Pembrolizumb continued to elicit superior clinical outcomes in patients with previously treated, programmed cell death-ligand 1 (PD-L1)‒expressing advanced non-small cell lung cancer (NSCLC) compared with docetaxel, according to long-term follow-up data from the phase 2/3 KEYNOTE-010 study (ClinicalTrials.gov Identifier: NCT01905657) that were recently published in the Journal of Clinical Oncology.
The study included 690 patients who were randomly assigned to receive 35 cycles or 2 years of single-agent pembrolizumab and 343 patients who were randomized to receive docetaxel.
At a median follow-up of 42.6 months (range, 35.2-53.2 months), patients with a tumor proportion score (TPS) of at least 50%, which is a measure of PD-L1 expression, had a significantly reduced risk of death with pembrolizumab compared with docetaxel (hazard ratio [HR], 0.53; 95% CI, 0.42-0.66; P <.00001). Similarly, patients with a TPS of at least 1% had a significantly reduced risk of death with pembrolizumab compared with docetaxel (HR, 0.69; 95% CI, 0.60-0.80; P <.00001).
For patients with a TPS of at least 50%, the median overall survival (OS) was higher for pembrolizumab compared with docetaxel (16.9 vs 8.2 months), as was the case for patients with a TPS of at least 1% (11.8 vs 8.4 months). The estimated OS rate for 36 months was also higher among patients who received pembrolizumab compared with docetaxel, both for patients with a TPS of at least 50% (34.5% vs 12.7%) or 1% (22.9% vs 11.0%).
The proportion of patients with grade 3 through grade 5 adverse events was lower among patients who received pembrolizumab compared with docetaxel (16% vs 37%).
“Long-term safety with pembrolizumab was manageable, with no new safety signals identified,” the study authors wrote.
Herbst RS, Garon EB, Kim DW, et al. Long-term outcomes and retreatment among patients with previously treated, programmed death-ligand 1‒positive, advanced non‒small-cell lung cancer in the KEYNOTE-010 study [published online February 20, 2020]. J Clin Oncol. doi: 10.1200/JCO.19.02446