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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 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 ADC for residual disease after KEYNOTE-522, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522.
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 Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, Immune-related adverse events (irAEs), Paclitaxel / nab-paclitaxel.
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), Pathologic complete response (pCR), Dormant cells and minimal residual disease, No one can predict who responds to immunotherapy.
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