Immune-Related Adverse Events

Immunomodulators, such as immune checkpoint inhibitors (ICIs), represent significant hope for cancer patients. Oncologists are administering novel combinations of immunomodulators in addition to combining them with chemotherapy, radiation therapy, targeted therapy and surgery, in efforts to explore every potential treatment that may improve patient outcomes. All cancer therapies have the potential for side effects, but the mechanism of action behind immunomodulators poses additional risks for severe toxicity and consequent inflammatory side effects known as immune-related adverse events (irAEs). Although uncommon, irAEs can cause significant patient morbidity and may even be fatal. It's not unheard of for a patient who dies from an irAE to be cancer-free at the time of death.

In December 2017, Project Data Sphere co-sponsored a workshop with the FDA to examine the incidence of myocarditis, an uncommon but potentially life-threatening cardiac condition associated with the use of immune checkpoint inhibitor drugs. This collaborative effort was a call to action that resulted in a publication in The Oncologist and ultimately set the stage for Project Data Sphere's Immune-Related Adverse Events research program, which kicked off with the April 2019 convening of FDA-PDS Symposium VII: Immune-Related Adverse Events and Checkpoint Blockade Combination Therapies.

The PDS irAE research program has two primary deliverables:

1) to develop a multi-institutional irAE patient registry to understand the natural history of patients suffering from irAEs and guide regulatory decision making.

2) to conduct a crowdsource challenge using the FDA Adverse Event Reporting System to identify high-risk patient subsets.