Abstract 3148
Background
Previous studies have shown that early immune-related adverse events (irAEs) are associated with better outcomes in patients with advanced non-small cell lung cancer (NSCLC) who received nivolumab, and the associations differ among various types of early irAEs. However, these previous studies included patients regardless of their PD-L1 status and lines of therapy.
Methods
We retrospectively analyzed patients with advanced NSCLC and PD-L1 TPS of ≥ 50% who received pembrolizumab as the first line therapy at 10 institutions between February 2017 and January 2018. Patients were excluded if they were treated with systemic glucocorticoids or other immunosuppressive agents. Early irAEs were defined as irAEs that occurred within 3 weeks after commencing pembrolizumab therapy.
Results
In total, 145 patients were included; their median age was 71 (range: 39-87) years. Of the 145 patients, 122 (84%) were men, 119 (82%) had PS 0-1, and 5 (3%) had EGFR-mutations or ALK-rearrangements. In all patients, the objective response and disease control rates were 55% and 77%, respectively. Common early irAEs included rash, pyrexia, and interstitial lung disease. The objective response and disease control rates were significantly higher in patients with early irAEs than in those without (79% versus 46% and 95% versus 71% [both p < 0.01]), respectively. Similarly, the median PFS was significantly longer in patients with early irAEs than those without (not reached versus 7.0 months, p = 0.04). When we analyzed the association between types of early irAEs and clinical outcomes, rash and/or pyrexia was strongly associated with longer PFS than those without rash or pyrexia (not reached vs. 6.9 months, p = 0.01). The follow-up is ongoing.
Conclusions
In patients with advanced NSCLC and PD-L1 TPS of ≥ 50% who received first-line pembrolizumab, early irAEs were associated with better clinical outcomes. Moreover, early development of rash and pyrexia was strongly associated with better clinical outcomes.
Clinical trial identification
UMIN000032470.
Legal entity responsible for the study
Hanshin Oncology clinical Problem Evaluation group (HOPE).
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
D. Fujimoto, M. Tamiya, A. Tamiya, K. Hirano: Speaking fees: MSD, Taiho. T. Yokoyama: Speaking fees: Taiho. M. Kanazu: Speaking fees: MSD. All other authors have declared no conflicts of interest.
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