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The first new treatment for curable head and neck cancer in six years: immunotherapy around surgery doubled the time patients stayed free of events.
Presented AACR April 2025; FDA approval 12 June 2025 for PD-L1 CPS ≥1. In the CPS ≥1 population (n=682), median EFS 59.7 vs 29.6 months. Major pathological response in ~10% of the neoadjuvant arm predicted excellent outcomes. First perioperative approval in HNSCC and the first HNSCC approval since 2019.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
714 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival (CPS ≥1)primary | Perioperative pembrolizumab | 682 | 59.7 months | - | - | link |
| Standard of care | - | 29.6 months |
Shares Test one-tenth-dose immunotherapy where the full dose is unaffordable, Photoimmunotherapy as an in situ vaccine with PD-1 blockade, Hypopharyngeal cancer, Oral tongue and floor of mouth cancer.
Shares Test one-tenth-dose immunotherapy where the full dose is unaffordable, Photoimmunotherapy as an in situ vaccine with PD-1 blockade, HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Merck & Co. (MSD).
Shares Test one-tenth-dose immunotherapy where the full dose is unaffordable, Photoimmunotherapy as an in situ vaccine with PD-1 blockade, Oral tongue and floor of mouth cancer, Combined positive score (CPS).
Shares Immunotherapy before surgery rather than with chemoradiation (HNSCC), HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Head and neck squamous cell carcinoma, IMRT / IGRT (modern external beam).
Shares Hypopharyngeal cancer, HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Head and neck squamous cell carcinoma, IMRT / IGRT (modern external beam).
Shares NIVOPOSTOP (GORTEC 2018-01), HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Head and neck squamous cell carcinoma.
Shares Test one-tenth-dose immunotherapy where the full dose is unaffordable, Photoimmunotherapy as an in situ vaccine with PD-1 blockade.
Shares Test one-tenth-dose immunotherapy where the full dose is unaffordable, Photoimmunotherapy as an in situ vaccine with PD-1 blockade.