Summary of Research: Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC

This is a summary of the original article ‟Overall survival with osimertinib in resected EGFR-mutated NSCLC.ˮ Osimertinib blocks the activity of the epidermal growth factor receptor (EGFR) on cancer cells, causing cancer cell death and tumor shrinkage, and is an effective treatment for EGFR-mutated non-small cell lung cancer (NSCLC). The ADAURA study assessed the effects of osimertinib versus placebo in patients with EGFR-mutated (exon 19 deletion or L858R) early stage (IB–IIIA) NSCLC removed by surgery (resected). Previous results from ADAURA demonstrated that patients treated with osimertinib stayed alive and cancer-free (disease-free survival) significantly longer than patients who received placebo. Recent data showed the overall length of time patients were alive after starting treatment (overall survival). In both the primary stage II–IIIA and overall stage IB–IIIA populations, patients in the osimertinib group had a significant 51% reduction in the risk of death compared with the placebo group. The data demonstrated that osimertinib after surgery significantly improved overall survival in patients with resected, EGFR-mutated, stage IB–IIIA NSCLC.

• 21 March 2024

  The chapter 1 Summary of Research has been placed in the first page of the article

The authors thank Laura Floyd and Shannon Gall for reviewing and providing valuable contributions to the development of this summary.

Authors and Affiliations

1. National Cancer Center Hospital East, Kashiwa, Japan

   Masahiro Tsuboi

2. Yale School of Medicine and Yale Cancer Center, New Haven, CT, USA

   Roy S. Herbst

3. Peter MacCallum Cancer Centre, Melbourne, Australia

   Thomas John

4. Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia

   Thomas John

5. Kanagawa Cancer Center, Yokohama, Japan

   Terufumi Kato

6. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

   Margarita Majem

7. Klinik für Pneumologie, Evangelische Lungenklinik Berlin Buch, Berlin, Germany

   Christian Grohé

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

   Jie Wang

9. David Geffen School of Medicine, University of California, Los Angeles, CA, USA

   Jonathan W. Goldman

10. Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China

    Shun Lu

11. European Institute of Oncology (IEO), IRCCS, Milan, Italy

    Filippo de Marinis

12. University Health Network, Princess Margaret Cancer Centre, Toronto, ON, Canada

    Frances A. Shepherd

13. National University Hospital, Cheongju, South Korea

    Ki Hyeong Lee

14. Ho Chi Minh City Oncology Hospital, Binh Thanh District, Ho Chi Minh City, Vietnam

    Nhieu Thi Le

15. Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand

    Arunee Dechaphunkul

16. Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland

    Dariusz Kowalski

17. Istituto Oncologico Veneto IOV IRCCS, Padova, Italy

    Laura Bonanno

18. Hospital Universitario Fundación Jiménez Díaz (IIS-FJD), Madrid, Spain

    Manuel Dómine

19. AstraZeneca, Cambridge, UK

    Lynne Poole & Yuri Rukazenkov

20. AstraZeneca, Toronto, Canada

    Ana Bolanos

21. Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China

    Yi-Long Wu

Corresponding author

Correspondence to Roy S. Herbst.

Funding

Funded by AstraZeneca; ADAURA ClinicalTrials.gov number, NCT02511106. Medical writing assistance was provided by Sally Cotterill, Ph.D., CMPP, of Ashfield MedComms, an Inizio Company, and was funded by AstraZeneca in accordance with Good Publications Practice (GPP) guidelines (https://www.ismpp.org/gpp-2022).

Disclosures

Please see the original article for full author disclosures. In addition to these disclosures, Masahiro Tsuboi reports invited speaker/honoraria roles: Daiichi Sankyo. Thomas John reports consulting/advisory roles: Gilead Sciences, Johnson & Johnson, Seagen, Specialised Therapeutics, and Takeda. Margarita Majem reports a consulting/advisory role with Cassen Recordatti; invitation to a speaker/speakers’ bureau from Amgen, AstraZeneca, Helssin, Merck Sharp & Dohme, Roche, and Sanofi; meeting/travel support from AstraZeneca, Merck Sharp & Dohme, and Roche; and research support from Bristol Myers Squibb. Filippo de Marinis reports a consulting/advisory role: AstraZeneca. Laura Bonanno reports consulting/advisory roles with AstraZeneca, Bristol Myers Squibb/Medarex, MSD Oncology, Novartis, and Roche/Genentech and speakers’ bureau participation with Novartis/Ipsen, AstraZeneca/MedImmune, Bristol Myers Squibb/Medarex, and Novartis/Ipsen. Manuel Dómine reports consulting/advisory roles: AstraZeneca, MSD Oncology, Pfizer, Roche, and Takeda.

Compliance and Ethics Guidelines

The trial was conducted in accordance with the provisions of the Declaration of Helsinki, the Good Clinical Practice guidelines of the International Council for Harmonization, applicable regulatory requirements, and the bioethics and human samples policy of the sponsor. The protocol was approved by relevant institutional review boards or ethics committees. All patients provided written informed consent. This article is based on a previously conducted study and does not contain any new data from studies with human participants or animals performed by any of the authors.

Consent for Publication

Not applicable.

Data Availability

Provision of standard data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Code Availability

Not applicable.

Author Contributions

All authors contributed to the development of this article and approved the final document.

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