{
    "abstract": "The FIR phase II study (NCT01846416) evaluated the efficacy and safety of anti-programmed death-ligand 1 (PD-L1) atezolizumab in advanced NSCLC selected by tumor cell (TC) or tumor-infiltrating immune cell (IC) PD-L1 expression.\nPatients with PD-L1 TC2/3 (PD-L1 staining on \u22655% of TC) or IC2/3 tumors (PD-L1 staining on \u22655% of IC; determined by SP142 PD-L1 immunohistochemistry assay) with paired fresh and archival histology samples were recruited into cohort 1 (chemotherapy-naive/>6 months between adjuvant chemotherapy and recurrence), cohort 2 (\u2265 second-line without brain metastases), or cohort 3 (\u2265 second-line with treated brain metastases). Patients received 1200 mg atezolizumab on day 1 (21-day cycles). Primary endpoint was investigator-assessed modified Response Evaluation Criteria in Solid Tumors, objective response rate (Response Evaluation Criteria in Solid Tumors v1.1). Secondary endpoints were overall survival, progression-free survival, duration of response, and safety.\nPatients (N\u00a0= 138) were enrolled (137 evaluable for response: cohort 1, n\u00a0= 31; cohort 2, n\u00a0= 93; and cohort 3, n\u00a0= 13). Investigator-assessed objective response rate was 32%, 21%, and 23% for cohorts 1, 2, and 3, respectively. Treatment-related adverse events were reported in 81%, 67%, and 69% of patients, respectively, including grade 3-4 treatment-related adverse events in 16%, 19%, and 15%, respectively. Moreover, 88.6% (86 of 97) paired baseline tumor samples had <5% change in TC/IC PD-L1 expression over time.\nAtezolizumab monotherapy showed clinical activity in patients with NSCLC, including those with brain metastases; safety was consistent with previous trials. Atezolizumab has completed phase III monotherapy studies in second-line. Front-line trials are ongoing, confirming these favorable results.",
    "authors": [
        {
            "affiliation": "Sarah Cannon Research Institute, Nashville, Tennessee. Electronic address: dspigel@tnonc.com.",
            "firstname": "David R",
            "initials": "DR",
            "lastname": "Spigel"
        },
        {
            "affiliation": "Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, New York.",
            "firstname": "Jamie E",
            "initials": "JE",
            "lastname": "Chaft"
        },
        {
            "affiliation": "Yale School of Medicine, New Haven, Connecticut.",
            "firstname": "Scott",
            "initials": "S",
            "lastname": "Gettinger"
        },
        {
            "affiliation": "Wexner Medical Center, Ohio State University, Columbus, Ohio.",
            "firstname": "Bo H",
            "initials": "BH",
            "lastname": "Chao"
        },
        {
            "affiliation": "Sint-Augustinus Hospital Oncology Center, Antwerp, Belgium.",
            "firstname": "Luc",
            "initials": "L",
            "lastname": "Dirix"
        },
        {
            "affiliation": "Barts Cancer Institute, London, United Kingdom.",
            "firstname": "Peter",
            "initials": "P",
            "lastname": "Schmid"
        },
        {
            "affiliation": "University of Washington, Seattle, Washington.",
            "firstname": "Laura Q M",
            "initials": "LQM",
            "lastname": "Chow"
        },
        {
            "affiliation": "Peter MacCallum Cancer Center, Melbourne, Australia.",
            "firstname": "Rodney J",
            "initials": "RJ",
            "lastname": "Hicks"
        },
        {
            "affiliation": "Genentech, Inc., South San Francisco, California.",
            "firstname": "Larry",
            "initials": "L",
            "lastname": "Leon"
        },
        {
            "affiliation": "Genentech, Inc., South San Francisco, California.",
            "firstname": "Jill",
            "initials": "J",
            "lastname": "Fredrickson"
        },
        {
            "affiliation": "Genentech, Inc., South San Francisco, California.",
            "firstname": "Marcin",
            "initials": "M",
            "lastname": "Kowanetz"
        },
        {
            "affiliation": "Genentech, Inc., South San Francisco, California.",
            "firstname": "Alan",
            "initials": "A",
            "lastname": "Sandler"
        },
        {
            "affiliation": "Genentech, Inc., South San Francisco, California.",
            "firstname": "Roel",
            "initials": "R",
            "lastname": "Funke"
        },
        {
            "affiliation": "Columbia University, New York, New York.",
            "firstname": "Naiyer A",
            "initials": "NA",
            "lastname": "Rizvi"
        }
    ],
    "conclusions": null,
    "copyrights": "Copyright \u00a9 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.",
    "doi": "10.1016/j.jtho.2018.05.004",
    "journal": "Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer",
    "keywords": [
        "Anti\u2013PD-L1",
        "Immunotherapy",
        "NSCLC"
    ],
    "methods": null,
    "publication_date": "2018-05-19",
    "pubmed_id": "29775807\n10856094\n10811675\n26028407\n26412456\n26712084\n27979383\n23890059\n23087408\n27718847\n27745820\n26970723\n28609226\n25428504\n22658127\n20516446\n25891174\n19380411\n22137017\n26261262\n26483045",
    "results": "Patients (N\u00a0= 138) were enrolled (137 evaluable for response: cohort 1, n\u00a0= 31; cohort 2, n\u00a0= 93; and cohort 3, n\u00a0= 13). Investigator-assessed objective response rate was 32%, 21%, and 23% for cohorts 1, 2, and 3, respectively. Treatment-related adverse events were reported in 81%, 67%, and 69% of patients, respectively, including grade 3-4 treatment-related adverse events in 16%, 19%, and 15%, respectively. Moreover, 88.6% (86 of 97) paired baseline tumor samples had <5% change in TC/IC PD-L1 expression over time.",
    "title": "FIR: Efficacy, Safety, and Biomarker Analysis of a Phase II Open-Label Study of Atezolizumab in PD-L1-Selected Patients With NSCLC.",
    "xml": "<Element 'PubmedArticle' at 0x78850282b1a0>"
}