{
  "abstract": "Background The phase II NEOMUN trial was conducted to investigate the therapeutic effect of preoperative programmed death receptor-1 inhibitor pembrolizumab for treating non-small cell lung cancer (NSCLC). Herein, we report the final efficacy, safety, and long-term survival results.Methods Patients with resectable stage II/IIIA NSCLC were included. Two cycles of pembrolizumab (200 mg intravenously once every 3 weeks) were administered before surgery. The primary objectives were to assess the feasibility and safety of neoadjuvant treatment and evaluate antitumor activity. We analyzed the clinical parameters and pathologic, radiological, and metabolic tumor response data.Results 29 patients with NSCLC were enrolled. NSCLC histology revealed adenocarcinoma and squamous cell carcinoma in 24 and in 5 patients, respectively. 93.1% of patients were treated with two therapy cycles. 73 adverse events were reported, of which 18 were treatment-related. Complete tumor resection rate was 100%. Major (≤10% vital tumor cells) and complete pathologic response rates were 24.1% and 13.8%, respectively. Tumor response increased with higher programmed death-ligand 1 tumor proportion scores (TPS) and high pretherapeutic tumor mutational burden (≥10 mut./Mb). The metabolic response, quantified non-invasively using positron emission tomography/CT, predicted the pathologic tumor response. The disease-free survival was 75.9% at 24 and 36 months, and the overall survival was 82.7% at 24 and 36 months.Conclusions Neoadjuvant immunotherapy with pembrolizumab appears safe and feasible and is associated with a remarkable major pathologic response rate. Preoperative TPS, change in maximal standardized uptake value during the induction phase, and high mutational burden might be suitable clinical parameters for predicting pathologic response in surgical candidates.Trial registration number NCT0319746.",
  "authors": [
    {
      "affiliations": [
        "Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany",
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany"
      ],
      "name": "Martin E Eichhorn"
    },
    {
      "affiliations": [
        "Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany",
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany"
      ],
      "name": "Benedikt Niedermaier"
    },
    {
      "affiliations": [
        "Department of Medical Oncology and Internal Medicine VI, Heidelberg University Hospital, Heidelberg, Germany",
        "Clinical Cooperation Unit Applied Tumor Immunity, National Center for Tumor Diseases, German Cancer Research Center, Heidelberg, Germany",
        "Center for Quantitative Analysis of molecular and Cellular Biosystems (Bioquant), Heidelberg University, Heidelberg, Germany",
        "National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany"
      ],
      "name": "Pornpimol Charoentong"
    },
    {
      "affiliations": [
        "Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany",
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany"
      ],
      "name": "Laura V Klotz"
    },
    {
      "affiliations": [
        "Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany",
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany"
      ],
      "name": "Philip Baum"
    },
    {
      "affiliations": [
        "Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany",
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany"
      ],
      "name": "Raffaella Griffo"
    },
    {
      "affiliations": [
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany",
        "Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany"
      ],
      "name": "Michael Allgäuer"
    },
    {
      "affiliations": [
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany",
        "Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany"
      ],
      "name": "Albrecht Stenzinger"
    },
    {
      "affiliations": [
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany",
        "Department of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany"
      ],
      "name": "Helge Bischoff"
    },
    {
      "affiliations": [
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany",
        "Translational Research Unit (STF), Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany"
      ],
      "name": "Marc A Schneider"
    },
    {
      "affiliations": [
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany",
        "Department of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany"
      ],
      "name": "Petros Christopoulos"
    },
    {
      "affiliations": [
        "Department of Nuclear Medicine, Heidelberg University Hospital, Heidelberg, Germany"
      ],
      "name": "Uwe Haberkorn"
    },
    {
      "affiliations": [
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany",
        "Department of Diagnostic and Interventional Radiology with Nuclear Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany",
        "Department of Diagnostic and Interventional Radiology, Heidelberg University Hospital, Heidelberg, Germany"
      ],
      "name": "Claus-Peter Heußel"
    },
    {
      "affiliations": [
        "Department of Lung Development and Remodeling, Max Planck Institute for Heart and Lung Research, Member of the German Center for Lung Research (DZL), Member of the Cardio-Pulmonary Institute (CPI), Bad Nauheim, Germany",
        "Institute for Lung Health (ILH), Justus Liebig University, Giessen, Germany"
      ],
      "name": "Rajkumar Savai"
    },
    {
      "affiliations": [
        "Department of Medical Oncology and Internal Medicine VI, Heidelberg University Hospital, Heidelberg, Germany",
        "Clinical Cooperation Unit Applied Tumor Immunity, National Center for Tumor Diseases, German Cancer Research Center, Heidelberg, Germany",
        "Center for Quantitative Analysis of molecular and Cellular Biosystems (Bioquant), Heidelberg University, Heidelberg, Germany",
        "National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany"
      ],
      "name": "Maria Paula Roberti"
    },
    {
      "affiliations": [
        "Department of Medical Oncology and Internal Medicine VI, Heidelberg University Hospital, Heidelberg, Germany",
        "Clinical Cooperation Unit Applied Tumor Immunity, National Center for Tumor Diseases, German Cancer Research Center, Heidelberg, Germany",
        "Center for Quantitative Analysis of molecular and Cellular Biosystems (Bioquant), Heidelberg University, Heidelberg, Germany",
        "National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany"
      ],
      "name": "Inka Zoernig"
    },
    {
      "affiliations": [
        "Department of Medical Oncology and Internal Medicine VI, Heidelberg University Hospital, Heidelberg, Germany",
        "Clinical Cooperation Unit Applied Tumor Immunity, National Center for Tumor Diseases, German Cancer Research Center, Heidelberg, Germany",
        "Center for Quantitative Analysis of molecular and Cellular Biosystems (Bioquant), Heidelberg University, Heidelberg, Germany",
        "National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany"
      ],
      "name": "Dirk Jäger"
    },
    {
      "affiliations": [
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany",
        "Department of Pulmonology and Critical Care Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany"
      ],
      "name": "Felix Herth"
    },
    {
      "affiliations": [
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany",
        "Department of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany"
      ],
      "name": "Michael Thomas"
    },
    {
      "affiliations": [
        "Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany",
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany"
      ],
      "name": "Hauke Winter"
    },
    {
      "affiliations": [
        "Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany",
        "Translational Lung Research Center (TLRC) Heidelberg, German Center for Lung Research (DZL), Heidelberg, Germany"
      ],
      "name": "Florian Eichhorn"
    }
  ],
  "title": "Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: results of the NEOMUN trial",
  "uid": "d343fbbc-ff87-5156-a1f0-37fc05f1bf89"
}