Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non–Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial

Author:

Herbst Roy S.1ORCID,Wu Yi-Long2ORCID,John Thomas3,Grohe Christian4,Majem Margarita5,Wang Jie6ORCID,Kato Terufumi7ORCID,Goldman Jonathan W.8ORCID,Laktionov Konstantin9ORCID,Kim Sang-We10,Yu Chong-Jen1112ORCID,Vu Huu Vinh13ORCID,Lu Shun14ORCID,Lee Kye Young15ORCID,Mukhametshina Guzel16,Akewanlop Charuwan17ORCID,de Marinis Filippo18,Bonanno Laura19ORCID,Domine Manuel20ORCID,Shepherd Frances A.21,Urban Damien2223ORCID,Huang Xiangning24,Bolanos Ana25,Stachowiak Marta26,Tsuboi Masahiro27ORCID

Affiliation:

1. Medical Oncology, Yale School of Medicine and Yale Cancer Center, New Haven, CT

2. Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China

3. Department of Medical Oncology, Austin Health, Melbourne, Australia

4. Klinik für Pneumologie—Evangelische Lungenklinik Berlin Buch, Berlin, Germany

5. Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

6. Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China

7. Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan

8. David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA

9. Federal State Budgetary Institution “N.N.Blokhin National Medical Research Center of Oncology” of the Ministry of Health of the Russian Federation, Moscow, Russia

10. Department of Oncology, Asan Medical Center, Seoul, South Korea

11. Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan

12. National Taiwan University Hospital Hsin-Chu Branch, Zhubei City, Hsin-Chu County, Taiwan

13. Department Thoracic Surgery, Cho Ray Hospital, Hochiminh City, Vietnam

14. Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan

15. Precision Medicine Lung Cancer Center, Konkuk University Medical Center, Seoul, South Korea

16. Republican Clinical Oncology Center, Kazan, Republic of Tatarstan, Russia

17. Division of Medical Oncology, Faculty of Medicine, Siriraj Hospital, Bangkok, Thailand

18. Thoracic Oncology Division, European Institute of Oncology (IEO), IRCCS, Milan, Italy

19. Medical Oncology 2, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy

20. Department of Oncology, Hospital Universitario Fundación Jiménez Díaz (IIS-FJD), Madrid, Spain

21. Department of Medical Oncology and Hematology, University Health Network, Princess Margaret Cancer Center, Toronto, Canada

22. Department of Oncology, Sheba Medical Center, Tel Hashomer, Israel

23. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

24. Oncology Biometrics, AstraZeneca, Cambridge, United Kingdom

25. Oncology Research and Development, AstraZeneca, Toronto, Ontario, Canada

26. Late Oncology Research and Development, AstraZeneca, Warsaw, Poland

27. Department of Thoracic Surgery and Oncology, National Cancer Center Hospital East, Kashiwa, Japan

Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. PURPOSE The phase III ADAURA (ClinicalTrials.gov identifier: NCT02511106 ) primary analysis demonstrated a clinically significant disease-free survival (DFS) benefit with adjuvant osimertinib versus placebo in EGFR-mutated stage IB-IIIA non–small-cell lung cancer (NSCLC) after complete tumor resection (DFS hazard ratio [HR], 0.20 [99.12% CI, 0.14 to 0.30]; P < .001). We report an updated exploratory analysis of final DFS data. METHODS Overall, 682 patients with stage IB-IIIA (American Joint Committee on Cancer/Union for International Cancer Control, seventh edition) EGFR-mutated (exon 19 deletion/L858R) NSCLC were randomly assigned 1:1 (stratified by stage, mutational status, and race) to receive osimertinib 80 mg once-daily or placebo for 3 years. The primary end point was DFS by investigator assessment in stage II-IIIA disease analyzed by stratified log-rank test; following early reporting of statistical significance in DFS, no further formal statistical testing was planned. Secondary end points included DFS in stage IB-IIIA, overall survival, and safety. Patterns of recurrence and CNS DFS were prespecified exploratory end points. RESULTS At data cutoff (April 11, 2022), in stage II-IIIA disease, median follow-up was 44.2 months (osimertinib) and 19.6 months (placebo); the DFS HR was 0.23 (95% CI, 0.18 to 0.30); 4-year DFS rate was 70% (osimertinib) and 29% (placebo). In the overall population, DFS HR was 0.27 (95% CI, 0.21 to 0.34); 4-year DFS rate was 73% (osimertinib) and 38% (placebo). Fewer patients treated with osimertinib had local/regional and distant recurrence versus placebo. CNS DFS HR in stage II-IIIA was 0.24 (95% CI, 0.14 to 0.42). The long-term safety profile of osimertinib was consistent with the primary analysis. CONCLUSION These updated data demonstrate prolonged DFS benefit over placebo, reduced risk of local and distant recurrence, improved CNS DFS, and a consistent safety profile, supporting the efficacy of adjuvant osimertinib in resected EGFR-mutated NSCLC.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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