Phase 2 study of first-line nivolumab for locally advanced or metastatic cutaneous squamous cell carcinoma

Immune checkpoint inhibition with anti-PD-1 antibodies has emerged as a novel therapeutic option for cutaneous squamous cell carcinoma (CSCC). The phase 2 CA209-9JC trial at the University of Sao Paolo (Brazil) evaluated first-line nivolumab for locally advanced or metastatic CSCC. Best objective response rate was 58.3%. With a median follow-up of 17.6 months, median duration of response was not reached. Median PFS and OS were 12.7 months and 20.7 months, respectively. Treatment-related adverse events of any grade and grade ≥3 occurred in 87.5% and 25% of patients, respectively. The authors conclude that nivolumab had robust and sustained antitumor activity and good tolerability as first-line treatment for locally advanced or metastatic CSCC.