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Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC

Masahiro Tsuboi1, Roy S Herbst1, Thomas John1

  • 1From the Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa (M.T.), the Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama (T.K.) - both in Japan; the Section of Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT (R.S.H.); the Department of Medical Oncology, Peter MacCallum Cancer Centre, and the Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia (T.J.); the Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.); Klinik für Pneumologie, Evangelische Lungenklinik Berlin Buch, Berlin (C.G.); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing (J.W.), Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai (S.L.), and Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W.) - all in China; David Geffen School of Medicine, University of California, Los Angeles, Los Angeles (J.W.G.); the Department of Oncology, National Cheng Kung University, Tainan, Taiwan (W.-C.S.); the Division of Thoracic Oncology, European Institute of Oncology, IRCCS, Milan (F.M.); the Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Centre (F.A.S.), and Oncology Research and Development, AstraZeneca (A.B.) - both in Toronto; the Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, South Korea (K.H.L.); Ho Chi Minh City Oncology Hospital, Binh Thanh District, Ho Chi Minh City, Vietnam (N.T.L.); the Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand (A.D.); the Department of Lung Cancer and Thoracic Tumors, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland (D.K.); and Oncology Biometrics (L.P.), and Oncology Research and Development (Y.R.), AstraZeneca, Cambridge, United Kingdom.

The New England Journal of Medicine
|June 5, 2023
PubMed
Abstract

Insights

Adjuvant osimertinib significantly improved overall survival in patients with resected EGFR-mutated NSCLC. This final analysis of the ADAURA trial confirms long-term benefits for early-stage lung cancer.

Area of Science:

  • Oncology
  • Medical Research
  • Clinical Trials

Background:

  • The ADAURA trial investigated adjuvant osimertinib in resected, EGFR-mutated, stage IB-IIIA non-small-cell lung cancer (NSCLC).
  • Previous findings showed improved disease-free survival with osimertinib compared to placebo.
  • This report presents the final overall survival (OS) analysis.

Purpose of the Study:

  • To determine the effect of adjuvant osimertinib on overall survival in patients with resected EGFR-mutated NSCLC.
  • To report the final survival outcomes from the ADAURA trial.

Main Methods:

  • Phase 3, double-blind, randomized controlled trial comparing osimertinib to placebo.
  • Patients received 80 mg osimertinib or placebo daily until disease recurrence, completion of 3 years, or discontinuation.
  • Primary endpoint was disease-free survival (DFS) in stage II-IIIA; secondary endpoints included OS and safety.

Main Results:

  • In stage II-IIIA NSCLC, 5-year OS was 85% with osimertinib vs. 73% with placebo (HR 0.49, P<0.001).
  • In the overall population (stage IB-IIIA), 5-year OS was 88% with osimertinib vs. 78% with placebo (HR 0.49, P<0.001).
  • Adverse events were consistent with previous analyses; no new safety concerns related to the trial regimen were reported.

Conclusions:

  • Adjuvant osimertinib significantly improves overall survival in patients with resected, EGFR-mutated, stage IB-IIIA NSCLC.
  • The findings confirm a substantial long-term survival benefit for this patient population.

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