Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): A randomised controlled trial

Roy S. Herbst, Paul Baas, Dong Wan Kim, Enriqueta Felip, José L. Pérez-Gracia, Ji Youn Han, Julian R Molina, Joo Hang Kim, Catherine Dubos Arvis, Myung Ju Ahn, Margarita Majem, Mary J. Fidler, Gilberto De Castro, Marcelo Garrido, Gregory M. Lubiniecki, Yue Shentu, Ellie Im, Marisa Dolled-Filhart, Edward B. Garon

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Abstract

Background Despite recent advances in the treatment of advanced non-small-cell lung cancer, there remains a need for effective treatments for progressive disease. We assessed the efficacy of pembrolizumab for patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. Methods We did this randomised, open-label, phase 2/3 study at 202 academic medical centres in 24 countries. Patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells were randomly assigned (1:1:1) in blocks of six per stratum with an interactive voice-response system to receive pembrolizumab 2 mg/kg, pembrolizumab 10 mg/kg, or docetaxel 75 mg/m2 every 3 weeks. The primary endpoints were overall survival and progression-free survival both in the total population and in patients with PD-L1 expression on at least 50% of tumour cells. We used a threshold for significance of p

Original languageEnglish (US)
Pages (from-to)1540-1550
Number of pages11
JournalThe Lancet
Volume387
Issue number10027
DOIs
StatePublished - Apr 9 2016

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docetaxel
Non-Small Cell Lung Carcinoma
Randomized Controlled Trials
Disease-Free Survival
Neoplasms
Survival
Therapeutics
Population
pembrolizumab

ASJC Scopus subject areas

  • Medicine(all)

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Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010) : A randomised controlled trial. / Herbst, Roy S.; Baas, Paul; Kim, Dong Wan; Felip, Enriqueta; Pérez-Gracia, José L.; Han, Ji Youn; Molina, Julian R; Kim, Joo Hang; Arvis, Catherine Dubos; Ahn, Myung Ju; Majem, Margarita; Fidler, Mary J.; De Castro, Gilberto; Garrido, Marcelo; Lubiniecki, Gregory M.; Shentu, Yue; Im, Ellie; Dolled-Filhart, Marisa; Garon, Edward B.

In: The Lancet, Vol. 387, No. 10027, 09.04.2016, p. 1540-1550.

Research output: Contribution to journalArticle

Herbst, RS, Baas, P, Kim, DW, Felip, E, Pérez-Gracia, JL, Han, JY, Molina, JR, Kim, JH, Arvis, CD, Ahn, MJ, Majem, M, Fidler, MJ, De Castro, G, Garrido, M, Lubiniecki, GM, Shentu, Y, Im, E, Dolled-Filhart, M & Garon, EB 2016, 'Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): A randomised controlled trial', The Lancet, vol. 387, no. 10027, pp. 1540-1550. https://doi.org/10.1016/S0140-6736(15)01281-7
Herbst, Roy S. ; Baas, Paul ; Kim, Dong Wan ; Felip, Enriqueta ; Pérez-Gracia, José L. ; Han, Ji Youn ; Molina, Julian R ; Kim, Joo Hang ; Arvis, Catherine Dubos ; Ahn, Myung Ju ; Majem, Margarita ; Fidler, Mary J. ; De Castro, Gilberto ; Garrido, Marcelo ; Lubiniecki, Gregory M. ; Shentu, Yue ; Im, Ellie ; Dolled-Filhart, Marisa ; Garon, Edward B. / Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010) : A randomised controlled trial. In: The Lancet. 2016 ; Vol. 387, No. 10027. pp. 1540-1550.
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AU - Baas, Paul

AU - Kim, Dong Wan

AU - Felip, Enriqueta

AU - Pérez-Gracia, José L.

AU - Han, Ji Youn

AU - Molina, Julian R

AU - Kim, Joo Hang

AU - Arvis, Catherine Dubos

AU - Ahn, Myung Ju

AU - Majem, Margarita

AU - Fidler, Mary J.

AU - De Castro, Gilberto

AU - Garrido, Marcelo

AU - Lubiniecki, Gregory M.

AU - Shentu, Yue

AU - Im, Ellie

AU - Dolled-Filhart, Marisa

AU - Garon, Edward B.

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N2 - Background Despite recent advances in the treatment of advanced non-small-cell lung cancer, there remains a need for effective treatments for progressive disease. We assessed the efficacy of pembrolizumab for patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. Methods We did this randomised, open-label, phase 2/3 study at 202 academic medical centres in 24 countries. Patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells were randomly assigned (1:1:1) in blocks of six per stratum with an interactive voice-response system to receive pembrolizumab 2 mg/kg, pembrolizumab 10 mg/kg, or docetaxel 75 mg/m2 every 3 weeks. The primary endpoints were overall survival and progression-free survival both in the total population and in patients with PD-L1 expression on at least 50% of tumour cells. We used a threshold for significance of p

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