A Phase II Trial of Nintedanib in Patients with Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC): In-Depth Analysis of Nintendanib Arm from the KCSG HN 15-16 TRIUMPH Trial.

Single-agent nintedanib has demonstrated significant efficacy in FGFR-mutated, recurrent, or metastatic HNSCC patients, with tolerable toxicity profiles. The results from the study have provided the basis for routine NGS screening and FGFR-targeted therapy. Because of small number of patients due to slow accrual in this study, further studies with large cohort are warranted for statistical power.