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Poster Display session 1

1658 - Frequency of epidermal growth factor receptor (EGFR) mutations in stage IB–IIIA EGFR mutation positive non-small-cell lung cancer (NSCLC) after complete tumour resection


28 Sep 2019


Poster Display session 1


Tumour Site

Non-Small Cell Lung Cancer


Masahiro Tsuboi


Annals of Oncology (2019) 30 (suppl_5): v585-v590. 10.1093/annonc/mdz258


M. Tsuboi1, R.S. Herbst2, T. John3, C. Grohe4, M. Majem5, J.W. Goldman6, S. Kim7, C. Yu8, J.E.A. Miziara9, S. Novello10, D. Urban11, C. Akewanlop12, A. Öztürk13, B.V. Quang14, D. Kowalski15, D. Marmol16, M. Marotti16, G. Laus16, Y. Wu17

Author affiliations

  • 1 Department Of Thoracic Surgery And Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 2 Medical Oncology, Yale University School of Medicine, Yale Cancer Center, 06520 - New Haven/US
  • 3 Department Of Medical Oncology, Austin Health, Melbourne/AU
  • 4 Klinik Für Pneumologie, Evangelische Lungenklinik Berlin Buch, 13125 - Berlin/DE
  • 5 Medical Oncology Services, Hospital de la Santa Creu i Sant Pau, Barcelona/ES
  • 6 Division Of Medicine, David Geffen School of Medicine at UCLA, 90404 - Los Angeles/US
  • 7 Department Of Oncology, Asan Medical Center, Seoul/KR
  • 8 Department Of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, 10002 - Taipei/TW
  • 9 Department Of Thoracic Surgery, Barretos Cancer Hospital, Barretos/BR
  • 10 Department Of Oncology, University of Turin, AOU San Luigi, Turin/IT
  • 11 Department Of Medical Oncology, Institute Of Oncology, Chaim Sheba Medical Center, Tel Hashomer, affiliated to Sackler Faculty of Medicine, Tel Aviv University, 52621 - Ramat Gan/IL
  • 12 Division Of Medical Oncology, Department Of Internal Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, 10700 - Bangkok/TH
  • 13 Department Of Medical Oncology, Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul/TR
  • 14 Department Of Radiation Oncology, Hanoi Oncology Hospital, Hanoi/VN
  • 15 Department Of Lung Cancer And Chest Tumours, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw/PL
  • 16 R&d Oncology, AstraZeneca, Cambridge/GB
  • 17 Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou/CN


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Abstract 1658


Data on the frequency of EGFR mutations in patients (pts) with NSCLC potentially eligible for adjuvant therapy are limited. Osimertinib, a 3rd-generation, irreversible, oral EGFR-tyrosine kinase inhibitor (TKI), potently and selectively inhibits both EGFR-TKI sensitising (EGFRm) and EGFR T790M mutations, and has shown efficacy in the CNS. The ADAURA study (NCT02511106) will assess osimertinib as adjuvant therapy in early-stage NSCLC after complete resection. Here we report frequency of the most common EGFR activating mutations from pts screened for ADAURA.


ADAURA is a Phase III, double-blind, randomised, placebo-controlled study assessing efficacy and safety of osimertinib vs placebo in adult pts with mainly non-squamous histology, stage IB–IIIA EGFRm NSCLC, following complete tumour resection, without or after adjuvant chemotherapy. At screening, EGFR mutations associated with EGFR-TKI sensitivity (ex19del, L858R), alone or in combination with exon 20 insertion, G719X, S768I, T790M or L861Q were centrally assessed from resected tumour samples using the cobas® EGFR Mutation Test (Roche Molecular Systems). Some pts may have been pre-screened for EGFR mutations using local tests.


In total, 2447 pts were screened. Median age was 63 years (range 23–88), 54% were female, and 61% were non-Asian. At screening, 1087 (44%) pts were EGFR mutation positive; 110/2447 (4%) pts had an unknown/unevaluable test result. Of pts EGFR mutation positive, the most common mutations were ex19del and L858R in 572 (53%) and 458 (42%) pts, respectively; exon 20 insertion, G719X, T790M, S768I, and L861Q mutations occurred in 28 (3%), 24 (2%), 19 (2%), 11 (1%) and 8 (1%) pts, respectively. Mutations occurred alone or in combination. A higher proportion of EGFR mutation positive pts were Asian vs non-Asian (681 [63%] vs 402 [37%]; 4 pts missing) and female vs male (755 [69%] vs 331 [30%]; 1 pt missing).


This analysis shows a high prevalence of EGFRm mutations in Asian and female pts with stage IB–IIIA NSCLC following complete resection, which is consistent with the advanced setting. International screening for EGFR mutations in the adjuvant setting should be considered.

Clinical trial identification


Editorial acknowledgement

Natalie Griffiths, PhD, from iMed Comms, an Ashfield Company; funded by AstraZeneca.

Legal entity responsible for the study





M. Tsuboi: Research grant / Funding (institution): Boehringer Ingelheim Japan; Honoraria (self): Johnson & Johnson Japan, AstraZeneca KK, Eli Lilly Japan, Boehringer Ingelheim Japan, Daiichi-Sankyo, Chugai Pharmaceutical, Taiho Pharma, Covidien Japan, Ono Pharmaceutical, Merck Sharp & Dohme, Bristol-Myers Squibb KK, Teijin Pharma. R.S. Herbst: Advisory / Consultancy, Consulting: AbbVie Pharmaceuticals, ARMO Biosciences, AstraZeneca, Biodesix, Bristol-Myers Squibb, Eli Lilly, EMD Serrano, Genentech/Roche, Genmab, Heat Biologics, Halozyme, Loxo Oncology, Merck & Company, Nektar, NextCure, Novartis, Pfizer, Sanofi, Seattle Genetics,; Research grant / Funding (institution): AstraZeneca, Eli Lilly, Merck; Advisory / Consultancy, Scientific Advisory Boards: Neon Therapeutics, Infinity Pharmaceuticals, NextCure; Leadership role, Board Member (non-executive/independent): Junshi Pharmaceuticals. T. John: Advisory / Consultancy: Roche, Bristol-Myers Squibb, Merck, Ignyta, AstraZeneca, Takeda. M. Majem: Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Speaker Bureau / Expert testimony, Research grant / Funding (self), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Merck Sharp & Dohme; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Advisory / Consultancy: Tesaro; Speaker Bureau / Expert testimony: Hellsin; Travel / Accommodation / Expenses: Lilly; Advisory / Consultancy: Takeda; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pierre Fabre; Speaker Bureau / Expert testimony: Amgen. J.W. Goldman: Research grant / Funding (institution): AbbVie; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Merck; Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (institution): AstraZeneca. S. Novello: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Roche, Merck Sharp & Dohme, Takeda, Pfizer, AbbVie, AstraZeneca, Celgene. D. Urban: Honoraria (self), Travel / Accommodation / Expenses: AstraZeneca. C. Akewanlop: Travel / Accommodation / Expenses: Amgen, AstraZeneca, Roche. D. Kowalski: Advisory / Consultancy, Travel / Accommodation / Expenses: Boehringer Ingelheim. D. Marmol: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. M. Marotti: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. G. Laus: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. Y. Wu: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca, Roche; Honoraria (self), Advisory / Consultancy: Boehringer Ingelheim; Honoraria (self): Eli Lilly, Pfizer, Merck Sharp & Dohme, Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

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