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The use of immune checkpoint inhibitors (IO) in breast cancer has largely been restricted to patients with triple-negative breast cancer (TNBC). Currently, pembrolizumab is used in combination with chemotherapy in the preoperative setting (PD-L1 agnostic) and in the metastatic setting for those with PD-L1–positive disease. To date there has been little evidence to support the use of IO in patients with ER-positive tumors as these are generally viewed as immunologically “cold.” Two recent studies evaluated the addition of IO to preoperative HER2-directed therapy in patients with operable, HER-positive breast cancer.
In the industry-sponsored, phase 3, multinational IMpassion050 study, 454 patients with tumors >2 cm and positive axillary nodes…