Long-term survival in patients with advanced non–small-cell lung cancer treated with atezolizumab versus docetaxel: Results from the randomised phase III OAK study

J. von Pawel, R. Bordoni, M. Satouchi, L. Fehrenbacher, M. Cobo, J. Y. Han, T. Hida, D. Moro-Sibilot, P. Conkling, David R Gandara, A. Rittmeyer, M. Gandhi, W. Yu, C. Matheny, H. Patel, A. Sandler, M. Ballinger, M. Kowanetz, K. Park

Research output: Contribution to journalArticle

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Abstract

Background: Atezolizumab (anti–programmed death-ligand 1 [PD-L1]) received approval from the US Food and Drug Administration and European Medicines Agency for previously treated advanced non–small-cell lung cancer based on OAK—a randomised, phase III trial that showed significantly improved survival with atezolizumab versus docetaxel regardless of PD-L1 expression. With longer follow-up, we summarised the characteristics of long-term survivors (LTSs). Methods: In OAK (NCT02008227), patients were randomised 1:1 to receive atezolizumab or docetaxel until loss of clinical benefit or disease progression, respectively. Overall survival was evaluated after a 26-month minimum follow-up, including in patient subgroups defined by best overall response (BOR). LTSs were defined as patients who lived ≥24 months since randomisation. Non-LTSs died within 24 months, and patients censored before 24 months were excluded from the analysis. The baseline characteristics, including biomarkers, BOR, subsequent non-protocol therapy (NPT) and safety, are reported. Results: Survival benefit with atezolizumab was observed across all patient subgroups defined by BOR. More atezolizumab-treated patients were LTSs versus those treated with docetaxel (28% versus 18%). Most atezolizumab responders were LTSs (77%) versus only 48% of docetaxel responders. However, 21% of atezolizumab-arm LTSs had progressive disease (PD) as BOR, and more atezolizumab-arm LTSs than non-LTSs continued treatment post-PD. Fifty-two percent of docetaxel-arm LTSs received immunotherapy as subsequent NPT. Despite extended treatment duration in atezolizumab-arm LTSs (median, 18 months), atezolizumab was well tolerated. Conclusions: After >2 years of follow-up, atezolizumab continued to provide durable survival benefit versus docetaxel, with tolerable safety. Atezolizumab-arm LTSs were enriched for patients with high PD-L1 expression and included PD-L1–negative patients. Long-term survival was not limited to responders.

Original languageEnglish (US)
Pages (from-to)124-132
Number of pages9
JournalEuropean Journal of Cancer
Volume107
DOIs
StatePublished - Jan 1 2019

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docetaxel
Non-Small Cell Lung Carcinoma
Survivors
Survival
MPDL3280A
Safety

Keywords

  • Atezolizumab
  • Cancer immunotherapy
  • Long-term survival
  • PD-L1
  • Second-line NSCLC

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Long-term survival in patients with advanced non–small-cell lung cancer treated with atezolizumab versus docetaxel : Results from the randomised phase III OAK study. / von Pawel, J.; Bordoni, R.; Satouchi, M.; Fehrenbacher, L.; Cobo, M.; Han, J. Y.; Hida, T.; Moro-Sibilot, D.; Conkling, P.; Gandara, David R; Rittmeyer, A.; Gandhi, M.; Yu, W.; Matheny, C.; Patel, H.; Sandler, A.; Ballinger, M.; Kowanetz, M.; Park, K.

In: European Journal of Cancer, Vol. 107, 01.01.2019, p. 124-132.

Research output: Contribution to journalArticle

von Pawel, J, Bordoni, R, Satouchi, M, Fehrenbacher, L, Cobo, M, Han, JY, Hida, T, Moro-Sibilot, D, Conkling, P, Gandara, DR, Rittmeyer, A, Gandhi, M, Yu, W, Matheny, C, Patel, H, Sandler, A, Ballinger, M, Kowanetz, M & Park, K 2019, 'Long-term survival in patients with advanced non–small-cell lung cancer treated with atezolizumab versus docetaxel: Results from the randomised phase III OAK study', European Journal of Cancer, vol. 107, pp. 124-132. https://doi.org/10.1016/j.ejca.2018.11.020
von Pawel, J. ; Bordoni, R. ; Satouchi, M. ; Fehrenbacher, L. ; Cobo, M. ; Han, J. Y. ; Hida, T. ; Moro-Sibilot, D. ; Conkling, P. ; Gandara, David R ; Rittmeyer, A. ; Gandhi, M. ; Yu, W. ; Matheny, C. ; Patel, H. ; Sandler, A. ; Ballinger, M. ; Kowanetz, M. ; Park, K. / Long-term survival in patients with advanced non–small-cell lung cancer treated with atezolizumab versus docetaxel : Results from the randomised phase III OAK study. In: European Journal of Cancer. 2019 ; Vol. 107. pp. 124-132.
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abstract = "Background: Atezolizumab (anti–programmed death-ligand 1 [PD-L1]) received approval from the US Food and Drug Administration and European Medicines Agency for previously treated advanced non–small-cell lung cancer based on OAK—a randomised, phase III trial that showed significantly improved survival with atezolizumab versus docetaxel regardless of PD-L1 expression. With longer follow-up, we summarised the characteristics of long-term survivors (LTSs). Methods: In OAK (NCT02008227), patients were randomised 1:1 to receive atezolizumab or docetaxel until loss of clinical benefit or disease progression, respectively. Overall survival was evaluated after a 26-month minimum follow-up, including in patient subgroups defined by best overall response (BOR). LTSs were defined as patients who lived ≥24 months since randomisation. Non-LTSs died within 24 months, and patients censored before 24 months were excluded from the analysis. The baseline characteristics, including biomarkers, BOR, subsequent non-protocol therapy (NPT) and safety, are reported. Results: Survival benefit with atezolizumab was observed across all patient subgroups defined by BOR. More atezolizumab-treated patients were LTSs versus those treated with docetaxel (28{\%} versus 18{\%}). Most atezolizumab responders were LTSs (77{\%}) versus only 48{\%} of docetaxel responders. However, 21{\%} of atezolizumab-arm LTSs had progressive disease (PD) as BOR, and more atezolizumab-arm LTSs than non-LTSs continued treatment post-PD. Fifty-two percent of docetaxel-arm LTSs received immunotherapy as subsequent NPT. Despite extended treatment duration in atezolizumab-arm LTSs (median, 18 months), atezolizumab was well tolerated. Conclusions: After >2 years of follow-up, atezolizumab continued to provide durable survival benefit versus docetaxel, with tolerable safety. Atezolizumab-arm LTSs were enriched for patients with high PD-L1 expression and included PD-L1–negative patients. Long-term survival was not limited to responders.",
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TY - JOUR

