Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer

Author:

Borghaei Hossein1ORCID,Gettinger Scott2ORCID,Vokes Everett E.3ORCID,Chow Laura Q. M.4ORCID,Burgio Marco Angelo5,de Castro Carpeno Javier6ORCID,Pluzanski Adam7,Arrieta Oscar8ORCID,Frontera Osvaldo Arén9,Chiari Rita10,Butts Charles11,Wójcik-Tomaszewska Joanna12,Coudert Bruno13ORCID,Garassino Marina Chiara14,Ready Neal15,Felip Enriqueta16ORCID,García Miriam Alonso17,Waterhouse David18ORCID,Domine Manuel19ORCID,Barlesi Fabrice20,Antonia Scott21,Wohlleber Markus22,Gerber David E.23ORCID,Czyzewicz Grzegorz24,Spigel David R.25ORCID,Crino Lucio5,Eberhardt Wilfried Enst Erich26,Li Ang27,Marimuthu Sathiya27,Brahmer Julie28

Affiliation:

1. Fox Chase Cancer Center, Philadelphia, PA

2. Yale Comprehensive Cancer Center, New Haven, CT

3. Univeristy of Chicago Medicine and Biologic Sciences Division, Chicago, IL

4. University of Washington, Seattle Cancer Care Alliance, Seattle, WA

5. Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy

6. Hospital De Madrid, Norte Sanchinarro, Madrid, Spain

7. Maria Sklodowska-Curie Inst of Oncology, Warsaw, Poland

8. Instituto Nacional De Cancerología, Mexico City, Mexico

9. Centro de Investigación Clínica Bradford Hill and Centro Internacional de Estudios Clinicos, Santiago, Chile

10. Ospedale S. Maria Della Misericordia, Perugia, Italy

11. Cross Cancer Institute, Edmonton, AB, Canada

12. Provincial Center of Oncology in Gdańsk, Gdańsk, Poland

13. Centre Georges-François Leclerc, Dijon, France

14. Instituto Nazionale per Lo Studio e La Cura, Milano, Italy

15. Duke University Medical Center, Durham, NC

16. Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain

17. Hospital Universitario Virgen Del Rocio, Sevilla, Spain

18. Oncology Hematology Care, Inc, Cincinnati, OH

19. Fundacion Jimenez Diaz, IIS-FJD Madrid, Spain

20. Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France

21. H. Lee Moffitt Cancer Center, Tampa, FL

22. Robert Bosch Cancer Center, Gerlingen, Germany

23. UT Southwestern Medical Center, Dallas, TX

24. John Paul II Hospital, Kraków, Poland

25. Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN

26. Universitaetsmedizin Essen und Ruhrlandklinik, Essen, Germany

27. Bristol Myers Squibb, Princeton, NJ

28. Johns Hopkins Kimmel Cancer Center, Baltimore, MD

Abstract

PURPOSE Immunotherapy has revolutionized the treatment of advanced non–small-cell lung cancer (NSCLC). In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) and favorable safety versus docetaxel in patients with previously treated, advanced squamous and nonsquamous NSCLC, respectively. We report 5-year pooled efficacy and safety from these trials. METHODS Patients (N = 854; CheckMate 017/057 pooled) with advanced NSCLC, ECOG PS ≤ 1, and progression during or after first-line platinum-based chemotherapy were randomly assigned 1:1 to nivolumab (3 mg/kg once every 2 weeks) or docetaxel (75 mg/m2 once every 3 weeks) until progression or unacceptable toxicity. The primary end point for both trials was OS; secondary end points included progression-free survival (PFS) and safety. Exploratory landmark analyses were investigated. RESULTS After the minimum follow-up of 64.2 and 64.5 months for CheckMate 017 and 057, respectively, 50 nivolumab-treated patients and nine docetaxel-treated patients were alive. Five-year pooled OS rates were 13.4% versus 2.6%, respectively; 5-year PFS rates were 8.0% versus 0%, respectively. Nivolumab-treated patients without disease progression at 2 and 3 years had an 82.0% and 93.0% chance of survival, respectively, and a 59.6% and 78.3% chance of remaining progression-free at 5 years, respectively. Treatment-related adverse events (TRAEs) were reported in 8 of 31 (25.8%) nivolumab-treated patients between 3–5 years of follow-up, seven of whom experienced new events; one (3.2%) TRAE was grade 3, and there were no grade 4 TRAEs. CONCLUSION At 5 years, nivolumab continued to demonstrate a survival benefit versus docetaxel, exhibiting a five-fold increase in OS rate, with no new safety signals. These data represent the first report of 5-year outcomes from randomized phase III trials of a programmed death-1 inhibitor in previously treated, advanced NSCLC.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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