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J Clin Oncol. 2019 Jun 2:JCO1900934. doi: 10.1200/JCO.19.00934. [Epub ahead of print]

Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study.

Author information

1
1 University of California, Los Angeles, Los Angeles, CA.
2
2 Memorial Sloan Kettering Cancer Center, New York, NY.
3
3 Columbia University Medical Center, New York, NY.
4
4 Catalan Institute of Oncology Badalona, Badalona, Spain.
5
5 Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
6
6 Samsung Medical Center, Seoul, South Korea.
7
7 Yale University, New Haven, CT.
8
8 The Angeles Clinic and Research Institute, Los Angeles, CA.
9
9 University of Pennsylvania, Philadelphia, PA.
10
10 Vanderbilt-Ingram Cancer Center, Nashville, TN.
11
11 South Texas Accelerated Research Therapeutics, San Antonio, TX.
12
12 University of California, San Francisco, San Francisco, CA.
13
13 Emory University, Atlanta, GA.
14
14 Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
15
15 Merck & Co., Inc., Kenilworth, NJ.
16
16 Westmead Hospital, University of Sydney, Sydney, NSW, Australia.

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.

PMID:
31154919
DOI:
10.1200/JCO.19.00934

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