TY - JOUR
T1 - Five-year follow-up of nivolumab in previously treated advanced non–small-cell lung cancer
T2 - Results from the CA209-003 study
AU - Gettinger, Scott
AU - Horn, Leora
AU - Jackman, David
AU - Spigel, David
AU - Antonia, Scott
AU - Hellmann, Matthew
AU - Powderly, John
AU - Heist, Rebecca
AU - Sequist, Lecia V.
AU - Smith, David C.
AU - Leming, Philip
AU - Geese, William J.
AU - Yoon, Dennis
AU - Li, Ang
AU - Brahmer, Julie
N1 - Funding Information:
We thank the patients and their families. We thank Allyson Pollack for her contributions as protocol manager for this study and Dako for collaborative development of the PD-L1 IHC 28-8 pharmDx assay. Medical-writing and editorial assistance was provided by Roland Tacke of Evidence Scientific Solutions, with funding from Bristol-Myers Squibb.
Publisher Copyright:
Copyright © 2018 American Society of Clinical Oncology. All rights reserved.
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2018/6/10
Y1 - 2018/6/10
N2 - In two phase III studies, nivolumab, a programmed death-1 (PD-1) inhibitor antibody, improved overall survival (OS) versus docetaxel in pretreated advanced non–small-cell lung cancer (NSCLC). We report 5-year follow-up results from an early phase I study of nivolumab in this patient population and describe characteristics of 5-year survivors. Patients and Methods Patients with pretreated, advanced NSCLC received nivolumab 1, 3, or 10 mg/kg every 2 weeks in 8-week cycles for up to 96 weeks. OS from the time of first dose was estimated by the Kaplan-Meier method. Results The estimated 5-year OS rate was 16% for all treated patients (N = 129); 5-year OS rates were similar for squamous (16%) and nonsquamous (15%) NSCLC. Of 16 5-year survivors, most (88%) were known current or former smokers. Of 10 5-year survivors with quantifiable PD-1 ligand 1 expression, 70% had $ 1% PD-1 ligand 1 expression at baseline. Twelve 5-year survivors (75%) achieved a partial response to nivolumab per Response Evaluation Criteria in Solid Tumors, version 1.0, and two each (12%) had stable disease and progressive disease as best response. Nine 5-year survivors (56%) completed the maximum 96 weeks of nivolumab; four (25%) discontinued owing to adverse events and three (19%) owing to disease progression. As of a November 2016 database lock, 12 5-year survivors (75%) received no subsequent therapy and were without evidence of progressive disease at last follow-up. Conclusions Nivolumab treatment resulted in long-term OS and durable responses in a proportion of patients with pretreated advanced NSCLC. Long-term survivors had diverse baseline and on-treatment characteristics.
AB - In two phase III studies, nivolumab, a programmed death-1 (PD-1) inhibitor antibody, improved overall survival (OS) versus docetaxel in pretreated advanced non–small-cell lung cancer (NSCLC). We report 5-year follow-up results from an early phase I study of nivolumab in this patient population and describe characteristics of 5-year survivors. Patients and Methods Patients with pretreated, advanced NSCLC received nivolumab 1, 3, or 10 mg/kg every 2 weeks in 8-week cycles for up to 96 weeks. OS from the time of first dose was estimated by the Kaplan-Meier method. Results The estimated 5-year OS rate was 16% for all treated patients (N = 129); 5-year OS rates were similar for squamous (16%) and nonsquamous (15%) NSCLC. Of 16 5-year survivors, most (88%) were known current or former smokers. Of 10 5-year survivors with quantifiable PD-1 ligand 1 expression, 70% had $ 1% PD-1 ligand 1 expression at baseline. Twelve 5-year survivors (75%) achieved a partial response to nivolumab per Response Evaluation Criteria in Solid Tumors, version 1.0, and two each (12%) had stable disease and progressive disease as best response. Nine 5-year survivors (56%) completed the maximum 96 weeks of nivolumab; four (25%) discontinued owing to adverse events and three (19%) owing to disease progression. As of a November 2016 database lock, 12 5-year survivors (75%) received no subsequent therapy and were without evidence of progressive disease at last follow-up. Conclusions Nivolumab treatment resulted in long-term OS and durable responses in a proportion of patients with pretreated advanced NSCLC. Long-term survivors had diverse baseline and on-treatment characteristics.
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U2 - 10.1200/JCO.2017.77.0412
DO - 10.1200/JCO.2017.77.0412
M3 - Article
C2 - 29570421
AN - SCOPUS:85046686545
SN - 0732-183X
VL - 36
SP - 1675
EP - 1684
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 17
ER -