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 language | English (US) |
|---|---|
| Pages (from-to) | 124-132 |
| Number of pages | 9 |
| Journal | European Journal of Cancer |
| Volume | 107 |
| DOIs | |
| State | Published - Jan 1 2019 |
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Keywords
- Atezolizumab
- Cancer immunotherapy
- Long-term survival
- PD-L1
- Second-line NSCLC
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
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 journal › Article
}
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
UR - http://www.scopus.com/inward/record.url?scp=85058375265&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85058375265&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2018.11.020
DO - 10.1016/j.ejca.2018.11.020
M3 - Article
C2 - 30562710
AN - SCOPUS:85058375265
VL - 107
SP - 124
EP - 132
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
ER -