Immune-related adverse events associated with immune checkpoint inhibitors: a call to action for collecting and sharing clinical trial and real-world data.

Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, improving outcomes in patients with advanced malignancies. The use of ICIs in clinical practice, and the number of ICI clinical trials, are rapidly increasing. The use of ICIs in combination with other forms of cancer therapy, such as chemotherapy, radiotherapy, or targeted therapy, is also expanding. However, immune-related adverse events (irAEs) can be serious in up to a third of patients. Critical questions remain surrounding the characteristics and outcomes of irAEs, and how they may affect the overall risk-benefit relationship for combination therapies. This article proposes a framework for irAE classification and reporting, and identifies limitations in the capture and sharing of data on irAEs from current clinical trial and real-world data. We outline key gaps and suggestions for clinicians, clinical investigators, drug sponsors, patients, and other stakeholders to make these critical data more available to researchers for pooled analysis, to advance contemporary understanding of irAEs, and ultimately improve the efficacy of ICIs.
Competing Interests: Competing interests: KLR receives support from Teladoc and Project Data Sphere. MR owns shares of Pfizer Inc. ACG has served on advisory boards/consulted with Alexion, RA Pharma (UCB), and Momenta (Jansen). She also receives support from Project Data Sphere. MD has received support from Novartis, Eli Lilly, Moderna, Tillotts Pharma, ORIC Pharmaceuticals, and Partner Therapeutics. He is engaged with Moderna and Neoleukin Therapeutics. LZ has received support from Merck US. DBJ has received support from BMS and Incyte and serves on advisory boards for Array Biopharma, BMS, Catalyst, Iovance, Jansen, Merck, Novartis, and Oncosec. OR has received support from Merck, Celgene, Five Prime, GSK, Bayer, Roche, Puretech, Imvacx, and Sobi, has an immunotherapy patent pending, and serves as CMO of Outcomes4me.
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