Characterizing pulmonary adverse events associated with the immune checkpoint inhibitor avelumab: a FAERS-based pharmacovigilance study from 2013 to 2024

The rise of immunotherapies, particularly PD-L1 inhibitors like avelumab, has advanced cancer care, but its pulmonary safety profile remains unclear. Using FAERS data from 2013–2023, we evaluated respiratory complications linked to avelumab through disproportionality analysis with OpenVigil 2.1. Several significant associations emerged: bacterial pneumonia (ROR 6.79, 95% CI 2.19–21.10, n=3), pneumonitis (ROR 4.37, 95% CI 1.96–9.74, n=6), respiratory failure (ROR 3.99, 95% CI 2.31–6.90), pulmonary edema (ROR 3.40), respiratory distress (ROR 3.31), and pulmonary embolism (ROR 2.87). By contrast, non-specific pneumonia (ROR 0.97) and dyspnea (ROR 0.97) showed no signal. These results suggest avelumab may predispose to specific severe pulmonary toxicities. Clinicians should monitor for early respiratory compromise, with prospective studies warranted to clarify causality and preventative strategies.