OBJECTIVES

PD-1 inhibitors have emerged as a front-line treatment for several types of cancer based on their ability to support the immune system in attacking and shrinking tumors. However, PD-1 inhibitor therapies are known to be associated with irAEs. The study evaluated irAEs reported in different organ classes by NSCLC patients treated with PD-1 inhibitor therapies.

METHODS

The study was carried out using FAERS database in NSCLC patients and limited to the period January 2015 to September 2020. The study considered those AEs which were equal or more prevalent in PD-1/PD-L1 inhibitors as compared to other oncology drugs. From the shortlisted AEs, the irAEs were identified using MedDRA preferred terms and were classified in different organ classes including endocrine, cardio-vascular, digestive, musculo-skeletal, nervous-system and skin. Disproportionality analysis with reporting odds ratios (ROR) and 95% confidence intervals (95% CI) were used to estimate the irAEs reported in these organ classes.

RESULTS

Out of 44,375 adverse events reported in NSCLC patients, 1,679 (3.8%) were identified as irAEs of interest. Of these irAEs, PD-1 inhibitor therapies were the primary suspect in 1,233 (73.4%) cases. The patients involved in these cases were more males (65%) than females (28%), and with mean age of 67.8 years. The analysis showed that PD-1 inhibitor therapies had disproportionality signals and were potentially associated with irAEs as compared to non-PD-1 treated patients (ROR: 6.13; 95% CI: 5.49-6.84). Among organ classes, ROR for irAEs affecting the endocrine system (8.20; 95% CI: 5.97-11.26) and musculoskeletal system (8.20; 95% CI: 5.95-11.30) were the highest, followed by skin (7.25; 95% CI: 5.35-9.82) and systemic/multi-organ/non-specific (6.75; 95% CI: 5.03-9.07). Relatively smaller ROR was observed in heart/ vasculature/ blood organs and lung.

CONCLUSIONS

The current analysis identified the disproportionality signals of irAEs in NSCLC patients treated with PD-1 inhibitor therapies as compared to non-PD-1 inhibitor treatments.