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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

4056 - ASTRIS: A real world treatment study of osimertinib in patients (pts) with EGFR T790M-positive non-small cell lung cancer (NSCLC); European subset


20 Oct 2018


Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research


Targeted Therapy

Tumour Site


Marcello Tiseo


Annals of Oncology (2018) 29 (suppl_8): viii493-viii547. 10.1093/annonc/mdy292


M. Tiseo1, A. Santo2, M.J. Hochmair3, T. Geldart4, G. Metro5, E. Hanrahan6, K. Lamberg7, T. Moran8, C. Nyhus9, A. Paredes10, J.F. Vansteenkiste11, D. Vicente12, M. Miranda13, J. Rigas14, F. de Marinis15

Author affiliations

  • 1 Medical Oncology, University Hospital of Parma, 43126 - Parma/IT
  • 2 Medical Oncology, University of Verona, University Hospital of Verona, 37134 - Verona/IT
  • 3 Respiratory Oncology Unit, Otto Wagner Spital, 1140 - Vienna/AT
  • 4 Medical Oncology, 4. Poole Hospital NHS Foundation Trust, BH7 7DW - Poole/GB
  • 5 Oncology, 5. Santa Maria della Misericordia Hospital, 6132 - Perugia/IT
  • 6 Department Of Oncology, St Vincents University Hospital, 4 - Dublin/IE
  • 7 7. department Of Medical Sciences, Respiratory, Allergy And Sleep Research, Uppsala University Hospital, Uppsala/SE
  • 8 Medical Oncology Service, ICO Badalona-Hospital Germans Trias i Pujol, 08912 - Badalona/ES
  • 9 Oncology Department, Vejle Hospital, 7100 - Vejle/DK
  • 10 Department Of Surgery, The Ohio State University Wexner Medical Center, Columbus/US
  • 11 Respiratory Oncology Unit (pulmonology), University Hospitals KU Leuven, 3000 - Leuven/BE
  • 12 Medical Oncology, Hospital Universitario Virgen Macarena, Seville/ES
  • 13 Biometrics And Information Sciences, AstraZeneca, Cambridge/GB
  • 14 Gma Oncology Ta, AstraZeneca, Gaithersburg/US
  • 15 Division Of Thoracic Oncology, European Institute of Oncology, 20141 - Milan/IT


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Abstract 4056


Osimertinib is a third-generation, CNS-active EGFR-TKI that potently and selectively inhibits both EGFR-TKI sensitising and EGFR T790M resistance mutations. We report results from the European subset of the ongoing global ASTRIS study (NCT02474355).


Eligible pts receive osimertinib 80 mg once daily. Inclusion criteria: Stage IIIB/IV T790M-positive NSCLC; T790M status confirmed locally by validated test, not restricted by sample type; prior EGFR-TKI therapy received; WHO performance status (PS) 0 − 2; acceptable organ and bone marrow function and no history of interstitial lung disease (ILD) or QTc prolongation. Asymptomatic, stable CNS metastases are permitted. The primary efficacy outcome is overall survival (OS). Second interim data cut-off (DCO) 20 Oct 2017.


From Sept 18 2015, 759 pts were enrolled across 8 European countries and received ≥1 dose of osimertinib: median follow-up 10.9 months (mo) (range <1 − 24), median age 66 yrs (32–92), 24% ≥75 yrs, 69% female, 97% White, 14% WHO PS 2, 44% prior chemotherapy. T790M-positive status was identified from tissue in 290 pts (38%), plasma ctDNA in 415 pts (55%) and from other sources in 53 pts (7%). At DCO, 545 pts (72%) had discontinued treatment (214 [28%] ongoing); 442 pts (58%) had withdrawn from the study, including 268 deaths (35%); median duration of exposure 9.7 mo (<1–25). In pts evaluable for response, investigator-assessed clinical response rate was 55.3% (381/689; 95% CI 51.5, 59.1). Estimated median progression-free survival (PFS) was 9.7 mo (95% CI 8.5, 10.8), with 470 (62%) progressions/deaths. OS data are not mature (OS at 12 mo was 67.4%; 95% CI 63.7, 70.8). Adverse events (AEs) leading to dose modification and treatment discontinuation were reported in 149 pts (20%) and 53 pts (7%), respectively. Serious AEs were reported in 147 pts (19%). ILD / pneumonitis-like events were reported in 22 pts (3%), and QTc prolongation in 7 pts (1%).


In this European dataset from ASTRIS, clinical activity (response and PFS) with osimertinib in patients with T790M-positive NSCLC is similar to that observed in the global ASTRIS population and the wider osimertinib clinical trial programme with no new safety signals.

Clinical trial identification


Legal entity responsible for the study




Editorial Acknowledgement

The authors would like to acknowledge Tom Hudson, PhD, of iMed Comms, Macclesfield, UK, an Ashfield Company, part of UDG Healthcare plc, for editorial assistance that was funded by AstraZeneca, Cambridge, UK, in accordance with Good Publications Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).


M. Tiseo: Advisory boards and speakers’ fee: AstraZeneca, Pfizer, Eli-Lilly, Bristol-Myers Squibb, Novartis, Roche, MSD, Boehringer Ingelheim, Otsuka, Pierre Fabre. A. Santo: Grants/research support/consultancy: AstraZeneca, Boehringer Ingelheim. M.J. Hochmair: Honoria: AstraZeneca, Boehringer Ingelheim, Pfizer, Roche. J.F. Vansteenkiste: Research funding at University Hospitals KU Leuven: MSD; Advisory functions: Apotex, AstraZeneca, Boehringer Ingelheim, MSD, Novartis, Roche; Lectures: AstraZeneca, BMS, MSD, Roche. M. Miranda: Full time employee: AstraZeneca; Shares: AstraZeneca. J. Rigas: Consultant: AstraZeneca; Employee: Kelly Services. F. de Marinis: Honoraria: Bristol-Myers Squibb, AstraZeneca, Roche, Merck Sharp & Dohme. All other authors have declared no conflicts of interest.

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