Pembrolizumab With or Without Lenvatinib as First-Line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Phase III LEAP-010 Study

The Phase III LEAP-010 trial, published in the Journal of Clinical Oncology, evaluated whether adding the multi-kinase inhibitor lenvatinib to pembrolizumab improves outcomes in patients with PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma treated in the first-line setting. The study compared pembrolizumab plus lenvatinib against pembrolizumab plus placebo, with overall survival and progression-free survival as co-primary endpoints. Results indicated that the addition of lenvatinib did not significantly improve efficacy over pembrolizumab monotherapy, which remains the standard first-line immunotherapy for this population. While the trial did not establish a new combination regimen, it provides important negative data that helps refine the treatment landscape and discourages unnecessary escalation of therapy in CPS ≥1 head and neck cancer patients.