Garon EB, et al. - In the first trial assessing pembrolizumab (pembro) in advanced NSCLC, ie, the phase 1b KEYNOTE-001 study, researchers focused on 5-y OS for NSCLC patients (pts) treated with pembro. The participants had confirmed locally advanced/metastatic NSCLC and were given pembro 2 mg/kg Q3W or 10 mg/kg Q2W or Q3W. Overall 550 pts, including 101 treatment-naive and 449 previously treated, were enrolled. For treatment-naive pts and for previously treated pts, the estimated ORR (by investigator per irRC) was 42% and 23%, respectively. The median (range) DOR was 16.8 (2.1+ to 55.7+) mo for the former group and 38.9 (1.0+ to 71.8+) mo for the latter group. A 23.2% and 15.5% of 5-y OS rate was reported in treatment-naive pts and in previously treated pts with advanced NSCLC treated with pembro, respectively, in KEYNOTE-001, compared to a historical rate of approximately 5% (per SEER 2008–2014), before the introduction of anti–PD-1 therapy. In KEYNOTE-001, pts with PD-L1 TPS ≥50% had 5-y OS rate of at least 25% in both pt populations.