Pembrolizumab had an acceptable side-effect profile and showed antitumor activity in patients with advanced non-small-cell lung cancer (NSCLC), a new study published online early in The England Journal of Medicine has shown.
For the study, researchers sought to assess the safety and efficacy of pembrolizumab, a programmed cell death 1 (PD-1) inhibitor, as treatment for patients with advanced NSCLC.
Researchers enrolled 495 patients who were enrolled in a phase I study. Participants were assigned to receive pembrolizumab 2 or 10mg/kg every 3 weeks of 10mg/kg every 2 weeks. Researchers also evaluated whether PD-1 ligand 1 (PD-L1) expression level was associated with clinical benefit.
Results showed that the overall objective response rate was 19.4% and the median duration of response was 3.7 months. The median duration of overall survival was 12.0 months.
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The study also showed that PD-L1 expression in at least 50% of tumor cells correlated with improved efficacy of pembrolizumab.
The response rate was 45.2% with a median progression-free survival of 6.3 months and median overall survival had not yet been reached.
In regard to safety, the most common pembrolizumab-associated adverse events were fatigue, pruritus, and decreased appetite.