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New and Worsening Long‐term Immune‐Related Adverse Events with PD‐1/PD‐L1 Pathway Agents in Patients with Cancer

Immune checkpoint inhibitors have produced durable responses across a variety of cancers. Although programmed cell death protein 1 (PD‐1) and its ligand (PD‐L1) inhibitors activate T cells against tumor cells, they may also cause autoimmune‐like toxicities termed immune‐related adverse events (irAEs). Although much is known regarding irAEs that occur early during treatment, data on the long‐term toxicity profile of these agents are more limited. Our primary objective was to evaluate the frequency of patients receiving anti‐PD‐1/PD‐L1 therapy for at least 6 continuous months who experienced new or worsening irAEs requiring clinical interventions. Secondary objectives included assessment of other factors associated with clinically significant irAEs after at least 6 months of therapy.