P1.16-29 Profiling Immune-Related Adverse Events (iraes) in Patients with Anti-PD-1 for Advanced Non-Small Cell Lung Cancer

Immune-related adverse events (irAEs) are frequently observed during anti-programmed death-1 antibody therapy. We previously reported that patients with irAEs were associated with clinical efficacy. However, little is known about which irAEs are related with clinical efficacy in patients with non-small cell lung cancer (NSCLC). This study aimed to evaluate the correlations between different irAEs and treatment response. Patients with advanced NSCLC who received nivolumab or pembrolizumab monotherapy at our hospital (n=154) from January 2016 to April 2018 were included in this study. Subjects were categorized into the irAE-incident group (with irAEs group) or non-irAE-incident group (without irAEs group), specific for each irAE. We evaluated the objective response rate (ORR), time to treatment failure (TTF), progression-free survival (PFS), and overall survival (OS) in each group. The categorization of irAEs identified 51 cases of skin reactions (31%), 16 of infusion reactions (10%), 19 of pneumonitis (12%), 21 of thyroid dysfunction (14%), and 10 of hepatitis (6%). In the with/without skin reaction groups, the ORRs were 57% (29 cases)/19% (20 cases) (p<.001), median TTFs (months) were 8.7/2.8 (p<.001), median PFSs were 12.9/3.4 months (p<.001), and median OSs were NR/11.4 months (p<.001), respectively. In the with/without infusion reaction groups, the ORRs were 56% (9 cases)/29% (40 cases) (p=.05), median TTFs were 7.6/3.7 months (p=.11), median PFSs were 11.1/4.1 months (p=.045), and median OSs were NR/14.8 months (p<.001), respectively. In the with/without pneumonitis groups, the ORRs were 63% (12 cases)/27% (37 cases) (p=.004), median TTFs were 4.4/3.7 months (p=.44), median PFSs were 18.9/4.1 months (p=.02), and median OSs were NR/14.8 months (p=.09), respectively. In the with/without thyroid dysfunction groups, the ORRs were 52% (11 cases)/29% (38 cases) (p=.08), median TTFs were 7.4/3.7 months (p=.63), median PFSs were 8.7/4.2 months (p=0.22), and median OSs were 11.8/15.9 months (p=.84), respectively. In the with/without hepatitis groups, the ORRs were 40% (4 cases)/31% (45 cases) (p=.82), median TTFs were 2.7/4.1 months (p=.42), median PFSs were 6.4/4.20 months (p=.70), and median OSs were NR/15.6 months (p=.43). The PFS was significantly longer in patients with skin reactions, infusion reactions, and pneumonitis than that in those without, whereas the OS was significantly longer in patients with skin and infusion reactions than that in those without. The development of skin and infusion reactions during nivolumab or pembrolizumab monotherapy for NSCLC might be strongly associated with improved clinical efficacy, and clinical benefits should be validated through large-scale prospective analysis.