Multicenter phase 3 trial of finotonlimab with chemotherapy in recurrent of metastatic head and neck squamous cell carcinoma

A multicenter phase 3 trial in China randomized patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) to first-line finotonlimab (anti-PD-1) plus cisplatin and 5-fluorouracil (C5F) chemotherapy or placebo plus C5F. The primary end point was overall survival. The median overall survival was 14.1 months in the finotonlimab group versus 10.5 months in the placebo group (HR 0.73; p=0.0165). The median progression-free survival was 5.8 months in the finotonlimab group versus 5.6 months in the placebo group (HR 0.77; p=0.0493), whereas the median duration of response was 19.1 months versus 5.0 months. The safety profile of finotonlimab plus C5F was acceptable. The authors conclude that addition of finotonlimab to first-lin C5F for R/M HNSCC was associated with improved OS.