Immuno-oncology safety education experience: Key lessons from ipilimumab (IPI)

Background IPI (Yervoy, Bristol-Myers Squibb) blocks cytotoxic Tlymphocyte antigen-4, a regulatory molecule on activated T cells. In March 2011, IPI, indicated for unresectable or metastatic melanoma (MEL), became the first immune checkpoint inhibitor approved by the US Food and Drug Administration (FDA). Early in development, severe and fatal immune-related adverse events (irAEs) emerged and were attributed to IPI’s mechanism of action, occurring mostly during treatment, although a minority occurred weeks to months after drug discontinuation. irAE management guidelines created in collaboration with external experts and study investigators were progressively incorporated into the IPI Investigator’s Brochure.