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

• Published in: Journal for immunotherapy of cancer 2021-03, Vol.9 (3), p.e001865
• Main Authors: Ardizzoni, Andrea, Azevedo, Sergio, Rubio-Viqueira, Belen, Rodríguez-Abreu, Delvys, Alatorre-Alexander, Jorge, Smit, Hans J M, Yu, Jinming, Syrigos, Konstantinos, Trunzer, Kerstin, Patel, Hina, Tolson, Jonathan, Cardona, Andres, Perez-Moreno, Pablo D, Newsom-Davis, Tom
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Autoimmune diseases; B7-H1 Antigen - antagonists & inhibitors; B7-H1 Antigen - immunology; Cancer; Cancer therapies; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - immunology; Carcinoma, Non-Small-Cell Lung - mortality; Carcinoma, Non-Small-Cell Lung - secondary; Chemotherapy; Clinical/Translational Cancer Immunotherapy; Collaboration; Disease Progression; Epidemiology; Female; Hepatitis B; Hepatitis C; Hispanic Americans; Histology; Humans; Hypothesis testing; Immune Checkpoint Inhibitors - adverse effects; Immune Checkpoint Inhibitors - therapeutic use; Immunotherapy; Kidney diseases; Ligands; Lung cancer; Lung Neoplasms - drug therapy; Lung Neoplasms - immunology; Lung Neoplasms - mortality; Lung Neoplasms - pathology; Male; Metastasis; Middle Aged; Monoclonal antibodies; Neoplasm Staging; Nervous system; Patients; Progression-Free Survival; Prospective Studies; Targeted cancer therapy; Time Factors; Young Adult
• ISSN: 2051-1426; 2051-1426
• DOI: 10.1136/jitc-2020-001865

BackgroundAtezolizumab 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.MethodsPatients 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.Results619 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%.ConclusionsThis 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.