Headed towards more indications.
Pembro is looking to take the next leap from unresectable to resectable head and neck cancers. On this single arm phase 2 trial, 92 patients with resectable locally-advanced (cT3-4 and/or cN2-3) head and neck squamous cell carcinoma (other than oropharyngeal p16+ disease) received neoadjuvant pembrolizumab 200 mg x 1 at 1–3 weeks prior to resection followed by standard adjuvant radiation with concurrent pembro every 3 weeks x 6. Those with the classic pathologic high-risk features of positive margins and/or extracapsular extension also received weekly cisplatin 40 mg/m2 concurrent with immuno-radiation. The primary endpoint of disease-free survival at one year was an impressive 97% without high-risk features and 66% with high-risk features, representing quite the improvement from historical outcomes for those with locally-advanced disease without high-risk features. The big question mark is how to apply this to patients without oral cavity or T4 laryngeal tumors who would typically opt for organ preservation and bimodality treatment sans surgery. | Wise-Draper, Clin Cancer Res 2022