ASTRIS: a global real-world study of osimertinib in >3000 patients with EGFR T790M positive non-small-cell lung cancer.

Aim: Osimertinib is a third-generation, irreversible, oral EGFR tyrosine kinase inhibitor. We report real-world effectiveness and safety data. Patients & methods: EGFR T790M positive advanced non-small-cell lung cancer adults, who received >= 1 prior EGFR tyrosine kinase inhibitor, received osimertinib 80 mg daily. Primary effectiveness outcome: overall survival. Secondary effectiveness outcomes included: investigato-rassessed clinical response, progression-free survival, time-to-treatment discontinuation. Results: At data cutoff, 3015 patients had enrolled: 57.1% had investigator-assessed response (95% CI: 55.2-58.9). Median progression-free survival: 11.1 months (95% CI: 11.0-12.0) and median time- to-treatment discontinuation: 13.5 months (95% CI: 12.6-13.9). Interstitial lung disease/pneumonitis-like events reported in 28 (1%) patients. Conclusion: Osimertinib demonstrated clinical effectiveness similar to efficacy observed in the clinical trial program with no new safety signals. Lay abstract: Osimertinib is a drug used to treat a type of non-small-cell lung cancer with a change (mutation) in a gene called EGFR. We studied 3015 adults with non-small-cell lung cancer containing a specific EGFR mutation called T790M. The patients had osimertinib treatment once a day. Prior to receiving a new supply of tablets (every 6 weeks), patients were checked to see if the osimertinib treatment was helping to treat their cancer and if they were experiencing any side effects. Osimertinib appeared to reduce the size of cancerous growths (tumors) in most patients (57%). On average, patients had 11.1 months of osimertinib treatment before their cancer worsened. The effectiveness and side effects of osimertinib treatment seen in this study were similar to previous studies with osimertinib.