Five-year outcomes from the randomized, phase iii trials checkmate 017 and 057: nivolumab versus docetaxel in previously treated non-small-cell lung cancer

Hossein Borghaei; Scott Gettinger; Everett E. Vokes; Laura Q.M. Chow; Marco Angelo Burgio; Javier de Castro Carpeno; Adam Pluzanski; Oscar Arrietac; Osvaldo Arén Frontera; Rita Chiari; Charles Butts; Joanna Wójcik-Tomaszewska; Bruno Coudert; Marina Chiara Garassino; Neal Ready; Enriqueta Felip; Miriam Alonso García; David Waterhouse; Manuel Domine; Fabrice Barlesi; Scott Antonia; Markus Wohlleber; David E. Gerber; Grzegorz Czyzewicz; David R. Spigel; Lucio Crino; Wilfried Enst Erich Eberhardt; Ang Li; Sathiya Marimuthu; Julie Brahmerc

doi:10.1200/JCO.20.01605

Five-year outcomes from the randomized, phase iii trials checkmate 017 and 057: nivolumab versus docetaxel in previously treated non-small-cell lung cancer

Hossein Borghaei
, Scott Gettinger
, Everett E. Vokes
, Laura Q.M. Chow
, Marco Angelo Burgio
, Javier de Castro Carpeno
, Adam Pluzanski
, Oscar Arrietac
, Osvaldo Arén Frontera
, Rita Chiari
, Charles Butts
, Joanna Wójcik-Tomaszewska
, Bruno Coudert
, Marina Chiara Garassino
, Neal Ready
, Enriqueta Felip
, Miriam Alonso García
, David Waterhouse
, Manuel Domine
, Fabrice Barlesi

Scott Antonia, Markus Wohlleber, David E. Gerber, Grzegorz Czyzewicz, David R. Spigel, Lucio Crino, Wilfried Enst Erich Eberhardt, Ang Li, Sathiya Marimuthu, Julie Brahmerc

Yale University
University of Chicago
University of Washington
IRCCS Istituto scientifico romagnolo per lo studio e la cura dei tumori - Meldola (FC)
Hospital de Madrid
Maria Sklodowska-Curie Institute of Oncology
Instituto Nacional de Cancerologia - Mexico
Centro Internacional de Estudios Clinicos
University Hospital of Perugia
Cross Cancer Institute
Provincial Center of Oncology in Gdansk
Georges François Leclerc Cancer Center
Fondazione IRCCS Istituto Nazionale dei Tumori
Duke University
Vall d'Hebron Institute of Oncology
Hospital Universitario Virgen del Rocio
Oncology Hematology Care Inc
Hospital Universitario Puerta de Hierro Majadahonda
Aix-Marseille University
University of South Florida
Robert Bosch Cancer Center
University of Texas Southwestern Medical Center
John Paul II Hospital, Krakow
Sarah Cannon Research Institute
University Hospital and Ruhrlandclinic
Bristol-Myers Squibb
Johns Hopkins University

Research output: Contribution to journal › Article › peer-review

600 Scopus citations

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/m 2 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.

Original language	English
Pages (from-to)	723-733
Number of pages	11
Journal	Journal of Clinical Oncology
Volume	39
Issue number	7
DOIs	https://doi.org/10.1200/JCO.20.01605
State	Published - Mar 1 2021

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Adult
Aged
Aged, 80 and over
Carcinoma, Non-Small-Cell Lung/drug therapy
Clinical Trials, Phase III as Topic
Disease Progression
Docetaxel/adverse effects
Female
Humans
Immune Checkpoint Inhibitors/adverse effects
Immunotherapy/adverse effects
Lung Neoplasms/drug therapy
Male
Middle Aged
Nivolumab/adverse effects
Progression-Free Survival
Randomized Controlled Trials as Topic
Time Factors
Tubulin Modulators/adverse effects
Young Adult

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10.1200/JCO.20.01605

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Borghaei, H., Gettinger, S., Vokes, E. E., Chow, L. Q. M., Burgio, M. A., de Castro Carpeno, J., Pluzanski, A., Arrietac, O., Frontera, O. A., Chiari, R., Butts, C., Wójcik-Tomaszewska, J., Coudert, B., Garassino, M. C., Ready, N., Felip, E., García, M. A., Waterhouse, D., Domine, M., ... Brahmerc, J. (2021). Five-year outcomes from the randomized, phase iii trials checkmate 017 and 057: nivolumab versus docetaxel in previously treated non-small-cell lung cancer. Journal of Clinical Oncology, 39(7), 723-733. https://doi.org/10.1200/JCO.20.01605

@article{85400a738f3c4f45b79a10a6de86fea9,

title = "Five-year outcomes from the randomized, phase iii trials checkmate 017 and 057: nivolumab versus docetaxel in previously treated non-small-cell lung cancer",

