Carol O'Hear

Immune biomarkers associated with clinical benefit from atezolizumab (MPDL3280a; anti-PD-L1) in advanced urothelial bladder cancer (UBC)

Meeting abstracts Atezolizumab (anti-PD-L1) has demonstrated robust clinical activity in UBC [[1][1]]. Elevated PD-L1 expression on tumor-infiltrating immune cells (IC) is associated with increased clinical efficacy; however, the contribution of other immune biomarkers is unknown. In this study, we

PS01.62: Long-Term Safety and Clinical Activity of Atezolizumab Monotherapy in Metastatic NSCLC: Final Results from a Phase Ia Study: Topic: Medical Oncology.

provide information on the current management and outcomes of patients diagnosed with NSCLC who are eligible for their first systemic therapy. REVOLUTION has two primary objectives: 1) characterize current practice patterns in patients with NSCLC, with a special emphasis on pharmacotherapy (ie, chemotherapy, targeted agents, immunotherapy), and epidermal growth factor receptor mutated disease); 2) compare progression-free survival, overall survival, and duration of response in patients treated with cytotoxic chemotherapy, targeted therapies, and immune checkpoint inhibitors. Secondary objectives include assessment of which patients undergo molecular testing, sequence of treatments, toxicities, treatmentand toxicity-related costs, quality of life (QOL), and how decision-making is influenced by these factors from the patient, payer, and provider perspectives. Methods: Approximately 2500 patients will be enrolled across 25 US academic and community-based centers. Detailed patient demographic and clinical data will be collected at baseline and every 3 months via electronic portal. Patients (or their proxies) will complete 3 outcome scales (QoL EORTC-QLQ C30, symptom-specific EORTC-QLQ LC13). Additional treatment, outcome, and healthcare utilization data will be collected by electronic medical record abstraction for 5 years or until patient death or withdrawal of consent. Medicare claims data for the first year will be linked. Archived and residual specimens will be collected for genomic testing and biomarker evaluation. REVOLUTION is expected to begin accrual in July 2016 (NCT02835599). Results: Not Applicable. Conclusion: REVOLUTION will be the most comprehensive US registry of patients with NSCLC treated in the real-world environment in the era of targeted and immunotherapy, allowing analyses of clinical practice, treatment choice and effects, safety, QOL, and economic and efficacy outcomes.