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Adding the immunotherapy pembrolizumab to chemotherapy before surgery, then continuing it afterwards, cut the risk of relapse or death by about a third in stage II-III triple-negative breast cancer and later improved survival.
Phase 3, double-blind trial randomising 1,174 patients with untreated stage II-III triple-negative breast cancer (2:1) to neoadjuvant pembrolizumab or placebo plus carboplatin-paclitaxel then anthracycline-cyclophosphamide, followed by surgery and nine cycles of adjuvant pembrolizumab or placebo. Dual primary endpoints were pathological complete response (pCR) and event-free survival (EFS).
The 2020 report showed pCR 64.8% vs 51.2%. This 2022 report showed the EFS benefit: 36-month EFS 84.5% vs 76.8% (HR 0.63). A 2024 report added an overall survival benefit (5-year OS 86.6% vs 81.7%, HR 0.66). It established chemo-immunotherapy as the standard for stage II-III TNBC regardless of PD-L1 status.
For stage II-III triple-negative breast cancer, chemotherapy plus pembrolizumab before surgery and pembrolizumab alone afterwards is now the standard approach worldwide, and the survival gain is real, not just a surrogate. It does not apply to stage I disease or to hormone-receptor-positive or HER2-positive cancers. The price is a year of immunotherapy with a meaningful chance of a permanent endocrine side effect such as hypothyroidism or adrenal insufficiency.
Shares Residual cancer burden (RCB), KEYNOTE-522, Pathologic complete response (pCR), Merck & Co. (MSD).
Shares Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, Pathologic complete response (pCR).
Shares ADC for residual disease after KEYNOTE-522, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Pathologic complete response (pCR), Dormant cells and minimal residual disease, No one can predict who responds to immunotherapy.
Shares KEYNOTE-522, Pathologic complete response (pCR), Neoadjuvant / adjuvant / perioperative, Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares ctDNA-triggered escalation in early TNBC, KEYNOTE-522, Pathologic complete response (pCR), Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, Immune-related adverse events (irAEs), Paclitaxel / nab-paclitaxel.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Pathologic complete response (pCR), Dormant cells and minimal residual disease, No one can predict who responds to immunotherapy.