Evaluation of Durvalumab-induced Lung Toxicity Using a Spontaneous Reporting Database

Area of Science:

• Oncology
• Pulmonology
• Pharmacovigilance

Background:

• Durvalumab, an immune checkpoint inhibitor, is effective for lung cancer but associated with interstitial lung disease.
• Understanding durvalumab-induced lung toxicity is critical for patient safety.

Purpose of the Study:

• To assess the incidence and timing of lung toxicity associated with durvalumab.
• To analyze adverse event reports for durvalumab-related lung toxicities.

Main Methods:

• Extracted adverse events (AEs) of durvalumab from the Japanese Adverse Drug Event Report (JADER) database (August 2018–March 2021).
• Analyzed lung AEs using reporting odds ratios (RORs) and 95% confidence intervals (CIs).
• Estimated the time of onset for lung toxicity symptoms.

Main Results:

• Identified 1,239 lung toxicities among 2,162 durvalumab-related AEs.
• Pneumonia (ROR: 271.50) and radiation-associated pneumonitis (ROR: 713.21) showed high RORs.
• Median onset for interstitial lung disease and radiation-induced pneumonitis was approximately 30 days.

Conclusions:

• Durvalumab is strongly associated with pneumonia, interstitial lung disease, and radiation-induced pneumonitis.
• Early monitoring for lung toxicity is essential, particularly within the first 30 days of treatment.