Neoadjuvant and Adjuvant Pembrolizumab for eTNBC

The target population was patients with high-risk eTNBC, based on the population of KEYNOTE-522. Patients in KEYNOTE-522 were randomized to pembrolizumab + chemotherapy/pembrolizumab or placebo + chemotherapy/placebo arms. In the neoadjuvant phase, pembrolizumab (at a dose of 200 mg) or placebo was administered once every 3 weeks (q3w) up to eight cycles, and the chemotherapy consisted of four cycles of paclitaxel (80 mg/m² once weekly [qw]) and carboplatin (area under the curve [AUC5]) q3w or AUC 1.5 qw in the first 12 weeks), followed by four cycles of doxorubicin (60 mg/m²) or epirubicin (90 mg/m²) plus cyclophosphamide (600 mg/m² q3w in the subsequent 12 weeks). Each subject underwent definitive surgery 3–6 weeks after conclusion of the neoadjuvant treatment. In the adjuvant phase, pembrolizumab 200 mg or placebo was administered q3w for up to nine cycles. Postoperative radiation therapy was acceptable in accordance with the standard of care as applicable.