News release

From: PNAS

Checkpoint immunotherapy linked to fatal adverse events
A cancer treatment that releases the brakes on the immune system may put some patients at increased risk of fatal adverse events, a study finds. Immune checkpoint inhibitors (ICIs) are a type of immunotherapy that resets the immune system’s checks and balances against cancer cells, often increasing survival rates. However, most patients treated with ICIs experience adverse events, and little is known about the impact of different adverse events on clinical outcomes. Haojie Jin, Ming Guan, Gang Chen, and colleagues developed an algorithm to identify death-related adverse events based on postmarketing real-world data for ICIs. The authors used data from 148,972 cases in the US Food and Drug Administration Adverse Event Reporting System and 142,645 cases in the World Health Organization's global VigiBase database. The analyses revealed a spectrum of 63 high-mortality adverse events, such as aortic aneurysm rupture, lung disease, muscle inflammation, liver failure, and infectious diseases, which together account for approximately 20% of all ICI-related adverse events. Patients who experienced these adverse events had a fatality rate of around 36%, compared with nearly 11% for other cases. Unlike previous studies suggesting that immune-related adverse events are associated with improved treatment efficacy, the high-mortality adverse events indicate that heightened clinical vigilance may be necessary in some cases to improve patient management in immunotherapy, according to the authors.