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: investigator-assessed 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. 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.
Bibliographical noteFunding Information:
The study (NCT02474355) was funded by AstraZeneca, Cambridge, UK, the manufacturer of osimertinib. F de Marinis declares consulting/advisory roles for Roche, Bristol-Myers Squibb and AstraZeneca. Y-L Wu declares consulting/advisory roles for As-traZeneca, Roche, Merck and Boehringer Ingelheim; research funding from Roche and Boehringer Ingelheim; honoraria from AstraZeneca, Roche, Eli Lilly and Pfizer. G de Castro declares honoraria, speakers’ bureau, travel and accommodation and advisory boards for AstraZeneca, Roche, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Novartis and MSD; advisory boards for Yuhan and Teva. BC Cho declares honoraria from AstraZeneca, Roche, Boehringer Ingelheim, Novartis, MSD and Yuhan; speakers’ bureau for AstraZeneca, Novartis and MSD; research grants from AstraZeneca, Novartis and Yuhan; advisory boards for As-traZeneca, Roche, Boehringer Ingelheim, Novartis, MSD and Yuhan. H Freitas declares consulting/advisory roles for AstraZeneca, MSD and Pfizer. M Provencio declares advisory boards for AstraZeneca, Bristol-Myers Squibb, Pierre Fabre, MSD and Roche. J Vansteenkiste declares research funding from AstraZeneca, Boehringer Ingelheim, MSD and Novartis; honoraria from AstraZeneca, Bristol-Myers Squibb, MSD and Roche. NA Bakker and MF Miranda are AstraZeneca employees and shareholders. JR Rigas declares consulting/advisory role for AstraZeneca, via Kelly Services. PK Cheema declares consulting/advisory roles for AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Roche, Novartis, Merck, Pfizer and Takeda. Y-M Chen declares consulting/advisory roles for Astrazeneca, Roche and Merck; advisory boards for AstraZeneca, Bristol-Myers Squibb and Boehringer Ingelheim; honoraria from Eli Lilly, Roche, Novartis, Merck and Pfizer. D Vicente declares advisory boards for AstraZeneca, Bristol-Myers Squibb, MSD and Roche. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
The authors would like to acknowledge B Tynan, iMed Comms, Macclesfield, UK, an Ashfield Company, part of UDG Healthcare, PLC, for medical writing support that was funded by AstraZeneca, Cambridge, UK, in accordance with Good Publications Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).
All Science Journal Classification (ASJC) codes
- Cancer Research