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      Primary results from TAIL: a global single-arm safety study of atezolizumab monotherapy in a diverse population of patients with previously treated advanced non-small cell lung cancer

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          Abstract

          Background

          Atezolizumab treatment improves survival, with manageable safety, in patients with previously treated advanced/metastatic non-small cell lung cancer. The global phase III/IV study TAIL (NCT03285763) was conducted to evaluate the safety and efficacy of atezolizumab monotherapy in a clinically diverse population of patients with previously treated non-small cell lung cancer, including those not eligible for pivotal trials.

          Methods

          Patients with stage IIIB/IV non-small cell lung cancer whose disease progressed after 1–2 lines of chemotherapy were eligible for this open-label, single-arm, multicenter study, including those with severe renal impairment, an Eastern Cooperative Oncology Group performance status of 2, prior anti-programmed death 1 (PD-1) therapy, and autoimmune disease. Atezolizumab was administered intravenously (1200 mg every 3 weeks). Coprimary endpoints were treatment-related serious adverse events and immune-related adverse events.

          Results

          619 patients enrolled and 615 received atezolizumab. At data cutoff, the median follow-up was 12.6 months (95% CI 11.9 to 13.1). Treatment-related serious adverse events occurred in 7.8% and immune-related adverse events in 8.3% of all patients and as follows, respectively, in these subgroups: renal impairment (n=78), 11.5% and 12.8%; Eastern Cooperative Oncology Group performance status of 2 (n=61), 14.8% and 8.2%; prior anti–PD-1 therapy (n=39), 5.1% and 7.7%; and autoimmune disease (n=30), 6.7% and 10.0%. No new safety signals were reported. In the overall population, the median overall survival was 11.1 months (95% CI 8.9 to 12.9), the median progression-free survival was 2.7 months (95% CI 2.1 to 2.8) and the objective response rate was 11%.

          Conclusions

          This study confirmed the benefit–risk profile of atezolizumab monotherapy in a clinically diverse population of patients with previously treated non-small cell lung cancer. These safety and efficacy outcomes may inform treatment decisions for patients generally excluded from checkpoint inhibitor trials.

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          Most cited references30

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          Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer

          Nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, disrupts PD-1-mediated signaling and may restore antitumor immunity.
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            Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer

            New England Journal of Medicine, 373(2), 123-135
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              Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial.

              Atezolizumab is a humanised antiprogrammed death-ligand 1 (PD-L1) monoclonal antibody that inhibits PD-L1 and programmed death-1 (PD-1) and PD-L1 and B7-1 interactions, reinvigorating anticancer immunity. We assessed its efficacy and safety versus docetaxel in previously treated patients with non-small-cell lung cancer.
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                Author and article information

                Journal
                J Immunother Cancer
                J Immunother Cancer
                jitc
                jitc
                Journal for Immunotherapy of Cancer
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2051-1426
                2021
                18 March 2021
                : 9
                : 3
                : e001865
                Affiliations
                [1 ] departmentDepartment of Medical Oncology , IRCCS Azienda Ospedaliero-Universitaria di Bologna , Bologna, Italy
                [2 ] departmentOncology Service , Hospital de Clínicas de Porto Alegre , Porto Alegre, Brazil
                [3 ] departmentDepartment of Medical Oncology , Hospital Universitario Quirónsalud Madrid , Madrid, Spain
                [4 ] departmentDepartment of Medical Oncology , Hospital Universitario Insular de Gran Canaria , Las Palmas, Canarias, Spain
                [5 ] departmentThoracic Oncology Clinic , Health Pharma Professional Research , Mexico City, Mexico
                [6 ] departmentDepartment of Pulmonary Diseases , Rijnstate Hospital , Arnhem, The Netherlands
                [7 ] departmentDepartment of Radiation Oncology , Shandong Cancer Hospital, affiliated to Shandong University , Jinan, Shandong, China
                [8 ] department3rd Department of Medicine , National and Kapodistrian University of Athens , Athens, Attica, Greece
                [9 ] departmentDepartment of Oncology Biomarker Development , F. Hoffmann-La Roche Ltd , Basel, Basel-Stadt, Switzerland
                [10 ] departmentDepartment of Safety Science Oncology , Genentech Inc , South San Francisco, California, USA
                [11 ] departmentDepartment of Global Product Development , F. Hoffmann-La Roche Ltd , Basel, Basel-Stadt, Switzerland
                [12 ] departmentDepartment of Product Development Biometrics , F. Hoffmann-La Roche Ltd , Basel, Basel-Stadt, Switzerland
                [13 ] departmentDepartment of Product Development , Genentech Inc , South San Francisco, California, USA
                [14 ] departmentDepartment of Oncology , Chelsea and Westminster Hospital , London, UK
                Author notes
                [Correspondence to ] Professor Andrea Ardizzoni; andrea.ardizzoni@ 123456aosp.bo.it
                Author information
                http://orcid.org/0000-0003-0623-4257
                Article
                jitc-2020-001865
                10.1136/jitc-2020-001865
                7978274
                33737339
                376884ee-adb4-4ef9-910a-8a6b342d1a52
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 11 December 2020
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004328, Genentech;
                Funded by: FundRef http://dx.doi.org/10.13039/100007013, F. Hoffmann-La Roche;
                Categories
                Clinical/Translational Cancer Immunotherapy
                1506
                2435
                Original research
                Custom metadata
                unlocked

                clinical trials,phase iiii clinical trial,immunotherapy,lung neoplasms,pd-l1 inhibitor,checkpoint inhibitor,metastatic,subgroup analysis

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