T1 - Long-term survival in patients with advanced non–small-cell lung cancer treated with atezolizumab versus docetaxel

T2 - Results from the randomised phase III OAK study

AU - von Pawel, J.

AU - Bordoni, R.

AU - Satouchi, M.

AU - Fehrenbacher, L.

AU - Cobo, M.

AU - Han, J. Y.

AU - Hida, T.

AU - Moro-Sibilot, D.

AU - Conkling, P.

AU - Gandara, David R

AU - Rittmeyer, A.

AU - Gandhi, M.

AU - Yu, W.

AU - Matheny, C.

AU - Patel, H.

AU - Sandler, A.

AU - Ballinger, M.

AU - Kowanetz, M.

AU - Park, K.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Atezolizumab (anti–programmed death-ligand 1 [PD-L1]) received approval from the US Food and Drug Administration and European Medicines Agency for previously treated advanced non–small-cell lung cancer based on OAK—a randomised, phase III trial that showed significantly improved survival with atezolizumab versus docetaxel regardless of PD-L1 expression. With longer follow-up, we summarised the characteristics of long-term survivors (LTSs). Methods: In OAK (NCT02008227), patients were randomised 1:1 to receive atezolizumab or docetaxel until loss of clinical benefit or disease progression, respectively. Overall survival was evaluated after a 26-month minimum follow-up, including in patient subgroups defined by best overall response (BOR). LTSs were defined as patients who lived ≥24 months since randomisation. Non-LTSs died within 24 months, and patients censored before 24 months were excluded from the analysis. The baseline characteristics, including biomarkers, BOR, subsequent non-protocol therapy (NPT) and safety, are reported. Results: Survival benefit with atezolizumab was observed across all patient subgroups defined by BOR. More atezolizumab-treated patients were LTSs versus those treated with docetaxel (28% versus 18%). Most atezolizumab responders were LTSs (77%) versus only 48% of docetaxel responders. However, 21% of atezolizumab-arm LTSs had progressive disease (PD) as BOR, and more atezolizumab-arm LTSs than non-LTSs continued treatment post-PD. Fifty-two percent of docetaxel-arm LTSs received immunotherapy as subsequent NPT. Despite extended treatment duration in atezolizumab-arm LTSs (median, 18 months), atezolizumab was well tolerated. Conclusions: After >2 years of follow-up, atezolizumab continued to provide durable survival benefit versus docetaxel, with tolerable safety. Atezolizumab-arm LTSs were enriched for patients with high PD-L1 expression and included PD-L1–negative patients. Long-term survival was not limited to responders.

AB - Background: Atezolizumab (anti–programmed death-ligand 1 [PD-L1]) received approval from the US Food and Drug Administration and European Medicines Agency for previously treated advanced non–small-cell lung cancer based on OAK—a randomised, phase III trial that showed significantly improved survival with atezolizumab versus docetaxel regardless of PD-L1 expression. With longer follow-up, we summarised the characteristics of long-term survivors (LTSs). Methods: In OAK (NCT02008227), patients were randomised 1:1 to receive atezolizumab or docetaxel until loss of clinical benefit or disease progression, respectively. Overall survival was evaluated after a 26-month minimum follow-up, including in patient subgroups defined by best overall response (BOR). LTSs were defined as patients who lived ≥24 months since randomisation. Non-LTSs died within 24 months, and patients censored before 24 months were excluded from the analysis. The baseline characteristics, including biomarkers, BOR, subsequent non-protocol therapy (NPT) and safety, are reported. Results: Survival benefit with atezolizumab was observed across all patient subgroups defined by BOR. More atezolizumab-treated patients were LTSs versus those treated with docetaxel (28% versus 18%). Most atezolizumab responders were LTSs (77%) versus only 48% of docetaxel responders. However, 21% of atezolizumab-arm LTSs had progressive disease (PD) as BOR, and more atezolizumab-arm LTSs than non-LTSs continued treatment post-PD. Fifty-two percent of docetaxel-arm LTSs received immunotherapy as subsequent NPT. Despite extended treatment duration in atezolizumab-arm LTSs (median, 18 months), atezolizumab was well tolerated. Conclusions: After >2 years of follow-up, atezolizumab continued to provide durable survival benefit versus docetaxel, with tolerable safety. Atezolizumab-arm LTSs were enriched for patients with high PD-L1 expression and included PD-L1–negative patients. Long-term survival was not limited to responders.

KW - Atezolizumab

KW - Cancer immunotherapy

KW - Long-term survival

KW - PD-L1

KW - Second-line NSCLC

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