TNBC: Neoadjuvant and adjuvant pembrolizumab prolongs EFS in KEYNOTE-522

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