KEYNOTE-001: 5-Year Overall Survival With Pembrolizumab in Advanced NSCLC
Long-term follow-up of the phase I KEYNOTE-001 study reported in the Journal of Clinical Oncology by Garon et al showed that pembrolizumab monotherapy was associated with an estimated 5-year overall survival of 23.2% for treatment-naive patients and 15.5% for previously treated patients with locally advanced/metastatic non–small cell lung cancer (NSCLC).
The study involved 101 treatment-naive and 449 previously treated patients who received pembrolizumab monotherapy at 2 mg/kg every 3 weeks or 10 mg/kg every 2 or 3 weeks. Median follow-up was 60.6 months.
Overall Survival
At data cutoff in November 2018, 450 patients (82%) had died. Median overall survival was 22.3 months among treatment-naive patients and 10.5 months among previously treated patients. The estimated 5-year overall survival was 23.2% among treatment-naive patients and 15.5% among previously treated patients. In patients with a programmed cell death ligand 1 (PD-L1) tumor proportion score ≥ 50%, 5-year overall survival was 29.6% in treatment-naive patients and 25.0% in previously treated patients.
Since analysis at 3 years, three new-onset treatment-related grade 3 adverse events occurred, consisting of hypertension, glucose intolerance, and hypersensitivity reaction. No late-onset grade 4 or 5 treatment-related adverse events were observed.
The investigators concluded: “Pembrolizumab monotherapy provided durable antitumor activity and high 5-year [overall survival] rates in patients with treatment-naive or previously treated advanced NSCLC. Of note, the 5-year [overall survival] 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.”
Edward B. Garon, MD, MS, of David Geffen School of Medicine, University of California, Los Angeles, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc. For full disclosures of the study authors, visit jco.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
