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

22 Scopus citations

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

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    von Pawel, J., Bordoni, R., Satouchi, M., Fehrenbacher, L., Cobo, M., Han, J. Y., Hida, T., Moro-Sibilot, D., Conkling, P., Gandara, D. R., 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, 107, 124-132. https://doi.org/10.1016/j.ejca.2018.11.020