT Health, Houston, TX, USA"
      ],
      "name": "Virginia Mohlere"
    },
    {
      "affiliations": [
        "UT Health, Houston, TX, USA"
      ],
      "name": "Muhammad B Abid"
    }
  ],
  "title": "386 Non-relapse mortality and immune-related adverse events with lifileucel: a post-marketing surveillance analysis",
  "uid": "1bb62042-a6cd-5f35-9062-25a7d4476640"
}