Five-year overall survival for patients with advanced non-small-cell lung cancer treated with pembrolizumab: Results from the phase I KEYNOTE-001 study Journal Article


Authors: Garon, E. B.; Hellmann, M. D.; Rizvi, N. A.; Carcereny, E.; Leighl, N. B.; Ahn, M. J.; Eder, J. P.; Balmanoukian, A. S.; Aggarwal, C.; Horn, L.; Patnaik, A.; Gubens, M.; Ramalingam, S. S.; Felip, E.; Goldman, J. W.; Scalzo, C.; Jensen, E.; Kush, D. A.; Hui, R.
Article Title: Five-year overall survival for patients with advanced non-small-cell lung cancer treated with pembrolizumab: Results from the phase I KEYNOTE-001 study
Abstract: PURPOSE Pembrolizumab monotherapy has demonstrated durable antitumor activity in advanced programmed death ligand 1 (PD-L1)-expressing nonsmall-cell lung cancer (NSCLC). We report 5-year outcomes from the phase Ib KEYNOTE-001 study. These data provide the longest efficacy and safety follow-up for patients with NSCLC treated with pembrolizumab monotherapy. PATIENTS AND METHODS Eligible patients had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor sample for PD-L1 evaluation by immunohistochemistry using the 22C3 antibody. Patients received intravenous pembrolizumab 2 mg/kg every 3 weeks or 10 mg/kg every 2 or 3 weeks. Investigators assessed response per immune-related response criteria. The primary efficacy end point was objective response rate. Overall survival (OS) and duration of response were secondary end points. RESULTS We enrolled 101 treatment-naive and 449 previously treated patients. Median follow-up was 60.6 months (range, 51.8 to 77.9 months). At data cutoff-November 5, 2018-450 patients (82%) had died. Median OS was 22.3 months (95% CI, 17.1 to 32.3 months) in treatment-naive patients and 10.5 months (95% CI, 8.6 to 13.2 months) in previously treated patients. Estimated 5-year OS was 23.2% for treatment-naive patients and 15.5% for previously treated patients. In patients with a PD-L1 tumor proportion score of 50% or greater, 5-year OS was 29.6% and 25.0% in treatment-naive and previously treated patients, respectively. Compared with analysis at 3 years, only three new-onset treatment-related grade 3 adverse events occurred (hypertension, glucose intolerance, and hypersensitivity reaction, all resolved). No late-onset grade 4 or 5 treatment-related adverse events occurred. CONCLUSION Pembrolizumab monotherapy provided durable antitumor activity and high 5-year OS rates in patients with treatment-naive or previously treated advanced NSCLC. Of note, the 5-year OS rate exceeded 25% among patients with a PD-L1 tumor proportion score of 50% or greater. Pembrolizumab had a tolerable long-term safety profile with little evidence of late-onset or new toxicity. (C) 2019 by American Society of Clinical Oncology.
Keywords: immunohistochemistry; therapy
Journal Title: Journal of Clinical Oncology
Volume: 37
Issue: 28
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2019-10-01
Start Page: 2518
End Page: 2527
Language: English
ACCESSION: WOS:000489721100003
DOI: 10.1200/jco.19.00934
PROVIDER: wos
PMCID: PMC6768611
PUBMED: 31154919
Notes: Article -- Source: Wos
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  1. Matthew David Hellmann
    257 Hellmann