Key clinical point: Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab postsurgery significantly prolonged event-free survival (EFS) compared with neoadjuvant chemotherapy alone in patients with early triple-negative breast cancer (TNBC).
Major finding: At 36 months, estimated EFS significantly improved in the pembrolizumab-chemotherapy vs. placebo-chemotherapy group (84.5% vs. 76.8%; hazard ratio for event or death, 0.63; P < .001). No new adverse events were reported.
Study details: Findings are from an interim analysis of the phase 3 KEYNOTE-522 study including 1,174 patients with early, previously untreated stage II/III TNBC who were randomly assigned to receive neoadjuvant therapy with pembrolizumab or placebo. In the adjuvant phase, patients received pembrolizumab or placebo after definitive surgery and radiotherapy, if indicated.
Disclosures: This study was supported by Merck Sharp and Dohme. The authors declared serving as consultants, advisory board members, or receiving research grants, contracts, and honoraria from several sources, including Merck/Merck Sharp and Dohme. Four authors declared being employees and stock/stock option owners of Merck/Merck Sharp and Dohme.
Source: Schmid P et al. Event-free survival with pembrolizumab in early triple-negative breast cancer. N Engl J Med. 2022;386:556-567 (Feb 10). Doi: 10.1056/NEJMoa2112651