FAERS Signal Links EGFR-TKI Plus Checkpoint Inhibitor to Pneumonitis
This pharmacovigilance analysis quantifies a disproportionate interstitial pneumonitis reporting signal when EGFR-TKIs and PD-1/PD-L1 inhibitors are co-reported in NSCLC, with agent-specific variation relevant to counseling and monitoring.
📅 Journal publication: 2026(online Aug 28, 2026)·Last updated: Oct 5, 2026
Increased interstitial pneumonitis risk with combined NSCLC therapy.
The combination of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) and PD-1/PD-L1 inhibitors is used in non-small cell lung cancer (NSCLC), but safety concerns about interstitial pneumonitis (IP) exist. The study found increased reporting of IP with combination therapy (15.64%) compared to EGFR-TKI (4.88%) or PD-1/PD-L1 inhibitors alone (10.59%), with adjusted odds ratios (aOR) of 3.46 for the combination. These results indicate a strong safety signal for IP with combined therapy, suggesting the need for further prospective safety evaluations, despite limitations in defining risk due to spontaneous reporting data. EGFR-TKI and PD-1/PD-L1 inhibitor combinations show increased IP reports, warranting cautious use and further study.
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Citation:Tao J, Fu Z Increased reporting of interstitial pneumonitis with combined EGFR-TKI and PD-1/PD-L1 inhibitor therapy in NSCLC: a pharmacovigilance analysis of 67,818 reports. Frontiers in immunology. 2026;17:1901390. doi:10.3389/fimmu.2026.1901390
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Executive Summary
Study Design
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