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Pembrolizumab, either alone in PD-L1-positive tumours or combined with chemotherapy, helped patients with recurrent or metastatic head and neck squamous cell cancer live longer than the previous cetuximab-based standard.
Open-label phase 3 trial of 882 patients with untreated recurrent or metastatic head and neck squamous cell carcinoma randomised to pembrolizumab alone, pembrolizumab plus platinum and fluorouracil, or the EXTREME regimen (cetuximab plus platinum and fluorouracil). Primary endpoints were OS and PFS in PD-L1 CPS 20 or more, CPS 1 or more, and all patients.
Pembrolizumab alone improved OS in CPS 20 or more (14.9 vs 10.7 months, HR 0.61) and CPS 1 or more (12.3 vs 10.3 months, HR 0.78) and was non-inferior overall. Pembrolizumab plus chemotherapy improved OS in all patients (13.0 vs 10.7 months, HR 0.77). It replaced EXTREME as the first-line standard and made PD-L1 CPS testing routine in head and neck cancer.
Patients with head and neck squamous cell cancer that has recurred or spread should be treated first with pembrolizumab: alone if their tumour is strongly PD-L1 positive and they can wait for a slower response, or with chemotherapy if the tumour is bulky or PD-L1 low. Cetuximab-based chemotherapy is no longer the default. Long-term follow-up shows a small but real group of patients alive at four to five years, which was almost unheard of before.
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, Oropharyngeal cancer (tonsil and base of tongue), Oral cavity cancer (mouth and tongue), Recurrent or metastatic head and neck squamous cell carcinoma.
Shares Lines of therapy, Combined positive score (CPS), Progression-free survival (PFS), Overall survival (OS).
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 Combined positive score (CPS), Progression-free survival (PFS), Overall survival (OS), No one can predict who responds to immunotherapy.
Shares Combined positive score (CPS), Progression-free survival (PFS), Overall survival (OS), No one can predict who responds to immunotherapy.
Shares Lines of therapy, Progression-free survival (PFS), Overall survival (OS), No one can predict who responds to immunotherapy.
Shares Lines of therapy, Progression-free survival (PFS), Overall survival (OS), No one can predict who responds to immunotherapy.