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/m 2 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.",

keywords = "Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung/drug therapy, Clinical Trials, Phase III as Topic, Disease Progression, Docetaxel/adverse effects, Female, Humans, Immune Checkpoint Inhibitors/adverse effects, Immunotherapy/adverse effects, Lung Neoplasms/drug therapy, Male, Middle Aged, Nivolumab/adverse effects, Progression-Free Survival, Randomized Controlled Trials as Topic, Time Factors, Tubulin Modulators/adverse effects, Young Adult",

author = "Hossein Borghaei and Scott Gettinger and Vokes, \{Everett E.\} and Chow, \{Laura Q.M.\} and Burgio, \{Marco Angelo\} and \{de Castro Carpeno\}, Javier and Adam Pluzanski and Oscar Arrietac and Frontera, \{Osvaldo Ar{\'e}n\} and Rita Chiari and Charles Butts and Joanna W{\'o}jcik-Tomaszewska and Bruno Coudert and Garassino, \{Marina Chiara\} and Neal Ready and Enriqueta Felip and Garc{\'i}a, \{Miriam Alonso\} and David Waterhouse and Manuel Domine and Fabrice Barlesi and Scott Antonia and Markus Wohlleber and Gerber, \{David E.\} and Grzegorz Czyzewicz and Spigel, \{David R.\} and Lucio Crino and Eberhardt, \{Wilfried Enst Erich\} and Ang Li and Sathiya Marimuthu and Julie Brahmerc",

note = "Publisher Copyright: {\textcopyright} 2021 by American Society of Clinical Oncology.",

year = "2021",

month = mar,

day = "1",

doi = "10.1200/JCO.20.01605",

language = "English",

volume = "39",

pages = "723--733",

journal = "Journal of Clinical Oncology",

issn = "0732-183X",

publisher = "Lippincott Williams and Wilkins",

number = "7",

}

Borghaei, H, Gettinger, S, Vokes, EE, Chow, LQM, Burgio, MA, de Castro Carpeno, J, Pluzanski, A, Arrietac, O, Frontera, OA, Chiari, R, Butts, C, Wójcik-Tomaszewska, J, Coudert, B, Garassino, MC, Ready, N, Felip, E, García, MA, Waterhouse, D, Domine, M, Barlesi, F, Antonia, S, Wohlleber, M, Gerber, DE, Czyzewicz, G, Spigel, DR, Crino, L, Eberhardt, WEE, Li, A, Marimuthu, S & Brahmerc, J 2021, 'Five-year outcomes from the randomized, phase iii trials checkmate 017 and 057: nivolumab versus docetaxel in previously treated non-small-cell lung cancer', Journal of Clinical Oncology, vol. 39, no. 7, pp. 723-733. https://doi.org/10.1200/JCO.20.01605

TY - JOUR

T1 - Five-year outcomes from the randomized, phase iii trials checkmate 017 and 057

T2 - nivolumab versus docetaxel in previously treated non-small-cell lung cancer

AU - Borghaei, Hossein

AU - Gettinger, Scott

AU - Vokes, Everett E.

AU - Chow, Laura Q.M.

AU - Burgio, Marco Angelo

AU - de Castro Carpeno, Javier

AU - Pluzanski, Adam

AU - Arrietac, Oscar

AU - Frontera, Osvaldo Arén

AU - Chiari, Rita

AU - Butts, Charles

AU - Wójcik-Tomaszewska, Joanna

AU - Coudert, Bruno

AU - Garassino, Marina Chiara

AU - Ready, Neal

AU - Felip, Enriqueta

AU - García, Miriam Alonso

AU - Waterhouse, David

AU - Domine, Manuel

AU - Barlesi, Fabrice

AU - Antonia, Scott

AU - Wohlleber, Markus

AU - Gerber, David E.

AU - Czyzewicz, Grzegorz

AU - Spigel, David R.

AU - Crino, Lucio

AU - Eberhardt, Wilfried Enst Erich

AU - Li, Ang

AU - Marimuthu, Sathiya

AU - Brahmerc, Julie

PY - 2021/3/1

Y1 - 2021/3/1

N2 - 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/m 2 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.

AB - 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/m 2 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.

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Carcinoma, Non-Small-Cell Lung/drug therapy

KW - Clinical Trials, Phase III as Topic

KW - Disease Progression

KW - Docetaxel/adverse effects

KW - Female

KW - Humans

KW - Immune Checkpoint Inhibitors/adverse effects

KW - Immunotherapy/adverse effects

KW - Lung Neoplasms/drug therapy

KW - Male

KW - Middle Aged

KW - Nivolumab/adverse effects

KW - Progression-Free Survival

KW - Randomized Controlled Trials as Topic

KW - Time Factors

KW - Tubulin Modulators/adverse effects

KW - Young Adult

UR - https://www.scopus.com/pages/publications/85102322096

UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=purepublist2023&SrcAuth=WosAPI&KeyUT=WOS:000635371200005&DestLinkType=FullRecord&DestApp=WOS

U2 - 10.1200/JCO.20.01605

DO - 10.1200/JCO.20.01605

M3 - Article

C2 - 33449799

SN - 0732-183X

VL - 39

SP - 723

EP - 733

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

IS - 7

ER -

Five-year outcomes from the randomized, phase iii trials checkmate 017 and 057: nivolumab versus docetaxel in previously treated non-small-cell lung cancer

Abstract

UN SDGs

Keywords

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