Multinational phase 2 study of pembrolizumab monotherapy for locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma

The multinational phase 2 trial KEYNOTE-629 evaluated pembrolizumab monotherapy for locally advanced (LA) or recurrent/metastatic (R/M) cutaneous squamous cell carcinoma. Median time from first dose to data cutoff was 14.9 months for the LA cohort and 27.2 months for the R/M cohort. In the LA cohort, ORR was 50.0% with complete response in 16.7% of patients. In the R/M cohort, ORR was 35.2% with complete response in 10.5% of patients. There were no unexpected safety signals. The authors conclude that pembrolizumab had robust antitumor activity in both LA and R/M cSCC.