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Made immunotherapy the first treatment for advanced head and neck cancer, alone for PD-L1-rich tumours and with chemotherapy for the rest.
Pembrolizumab monotherapy improved OS in CPS ≥20 (14.9 vs 10.7 months) and CPS ≥1 (12.3 vs 10.3); pembrolizumab-chemotherapy improved OS in the total population (13.0 vs 10.7). FDA approval June 2019. Five-year follow-up confirmed durable survival tails. Replaced the EXTREME regimen as first line after a decade.
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.
882 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, CPS ≥20, pembrolizumab monotherapyprimary | Pembrolizumab | - | 14.9 months | 0.61 | - | link |
| Cetuximab + chemotherapy | - | 10.7 months | ||||
| Overall survival, total population, pembrolizumab + chemotherapyprimary | Pembrolizumab + chemotherapy | - | 13 months | 0.77 | - | link |
| Cetuximab + chemotherapy | - | 10.7 months |
Shares Barbara Burtness, Lip cancer, 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, Hypopharyngeal cancer, Oral tongue and floor of mouth cancer.
Shares Test one-tenth-dose immunotherapy where the full dose is unaffordable, Oropharyngeal cancer (tonsil and base of tongue), Oral cavity cancer (mouth and tongue), Recurrent or metastatic 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, HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer), Merck & Co. (MSD).
Shares Hypopharyngeal cancer, Laryngeal and hypopharyngeal cancer, Oropharyngeal cancer (tonsil and base of tongue), HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer).
Shares Test one-tenth-dose immunotherapy where the full dose is unaffordable, Hypopharyngeal cancer, Oral tongue and floor of mouth cancer, HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer).
Shares Lip cancer, Oral tongue and floor of mouth cancer, Oral cavity cancer (mouth and tongue), HPV-negative head and neck squamous cell carcinoma (including HPV-negative oropharyngeal cancer).
Shares Lip cancer, Hypopharyngeal cancer, Laryngeal and hypopharyngeal cancer, Oral tongue and floor of mouth cancer.